Trial Outcomes & Findings for Study of Oral Treatments for Hepatitis C (NCT NCT02786537)

Last Updated: 2021-12-06

Results Overview

SVR (Sustained Virologic Response) 12 will be defined as undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation at discretion of provider). mITT with imputation (missing=failure). Total number of subjects reflects participants from EBR/GZR with or without RBV and SOF/LDV with or without RBV randomized during Phase 1 and Phase 2.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1275 participants

Primary outcome timeframe

12 weeks post-treatment

Results posted on

2021-12-06

Participant Flow

Participants were consented at 34 US centers Between June 2016 and March 2018. Patients' insurance was screened for inclusion of SOF/LDV on formulary (the HCV regimen not provided by the study). However, following randomization, participants who were unable to obtain SOF/LDV through insurance received 1 of 2 Direct Acting Antiviral (DAA) HCV Treatment regimens 1)EBR/GZR or 2)PrOD during Phase 1 and received EBR/GZR during Phase 2.

This study initially (Phase 1) randomized subjects to receive 1 of 3 HCV DAA regimens (EBR/GZR +/- RBV, LDV/SOF +/- RBV, or PrOD +/-RBV). In phase 2 of this study, randomization to PrOD regimen was discontinued and newly enrolled subjects were randomized to either EBR/GZR +/- RBV or LDV/SOF +/- RBV. Efficacy data was analyzed via original 'randomization' and as subjects were 'actually treated (regimen actually received)' while safety analysis was evaluated by actual treatment received.

Participant milestones

Participant milestones
Measure	EBR/GZR With RBV Patients received EBR/GZR (elbasvir/grazoprevir) (Zepatier™) orally once daily with RBV for 12 to 16 weeks (provider discretion) EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food and with RBV: Ribavirin (200 mg pill) 1-3 pills/day, once or twice daily. Total daily dosage ranged from 200 to 1200 mg.	EBR/GZR Patients received EBR/GZR (elbasvir/grazoprevir) (Zepatier™) orally once daily (without RBV) for 12 to 16 weeks EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks. Duration of treatment according to HCV treatment provider.	SOF/LDV With RBV Patients received SOF/LDV(sofosbuvir/ledipasvir) (Harvoni®) orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV/sofosbuvir/ledipasvir: Sofosbuvir/Ledipasvir (400/90 mg) 1 tablet daily for approximately 12 to 24 weeks (treatment duration is per discretion of HCV provider) RBV (200 mg pill): 1-3 pills, once or twice daily (dosing per discretion of HCV provider). Total daily dosage ranged from 200 to 1200 mg.	SOF/LDV Patients received SOF/LDV (sofosbuvir/ledipasvir) (Harvoni®) orally once daily with or without food 12 to 24 weeks SOF/LDV: Sofosbuvir/Ledipasvir (400/90 mg) for approximately 12 to 24 weeks (treatment duration is per discretion of HCV provider)	PrOD/RBV(Phase 1 Only) PrOD: Two ombitasvir/paritaprevir/ritonavir once daily and dasabuvir (Viekira) once or twice daily with a meal for 12 to 24 weeks + RBV (provider discretion). Randomization to PrOD discontinued January 2017. ombitasvir/paritaprevir/ritonavir (Phase 1 only): (Phase 1 only) Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) for 12 to 24 weeks with food (treatment duration and use of ribavirin as per HCV provider) Dasabuvir: 250 mg twice daily for 12 to 24 weeks with a meal RBV: Ribavirin 200 to 600 mg once or twice daily	PrOD (Phase 1 Only) Randomization to Prod discontinued January 2017 (defining end of Phase 1) PrOD: Two ombitasvir/paritaprevir/ritonavir once daily and dasabuvir twice daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (Phase 1 only): (Phase 1 only) Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir: 250 mg daily for 12 to 24 weeks
As Randomized STARTED	56	644	15	413	99	48
As Randomized COMPLETED	50	582	15	378	87	41
As Randomized NOT COMPLETED	6	62	0	35	12	7
As Treated STARTED	56	664	15	394	99	47
As Treated COMPLETED	50	602	15	359	87	40
As Treated NOT COMPLETED	6	62	0	35	12	7

Reasons for withdrawal

Reasons for withdrawal
Measure	EBR/GZR With RBV Patients received EBR/GZR (elbasvir/grazoprevir) (Zepatier™) orally once daily with RBV for 12 to 16 weeks (provider discretion) EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food and with RBV: Ribavirin (200 mg pill) 1-3 pills/day, once or twice daily. Total daily dosage ranged from 200 to 1200 mg.	EBR/GZR Patients received EBR/GZR (elbasvir/grazoprevir) (Zepatier™) orally once daily (without RBV) for 12 to 16 weeks EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks. Duration of treatment according to HCV treatment provider.	SOF/LDV Patients received SOF/LDV (sofosbuvir/ledipasvir) (Harvoni®) orally once daily with or without food 12 to 24 weeks SOF/LDV: Sofosbuvir/Ledipasvir (400/90 mg) for approximately 12 to 24 weeks (treatment duration is per discretion of HCV provider)	PrOD/RBV(Phase 1 Only) PrOD: Two ombitasvir/paritaprevir/ritonavir once daily and dasabuvir (Viekira) once or twice daily with a meal for 12 to 24 weeks + RBV (provider discretion). Randomization to PrOD discontinued January 2017. ombitasvir/paritaprevir/ritonavir (Phase 1 only): (Phase 1 only) Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) for 12 to 24 weeks with food (treatment duration and use of ribavirin as per HCV provider) Dasabuvir: 250 mg twice daily for 12 to 24 weeks with a meal RBV: Ribavirin 200 to 600 mg once or twice daily	PrOD (Phase 1 Only) Randomization to Prod discontinued January 2017 (defining end of Phase 1) PrOD: Two ombitasvir/paritaprevir/ritonavir once daily and dasabuvir twice daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (Phase 1 only): (Phase 1 only) Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir: 250 mg daily for 12 to 24 weeks
As Randomized Adverse Event	0	11	4	6	2
As Randomized Lack of Efficacy	0	0	1	0	0
As Randomized Withdrawal by Subject	1	2	1	1	0
As Randomized Death	0	2	3	1	0
As Randomized Non-compliance with study drug	1	11	1	0	1
As Randomized Lost to treatment follow-up	4	32	24	4	4
As Randomized Incarceration	0	1	0	0	0
As Randomized Opiate Dependency Relapse	0	1	0	0	0
As Randomized HCV drugs stolen from pt	0	1	0	0	0
As Randomized Advised to stop after lapse in dosing	0	1	0	0	0
As Randomized Subject lost insurance	0	0	1	0	0
As Treated Adverse Event	0	11	4	6	2
As Treated Death	0	2	3	1	0
As Treated Lack of Efficacy	0	0	1	0	0
As Treated Lost to Follow-up	4	32	25	4	4
As Treated Non-compliance with study drug	1	11	1	0	1
As Treated Lost insurance	0	0	1	0	0
As Treated Withdrawal by Subject	1	2	0	1	0
As Treated Incarceration	0	1	0	0	0
As Treated Opiate dependency relapse	0	1	0	0	0
As Treated Drugs stolen from patient	0	1	0	0	0
As Treated Advised to stop tx after loss of meds	0	1	0	0	0

Baseline Characteristics

Study of Oral Treatments for Hepatitis C

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EBR/GZR With RBV n=56 Participants Patients received EBR/GZR (elbasvir/grazoprevir) tablet tablet once daily with RBV for 12 to 16 weeks (provider discretion) EBR/GZR (Elbasvir/grazoprevir 50/100mg tablet) once daily with or without food with or without RBV for 12 to 16 weeks (with RBV)	EBR/GZR n=644 Participants Patients received EBR/GZR (elbasvir/grazoprevir) tablet tablet once daily without RBV for 12 to 16 weeks (provider discretion) EBR/GZR (Elbasvir/grazoprevir 50/100mg tablet): 1 tablet once daily with or without food with or without RBV for 12 to 16 weeks (without RBV)	SOF/LDV With RBV n=15 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) sofosbuvir/ledipasvir: Sofosbuvir/Ledipasvir (400/90 mg) for approximately 12 to 24 weeks with Ribavirin (RBV) (treatment duration and use of ribavirin is per discretion of HCV provider)	SOF/LDV n=413 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks without ribavirin (per discretion of provider) SOF/LDV: Sofosbuvir/Ledipasvir (400/90 mg tablet ) 1 tablet orally once daily for approximately 12 to 24 weeks	PROD With RBV (Phase 1 Only) n=99 Participants Phase 1 only - Two ombitasvir/paritaprevir/ritonavir once daily and dasabuvir twice daily for 12 to 24 weeks +/- RBV (provider discretion) ombitasvir/paritaprevir/ritonavir (Phase 1 only): (Phase 1 only) Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir: 250 mg daily for 12 to 24 weeks	PROD (Phase 1 Only) n=48 Participants Phase 1 only - Two ombitasvir/paritaprevir/ritonavir once daily and dasabuvir twice daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (Phase 1 only): (Phase 1 only) Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) for 12 to 24 weeks Dasabuvir: 250 mg daily for 12 to 24 weeks	Total n=1275 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=93 Participants	547 Participants n=4 Participants	8 Participants n=27 Participants	319 Participants n=483 Participants	86 Participants n=36 Participants	35 Participants n=10 Participants	1039 Participants n=115 Participants
Age, Categorical >=65 years	12 Participants n=93 Participants	97 Participants n=4 Participants	7 Participants n=27 Participants	94 Participants n=483 Participants	13 Participants n=36 Participants	13 Participants n=10 Participants	236 Participants n=115 Participants
Age, Continuous	55.1 years STANDARD_DEVIATION 11.0 • n=93 Participants	53.3 years STANDARD_DEVIATION 12.2 • n=4 Participants	61.1 years STANDARD_DEVIATION 6.6 • n=27 Participants	56.2 years STANDARD_DEVIATION 11.1 • n=483 Participants	54.5 years STANDARD_DEVIATION 11.3 • n=36 Participants	59.9 years STANDARD_DEVIATION 10.1 • n=10 Participants	54.7 years STANDARD_DEVIATION 11.8 • n=115 Participants
Sex: Female, Male Female	13 Participants n=93 Participants	280 Participants n=4 Participants	6 Participants n=27 Participants	157 Participants n=483 Participants	35 Participants n=36 Participants	16 Participants n=10 Participants	507 Participants n=115 Participants
Sex: Female, Male Male	43 Participants n=93 Participants	364 Participants n=4 Participants	9 Participants n=27 Participants	256 Participants n=483 Participants	64 Participants n=36 Participants	32 Participants n=10 Participants	768 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=93 Participants	44 Participants n=4 Participants	0 Participants n=27 Participants	26 Participants n=483 Participants	5 Participants n=36 Participants	1 Participants n=10 Participants	81 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=93 Participants	586 Participants n=4 Participants	14 Participants n=27 Participants	375 Participants n=483 Participants	90 Participants n=36 Participants	45 Participants n=10 Participants	1161 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	14 Participants n=4 Participants	1 Participants n=27 Participants	12 Participants n=483 Participants	4 Participants n=36 Participants	2 Participants n=10 Participants	33 Participants n=115 Participants
Region of Enrollment United States	56 participants n=93 Participants	644 participants n=4 Participants	15 participants n=27 Participants	413 participants n=483 Participants	99 participants n=36 Participants	48 participants n=10 Participants	1275 participants n=115 Participants
HCV RNA	4.9 10^6 units IU/mL STANDARD_DEVIATION 6.7 • n=93 Participants	3.1 10^6 units IU/mL STANDARD_DEVIATION 4.9 • n=4 Participants	5.9 10^6 units IU/mL STANDARD_DEVIATION 4.7 • n=27 Participants	3.5 10^6 units IU/mL STANDARD_DEVIATION 4.4 • n=483 Participants	3.5 10^6 units IU/mL STANDARD_DEVIATION 3.8 • n=36 Participants	3.7 10^6 units IU/mL STANDARD_DEVIATION 4.2 • n=10 Participants	3.4 10^6 units IU/mL STANDARD_DEVIATION 4.7 • n=115 Participants

PRIMARY outcome

Timeframe: 12 weeks post-treatment

Population: mITT with imputation, Missing SVR data = Failure. Numbers represent participants according to arm randomized (Period 1). Population excludes participants who did not start any HCV treatment.

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=56 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=644 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV n=15 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV n=413 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Sustained Virologic Response (SVR12) mITT With Imputation-Phase 1 and 2 EBR/GZR, SOF/LDV	40 Participants	516 Participants	14 Participants	335 Participants	—	—

PRIMARY outcome

Timeframe: 12-24 weeks post HCV treatment

Population: All mITT without imputation (missing data excluded). Includes only number of participants for whom SVR12 data is available and based on study drug as randomized (Period 1). Participants for whom SVR 12 is not available are excluded from this table.

SVR (Sustained Virologic Response) 12 will be defined as undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation as dictated by standard of care at each individual site). Number of subjects reflects participants who started EBR/GZR or SOF/LDV- based treatment (with or without RBV) during Phase 1 and 2.

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=46 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=540 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV n=15 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV n=344 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Phase 1/2 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation)	40 Participants	516 Participants	14 Participants	335 Participants	—	—

PRIMARY outcome

Timeframe: 12 weeks post-treatment

Population: mITT with imputation, Missing SVR data =failure. Numbers represent participants according to arm randomized (period 1). Population excludes participants who did not start any HCV treatment.

SVR (Sustained Virologic Response) 12 will be defined as patients who have undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation as dictated by standard of care at each individual site). mITT with imputation (missing=failure). Total number of subjects reflects participants from Phase 1 only.

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=13 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=134 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV n=6 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV n=105 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV n=99 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD n=48 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Phase 1-Sustained Virologic Response (SVR12) mITT With Imputation	9 Participants	108 Participants	6 Participants	88 Participants	77 Participants	42 Participants

PRIMARY outcome

Timeframe: 12 -24 weeks post-treatment

Population: Participants analyzed based on HCV treatment as assigned by randomization.

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=10 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=113 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV n=6 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV n=92 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV n=80 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD n=42 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Phase 1 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation)	9 Participants	108 Participants	6 Participants	88 Participants	77 Participants	42 Participants

PRIMARY outcome

Timeframe: Baseline to On-Treatment

Population: Analysis limited to patients who completed a baseline and on-treatment PRO and as treated (Period 2) during Phase 1 only.

Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Mean change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of mean change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for mean change represent improvement in symptom.

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=9 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=84 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV n=5 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV n=61 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV n=62 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD n=28 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Mean Change in Headache-PRO Scores -Phase 1	0.0 units on a scale Standard Deviation 1.4	-0.8 units on a scale Standard Deviation 3.5	-0.7 units on a scale Standard Deviation 5.0	-0.5 units on a scale Standard Deviation 4.8	-0.2 units on a scale Standard Deviation 4.7	-2.2 units on a scale Standard Deviation 4.1

PRIMARY outcome

Timeframe: Baseline to On-Treatment

Population: Analysis limited to participants who completed both baseline and end of treatment PRO

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=40 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=403 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV n=10 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV n=222 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Mean Change in Headache-EBR/GZR and SOF/LDV	-0.8 units on a scale Standard Deviation 3.1	-0.7 units on a scale Standard Deviation 4.4	0.4 units on a scale Standard Deviation 6.2	-0.8 units on a scale Standard Deviation 5.0	—	—

PRIMARY outcome

Timeframe: 12 weeks (Baseline and Average On-treatment Score)

Population: Analysis limited to patients randomized up to last patient randomized to PrOD and participants who completed baseline and on-treatment survey.

Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Median change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of mean change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for change represent improvement, while negative values for 'difference' indicate LDV/SOF performed better than PrOD

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=9 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=84 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV n=5 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV n=61 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV n=62 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD n=28 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Median Change in Headache -Phase 1	0.0 units on a scale Interval -2.0 to 2.0	0.0 units on a scale Interval -12.5 to 9.5	-2.0 units on a scale Interval -6.5 to 5.0	-1.0 units on a scale Interval -12.8 to 13.5	0.0 units on a scale Interval -17.0 to 8.5	-1.0 units on a scale Interval -15.0 to 3.0

PRIMARY outcome

Timeframe: Baseline -on Treatment (12-16 weeks)

Population: Analysis limited to patients randomized to EBR/GZR regimen or SOF/LDV regimen and participants who completed both baseline and on treatment survey.

Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Median change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of median change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for mean change represent improvement, while negative values for 'difference' indicate LDV/SOF performed better than PrOD

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=40 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=403 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV n=10 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV n=222 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Median Change in Headache-Phase 2	-1.0 units on a scale Interval -7.0 to 6.0	0.0 units on a scale Interval -20.0 to 14.0	0.5 units on a scale Interval -9.5 to 11.5	-0.5 units on a scale Interval -20.0 to 14.0	—	—

PRIMARY outcome

Timeframe: Baseline to On-Treatment

Population: Analysis is limited to patients who completed at least one baseline and one end of treatment PRO survey during Phase 1 (end date corresponds to last PrOD patient start date)

Patients completed the PROMIS® Nausea Short Form at Baseline (T1) and on-treatment. PROMIS raw scores from each of the completed questionnaires were converted to standardized T-scores. Change was calculated as the difference between baseline and on-treatment score. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Higher scores indicate worse nausea. Negative values for mean change represent improvement. The estimates of mean change and differences were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes. The model expressed mean score as a function of DAA regimen, cirrhosis status, HCV genotype, sex, age, race, and previous treatment status.

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=8 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=79 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV n=5 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV n=58 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV n=59 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD n=25 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Mean Change in Nausea/Vomiting PRO Score -Phase 1	1.3 units on a scale Standard Deviation 5.0	-1.4 units on a scale Standard Deviation 8.8	-3.9 units on a scale Standard Deviation 4.0	-0.7 units on a scale Standard Deviation 10.7	2.5 units on a scale Standard Deviation 8.6	0.7 units on a scale Standard Deviation 12.1

PRIMARY outcome

Timeframe: Baseline and Average On-Treatment Score

Population: Patients with Baseline PROMIS Nausea/vomiting score who started treatment by arm as treated and completed baseline and on-treatment survey.

Participants completed the Patient Reported Outcomes surveys (PROs) 'PROMIS Nausea/Vomiting -4 Short Form' at baseline and during treatment. Raw scores are converted to standardized T-scores with a range of 45.0-80.1. Higher scores indicate worse nausea/vomiting. Results presented as mean difference from baseline to average of on Treatment Scores (highest/worst) score during treatment. A negative (-) PROMIS change score is suggestive of symptom improvement or lack of drug side effect. Estimates of mean change were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes.

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=37 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=381 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV n=9 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV n=202 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Mean Change in Nausea/Vomiting PROMIS Score -EBR/GZR vs. LDV/SOF	-0.3 units on a scale Standard Deviation 8.3	-0.6 units on a scale Standard Deviation 8.7	-1.6 units on a scale Standard Deviation 4.7	-0.4 units on a scale Standard Deviation 9.2	—	—

PRIMARY outcome

Timeframe: Baseline to end of treatment

Population: Analysis limited to patients who completed baseline and on treatment Nausea short form during Phase 1 (up to last PrOD randomized) as treated.

Patients completed the PROMIS® Nausea Short Form at Baseline (T1) and on-treatment. PROMIS raw scores from each of the completed questionnaires were converted to standardized T-scores. Change was calculated as the difference between baseline and on-treatment score. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Higher scores indicate worse nausea. Negative values for mean change represent improvement. The estimates of change and differences were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes.

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=8 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=79 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV n=5 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV n=58 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV n=59 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD n=25 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Median Change in Nausea PRO Score -Phase 1	0.4 units on a scale Interval -6.5 to 10.0	0.0 units on a scale Interval -22.2 to 20.8	-6.1 units on a scale Interval -8.0 to 0.9	0.0 units on a scale Interval -21.6 to 23.7	0.0 units on a scale Interval -19.2 to 22.2	0.0 units on a scale Interval -25.2 to 31.7

PRIMARY outcome

Timeframe: Baseline- On Treatment (up to 16 weeks)

Patients completed the PROMIS® Nausea Short Form at Baseline (T1) and on-treatment. PROMIS raw scores from each of the completed questionnaires were converted to standardized T-scores. Change was calculated as the difference between baseline and on-treatment score. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Higher scores indicate worse nausea. Negative values for change represent improvement. The estimates of change and differences were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes.

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=37 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=381 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV n=9 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV n=202 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Median Change in Nausea PROMIS Score-EBR/GZR SOF/LDV	0.0 score on a scale Interval -21.0 to 18.3	0.0 score on a scale Interval -29.2 to 23.3	0.0 score on a scale Interval -8.0 to 7.3	0.0 score on a scale Interval -26.1 to 24.9	—	—

PRIMARY outcome

Timeframe: Baseline to On-treatment

Population: Analysis limited to patients who completed baseline and at least one on-treatment Fatigue PRO survey during phase 1 as treated.

Fatigue severity collected from validated, Patient Reported Outcomes survey (PROs), 'PROMIS Fatigue Short Form'. PROMIS® T-scores were computated to compare difference between baseline value of PROMIS score to the highest (worst) score during treatment. Results presented as computated t-score from baseline to average of on Treatment Scores. A positive (+) score suggests improvements in functional well-being. A negative (-) PRO change score is suggestive of symptom improvement or lack of drug side effect. PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35.

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=9 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=78 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV n=5 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV n=59 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV n=59 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD n=27 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Mean Change in Fatigue PRO Score -Phase 1	1.5 units on a scale Standard Deviation 7.7	-1.2 units on a scale Standard Deviation 9.2	-7.2 units on a scale Standard Deviation 10.2	-2.0 units on a scale Standard Deviation 7.9	-1.9 units on a scale Standard Deviation 11.3	-3.0 units on a scale Standard Deviation 7.9

PRIMARY outcome

Timeframe: Baseline and Average On-Treatment Score

Population: Patients with Baseline PROMIS Fatigue score who started treatment by arm as treated (Period 2)

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=38 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=398 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV n=10 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV n=213 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Mean Change in Fatigue PRO -EBR/GZR vs SOF/LDV	-1.0 score on a scale Standard Deviation 7.7	-2.1 score on a scale Standard Deviation 9.1	-3.7 score on a scale Standard Deviation 8.3	-2.2 score on a scale Standard Deviation 8.7	—	—

PRIMARY outcome

Timeframe: Baseline to End of Treatment

Population: Analysis is limited to patients who completed baseline and on-treatment fatigue PRO during Phase 1 (last PrOD patient started). Safety profiles of the evaluated regimens in PRIORITIZE are by actual treatment received.

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=9 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=78 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV n=5 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV n=59 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV n=59 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD n=27 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Median Change in Fatigue -Phase 1	2.2 units on a scale Interval -9.2 to 15.0	-0.9 units on a scale Interval -31.0 to 24.2	-10.2 units on a scale Interval -20.0 to 7.2	-3.4 units on a scale Interval -21.1 to 16.4	-0.2 units on a scale Interval -33.4 to 17.8	-4.1 units on a scale Interval -17.5 to 16.6

PRIMARY outcome

Timeframe: Baseline-On Treatment (up to 16 weeks)

Population: Analysis limited to Period 2 -as treated, participants who completed baseline and on-treatment surveys.

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=38 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=398 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV n=10 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV n=213 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Median Change in Fatigue-Phase 2	-1.3 units on a scale Interval -19.1 to 15.0	-1.2 units on a scale Interval -31.6 to 24.2	-2.4 units on a scale Interval -20.0 to 7.2	-1.4 units on a scale Interval -39.0 to 20.7	—	—

PRIMARY outcome

Timeframe: Baseline to End of Treatment

Population: Analysis limited to patients who completed baseline and at least one on treatment Fatigue Short form. Evaluation is based on actual HCV regimen received.

HCV-PRO, a survey for patients with HCV that measures physical, emotional, and social functioning, productivity, intimacy, and perception of quality of life, was used to assess 'overall functioning and well-being'. In general, lower score is worst outcome and higher scores indicate greater well-being and functioning. However, for ease of interpretation, HCV-PRO scale has been transformed by using '100 - HCV-PRO' ultimately revising the score to mean 0 (lowest score) is best to 100 (worst outcome). A positive change (End of treatment to baseline) suggests improvements in functional well-being. Total score = (SUM-N)/(4\*N)\*100, where N is the number of questions answered.

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=9 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=84 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV n=5 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV n=61 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV n=61 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD n=29 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Mean Change in HCV- PRO- Phase 1	-0.9 units on a scale Standard Deviation 12.4	5.6 units on a scale Standard Deviation 14.0	2.5 units on a scale Standard Deviation 7.1	6.9 units on a scale Standard Deviation 16.9	3.2 units on a scale Standard Deviation 22.8	9.9 units on a scale Standard Deviation 12.6

PRIMARY outcome

Timeframe: Baseline to End of Treatment

Population: Analysis limited to patients who completed baseline and at least one survey while on treatment up to end of treatment. Evaluation was based on actual regimen received versus regimen to which patient was randomized.

HCV-PRO, a survey for patients with HCV that measures physical, emotional, and social functioning, productivity, intimacy, and perception of quality of life, was used to assess 'Overall Functioning and Well-being'. In general, lower score is worst outcome and higher scores indicate greater well-being and functioning. However, for ease of interpretation, HCV-PRO scale has been transformed by using '100 - HCV-PRO' ultimately revising the score to mean 0 (lowest score) is best to 100 (worst outcome). A positive change (End of treatment to baseline) suggests improvements in functional well-being. Total score = (SUM-N)/(4\*N)\*100, where N is the number of questions answered.

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=9 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=84 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV n=5 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV n=61 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV n=61 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD n=29 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Median Change in HCV-PRO (Overall Well Being) -Phase 1	0.0 score on a scale Interval -21.9 to 16.4	4.3 score on a scale Interval -32.8 to 43.0	4.7 score on a scale Interval -9.4 to 7.8	4.7 score on a scale Interval -39.8 to 47.7	3.1 score on a scale Interval -50.0 to 71.9	8.6 score on a scale Interval -19.7 to 31.3

PRIMARY outcome

Timeframe: End of Treatment - Baseline

Population: Patients with completed Baseline and End of Treatment HCV-PRO survey who started treatment by arm as treated (Period 2)

HCV-PRO, a survey designed to assess functional status of patients with HCV and measures physical, emotional, and social functioning, productivity, intimacy, and perception of quality of life, was used to assess functional well-being. In general, lower score is worst outcome and higher scores indicate greater well-being and functioning. However, for ease of interpretation, HCV-PRO scale has been transformed by using '100 - HCV-PRO' ultimately revising the score to mean 0 (lowest score) is best to 100 (worst outcome). A positive change (End of treatment to baseline) suggests improvements in functional well-being. Total score = (SUM-N)/(4\*N)\*100, where N is the number of questions answered. End of Treatment -Baseline were used to calculate CHANGE in outcome. Number of subjects reflects participants from both Phase 1 and 2.

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=40 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=413 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV n=10 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV n=226 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Mean Change in HCV-PRO (Functional Well-being) EBR/GZR vs. SOF/LDV Score-Phase 2	3.2 score on a scale Standard Deviation 18.6	6.1 score on a scale Standard Deviation 15.7	6.3 score on a scale Standard Deviation 10.7	6.8 score on a scale Standard Deviation 18.3	—	—

PRIMARY outcome

Timeframe: 12 weeks post treatment

Population: All Genotype 1a patients who started treatment by arm randomized (Elbasvir/Grazobevir) with Baseline RAS at any location (28, 30, 31, or 93)

Efficacy of Hepatitis C Virus (HCV) Treatment with Zepatier (Elbasvir/Grazobevir) with Ribavirin (RBV) for 16 weeks when used in Genotype 1a patients with Baseline RASs (NS5a Resistance Associated Substitutions or RAPs -Resistance Associated Polymorphisms). Efficacy defined as HCV RNA undetectable 12 weeks post treatment. Table excludes Genotype 1b patients.

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=38 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
16 Wk EBR/GZR With RBV Efficacy on Patients With HCV RASs	34 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 12-16 weeks of HCV treatment

Population: Analysis is limited to participants to patients who started treatment prior to January 2017 (last day patient started on PrOD treatment)

The Voils Medication Adherence Survey (VMAS) was used to evaluate medication adherence during HCV treatment. Participants responded to three questions about the extent of adherence during the past seven days of treatment (during early and late on-treatment occasions). Participants responded using a five-point ordinal scale of missed dosing from 1 (none of the time) to 5 (all of the time). On each occasion participants were coded as being "Non-adherent" if any response was \> 1, otherwise they were coded as "Adherent". Probability estimates of percentage of patients reporting non-adherence were calculated per HCV treatment (Direct Acting Antiviral-DAA) regimen: 1)EBR/GZV (elbasvir/grazoprevir, 2)SOF/LDV (sofosbuvir/ledipasvir), 3)PrOD

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=151 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=108 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV n=146 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Treatment Non-Adherence Probability Estimates	23 percentage of patients Interval 17.0 to 29.0	19 percentage of patients Interval 10.0 to 27.0	26 percentage of patients Interval 19.0 to 33.0	—	—	—

SECONDARY outcome

Timeframe: 1 year post treatment discontinuation (Early post-tx)

Population: Analysis includes all patients who started treatment on either EBR/GZR or SOF/LDV regimen and is limited to patients who completed surveys. Analysis does not decipher between RBV usage given RBV usage was based on HCV provider selection and not study randomization

Change in HCV-associated symptoms was calculated as the mean differences of mean scores from multiple surveys from the NIH Patient-Reported Outcomes Measurement Information System (PROMIS)-- Fatigue, nausea, belly pain, sleep disturbance, and diarrhea) and functional status (well-being) when comparing baseline to early post-treatment and late post treatment surveys. Mean change scores were calculated by comparing baseline to early post-treatment (1 yr) and late post-treatment (approximately 3 years) surveys. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Higher scores indicate worse nausea. Negative values for mean change represent improvement.Negative numbers suggest better symptoms (improvement in HCV-associated symptoms). PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35.HCV-PRO positive estimates suggest baseline functional well-being improvement.

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=507 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=286 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Change in HCV-associated Symptoms (PROMIS Measures) After HCV Treatment Initiation Nausea	0.00 units on a scale Interval -2.34 to 2.35	-4.99 units on a scale Interval -8.16 to -1.81	—	—	—	—
Change in HCV-associated Symptoms (PROMIS Measures) After HCV Treatment Initiation Belly Pain	-0.82 units on a scale Interval -3.52 to 1.87	-6.47 units on a scale Interval -10.09 to -2.84	—	—	—	—
Change in HCV-associated Symptoms (PROMIS Measures) After HCV Treatment Initiation Diarrhea	-1.12 units on a scale Interval -3.46 to 1.22	-5.77 units on a scale Interval -8.91 to -2.64	—	—	—	—
Change in HCV-associated Symptoms (PROMIS Measures) After HCV Treatment Initiation Fatigue	-2.08 units on a scale Interval -4.74 to 0.58	-7.59 units on a scale Interval -11.17 to -4.01	—	—	—	—
Change in HCV-associated Symptoms (PROMIS Measures) After HCV Treatment Initiation Sleep Disturbance	0.65 units on a scale Interval -0.7 to 2.0	-1.72 units on a scale Interval -3.81 to 0.37	—	—	—	—
Change in HCV-associated Symptoms (PROMIS Measures) After HCV Treatment Initiation Cognitive Impairment	-0.54 units on a scale Interval -2.43 to 1.35	-4.48 units on a scale Interval -7.12 to -1.83	—	—	—	—
Change in HCV-associated Symptoms (PROMIS Measures) After HCV Treatment Initiation HCV-PRO	8.02 units on a scale Interval 3.94 to 12.11	9.90 units on a scale Interval 4.27 to 15.52	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to up to 3 years post treatment discontinuation

Population: Population analyzed limited to cirrhotic patients who had two separate FIB-4 values collected as part of standard care and achieved SVR (defined as undetectable HCV 24 weeks post treatment). Given pragmatic trial design, availability of fibrosis markers is limited thereby restricting analysis (substantially limited sample size) to difference in fibrosis markers following SVR with any HCV treatment used in study.

Mean change (delta) in FIB-4, an indirect non-invasive measure of liver fibrosis, calculated as baseline median -long term follow up median, following SVR after any of the study treatment regimens. Change in FIB-4 where negative values indicate improvement in liver fibrosis score and positive values indicate worsening of fibrosis score. There is no upper or lower limit for change. FIB-4 = age (years) \* AST(IU/L)/Platelets (10\^3/L) \* ALT\^.5(IU/L). In general, Score of 0-1.29 is low risk for advanced fibrosis, 1.30-1.67: intermediate risk for advanced liver fibrosis, \>2.67: high risk for advanced fibrosis.

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=108 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Post-treatment Progression/Regression of Liver Disease-Fib-4	-1.36 score on a scale Interval -11.02 to 10.67	—	—	—	—	—

SECONDARY outcome

Timeframe: Treatment start date up to 2 years post-treatment

Population: Analysis limited to patients who completed HCV-PRO assessments during post-treatment. For this safety analysis, regimen is based on treatment received versus treatment to which patient was randomized. Arms with and without RBV are combined in consideration that usage of RBV was decided by HCV provider and not part of study randomization.

HCV-PRO score, a validated PROMIS survey used to evaluate overall functioning and well-being in HCV patients, was utilized to compare long-term 'within treatment' changes of functional well-being. In general, lower score is worst outcome and higher scores indicate greater well-being and functioning. However, for ease of interpretation, HCV-PRO scale has been transformed by using '100 - HCV-PRO' ultimately revising the score to mean 0 (lowest score) is best to 100 (worst outcome). A positive estimate (Post treatment to baseline) suggests baseline functional well-being improvement. Total score = (SUM-N)/(4\*N)\*100, where N is the number of questions answered.

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=498 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=295 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Change in Functional Status (HCV-PRO) Within Treatment 9 months post treatment	8.02 score on a scale Interval 3.94 to 12.11	9.90 score on a scale Interval 4.27 to 15.52	—	—	—	—
Change in Functional Status (HCV-PRO) Within Treatment 20 months post treatment	9.87 score on a scale Interval 5.48 to 14.27	11.54 score on a scale Interval 5.07 to 18.02	—	—	—	—

SECONDARY outcome

Timeframe: Treatment start date through treatment completion (up to 24 weeks)

Population: As randomized and treated population during Phase 1 and 2 (See Period 1). Analysis based on HCV DAA regimen randomization per study. Differentiation between RBV usage was not included in analysis given that RBV was not part of study randomization but rather decided by HCV provider.

The number of participants with adverse events that led to early treatment discontinuation (defined as duration less than originally prescribed treatment regimen)

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=700 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=428 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Number of Participants With Adverse Events That Caused Treatment Discontinuation-EBR/GZR vs. LDV/SOF	12 Participants	4 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 24 weeks post-end of treatment up to 153 weeks

Population: Analysis limited to patients who have HCV RNA result at least 24 weeks after end of treatment regimen as per period 1 (As randomized).

Number/Percentage of patients with persistence of viral cure, SVR (SVR = Sustained Virologic Response)- defined as undetectable HCV RNA at least 24 weeks following HCV Treatment.

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=255 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=17 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV n=146 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV n=2 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV n=14 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD n=36 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
HCV SVR Durability -No Cirrhosis	255 Participants	17 Participants	146 Participants	2 Participants	14 Participants	36 Participants

SECONDARY outcome

Timeframe: Up to 132 weeks post HCV treatment

Population: Analysis limited to patients who had HCV viral load result at least 24 weeks after treatment and analyzed as per randomized (Period 1)

Percentage of Cirrhotic patients with persistence of viral cure, SVR, (SVR= Sustained Virologic Response) defined as undetectable HCV RNA at least 24 weeks following HCV Treatment.

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=43 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=7 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV n=35 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV n=7 Participants Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV n=6 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD n=7 Participants PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
HCV SVR Durability-Patients With Cirrhosis	43 Participants	7 Participants	35 Participants	7 Participants	6 Participants	7 Participants

SECONDARY outcome

Timeframe: 12 weeks post HCV treatment

Population: Analysis is based on as assigned by randomization and patients with available RAS data. Exploratory RAS analysis is grouped by DAA regimen with or without RBV given 1)RBV usage was decided by HCV provider and not part of study randomization and small sample size (limited number of RAS in regimens with RBV)

Number of participants who achieved SVR (sustained virologic response), defined as undetectable HCV RNA 12 weeks post-treatment with RASs (Resistant Associated Substitutions) after treatment with EBR/GZR or SOF/LDV regimen

Outcome measures

Outcome measures
Measure	EBR/GZR With RBV n=560 Participants Patients received EBR/GZR (elbasvir/grazoprevir) once daily with RBV for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet once daily with or without food for 12 to 16 weeks (duration per provider discretion) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	EBR/GZR n=337 Participants Patients received EBR/GZV tablet (elbasvir/grazoprevir) once daily for 12 to 16 weeks EBR/GZV (50/100mg) tablet: once daily with or without food 12 to 16 weeks	SOF/LDV With RBV Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)	SOF/LDV Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider)	PrOD With RBV PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider)	PrOD PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Impact of Baseline NS5A RASs on Treatment Outcomes-Phase 2 With NS5a RAS	47 Participants	42 Participants	—	—	—	—
Impact of Baseline NS5A RASs on Treatment Outcomes-Phase 2 Without NS5a RAS	485 Participants	286 Participants	—	—	—	—

Adverse Events

EBR/GZR

Serious events: 30 serious events

Other events: 298 other events

Deaths: 6 deaths

EBR/GZR With RBV

Serious events: 2 serious events

Other events: 46 other events

Deaths: 0 deaths

SOF/LDV With RBV

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

SOF/LDV

Serious events: 6 serious events

Other events: 184 other events

Deaths: 4 deaths

PrOD With RBV

Serious events: 5 serious events

Other events: 74 other events

Deaths: 1 deaths

PrOD

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	EBR/GZR n=664 participants at risk Patients received EBR/GZR (elbasvir/grazoprevir) tablet once daily without RBV for 12 to 16 weeks (provider discretion) EBR/GZR: Elbasvir/grazoprevir (50/100mg tablet) 1 tablet once daily with or without food	EBR/GZR With RBV n=56 participants at risk Patients received EBR/GZR (elbasvir/grazoprevir tablet) tablet once daily with Ribavirin (RBV) for 12 to 16 weeks (provider discretion) EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food with RBV (200 to 600 mg once or twice daily) for 12 to 16 weeks	SOF/LDV With RBV n=15 participants at risk Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (Sofosbuvir/Ledipasvir) (400/90 mg tablet) 1 tablet taken daily for approximately 12 to 24 weeks with RBV (Ribavirin) 200 mg: 1-3 pills, one to two times daily (dosage at discretion of HCV provider). Total daily dosage ranged fro 200 to 1200 mg.	SOF/LDV n=394 participants at risk Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks (treatment duration per discretion of provider) SOF/LDV (Sofosbuvir/Ledipasvir )(400/90 mg tablet) 1 tablet orally taken daily for approximately 12 to 24 weeks	PrOD With RBV n=99 participants at risk PrOD (ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) (treatment at duration provider discretion) ombitasvir/paritaprevir/ritonavir: 2 tablets orally once daily (12.5/75/50mg) for 12 to 24 weeks Dasabuvir (250 mg tablet): 1 tablet orally once or twice daily for 12 to 24 weeks Ribavirin (200 mg pill): 200 to 600 mg once or twice daily (dosage at provider discretion). Total daily dosage ranged from 200 to 1200 mg.	PrOD n=47 participants at risk Patients received PrOD orally (ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks without Ribavirin (RBV) (provider discretion) Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg): 2 tablets taken once orally daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Psychiatric disorders Mania	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Gastrointestinal disorders Abdominal Pain	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Nervous system disorders Adjustment Disorder	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Psychiatric disorders Alcohol withdrawal Syndrome	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Vascular disorders Arteriovenous fistula	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/664 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.25% 1/394 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Nervous system disorders Cerebrovascular Accident	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.25% 1/394 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Infections and infestations Cellulitis	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Cardiac disorders Chest Pain	0.00% 0/664 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.25% 1/394 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	1.0% 1/99 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.30% 2/664 • Number of events 2 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Psychiatric disorders Completed Suicide	0.00% 0/664 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	1.0% 1/99 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Vascular disorders Deep Vein Thrombosis	0.00% 0/664 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.25% 1/394 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Psychiatric disorders Drug Abuse	0.00% 0/664 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	1.0% 1/99 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Surgical and medical procedures Drug Detoxification	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
General disorders Drug Withdrawal Syndrome	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.30% 2/664 • Number of events 2 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.25% 1/394 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Injury, poisoning and procedural complications Fall	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Gastrointestinal disorders Femoral hernia, obstructive	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Gastrointestinal disorders Gastric ulcer perforation	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Infections and infestations Gastroenteritis viral	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Gastrointestinal disorders Gastrointestinal haemorrhage	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Metabolism and nutrition disorders Gout	0.00% 0/664 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.25% 1/394 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/664 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.25% 1/394 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Nervous system disorders Haemorrhagic stroke	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Infections and infestations Hepatitis B	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Injury, poisoning and procedural complications Hip fracture	0.00% 0/664 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.25% 1/394 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Immune system disorders Hypersensitivity	0.00% 0/664 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.25% 1/394 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Psychiatric disorders Mental status change	0.30% 2/664 • Number of events 2 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.00% 0/664 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	1.8% 1/56 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Nervous system disorders Neuropathy peripheral	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Infections and infestations Osteomyelitis	0.00% 0/664 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	1.0% 1/99 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Injury, poisoning and procedural complications Overdose	0.30% 2/664 • Number of events 2 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	1.0% 1/99 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/664 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.25% 1/394 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/664 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	1.8% 1/56 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Vascular disorders Peripheral ischaemia	0.00% 0/664 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.25% 1/394 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Infections and infestations Pneumonia	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.76% 3/394 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Renal and urinary disorders Renal failure acute	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Injury, poisoning and procedural complications Road traffic accident	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Psychiatric disorders Self-injurious ideation	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Gastrointestinal disorders Small intestinal obstruction	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Nervous system disorders Spinal Hematoma	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Nervous system disorders Syncope	0.00% 0/664 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	1.0% 1/99 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Injury, poisoning and procedural complications Thermal burn	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Injury, poisoning and procedural complications Toxicity to various agents	0.15% 1/664 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'

Other adverse events

Other adverse events
Measure	EBR/GZR n=664 participants at risk Patients received EBR/GZR (elbasvir/grazoprevir) tablet once daily without RBV for 12 to 16 weeks (provider discretion) EBR/GZR: Elbasvir/grazoprevir (50/100mg tablet) 1 tablet once daily with or without food	EBR/GZR With RBV n=56 participants at risk Patients received EBR/GZR (elbasvir/grazoprevir tablet) tablet once daily with Ribavirin (RBV) for 12 to 16 weeks (provider discretion) EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food with RBV (200 to 600 mg once or twice daily) for 12 to 16 weeks	SOF/LDV With RBV n=15 participants at risk Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (Sofosbuvir/Ledipasvir) (400/90 mg tablet) 1 tablet taken daily for approximately 12 to 24 weeks with RBV (Ribavirin) 200 mg: 1-3 pills, one to two times daily (dosage at discretion of HCV provider). Total daily dosage ranged fro 200 to 1200 mg.	SOF/LDV n=394 participants at risk Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks (treatment duration per discretion of provider) SOF/LDV (Sofosbuvir/Ledipasvir )(400/90 mg tablet) 1 tablet orally taken daily for approximately 12 to 24 weeks	PrOD With RBV n=99 participants at risk PrOD (ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) (treatment at duration provider discretion) ombitasvir/paritaprevir/ritonavir: 2 tablets orally once daily (12.5/75/50mg) for 12 to 24 weeks Dasabuvir (250 mg tablet): 1 tablet orally once or twice daily for 12 to 24 weeks Ribavirin (200 mg pill): 200 to 600 mg once or twice daily (dosage at provider discretion). Total daily dosage ranged from 200 to 1200 mg.	PrOD n=47 participants at risk Patients received PrOD orally (ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks without Ribavirin (RBV) (provider discretion) Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg): 2 tablets taken once orally daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks
Blood and lymphatic system disorders Anaemia	0.30% 2/664 • Number of events 2 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	30.4% 17/56 • Number of events 17 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	13.3% 2/15 • Number of events 2 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	20.2% 20/99 • Number of events 20 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Gastrointestinal disorders Abdominal discomfort	1.1% 7/664 • Number of events 7 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	1.8% 1/56 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	6.7% 1/15 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.51% 2/394 • Number of events 2 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	3.0% 3/99 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Nervous system disorders Dizziness	2.3% 15/664 • Number of events 15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	12.5% 7/56 • Number of events 7 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	2.8% 11/394 • Number of events 11 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	3.0% 3/99 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	2.1% 1/47 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.4% 9/664 • Number of events 9 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	14.3% 8/56 • Number of events 8 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	2.8% 11/394 • Number of events 11 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	9.1% 9/99 • Number of events 9 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	2.1% 1/47 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Nervous system disorders Fatigue	15.8% 105/664 • Number of events 105 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	32.1% 18/56 • Number of events 18 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	33.3% 5/15 • Number of events 5 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	20.8% 82/394 • Number of events 82 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	35.4% 35/99 • Number of events 35 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	10.6% 5/47 • Number of events 5 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Nervous system disorders Headache	14.2% 94/664 • Number of events 94 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	21.4% 12/56 • Number of events 12 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	6.7% 1/15 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	17.3% 68/394 • Number of events 68 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	15.2% 15/99 • Number of events 15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	19.1% 9/47 • Number of events 9 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Nervous system disorders Insomnia	3.9% 26/664 • Number of events 26 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	10.7% 6/56 • Number of events 6 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	6.7% 1/15 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	2.5% 10/394 • Number of events 10 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	8.1% 8/99 • Number of events 8 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	6.4% 3/47 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Gastrointestinal disorders Nausea	8.1% 54/664 • Number of events 54 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	21.4% 12/56 • Number of events 12 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	20.0% 3/15 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	8.6% 34/394 • Number of events 34 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	23.2% 23/99 • Number of events 23 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	10.6% 5/47 • Number of events 5 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Gastrointestinal disorders Diarrhoea	6.8% 45/664 • Number of events 45 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	5.4% 3/56 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	13.3% 2/15 • Number of events 2 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	4.8% 19/394 • Number of events 19 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	5.1% 5/99 • Number of events 5 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	6.4% 3/47 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Gastrointestinal disorders Abdominal Pain	1.7% 11/664 • Number of events 11 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	8.9% 5/56 • Number of events 5 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	6.7% 1/15 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	2.8% 11/394 • Number of events 11 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	3.0% 3/99 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Musculoskeletal and connective tissue disorders Back Pain	2.3% 15/664 • Number of events 15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	5.4% 3/56 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	3.0% 12/394 • Number of events 12 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Respiratory, thoracic and mediastinal disorders Bronchitis	0.75% 5/664 • Number of events 5 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	5.4% 3/56 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.51% 2/394 • Number of events 2 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	2.0% 2/99 • Number of events 2 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Gastrointestinal disorders Constipation	2.4% 16/664 • Number of events 16 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	8.9% 5/56 • Number of events 5 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	3.0% 12/394 • Number of events 12 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	2.0% 2/99 • Number of events 2 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	4.3% 2/47 • Number of events 2 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Respiratory, thoracic and mediastinal disorders Cough	2.3% 15/664 • Number of events 15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	5.4% 3/56 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	3.6% 14/394 • Number of events 14 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	3.0% 3/99 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Gastrointestinal disorders Dyspepsia	0.75% 5/664 • Number of events 5 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	7.1% 4/56 • Number of events 4 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	6.7% 1/15 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.76% 3/394 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	4.3% 2/47 • Number of events 2 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/664 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	5.4% 3/56 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	1.0% 1/99 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Infections and infestations Influenza like illness	2.7% 18/664 • Number of events 18 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	5.4% 3/56 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	1.8% 7/394 • Number of events 7 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	2.0% 2/99 • Number of events 2 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Skin and subcutaneous tissue disorders Pruritus	1.5% 10/664 • Number of events 10 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	5.4% 3/56 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.51% 2/394 • Number of events 2 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	4.0% 4/99 • Number of events 4 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	8.5% 4/47 • Number of events 4 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Gastrointestinal disorders Vomiting	2.0% 13/664 • Number of events 13 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	5.4% 3/56 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/15 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	3.3% 13/394 • Number of events 13 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	8.1% 8/99 • Number of events 8 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	2.1% 1/47 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Gastrointestinal disorders Abdominal Pain Upper	1.2% 8/664 • Number of events 8 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	3.6% 2/56 • Number of events 2 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	6.7% 1/15 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	2.3% 9/394 • Number of events 9 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	1.0% 1/99 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	2.1% 1/47 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Musculoskeletal and connective tissue disorders Arthralgia	2.6% 17/664 • Number of events 17 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	1.8% 1/56 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	6.7% 1/15 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	3.3% 13/394 • Number of events 13 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	4.0% 4/99 • Number of events 4 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Cardiac disorders Chest Pain	1.5% 10/664 • Number of events 10 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	1.8% 1/56 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	6.7% 1/15 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	2.3% 9/394 • Number of events 9 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	3.0% 3/99 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Hepatobiliary disorders Cholelithiasis	0.00% 0/664 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	6.7% 1/15 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Gastrointestinal disorders Decreased Appetite	1.4% 9/664 • Number of events 9 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	3.6% 2/56 • Number of events 2 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	6.7% 1/15 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	1.3% 5/394 • Number of events 5 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	3.0% 3/99 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	4.3% 2/47 • Number of events 2 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Injury, poisoning and procedural complications Fall	0.45% 3/664 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	6.7% 1/15 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.76% 3/394 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.30% 2/664 • Number of events 2 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	1.8% 1/56 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	6.7% 1/15 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.76% 3/394 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.30% 2/664 • Number of events 2 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	6.7% 1/15 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.76% 3/394 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Vascular disorders Oedema Peripheral	1.8% 12/664 • Number of events 12 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	1.8% 1/56 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	6.7% 1/15 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	1.0% 4/394 • Number of events 4 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	1.0% 1/99 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.00% 0/664 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	6.7% 1/15 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Skin and subcutaneous tissue disorders Rash	1.5% 10/664 • Number of events 10 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	3.6% 2/56 • Number of events 2 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	6.7% 1/15 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	1.3% 5/394 • Number of events 5 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	3.0% 3/99 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	6.4% 3/47 • Number of events 3 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Nervous system disorders Tremor	0.00% 0/664 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/56 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	6.7% 1/15 • Number of events 1 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/394 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/99 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'	0.00% 0/47 • 28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion). An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'

Additional Information

Lauren Morelli

UF Hepatology Research at CTRB

Phone: 352-273-9508

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place