Trial Outcomes & Findings for Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials (NCT NCT01428063)

NCT ID: NCT01428063

Last Updated: 2016-05-27

Results Overview

SVR12 defined as HCV RNA\<limit of quantitation at follow-up Week 12. Nonresponder (NR)=prior NR to pegIFN-2a or ribavirin.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 276 participants
• Primary outcome timeframe: Week 12 (Follow-up period)
• Results posted on: 2016-05-27

Participant Flow

The study was conducted at 92 centers in 20 countries.

A total of 276 participants were enrolled, 228 were randomized and 227 received treatment. Participants were not treated because they no longer met study criteria (n=41), withdrew their consent (n=4), showed poor/non-compliance (n=1) or were lost to follow-up (n=2). One participant was randomized by mistake but received no treatment.

Participant milestones

Measure	Daclatasvir + Asunaprevir Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks	Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks	Daclatasvir + pegIFN-2a+ Ribavirin Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.
Overall Study STARTED	99	122	6
Overall Study COMPLETED	89	112	5
Overall Study NOT COMPLETED	10	10	1

Reasons for withdrawal

Measure	Daclatasvir + Asunaprevir Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks	Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks	Daclatasvir + pegIFN-2a+ Ribavirin Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.
Overall Study Lack of Efficacy	8	4	1
Overall Study Adverse Event	2	3	0
Overall Study Lost to Follow-up	0	2	0
Overall Study No longer meets study criteria	0	1	0

Baseline Characteristics

Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials

Baseline characteristics by cohort

Measure	Daclatasvir + Asunaprevir n=99 Participants Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks	Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin n=122 Participants Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks	Daclatasvir + pegIFN-2a+ Ribavirin n=6 Participants Patients received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks	Total n=227 Participants Total of all reporting groups
Age, Customized Younger than 65 years	80 Participants n=5 Participants	114 Participants n=7 Participants	6 Participants n=5 Participants	200 Participants n=4 Participants
Age, Customized 65 years and older	19 Participants n=5 Participants	8 Participants n=7 Participants	0 Participants n=5 Participants	27 Participants n=4 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	84 Participants n=7 Participants	2 Participants n=5 Participants	134 Participants n=4 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	38 Participants n=7 Participants	4 Participants n=5 Participants	93 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 12 (Follow-up period)

Population: Participants with genotype 1 HCV who received at least 1 dose of study drug

SVR12 defined as HCV RNA<limit of quantitation at follow-up Week 12. Nonresponder (NR)=prior NR to pegIFN-2a or ribavirin.

Outcome measures

Measure	Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR) n=37 Participants Participants received daclatasvir, 60-mg tablet by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly for 24 weeks + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks	DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4) Genotype 4 participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) Participants who were nor responders to earlier boceprevir(BOC) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) Participants who were nor responders to earlier telaprevir (TVR) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 12 weeks.	DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 12 week.	DCV + pegIFN-2a+ RBV Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.
Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV)	94.6 Percentage of participants Interval 81.8 to 99.3	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 12 (Follow-up period)

Population: The analysis was performed in all treated participants who did not exhibit Genotype 1. One subject with indeterminate genotype in the Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin Arm/Group was excluded from the analysis

SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.

Outcome measures

Measure	Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR) n=99 Participants Participants received daclatasvir, 60-mg tablet by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly for 24 weeks + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks	DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4) n=10 Participants Genotype 4 participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) n=10 Participants Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) n=6 Participants Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) n=11 Participants Participants who were nor responders to earlier boceprevir(BOC) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) n=13 Participants Participants who were nor responders to earlier telaprevir (TVR) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) n=25 Participants HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 12 weeks.	DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) n=9 Participants pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 12 week.	DCV + pegIFN-2a+ RBV n=6 Participants Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.
Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12)	85.9 Percentage of participants Interval 77.4 to 92.0	90.0 Percentage of participants Interval 55.5 to 99.7	40.0 Percentage of participants Interval 12.2 to 73.8	100.0 Percentage of participants Interval 54.1 to 100.0	90.9 Percentage of participants Interval 58.7 to 99.8	76.9 Percentage of participants Interval 46.2 to 95.0	84.0 Percentage of participants Interval 63.9 to 95.5	88.9 Percentage of participants Interval 51.8 to 99.7	50.0 Percentage of participants Interval 11.8 to 88.2

SECONDARY outcome

Timeframe: Week 4

Population: The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.

RVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at Week 4.

Outcome measures

Measure	Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR) n=99 Participants Participants received daclatasvir, 60-mg tablet by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly for 24 weeks + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks	DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4) n=48 Participants Genotype 4 participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) n=10 Participants Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) n=6 Participants Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) n=11 Participants Participants who were nor responders to earlier boceprevir(BOC) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) n=13 Participants Participants who were nor responders to earlier telaprevir (TVR) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) n=25 Participants HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 12 weeks.	DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) n=9 Participants pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 12 week.	DCV + pegIFN-2a+ RBV n=6 Participants Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.
Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4	72.7 Percentage of participants	91.7 Percentage of participants	70.0 Percentage of participants	83.3 Percentage of participants	90.9 Percentage of participants	76.9 Percentage of participants	76.0 Percentage of participants	88.9 Percentage of participants	83.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 4 and 12

Population: The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.

eRVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at both weeks 4 and 12.

Outcome measures

Measure	Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR) n=99 Participants Participants received daclatasvir, 60-mg tablet by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly for 24 weeks + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks	DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4) n=48 Participants Genotype 4 participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) n=10 Participants Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) n=6 Participants Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) n=11 Participants Participants who were nor responders to earlier boceprevir(BOC) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) n=13 Participants Participants who were nor responders to earlier telaprevir (TVR) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) n=25 Participants HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 12 weeks.	DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) n=9 Participants pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 12 week.	DCV + pegIFN-2a+ RBV n=6 Participants Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.
Percentage of Participants With Extended Rapid Virologic Response (eRVR)	67.7 Percentage of participants	87.5 Percentage of participants	70.0 Percentage of participants	83.3 Percentage of participants	81.8 Percentage of participants	76.9 Percentage of participants	64.0 Percentage of participants	88.9 Percentage of participants	83.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.

cEVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at week 12.

Outcome measures

Measure	Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR) n=99 Participants Participants received daclatasvir, 60-mg tablet by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly for 24 weeks + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks	DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4) n=48 Participants Genotype 4 participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) n=10 Participants Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) n=6 Participants Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) n=11 Participants Participants who were nor responders to earlier boceprevir(BOC) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) n=13 Participants Participants who were nor responders to earlier telaprevir (TVR) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) n=25 Participants HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 12 weeks.	DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) n=9 Participants pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 12 week.	DCV + pegIFN-2a+ RBV n=6 Participants Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.
Percentage of Participants With Complete Early Virologic Response (cEVR)	87.9 Percentage of participants	95.8 Percentage of participants	90.0 Percentage of participants	100.0 Percentage of participants	90.9 Percentage of participants	92.3 Percentage of participants	76.0 Percentage of participants	88.9 Percentage of participants	83.3 Percentage of participants

SECONDARY outcome

Timeframe: End of the study (Week 24)

Population: The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.

EOTR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at end of treatment.

Outcome measures

Measure	Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR) n=99 Participants Participants received daclatasvir, 60-mg tablet by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly for 24 weeks + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks	DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4) n=48 Participants Genotype 4 participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) n=10 Participants Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) n=6 Participants Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) n=11 Participants Participants who were nor responders to earlier boceprevir(BOC) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) n=13 Participants Participants who were nor responders to earlier telaprevir (TVR) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) n=25 Participants HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 12 weeks.	DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) n=9 Participants pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 12 week.	DCV + pegIFN-2a+ RBV n=6 Participants Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.
Percentage of Participants With End of the Treatment Response (EOTR)	85.9 Percentage of participants	97.9 Percentage of participants	90.0 Percentage of participants	100.0 Percentage of participants	90.9 Percentage of participants	92.3 Percentage of participants	84.0 Percentage of participants	88.9 Percentage of participants	83.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 24 (Follow-up)

Population: The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.

SVR24 was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24.

Outcome measures

Measure	Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR) n=99 Participants Participants received daclatasvir, 60-mg tablet by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly for 24 weeks + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks	DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4) n=48 Participants Genotype 4 participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) n=10 Participants Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) n=6 Participants Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) n=11 Participants Participants who were nor responders to earlier boceprevir(BOC) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) n=13 Participants Participants who were nor responders to earlier telaprevir (TVR) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) n=25 Participants HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 12 weeks.	DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) n=9 Participants pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 12 week.	DCV + pegIFN-2a+ RBV n=6 Participants Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)	84.8 Percentage of participants	95.8 Percentage of participants	40.0 Percentage of participants	100.0 Percentage of participants	90.9 Percentage of participants	76.9 Percentage of participants	84.0 Percentage of participants	88.9 Percentage of participants	50.0 Percentage of participants

SECONDARY outcome

Timeframe: For AEs: Day 1 until last visit. For SAEs: Day 1 until 30 days post discontinuation of dosing or participation

Population: The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.

AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.

Outcome measures

Measure	Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR) n=99 Participants Participants received daclatasvir, 60-mg tablet by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly for 24 weeks + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks	DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4) n=48 Participants Genotype 4 participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) n=10 Participants Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) n=6 Participants Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) n=11 Participants Participants who were nor responders to earlier boceprevir(BOC) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) n=13 Participants Participants who were nor responders to earlier telaprevir (TVR) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) n=25 Participants HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 12 weeks.	DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) n=9 Participants pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 12 week.	DCV + pegIFN-2a+ RBV n=6 Participants Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study SAEs	4 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study AEs leading to discontinuation of therapy	2 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study Death	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Daclatasvir + Asunaprevir

Serious events: 4 serious events

Other events: 58 other events

Deaths: 0 deaths

Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin

Serious events: 3 serious events

Other events: 118 other events

Deaths: 0 deaths

Daclatasvir + pegIFN-2a+ Ribavirin

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Daclatasvir + Asunaprevir n=99 participants at risk Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks.	Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin n=122 participants at risk Participants received daclatasvir, 60-mg tablet by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly for 24 weeks + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	Daclatasvir + pegIFN-2a+ Ribavirin n=6 participants at risk Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	1.0% 1/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.82% 1/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Nervous system disorders Radiculopathy	0.00% 0/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.82% 1/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Psychiatric disorders Suicide attempt	1.0% 1/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	1.0% 1/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Injury, poisoning and procedural complications Animal bite	0.00% 0/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.82% 1/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.82% 1/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	1.0% 1/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	1.0% 1/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.

Other adverse events

Measure	Daclatasvir + Asunaprevir n=99 participants at risk Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks.	Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin n=122 participants at risk Participants received daclatasvir, 60-mg tablet by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly for 24 weeks + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks.	Daclatasvir + pegIFN-2a+ Ribavirin n=6 participants at risk Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks
Gastrointestinal disorders Abdominal pain upper	6.1% 6/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	6.6% 8/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
General disorders Asthenia	2.0% 2/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	12.3% 15/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.0% 2/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	1.6% 2/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	16.7% 1/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
General disorders Influenza like illness	5.1% 5/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	36.9% 45/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	50.0% 3/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	4.1% 5/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	16.7% 1/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	16.7% 1/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Reproductive system and breast disorders Uterine polyp	0.00% 0/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	16.7% 1/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Gastrointestinal disorders Abdominal pain	5.1% 5/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	7.4% 9/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	33.3% 2/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	9.8% 12/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	33.3% 2/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Gastrointestinal disorders Nausea	14.1% 14/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	25.4% 31/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	16.7% 1/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Skin and subcutaneous tissue disorders Rash	3.0% 3/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	12.3% 15/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Eye disorders Visual acuity reduced	0.00% 0/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.82% 1/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	16.7% 1/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Blood and lymphatic system disorders Anaemia	1.0% 1/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	18.9% 23/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Musculoskeletal and connective tissue disorders Arthralgia	6.1% 6/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	13.1% 16/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	33.3% 2/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Musculoskeletal and connective tissue disorders Back pain	4.0% 4/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	5.7% 7/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Respiratory, thoracic and mediastinal disorders Cough	5.1% 5/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	11.5% 14/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	33.3% 2/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
General disorders Fatigue	15.2% 15/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	53.3% 65/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	50.0% 3/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Psychiatric disorders Depression	0.00% 0/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	4.9% 6/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	16.7% 1/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Eye disorders Dry eye	0.00% 0/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	2.5% 3/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	16.7% 1/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Skin and subcutaneous tissue disorders Dry skin	2.0% 2/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	18.0% 22/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	33.3% 2/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Nervous system disorders Dysgeusia	0.00% 0/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	6.6% 8/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	16.7% 1/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	16.7% 1/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	7.4% 9/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	16.7% 1/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Investigations Transaminases increased	1.0% 1/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.82% 1/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	16.7% 1/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Gastrointestinal disorders Vomiting	5.1% 5/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	4.1% 5/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	16.7% 1/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Cardiac disorders Angina pectoris	0.00% 0/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	16.7% 1/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	6.6% 8/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.82% 1/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	16.7% 1/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Skin and subcutaneous tissue disorders Pruritus	5.1% 5/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	18.9% 23/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	50.0% 3/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	8.2% 10/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Infections and infestations Viral rhinitis	0.00% 0/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	16.7% 1/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Skin and subcutaneous tissue disorders Erythema	1.0% 1/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	2.5% 3/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	16.7% 1/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Psychiatric disorders Insomnia	3.0% 3/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	20.5% 25/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	33.3% 2/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Musculoskeletal and connective tissue disorders Myalgia	5.1% 5/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	11.5% 14/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	33.3% 2/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Infections and infestations Nasopharyngitis	7.1% 7/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	2.5% 3/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Blood and lymphatic system disorders Neutropenia	1.0% 1/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	24.6% 30/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Skin and subcutaneous tissue disorders Alopecia	3.0% 3/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	10.7% 13/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	33.3% 2/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Nervous system disorders Amnesia	0.00% 0/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.82% 1/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	16.7% 1/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Metabolism and nutrition disorders Decreased appetite	1.0% 1/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	16.4% 20/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	33.3% 2/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Nervous system disorders Headache	17.2% 17/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	35.2% 43/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	50.0% 3/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Psychiatric disorders Irritability	1.0% 1/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	9.0% 11/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	16.7% 1/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
General disorders Pyrexia	4.0% 4/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	13.9% 17/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	33.3% 2/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Investigations Weight decreased	1.0% 1/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	3.3% 4/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	16.7% 1/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
General disorders Chills	1.0% 1/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	8.2% 10/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	33.3% 2/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Gastrointestinal disorders Constipation	5.1% 5/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	3.3% 4/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Gastrointestinal disorders Diarrhoea	9.1% 9/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	27.0% 33/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Eye disorders Ocular icterus	0.00% 0/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	16.7% 1/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Infections and infestations Upper respiratory tract infection	9.1% 9/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/99 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	0.00% 0/122 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.	16.7% 1/6 • For AEs: From Day 1, first dose until participant's last scheduled visit. For SAEs: Date of participant's written consent until 30 days post discontinuation of dosing or participation in the study if the last scheduled visit occurred later (72 weeks). On treatment period.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
• Publication restrictions are in place

Restriction type: OTHER