Trial Outcomes & Findings for Evaluating the Safety and Effectiveness of Interferon-Free Treatment of Hepatitis C Virus Infection in HIV-Coinfected Adults on Antiretroviral Therapy (NCT NCT02194998)

NCT ID: NCT02194998

Last Updated: 2021-11-04

Results Overview

SVR12 was defined as HCV RNA less than the assay LLOQ (\<15 IU/mL) at 12 weeks post HCV treatment discontinuation. A two-sided 90% confidence interval was calculated for the percentage of participants with SVR12 response using Clopper-Pearson method. For those whose HCV early responses prior to SVR12 evaluation met the guidelines for HCV Virologic Failure (VF), their SVR12 outcome was defined as non-response. Those missing a HCV RNA result from the week 12 post HCV treatment discontinuation visit (and missing all subsequent evaluations) were considered non-responders. However, if HCV RNA evaluations subsequent to week 12 post treatment discontinuation were non-missing, then the first HCV RNA subsequent to week 12 post treatment discontinuation was instead used to define the primary outcome.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

At 12 weeks after last dose of HCV study treatment. The duration for study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

Results posted on

2021-11-04

Participant Flow

Participants were enrolled from September 2015 to December 2016 at 16 U.S. sites.

There was no randomization in this study. Participants were stratified according to evidence of cirrhosis (yes versus no). The enrollment to the strata level for cirrhosis=yes was limited to no more than 30% within any particular study cohort.

Participant milestones

Participant milestones
Measure	Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
On-HCV Treatment STARTED	21	6	15	4
On-HCV Treatment COMPLETED	21	5	15	4
On-HCV Treatment NOT COMPLETED	0	1	0	0
Post-HCV Treatment Follow-Up STARTED	21	5	15	4
Post-HCV Treatment Follow-Up COMPLETED	20	5	14	4
Post-HCV Treatment Follow-Up NOT COMPLETED	1	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
On-HCV Treatment Did not pick up study medication	0	1	0	0
Post-HCV Treatment Follow-Up Lost to Follow-up	1	0	1	0

Baseline Characteristics

All participants who initiated treatment and had baseline CD4 result available.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=21 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=5 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=15 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=4 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for participants with HCV genotype 1a only; participants with HCV genotype 1b did not receive RBV).	Total n=45 Participants Total of all reporting groups
Age, Continuous	48 years n=21 Participants	50 years n=5 Participants	58 years n=15 Participants	55 years n=4 Participants	53 years n=45 Participants
Age, Customized 30-39 years	5 Participants n=21 Participants	0 Participants n=5 Participants	0 Participants n=15 Participants	0 Participants n=4 Participants	5 Participants n=45 Participants
Age, Customized 40-49 years	11 Participants n=21 Participants	2 Participants n=5 Participants	0 Participants n=15 Participants	1 Participants n=4 Participants	14 Participants n=45 Participants
Age, Customized 50-59 years	3 Participants n=21 Participants	3 Participants n=5 Participants	8 Participants n=15 Participants	2 Participants n=4 Participants	16 Participants n=45 Participants
Age, Customized 60-69 years	2 Participants n=21 Participants	0 Participants n=5 Participants	7 Participants n=15 Participants	1 Participants n=4 Participants	10 Participants n=45 Participants
Sex: Female, Male Female	7 Participants n=21 Participants	1 Participants n=5 Participants	3 Participants n=15 Participants	2 Participants n=4 Participants	13 Participants n=45 Participants
Sex: Female, Male Male	14 Participants n=21 Participants	4 Participants n=5 Participants	12 Participants n=15 Participants	2 Participants n=4 Participants	32 Participants n=45 Participants
Race/Ethnicity, Customized White Non-Hispanic	5 Participants n=21 Participants	1 Participants n=5 Participants	3 Participants n=15 Participants	2 Participants n=4 Participants	11 Participants n=45 Participants
Race/Ethnicity, Customized Black Non-Hispanic	6 Participants n=21 Participants	3 Participants n=5 Participants	8 Participants n=15 Participants	1 Participants n=4 Participants	18 Participants n=45 Participants
Race/Ethnicity, Customized Hispanic (Regardless of Race)	10 Participants n=21 Participants	1 Participants n=5 Participants	4 Participants n=15 Participants	1 Participants n=4 Participants	16 Participants n=45 Participants
Region of Enrollment United States	21 Participants n=21 Participants	5 Participants n=5 Participants	15 Participants n=15 Participants	4 Participants n=4 Participants	45 Participants n=45 Participants
CD4 Count	752 cells/mm^3 n=20 Participants • All participants who initiated treatment and had baseline CD4 result available.	674 cells/mm^3 n=5 Participants • All participants who initiated treatment and had baseline CD4 result available.	646 cells/mm^3 n=15 Participants • All participants who initiated treatment and had baseline CD4 result available.	525 cells/mm^3 n=4 Participants • All participants who initiated treatment and had baseline CD4 result available.	665 cells/mm^3 n=44 Participants • All participants who initiated treatment and had baseline CD4 result available.
HIV-1 RNA Greater than 40 copies/mL	0 Participants n=21 Participants	0 Participants n=5 Participants	1 Participants n=15 Participants	0 Participants n=4 Participants	1 Participants n=45 Participants
HIV-1 RNA Less than or equal to 40 copies/mL	21 Participants n=21 Participants	5 Participants n=5 Participants	14 Participants n=15 Participants	4 Participants n=4 Participants	44 Participants n=45 Participants
HCV RNA, continuous	6.5 Log10 IU/mL n=21 Participants • All participants who initiated treatment and had baseline HCV RNA result available.	5.9 Log10 IU/mL n=5 Participants • All participants who initiated treatment and had baseline HCV RNA result available.	6.5 Log10 IU/mL n=14 Participants • All participants who initiated treatment and had baseline HCV RNA result available.	6.2 Log10 IU/mL n=4 Participants • All participants who initiated treatment and had baseline HCV RNA result available.	6.4 Log10 IU/mL n=44 Participants • All participants who initiated treatment and had baseline HCV RNA result available.
HCV RNA, categorized ≥6 million IU/mL	6 Participants n=21 Participants • All participants who initiated treatment and had baseline HCV RNA result available.	1 Participants n=5 Participants • All participants who initiated treatment and had baseline HCV RNA result available.	6 Participants n=14 Participants • All participants who initiated treatment and had baseline HCV RNA result available.	0 Participants n=4 Participants • All participants who initiated treatment and had baseline HCV RNA result available.	13 Participants n=44 Participants • All participants who initiated treatment and had baseline HCV RNA result available.
HCV RNA, categorized <6 million IU/mL	15 Participants n=21 Participants • All participants who initiated treatment and had baseline HCV RNA result available.	4 Participants n=5 Participants • All participants who initiated treatment and had baseline HCV RNA result available.	8 Participants n=14 Participants • All participants who initiated treatment and had baseline HCV RNA result available.	4 Participants n=4 Participants • All participants who initiated treatment and had baseline HCV RNA result available.	31 Participants n=44 Participants • All participants who initiated treatment and had baseline HCV RNA result available.
HCV Genotype 1A	16 Participants n=21 Participants	5 Participants n=5 Participants	13 Participants n=15 Participants	4 Participants n=4 Participants	38 Participants n=45 Participants
HCV Genotype 1B	5 Participants n=21 Participants	0 Participants n=5 Participants	2 Participants n=15 Participants	0 Participants n=4 Participants	7 Participants n=45 Participants
HCV Treatment Experience Naive	20 Participants n=21 Participants	5 Participants n=5 Participants	12 Participants n=15 Participants	3 Participants n=4 Participants	40 Participants n=45 Participants
HCV Treatment Experience Experienced	1 Participants n=21 Participants	0 Participants n=5 Participants	3 Participants n=15 Participants	1 Participants n=4 Participants	5 Participants n=45 Participants
Cirrhosis Status Cirrhotic	6 Participants n=21 Participants	0 Participants n=5 Participants	2 Participants n=15 Participants	0 Participants n=4 Participants	8 Participants n=45 Participants
Cirrhosis Status Non-Cirrhotic	15 Participants n=21 Participants	5 Participants n=5 Participants	13 Participants n=15 Participants	4 Participants n=4 Participants	37 Participants n=45 Participants

PRIMARY outcome

Timeframe: At 12 weeks after last dose of HCV study treatment. The duration for study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

Population: Participants who initiated study treatment.

Outcome measures

Outcome measures
Measure	Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=21 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=5 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=15 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=4 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
Percentage of Participants With Sustained Virologic Response at 12 Weeks After HCV Treatment Discontinuation (SVR12)	95.2 percentage of participants Interval 79.3 to 99.8	60 percentage of participants Interval 18.9 to 92.4	100 percentage of participants Interval 81.9 to 100.0	100 percentage of participants Interval 47.3 to 100.0

PRIMARY outcome

Timeframe: From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

Population: Participants who initiated study treatment.

Participants who experienced at least one observed SAEs as defined by ICH after initiating HCV study treatment through 30 days post date of last dose of HCV study treatment.

Outcome measures

Outcome measures
Measure	Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=21 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=5 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=15 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=4 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
Number of Participants With an Occurrence of Serious Adverse Events (SAEs) as Defined by International Conference on Harmonisation (ICH) Criteria	1 Participants	1 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: From treatment initiation to either 24 weeks (for Cohort A and C) or 12 weeks (for Cohort B and D). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

Population: Participants who initiated study treatment.

HCV VF was defined as follows: confirmed increase from nadir in HCV RNA (defined as two consecutive HCV RNA measurements of \>1 log10 IU/mL above nadir) at any time point; failure to achieve HCV RNA \<LLOQ (\<15 IU/mL) by week 6; confirmed HCV RNA ≥LLOQ (defined as two consecutive HCV RNA measurements ≥LLOQ (≥15 IU/mL)) at any point after HCV RNA \<LLOQ during HCV treatment

Outcome measures

Outcome measures
Measure	Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=21 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=5 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=15 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=4 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
Number of Participants Who Prematurely Discontinued HCV Study Treatment for Any Reason Other Than HCV Virologic Failure (VF)	1 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Population: Participants who initiated study treatment.

Participants with signs/symptoms of grade 3 or higher post treatment initiation. Participants with grade 3 sign/symptom prior to treatment initiation must have had one grade higher than pre-treatment to meet this outcome. Severity grading was based on DAIDS AE Grading Table, Version 1.0.

Outcome measures

Outcome measures
Measure	Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=21 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=5 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=15 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=4 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
Number of Participants With an Occurrence of Signs/Symptoms Grade 3 or Higher	0 Participants	2 Participants	3 Participants	0 Participants

PRIMARY outcome

Timeframe: From treatment initiation to end of study follow-up at 48 weeks.The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively. The duration for ARV treatment for all cohorts was 48 weeks.

Population: Participants who initiated study treatment.

Participants who had diagnoses leading to premature HCV study treatment or HIV-1 ARV discontinuation post treatment initiation.

Outcome measures

Outcome measures
Measure	Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=21 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=5 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=15 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=4 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
Number of Participants With an Occurrence of Diagnoses Leading to Premature HCV Study Treatment or HIV-1 Antiretroviral (ARV) Discontinuation.	0 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Population: Participants who initiated study treatment.

Participants with an observed laboratory abnormalities grade 3 or higher post treatment initiation. If entry (pre-treatment) lab result was grade 3, then a grade 4 result was required to meet this outcome. Severity grading was based on DAIDS AE Grading Table, Version 1.0.

Outcome measures

Outcome measures
Measure	Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=21 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=5 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=15 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=4 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
Number of Participants With an Occurrence of Laboratory Abnormality Grade 3 or Higher.	5 Participants	3 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: From treatment initiation to 4 weeks after last dose of HCV study treatment. HIV-1 RNA was measured at weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28. The durations for HCV study treatment for Cohorts A/C and Cohorts B/D were 24 and 12 weeks, respectively.

Population: Participants who initiated study treatment.

HIV-1 VF was defined as two consecutive HIV-1 RNA results ≥ 200 copies/mL.

Outcome measures

Outcome measures
Measure	Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=21 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=5 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=15 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=4 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
Number of Participants Who Experienced HIV-1 Virologic Failure (VF)	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: At confirmation of HIV-1 virologic failure.

Population: Participants who experienced confirmed HIV-1 virologic failure (a single participant from Cohort D \[PI-based + (3 DAA: 12 wks)\]).

Participants with one or more genotype mutations in protease conferring major resistance to any HIV-1 Protease Inhibitors (PI) antiretroviral drug, from a plasma sample drawn following confirmed HIV-1 VF outcome.

Outcome measures

Outcome measures
Measure	Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=1 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
Number of Participants With Selected HIV-1 Resistance Mutations Among Participants Who Experience HIV-1 Virologic Failure (VF)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

Population: All participants who initiated treatment and had available data at the study visit.

Levels of sCD14. Baseline was defined as the date of first treatment dose.

Outcome measures

Outcome measures
Measure	Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=21 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=4 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=15 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=4 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
Levels of Soluble CD14 (sCD14) sCD14 at Baseline	1,832.0 ng/mL	2,226.8 ng/mL	3,157.0 ng/mL	3,092.0 ng/mL
Levels of Soluble CD14 (sCD14) sCD14 at EOT	2,126.5 ng/mL	1,132.8 ng/mL	2,421.1 ng/mL	2,801.3 ng/mL
Levels of Soluble CD14 (sCD14) sCD14 at 12 weeks post EOT	1,977.3 ng/mL	1,367.4 ng/mL Interval 792.3 to	3,424.5 ng/mL	2,608.3 ng/mL

SECONDARY outcome

Timeframe: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

Population: All participants who initiated treatment and had available data at baseline and the respective post-baseline visit.

Absolute change from baseline in sCD14 levels in plasma calculated as value at the later time point minus baseline value. Baseline was defined as the date of first treatment dose.

Outcome measures

Outcome measures
Measure	Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=21 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=4 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=15 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=4 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
Change in Soluble CD14 (sCD14) Change from baseline to EOT	307.6 ng/mL Interval -190.4 to	-1,063.2 ng/mL Interval to -978.6	-380.3 ng/mL Interval to 887.8	318.2 ng/mL
Change in Soluble CD14 (sCD14) Change from baseline to 12 weeks post EOT	145.2 ng/mL Interval -173.6 to 526.7	-894.2 ng/mL Interval to -659.6	-22.6 ng/mL Interval -593.8 to 828.5	-987.0 ng/mL Interval to -483.7

SECONDARY outcome

Timeframe: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

Population: All participants who initiated treatment and had available data at the study visit.

Levels of IP-10 (Interferon gamma-induced protein 10) concentration in plasma. Baseline was defined as the date of first treatment dose.

Outcome measures

Outcome measures
Measure	Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=21 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=4 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=15 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=4 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
Levels of IP-10 Concentration. IP-10 at baseline	379 pg/mL Interval 172.7 to 537.8	120.2 pg/mL Interval 82.7 to 249.5	225.5 pg/mL Interval 119.9 to 628.0	196.4 pg/mL Interval 107.6 to 382.7
Levels of IP-10 Concentration. IP-10 at EOT	100.9 pg/mL Interval 62.8 to 184.0	60.4 pg/mL Interval 34.6 to 86.3	76.6 pg/mL Interval 52.2 to 124.2	182.6 pg/mL Interval 117.6 to 481.3
Levels of IP-10 Concentration. IP-10 at 12 weeks post EOT	94.6 pg/mL Interval 68.3 to 190.2	85.5 pg/mL Interval 33.0 to 92.8	82.5 pg/mL Interval 71.9 to 142.1	159.5 pg/mL Interval 81.5 to 238.8

SECONDARY outcome

Timeframe: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

Population: All participants who initiated treatment and had available data at baseline and the respective post-baseline visit.

Absolute change from baseline in IP-10 (Interferon gamma-induced protein 10) concentration in plasma, calculated as value at the later time point minus baseline value. Baseline was defined as the date of first treatment dose.

Outcome measures

Outcome measures
Measure	Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=21 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=4 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=15 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=4 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
Change in IP-10 Concentration. Change from baseline to EOT	-244.4 pg/mL Interval -333.1 to -87.0	-22.2 pg/mL Interval -32.2 to -12.2	-116 pg/mL Interval -201.0 to -49.4	-61.1 pg/mL Interval -263.5 to 372.0
Change in IP-10 Concentration. Change from baseline to 12 weeks post EOT	-127 pg/mL Interval -301.9 to -55.0	-29.1 pg/mL Interval -32.9 to -13.9	-83.1 pg/mL Interval -184.5 to -53.3	-114.9 pg/mL Interval -261.7 to 91.6

SECONDARY outcome

Timeframe: From treatment initiation to 12 weeks post date of last dose of HCV study treatment. The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

Population: No participants are included in this analysis. The outcome measure was withdrawn and no specimen testing was performed.

Study team decided to remove this secondary outcome measure due to reduced interest in study treatment as a result of development and approval of newer DAA's.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 24 weeks after the date of last dose of HCV study treatment. The duration for study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.

Population: Participants who initiated study treatment.

SVR24 was defined as HCV RNA less than the assay LLOQ (\<15 IU/mL) at 24 weeks post treatment discontinuation. A two-sided 90% confidence interval was calculated for the percentage of SVR24 response using method of Clopper-Pearson. For those whose HCV early responses prior to SVR24 evaluation met the guidelines for HCV VF, their SVR24 outcome was defined as non-response. Those missing a HCV RNA result from the week 24 post HCV treatment discontinuation visit (and missing all subsequent evaluations) were considered non-responders. However, if HCV RNA evaluations subsequent to week 24 post treatment discontinuation were non-missing, then the first HCV RNA subsequent to week 24 post treatment discontinuation was instead used to define the primary outcome.

Outcome measures

Outcome measures
Measure	Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=21 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=5 Participants Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=15 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=4 Participants Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
Percentage of Participants With Sustained Virologic Response at 24 Weeks After HCV Treatment Discontinuation (SVR24)	90.5 percentage of participants Interval 72.9 to 98.3	60 percentage of participants Interval 18.9 to 92.4	93.3 percentage of participants Interval 72.1 to 99.7	100 percentage of participants Interval 47.3 to 100.0

Adverse Events

Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=21 participants at risk Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=5 participants at risk Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks] n=15 participants at risk Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).	Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks] n=4 participants at risk Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
Cardiac disorders Myocardial infarction	0.00% 0/21 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/5 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	6.7% 1/15 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/4 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Infections and infestations Bronchitis	4.8% 1/21 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/5 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/15 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/4 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Nervous system disorders Hemiparesis	0.00% 0/21 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/5 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	6.7% 1/15 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/4 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Nervous system disorders Neuropathy peripheral	0.00% 0/21 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	20.0% 1/5 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/15 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/4 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	4.8% 1/21 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/5 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/15 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/4 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/21 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	20.0% 1/5 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/15 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.	0.00% 0/4 • From treatment initiation to off study at 48 weeks. At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.

Other adverse events

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights
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Restriction type: OTHER