Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3

A Multi-center, Open-Labeled Exploratory Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 400 mg and Ribavirin for 12 Weeks With and Without Pegylated Interferon in Treatment-Naïve Patients With Chronic HCV Infection Genotype 2 or Genotype 3

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01260350

Enrollment

292

Registered

2010-12-15

Start date

2010-12-31

Completion date

2013-12-31

Last updated

2014-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C Infection

Keywords

PSI-7977, Sofosbuvir, GS-7977, GS-5885, GS-9669, FDC, ribavirin, RBV, Pegylated Interferon, PEG-IFN, Chronic Hepatitis C Infection, HCV, Hepatitis, Genotype 1, Genotype 2, Genotype 3, GT 1, GT 2, GT 3, Hemophilia

Brief summary

This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in subjects with genotype 1, 2 or 3 hepatitis C (HCV) infection.

Detailed description

Part 1: HCV genotype 2 or 3: participants will receive SOF 400 mg once daily with weight-based RBV for 12 weeks. Participants will be randomized in equal proportions to: no PEG (Arm 1), PEG for 4 weeks (Arm 2), PEG for 8 weeks (Arm 3), or PEG for 12 weeks (Arm 4). Part 2: HCV genotype 2 or 3: participants will receive SOF 400 mg once daily (monotherapy) for 12 weeks (Arm 5), or SOF 400 mg once daily with PEG and weight-based RBV for 8 weeks (Arm 6); HCV genotype 1: null responders (did not respond to their prior treatment) will receive SOF 400 mg once daily with weight-based RBV for 12 weeks (Arm 7). Part 3: HCV genotype 1 treatment-naive (Arm 8) or HCV genotype 2 or 3 treatment-experienced participants (Arm 9) will receive SOF 400 mg once daily in combination with weight-based RBV for 12 weeks. Part 4: HCV genotype 2 or 3 treatment naive participants will receive SOF 400 mg once daily with weight-based RBV for 8 weeks (Arm 10) or SOF 400 mg once daily and 800 mg RBV for 12 weeks (Arm 11). HCV genotype 1 null responders will receive SOF 400 mg once daily, ledipasvir (LDV), and weight based RBV for 12 weeks (Arm 12). HCV genotype-1 treatment naive participants will receive SOF 400 mg once daily with weight-based RBV and LDV for 12 weeks (Arm 13). Part 5: HCV genotype 1 null responders will receive SOF 400 mg once daily with GS-9669 500 mg once daily and weight-based RBV for 12 weeks (Arm 14). HCV genotype-1 treatment naive participants receive SOF 400 mg once daily with GS-9669 500 mg once daily and weight-based RBV for 12 weeks (Arm 15). Part 6: HCV genotype 1 null responders with Stage F4 fibrosis will receive LDV/SOF FDC for 12 weeks (Arm 16) or LDV/SOF FDC with weight-based RBV for 12 weeks (Arm 17). HCV genotype 2 or 3 treatment-naive participants will receive LDV/SOF FDC for 12 weeks (Arm 18). HCV genotype 2 or 3 treatment-experienced participants will receive LDV/SOF FDC for 12 weeks (Arm 19). HCV genotype 1 hemophiliacs will receive LDV/SOF FDC with weight-based RBV for 12 weeks (Arm 20). HCV genotype 1 treatment-naive participants will receive LDV/SOF FDC with weight-based RBV for 6 weeks (Arm 21). HCV genotype 1 treatment-naive participants will receive LDV/SOF FDC for 6 weeks (Arm 22).

Interventions

DRUGSOF

Sofosbuvir (SOF) tablets administered orally once daily

DRUGRBV

Ribavirin (RBV) capsules administered orally in a divided daily dose

DRUGPEG

Peginterferon alfa-2a (PEG) administered via subcutaneous injection once weekly

DRUGLDV

Ledipasvir (LDV) tablets administered orally once daily

DRUGGS-9669

GS-9669 tablets administered orally once daily

DRUGLDV/SOF

LDV/SOF fixed-dose combination (FDC) tablet administered once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Chronic Genotype 2 or 3 HCV-infection or Genotype 1, serum HCV RNA ≥ 50,000 IU/mL * Not co-infected with HIV * Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion criteria

* History of any other clinically significant chronic liver disease * Pregnant or nursing female or male with pregnant female partner * History of significant drug allergy to nucleoside/nucleotide analogs. * Participation in a clinical study within 3 months prior to first dose * Positive result for significant drug use at Screening

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Who Experienced Adverse Events	Up to 12 weeks plus 30 days	Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.

Secondary

Measure	Time frame	Description
Percentage of Participants With HCV RNA < LOD at Week 6	Week 6	—
Percentage of Participants With HCV RNA < LOD at Week 8	Week 8	Data are not presented for Group 21 which ended treatment after Week 6.
Percentage of Participants With HCV RNA < LOD at Week 12	Week 12	Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6.
Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)	Posttreatment Week 12	SVR12 was defined as HCV RNA \< the limit of detection (LOD; \< 15 IU/mL) 12 weeks after the last dose of study drug.
Change From Baseline in HCV RNA at Week 8	Baseline to Week 8	Data are not presented for Group 21 which ended treatment after Week 6.
Change From Baseline in HCV RNA at Week 12	Baseline to Week 12	Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6. Data are not presented for Groups 16, 17, 18, and 20 because participants with detectable HCV RNA discontinued due to protocol-specified stopping rules.
Percentage of Participants With Virologic Failure	Up to Posttreatment Week 24	The percentage of participants with on-treatment virologic failure (viral breakthrough, rebound, or nonresponse) or following treatment (viral relapse) was summarized. On-treatment virologic failure was defined as: * Viral breakthrough (confirmed HCV RNA ≥ LOD after having previously had HCV RNA \< LOD while on treatment), * Viral rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, or * Nonresponse (HCV RNA persistently ≥ LOD through 6 weeks of treatment) Viral relapse was defined as confirmed HCV RNA ≥ LOD during the posttreatment period having achieved HCV RNA \< LOD at the last on-treatment visit.
Change From Baseline in HCV RNA at Week 6	Baseline to Week 6	—

Countries

New Zealand

Participant flow

Recruitment details

Participants were enrolled in a total of 2 study sites in New Zealand. The first participant was screened on 18 November 2010. The last participant observation was on 23 December 2013.

Participants by arm

Arm	Count
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection	10
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection	9
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection	10
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection	11
Group 5: SOF 12 wk: GT 2 or 3, TN SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection	10
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection	10
Group 7: SOF+RBV 12 wk: GT 1, TE SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment	10
Group 8: SOF+RBV 12 wk: GT 1, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection	25
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection	25
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection	25
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection	10
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment	9
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection	25
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment	10
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection	25
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment	10
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment	9
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection	10
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection	14
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection	25
Total	292

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007	FG008	FG009	FG010	FG011	FG012	FG013	FG014	FG015	FG016	FG017	FG018	FG019	FG020	FG021
Overall Study	Did Not Complete Follow-up 12 Visit	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Overall Study	Lack of Efficacy	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	3	0

Baseline characteristics

Characteristic	Total	Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac	Group 12: SOF+RBV+LDV 12 wk: GT 1, TE	Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN	Group 5: SOF 12 wk: GT 2 or 3, TN	Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN	Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis	Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE	Group 11: SOF+RBV 12 wk: GT 2 or 3, TN	Group 9: SOF+RBV 12 wk: GT 2 or 3, TE	Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN	Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis	Group 13: SOF+RBV+LDV 12 wk: GT 1, TN	Group 7: SOF+RBV 12 wk: GT 1, TE	Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN	Group 10: SOF+RBV 8 wk: GT 2 or 3, TN	Group 1: SOF+RBV 12 wk: GT 2 or 3, TN	Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN	Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN	Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN	Group 8: SOF+RBV 12 wk: GT 1, TN
Age, Continuous	48 years STANDARD_DEVIATION 10.6	54 years STANDARD_DEVIATION 13	50 years STANDARD_DEVIATION 13	39 years STANDARD_DEVIATION 10.8	43 years STANDARD_DEVIATION 13.5	46 years STANDARD_DEVIATION 6.3	61 years STANDARD_DEVIATION 4.9	55 years STANDARD_DEVIATION 6	39 years STANDARD_DEVIATION 8.9	53 years STANDARD_DEVIATION 7.9	39 years STANDARD_DEVIATION 12.2	57 years STANDARD_DEVIATION 5.2	45 years STANDARD_DEVIATION 9.2	48 years STANDARD_DEVIATION 10.4	47 years STANDARD_DEVIATION 10.2	48 years STANDARD_DEVIATION 9.4	47 years STANDARD_DEVIATION 6	51 years STANDARD_DEVIATION 9	46 years STANDARD_DEVIATION 9.3	49 years STANDARD_DEVIATION 9.9	48 years STANDARD_DEVIATION 11.4
Cirrhosis Status No	272 participants	13 participants	9 participants	10 participants	10 participants	11 participants	0 participants	10 participants	10 participants	25 participants	10 participants	0 participants	25 participants	10 participants	9 participants	25 participants	10 participants	25 participants	25 participants	10 participants	25 participants
Cirrhosis Status Yes	20 participants	1 participants	0 participants	0 participants	0 participants	0 participants	10 participants	0 participants	0 participants	0 participants	0 participants	9 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	289 Participants	14 Participants	9 Participants	10 Participants	10 Participants	11 Participants	8 Participants	10 Participants	10 Participants	25 Participants	9 Participants	9 Participants	25 Participants	10 Participants	9 Participants	25 Participants	10 Participants	25 Participants	25 Participants	10 Participants	25 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
HCV Genotype Genotype 1	162 participants	14 participants	9 participants	0 participants	0 participants	0 participants	10 participants	10 participants	0 participants	0 participants	0 participants	9 participants	25 participants	10 participants	0 participants	0 participants	0 participants	25 participants	25 participants	0 participants	25 participants
HCV Genotype Genotype 2	31 participants	0 participants	0 participants	2 participants	3 participants	4 participants	0 participants	0 participants	0 participants	6 participants	0 participants	0 participants	0 participants	0 participants	3 participants	5 participants	4 participants	0 participants	0 participants	4 participants	0 participants
HCV Genotype Genotype 3	99 participants	0 participants	0 participants	8 participants	7 participants	7 participants	0 participants	0 participants	10 participants	19 participants	10 participants	0 participants	0 participants	0 participants	6 participants	20 participants	6 participants	0 participants	0 participants	6 participants	0 participants
HCV RNA Category < 6 log10 IU/mL	87 participants	2 participants	0 participants	5 participants	5 participants	3 participants	2 participants	0 participants	4 participants	5 participants	5 participants	3 participants	11 participants	1 participants	1 participants	12 participants	1 participants	6 participants	8 participants	3 participants	10 participants
HCV RNA Category ≥ 6 log10 IU/mL	205 participants	12 participants	9 participants	5 participants	5 participants	8 participants	8 participants	10 participants	6 participants	20 participants	5 participants	6 participants	14 participants	9 participants	8 participants	13 participants	9 participants	19 participants	17 participants	7 participants	15 participants
Hepatitis C Virus (HCV) RNA	6.3 log10 IU/mL STANDARD_DEVIATION 0.73	6.5 log10 IU/mL STANDARD_DEVIATION 0.51	6.9 log10 IU/mL STANDARD_DEVIATION 0.2	6.1 log10 IU/mL STANDARD_DEVIATION 0.94	5.7 log10 IU/mL STANDARD_DEVIATION 0.89	6.3 log10 IU/mL STANDARD_DEVIATION 0.76	6.5 log10 IU/mL STANDARD_DEVIATION 0.57	7.0 log10 IU/mL STANDARD_DEVIATION 0.38	6.2 log10 IU/mL STANDARD_DEVIATION 0.96	6.5 log10 IU/mL STANDARD_DEVIATION 0.66	6.1 log10 IU/mL STANDARD_DEVIATION 0.88	6.3 log10 IU/mL STANDARD_DEVIATION 0.78	5.9 log10 IU/mL STANDARD_DEVIATION 0.85	6.8 log10 IU/mL STANDARD_DEVIATION 0.55	6.6 log10 IU/mL STANDARD_DEVIATION 0.52	6.1 log10 IU/mL STANDARD_DEVIATION 0.8	6.7 log10 IU/mL STANDARD_DEVIATION 0.42	6.5 log10 IU/mL STANDARD_DEVIATION 0.56	6.3 log10 IU/mL STANDARD_DEVIATION 0.54	6.4 log10 IU/mL STANDARD_DEVIATION 0.57	6.1 log10 IU/mL STANDARD_DEVIATION 0.75
IL28b Genotype CC	109 participants	4 participants	0 participants	3 participants	2 participants	4 participants	4 participants	1 participants	4 participants	0 participants	3 participants	2 participants	9 participants	10 participants	4 participants	13 participants	5 participants	5 participants	7 participants	4 participants	25 participants
IL28b Genotype CT	132 participants	7 participants	7 participants	6 participants	6 participants	5 participants	4 participants	8 participants	5 participants	6 participants	6 participants	5 participants	14 participants	0 participants	4 participants	12 participants	4 participants	15 participants	14 participants	4 participants	0 participants
IL28b Genotype TT	51 participants	3 participants	2 participants	1 participants	2 participants	2 participants	2 participants	1 participants	1 participants	19 participants	1 participants	2 participants	2 participants	0 participants	1 participants	0 participants	1 participants	5 participants	4 participants	2 participants	0 participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Race/Ethnicity, Customized Asian	11 participants	1 participants	0 participants	3 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	1 participants	2 participants	2 participants
Race/Ethnicity, Customized Native Hawaiian of Other Pacific Islander	5 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	2 participants	0 participants	0 participants	1 participants	0 participants	0 participants	1 participants	0 participants	1 participants	0 participants	0 participants	0 participants
Race/Ethnicity, Customized Other	36 participants	1 participants	0 participants	0 participants	0 participants	2 participants	2 participants	1 participants	0 participants	6 participants	3 participants	0 participants	1 participants	1 participants	4 participants	3 participants	3 participants	2 participants	4 participants	0 participants	3 participants
Race/Ethnicity, Customized White	239 participants	12 participants	9 participants	7 participants	10 participants	9 participants	8 participants	9 participants	9 participants	17 participants	7 participants	9 participants	23 participants	9 participants	4 participants	20 participants	7 participants	22 participants	20 participants	8 participants	20 participants
Sex: Female, Male Female	110 Participants	2 Participants	2 Participants	7 Participants	6 Participants	2 Participants	0 Participants	3 Participants	3 Participants	6 Participants	5 Participants	1 Participants	17 Participants	3 Participants	4 Participants	8 Participants	2 Participants	12 Participants	12 Participants	5 Participants	10 Participants
Sex: Female, Male Male	182 Participants	12 Participants	7 Participants	3 Participants	4 Participants	9 Participants	10 Participants	7 Participants	7 Participants	19 Participants	5 Participants	8 Participants	8 Participants	7 Participants	5 Participants	17 Participants	8 Participants	13 Participants	13 Participants	5 Participants	15 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk	EG011 affected / at risk	EG012 affected / at risk	EG013 affected / at risk	EG014 affected / at risk	EG015 affected / at risk	EG016 affected / at risk	EG017 affected / at risk	EG018 affected / at risk	EG019 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	10 / 10	9 / 9	10 / 10	11 / 11	10 / 10	10 / 10	10 / 10	25 / 25	24 / 25	25 / 25	10 / 10	9 / 9	24 / 25	10 / 10	25 / 25	7 / 10	8 / 9	7 / 10	13 / 14	22 / 25
serious Total, serious adverse events	1 / 10	0 / 9	0 / 10	0 / 11	0 / 10	1 / 10	0 / 10	1 / 25	0 / 25	2 / 25	0 / 10	0 / 9	2 / 25	0 / 10	0 / 25	0 / 10	0 / 9	0 / 10	2 / 14	0 / 25

Outcome results

Primary

Percentage of Participants Who Experienced Adverse Events

Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.

Time frame: Up to 12 weeks plus 30 days

Population: Safety Analysis Set: participants were randomized and received at least one dose of study medication.

Arm	Measure	Group	Value (NUMBER)
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Serious AE	1 Percentage of participants
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	AE leading to drug discontinuation	0 Percentage of participants
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Any AE	10 Percentage of participants
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Drug-related AE	8 Percentage of participants
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Grade 3 or higher AE	0 Percentage of participants
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Grade 3 or higher AE	2 Percentage of participants
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Drug-related AE	9 Percentage of participants
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Serious AE	0 Percentage of participants
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Any AE	9 Percentage of participants
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	AE leading to drug discontinuation	0 Percentage of participants
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Serious AE	0 Percentage of participants
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Any AE	10 Percentage of participants
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Grade 3 or higher AE	0 Percentage of participants
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	AE leading to drug discontinuation	0 Percentage of participants
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Drug-related AE	10 Percentage of participants
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	AE leading to drug discontinuation	1 Percentage of participants
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Grade 3 or higher AE	1 Percentage of participants
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Serious AE	0 Percentage of participants
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Any AE	11 Percentage of participants
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Drug-related AE	11 Percentage of participants
Group 5: SOF 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	AE leading to drug discontinuation	0 Percentage of participants
Group 5: SOF 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Any AE	10 Percentage of participants
Group 5: SOF 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Drug-related AE	7 Percentage of participants
Group 5: SOF 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Serious AE	0 Percentage of participants
Group 5: SOF 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Grade 3 or higher AE	0 Percentage of participants
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Drug-related AE	10 Percentage of participants
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	AE leading to drug discontinuation	0 Percentage of participants
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Any AE	10 Percentage of participants
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Grade 3 or higher AE	3 Percentage of participants
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Serious AE	1 Percentage of participants
Group 7: SOF+RBV 12 wk: GT 1, TE	Percentage of Participants Who Experienced Adverse Events	Serious AE	0 Percentage of participants
Group 7: SOF+RBV 12 wk: GT 1, TE	Percentage of Participants Who Experienced Adverse Events	Any AE	10 Percentage of participants
Group 7: SOF+RBV 12 wk: GT 1, TE	Percentage of Participants Who Experienced Adverse Events	AE leading to drug discontinuation	0 Percentage of participants
Group 7: SOF+RBV 12 wk: GT 1, TE	Percentage of Participants Who Experienced Adverse Events	Grade 3 or higher AE	0 Percentage of participants
Group 7: SOF+RBV 12 wk: GT 1, TE	Percentage of Participants Who Experienced Adverse Events	Drug-related AE	10 Percentage of participants
Group 8: SOF+RBV 12 wk: GT 1, TN	Percentage of Participants Who Experienced Adverse Events	Drug-related AE	25 Percentage of participants
Group 8: SOF+RBV 12 wk: GT 1, TN	Percentage of Participants Who Experienced Adverse Events	Any AE	25 Percentage of participants
Group 8: SOF+RBV 12 wk: GT 1, TN	Percentage of Participants Who Experienced Adverse Events	Grade 3 or higher AE	1 Percentage of participants
Group 8: SOF+RBV 12 wk: GT 1, TN	Percentage of Participants Who Experienced Adverse Events	Serious AE	1 Percentage of participants
Group 8: SOF+RBV 12 wk: GT 1, TN	Percentage of Participants Who Experienced Adverse Events	AE leading to drug discontinuation	0 Percentage of participants
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE	Percentage of Participants Who Experienced Adverse Events	Any AE	24 Percentage of participants
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE	Percentage of Participants Who Experienced Adverse Events	AE leading to drug discontinuation	0 Percentage of participants
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE	Percentage of Participants Who Experienced Adverse Events	Serious AE	0 Percentage of participants
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE	Percentage of Participants Who Experienced Adverse Events	Grade 3 or higher AE	0 Percentage of participants
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE	Percentage of Participants Who Experienced Adverse Events	Drug-related AE	20 Percentage of participants
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Drug-related AE	21 Percentage of participants
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Serious AE	2 Percentage of participants
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	AE leading to drug discontinuation	0 Percentage of participants
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Any AE	25 Percentage of participants
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Grade 3 or higher AE	1 Percentage of participants
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Grade 3 or higher AE	0 Percentage of participants
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Any AE	10 Percentage of participants
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Drug-related AE	7 Percentage of participants
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	AE leading to drug discontinuation	0 Percentage of participants
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Serious AE	0 Percentage of participants
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE	Percentage of Participants Who Experienced Adverse Events	AE leading to drug discontinuation	0 Percentage of participants
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE	Percentage of Participants Who Experienced Adverse Events	Grade 3 or higher AE	0 Percentage of participants
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE	Percentage of Participants Who Experienced Adverse Events	Drug-related AE	9 Percentage of participants
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE	Percentage of Participants Who Experienced Adverse Events	Serious AE	0 Percentage of participants
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE	Percentage of Participants Who Experienced Adverse Events	Any AE	9 Percentage of participants
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN	Percentage of Participants Who Experienced Adverse Events	Grade 3 or higher AE	3 Percentage of participants
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN	Percentage of Participants Who Experienced Adverse Events	Drug-related AE	24 Percentage of participants
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN	Percentage of Participants Who Experienced Adverse Events	AE leading to drug discontinuation	1 Percentage of participants
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN	Percentage of Participants Who Experienced Adverse Events	Any AE	24 Percentage of participants
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN	Percentage of Participants Who Experienced Adverse Events	Serious AE	2 Percentage of participants
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE	Percentage of Participants Who Experienced Adverse Events	Grade 3 or higher AE	0 Percentage of participants
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE	Percentage of Participants Who Experienced Adverse Events	Serious AE	0 Percentage of participants
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE	Percentage of Participants Who Experienced Adverse Events	Drug-related AE	10 Percentage of participants
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE	Percentage of Participants Who Experienced Adverse Events	Any AE	10 Percentage of participants
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE	Percentage of Participants Who Experienced Adverse Events	AE leading to drug discontinuation	0 Percentage of participants
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN	Percentage of Participants Who Experienced Adverse Events	AE leading to drug discontinuation	0 Percentage of participants
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN	Percentage of Participants Who Experienced Adverse Events	Serious AE	0 Percentage of participants
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN	Percentage of Participants Who Experienced Adverse Events	Drug-related AE	21 Percentage of participants
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN	Percentage of Participants Who Experienced Adverse Events	Any AE	25 Percentage of participants
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN	Percentage of Participants Who Experienced Adverse Events	Grade 3 or higher AE	2 Percentage of participants
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis	Percentage of Participants Who Experienced Adverse Events	Grade 3 or higher AE	0 Percentage of participants
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis	Percentage of Participants Who Experienced Adverse Events	Drug-related AE	5 Percentage of participants
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis	Percentage of Participants Who Experienced Adverse Events	AE leading to drug discontinuation	0 Percentage of participants
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis	Percentage of Participants Who Experienced Adverse Events	Any AE	7 Percentage of participants
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis	Percentage of Participants Who Experienced Adverse Events	Serious AE	0 Percentage of participants
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis	Percentage of Participants Who Experienced Adverse Events	Any AE	8 Percentage of participants
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis	Percentage of Participants Who Experienced Adverse Events	AE leading to drug discontinuation	0 Percentage of participants
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis	Percentage of Participants Who Experienced Adverse Events	Grade 3 or higher AE	1 Percentage of participants
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis	Percentage of Participants Who Experienced Adverse Events	Drug-related AE	8 Percentage of participants
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis	Percentage of Participants Who Experienced Adverse Events	Serious AE	0 Percentage of participants
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Drug-related AE	6 Percentage of participants
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	AE leading to drug discontinuation	0 Percentage of participants
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Any AE	7 Percentage of participants
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Grade 3 or higher AE	0 Percentage of participants
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN	Percentage of Participants Who Experienced Adverse Events	Serious AE	0 Percentage of participants
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac	Percentage of Participants Who Experienced Adverse Events	Grade 3 or higher AE	1 Percentage of participants
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac	Percentage of Participants Who Experienced Adverse Events	AE leading to drug discontinuation	3 Percentage of participants
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac	Percentage of Participants Who Experienced Adverse Events	Serious AE	2 Percentage of participants
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac	Percentage of Participants Who Experienced Adverse Events	Any AE	13 Percentage of participants
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac	Percentage of Participants Who Experienced Adverse Events	Drug-related AE	12 Percentage of participants
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN	Percentage of Participants Who Experienced Adverse Events	AE leading to drug discontinuation	2 Percentage of participants
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN	Percentage of Participants Who Experienced Adverse Events	Any AE	22 Percentage of participants
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN	Percentage of Participants Who Experienced Adverse Events	Serious AE	0 Percentage of participants
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN	Percentage of Participants Who Experienced Adverse Events	Drug-related AE	19 Percentage of participants
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN	Percentage of Participants Who Experienced Adverse Events	Grade 3 or higher AE	0 Percentage of participants

Secondary

Change From Baseline in HCV RNA at Week 12

Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6. Data are not presented for Groups 16, 17, 18, and 20 because participants with detectable HCV RNA discontinued due to protocol-specified stopping rules.

Time frame: Baseline to Week 12

Population: Participants in the Safety Analysis Set with available data were analyzed.

Arm	Measure	Value (MEAN)	Dispersion
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 12	-5.52 log10 IU/mL	Standard Deviation 0.418
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 12	-5.44 log10 IU/mL	Standard Deviation 0.519
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 12	-5.23 log10 IU/mL	Standard Deviation 0.571
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 12	-5.20 log10 IU/mL	Standard Deviation 0.756
Group 5: SOF 12 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 12	-4.59 log10 IU/mL	Standard Deviation 0.892
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 12	-5.70 log10 IU/mL	Standard Deviation 0.55
Group 7: SOF+RBV 12 wk: GT 1, TE	Change From Baseline in HCV RNA at Week 12	-4.95 log10 IU/mL	Standard Deviation 0.746
Group 8: SOF+RBV 12 wk: GT 1, TN	Change From Baseline in HCV RNA at Week 12	-5.39 log10 IU/mL	Standard Deviation 0.66
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE	Change From Baseline in HCV RNA at Week 12	-2.01 log10 IU/mL	Standard Deviation 0.962
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 12	-5.74 log10 IU/mL	Standard Deviation 0.203
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 12	-4.85 log10 IU/mL	Standard Deviation 0.823
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE	Change From Baseline in HCV RNA at Week 12	-5.84 log10 IU/mL	Standard Deviation 0.383
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN	Change From Baseline in HCV RNA at Week 12	-5.19 log10 IU/mL	Standard Deviation 0.536

Secondary

Change From Baseline in HCV RNA at Week 6

Time frame: Baseline to Week 6

Population: Safety Analysis Set

Arm	Measure	Value (MEAN)	Dispersion
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 6	-5.52 log10 IU/mL	Standard Deviation 0.418
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 6	-5.44 log10 IU/mL	Standard Deviation 0.519
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 6	-5.23 log10 IU/mL	Standard Deviation 0.571
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 6	-5.20 log10 IU/mL	Standard Deviation 0.756
Group 5: SOF 12 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 6	-6.23 log10 IU/mL	Standard Deviation 0.892
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 6	-4.94 log10 IU/mL	Standard Deviation 0.885
Group 7: SOF+RBV 12 wk: GT 1, TE	Change From Baseline in HCV RNA at Week 6	-5.70 log10 IU/mL	Standard Deviation 0.55
Group 8: SOF+RBV 12 wk: GT 1, TN	Change From Baseline in HCV RNA at Week 6	-4.95 log10 IU/mL	Standard Deviation 0.746
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE	Change From Baseline in HCV RNA at Week 6	-5.38 log10 IU/mL	Standard Deviation 0.66
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 6	-4.92 log10 IU/mL	Standard Deviation 0.803
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 6	-5.01 log10 IU/mL	Standard Deviation 0.962
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE	Change From Baseline in HCV RNA at Week 6	-5.74 log10 IU/mL	Standard Deviation 0.203
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN	Change From Baseline in HCV RNA at Week 6	-4.80 log10 IU/mL	Standard Deviation 0.851
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE	Change From Baseline in HCV RNA at Week 6	-5.84 log10 IU/mL	Standard Deviation 0.383
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN	Change From Baseline in HCV RNA at Week 6	-5.19 log10 IU/mL	Standard Deviation 0.536
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis	Change From Baseline in HCV RNA at Week 6	-5.36 log10 IU/mL	Standard Deviation 0.575
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis	Change From Baseline in HCV RNA at Week 6	-5.18 log10 IU/mL	Standard Deviation 0.781
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 6	-4.93 log10 IU/mL	Standard Deviation 0.942
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac	Change From Baseline in HCV RNA at Week 6	-5.35 log10 IU/mL	Standard Deviation 0.51
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN	Change From Baseline in HCV RNA at Week 6	-5.39 log10 IU/mL	Standard Deviation 0.559

Secondary

Change From Baseline in HCV RNA at Week 8

Data are not presented for Group 21 which ended treatment after Week 6.

Time frame: Baseline to Week 8

Population: Participants in the Safety Analysis Set with available data were analyzed.

Arm	Measure	Value (MEAN)	Dispersion
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 8	-5.52 log10 IU/mL	Standard Deviation 0.418
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 8	-5.44 log10 IU/mL	Standard Deviation 0.519
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 8	-5.23 log10 IU/mL	Standard Deviation 0.571
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 8	-5.20 log10 IU/mL	Standard Deviation 0.756
Group 5: SOF 12 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 8	-4.59 log10 IU/mL	Standard Deviation 0.892
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 8	-4.94 log10 IU/mL	Standard Deviation 0.885
Group 7: SOF+RBV 12 wk: GT 1, TE	Change From Baseline in HCV RNA at Week 8	-5.70 log10 IU/mL	Standard Deviation 0.55
Group 8: SOF+RBV 12 wk: GT 1, TN	Change From Baseline in HCV RNA at Week 8	-4.95 log10 IU/mL	Standard Deviation 0.746
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE	Change From Baseline in HCV RNA at Week 8	-5.38 log10 IU/mL	Standard Deviation 0.66
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 8	-4.92 log10 IU/mL	Standard Deviation 0.803
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 8	-5.01 log10 IU/mL	Standard Deviation 0.962
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE	Change From Baseline in HCV RNA at Week 8	-5.74 log10 IU/mL	Standard Deviation 0.203
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN	Change From Baseline in HCV RNA at Week 8	-4.80 log10 IU/mL	Standard Deviation 0.851
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE	Change From Baseline in HCV RNA at Week 8	-5.84 log10 IU/mL	Standard Deviation 0.383
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN	Change From Baseline in HCV RNA at Week 8	-5.19 log10 IU/mL	Standard Deviation 0.536
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis	Change From Baseline in HCV RNA at Week 8	-5.36 log10 IU/mL	Standard Deviation 0.575
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis	Change From Baseline in HCV RNA at Week 8	-5.18 log10 IU/mL	Standard Deviation 0.781
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN	Change From Baseline in HCV RNA at Week 8	-4.93 log10 IU/mL	Standard Deviation 0.942
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac	Change From Baseline in HCV RNA at Week 8	-5.35 log10 IU/mL	Standard Deviation 0.51

Secondary

Percentage of Participants With HCV RNA < LOD at Week 12

Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6.

Time frame: Week 12

Population: Participants in the Safety Analysis Set with available data were analyzed.

Arm	Measure	Value (NUMBER)
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 12	100.0 percentage of participants
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 12	100.0 percentage of participants
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 12	100.0 percentage of participants
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 12	100.0 percentage of participants
Group 5: SOF 12 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 12	100.0 percentage of participants
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 12	100.0 percentage of participants
Group 7: SOF+RBV 12 wk: GT 1, TE	Percentage of Participants With HCV RNA < LOD at Week 12	100.0 percentage of participants
Group 8: SOF+RBV 12 wk: GT 1, TN	Percentage of Participants With HCV RNA < LOD at Week 12	100.0 percentage of participants
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE	Percentage of Participants With HCV RNA < LOD at Week 12	100.0 percentage of participants
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 12	100.0 percentage of participants
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 12	100.0 percentage of participants
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE	Percentage of Participants With HCV RNA < LOD at Week 12	100.0 percentage of participants
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN	Percentage of Participants With HCV RNA < LOD at Week 12	100.0 percentage of participants
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE	Percentage of Participants With HCV RNA < LOD at Week 12	100.0 percentage of participants
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN	Percentage of Participants With HCV RNA < LOD at Week 12	100.0 percentage of participants
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis	Percentage of Participants With HCV RNA < LOD at Week 12	100.0 percentage of participants
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis	Percentage of Participants With HCV RNA < LOD at Week 12	100.0 percentage of participants

Secondary

Percentage of Participants With HCV RNA < LOD at Week 6

Time frame: Week 6

Population: Safety Analysis Set

Arm	Measure	Value (NUMBER)
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 6	100.0 percentage of participants
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 6	100.0 percentage of participants
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 6	100.0 percentage of participants
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 6	100.0 percentage of participants
Group 5: SOF 12 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 6	100.0 percentage of participants
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 6	100.0 percentage of participants
Group 7: SOF+RBV 12 wk: GT 1, TE	Percentage of Participants With HCV RNA < LOD at Week 6	100.0 percentage of participants
Group 8: SOF+RBV 12 wk: GT 1, TN	Percentage of Participants With HCV RNA < LOD at Week 6	100.0 percentage of participants
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE	Percentage of Participants With HCV RNA < LOD at Week 6	100.0 percentage of participants
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 6	100.0 percentage of participants
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 6	100.0 percentage of participants
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE	Percentage of Participants With HCV RNA < LOD at Week 6	100.0 percentage of participants
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN	Percentage of Participants With HCV RNA < LOD at Week 6	100.0 percentage of participants
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE	Percentage of Participants With HCV RNA < LOD at Week 6	100.0 percentage of participants
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN	Percentage of Participants With HCV RNA < LOD at Week 6	100.0 percentage of participants
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis	Percentage of Participants With HCV RNA < LOD at Week 6	100.0 percentage of participants
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis	Percentage of Participants With HCV RNA < LOD at Week 6	100.0 percentage of participants
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 6	100.0 percentage of participants
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac	Percentage of Participants With HCV RNA < LOD at Week 6	100.0 percentage of participants
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN	Percentage of Participants With HCV RNA < LOD at Week 6	100.0 percentage of participants

Secondary

Percentage of Participants With HCV RNA < LOD at Week 8

Data are not presented for Group 21 which ended treatment after Week 6.

Time frame: Week 8

Population: Participants in the Safety Analysis Set with available data were analyzed.

Arm	Measure	Value (NUMBER)
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 8	100.0 percentage of participants
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 8	100.0 percentage of participants
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 8	100.0 percentage of participants
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 8	100.0 percentage of participants
Group 5: SOF 12 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 8	100.0 percentage of participants
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 8	100.0 percentage of participants
Group 7: SOF+RBV 12 wk: GT 1, TE	Percentage of Participants With HCV RNA < LOD at Week 8	100.0 percentage of participants
Group 8: SOF+RBV 12 wk: GT 1, TN	Percentage of Participants With HCV RNA < LOD at Week 8	100.0 percentage of participants
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE	Percentage of Participants With HCV RNA < LOD at Week 8	100.0 percentage of participants
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 8	100.0 percentage of participants
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 8	100.0 percentage of participants
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE	Percentage of Participants With HCV RNA < LOD at Week 8	100.0 percentage of participants
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN	Percentage of Participants With HCV RNA < LOD at Week 8	100.0 percentage of participants
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE	Percentage of Participants With HCV RNA < LOD at Week 8	100.0 percentage of participants
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN	Percentage of Participants With HCV RNA < LOD at Week 8	100.0 percentage of participants
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis	Percentage of Participants With HCV RNA < LOD at Week 8	100.0 percentage of participants
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis	Percentage of Participants With HCV RNA < LOD at Week 8	100.0 percentage of participants
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN	Percentage of Participants With HCV RNA < LOD at Week 8	100.0 percentage of participants
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac	Percentage of Participants With HCV RNA < LOD at Week 8	100.0 percentage of participants

Secondary

Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)

SVR12 was defined as HCV RNA \< the limit of detection (LOD; \< 15 IU/mL) 12 weeks after the last dose of study drug.

Time frame: Posttreatment Week 12

Population: Safety Analysis Set

Arm	Measure	Value (NUMBER)
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN	Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)	100.0 percentage of participants
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN	Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)	100.0 percentage of participants
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN	Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)	100.0 percentage of participants
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN	Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)	100.0 percentage of participants
Group 5: SOF 12 wk: GT 2 or 3, TN	Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)	60.0 percentage of participants
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN	Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)	100.0 percentage of participants
Group 7: SOF+RBV 12 wk: GT 1, TE	Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)	10.0 percentage of participants
Group 8: SOF+RBV 12 wk: GT 1, TN	Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)	84.0 percentage of participants
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE	Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)	68.0 percentage of participants
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN	Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)	64.0 percentage of participants
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN	Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)	60.0 percentage of participants
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE	Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)	100.0 percentage of participants
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN	Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)	100.0 percentage of participants
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE	Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)	100.0 percentage of participants
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN	Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)	92.0 percentage of participants
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis	Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)	70.0 percentage of participants
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis	Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)	100.0 percentage of participants
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN	Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)	80.0 percentage of participants
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac	Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)	100.0 percentage of participants
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN	Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)	68.0 percentage of participants

Secondary

Percentage of Participants With Virologic Failure

The percentage of participants with on-treatment virologic failure (viral breakthrough, rebound, or nonresponse) or following treatment (viral relapse) was summarized. On-treatment virologic failure was defined as: * Viral breakthrough (confirmed HCV RNA ≥ LOD after having previously had HCV RNA \< LOD while on treatment), * Viral rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, or * Nonresponse (HCV RNA persistently ≥ LOD through 6 weeks of treatment) Viral relapse was defined as confirmed HCV RNA ≥ LOD during the posttreatment period having achieved HCV RNA \< LOD at the last on-treatment visit.

Time frame: Up to Posttreatment Week 24

Population: Safety Analysis Set

Arm	Measure	Group	Value (NUMBER)
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN	Percentage of Participants With Virologic Failure	On-treatment virologic failure	0.0 percentage of participants
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN	Percentage of Participants With Virologic Failure	Viral relapse	0.0 percentage of participants
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN	Percentage of Participants With Virologic Failure	On-treatment virologic failure	0.0 percentage of participants
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN	Percentage of Participants With Virologic Failure	Viral relapse	0.0 percentage of participants
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN	Percentage of Participants With Virologic Failure	On-treatment virologic failure	0.0 percentage of participants
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN	Percentage of Participants With Virologic Failure	Viral relapse	0.0 percentage of participants
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN	Percentage of Participants With Virologic Failure	On-treatment virologic failure	0.0 percentage of participants
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN	Percentage of Participants With Virologic Failure	Viral relapse	0.0 percentage of participants
Group 5: SOF 12 wk: GT 2 or 3, TN	Percentage of Participants With Virologic Failure	Viral relapse	40.0 percentage of participants
Group 5: SOF 12 wk: GT 2 or 3, TN	Percentage of Participants With Virologic Failure	On-treatment virologic failure	0.0 percentage of participants
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN	Percentage of Participants With Virologic Failure	Viral relapse	0.0 percentage of participants
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN	Percentage of Participants With Virologic Failure	On-treatment virologic failure	0.0 percentage of participants
Group 7: SOF+RBV 12 wk: GT 1, TE	Percentage of Participants With Virologic Failure	On-treatment virologic failure	0.0 percentage of participants
Group 7: SOF+RBV 12 wk: GT 1, TE	Percentage of Participants With Virologic Failure	Viral relapse	90.0 percentage of participants
Group 8: SOF+RBV 12 wk: GT 1, TN	Percentage of Participants With Virologic Failure	On-treatment virologic failure	0.0 percentage of participants
Group 8: SOF+RBV 12 wk: GT 1, TN	Percentage of Participants With Virologic Failure	Viral relapse	16.0 percentage of participants
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE	Percentage of Participants With Virologic Failure	Viral relapse	32.0 percentage of participants
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE	Percentage of Participants With Virologic Failure	On-treatment virologic failure	0.0 percentage of participants
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN	Percentage of Participants With Virologic Failure	On-treatment virologic failure	0.0 percentage of participants
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN	Percentage of Participants With Virologic Failure	Viral relapse	36.0 percentage of participants
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN	Percentage of Participants With Virologic Failure	Viral relapse	40.0 percentage of participants
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN	Percentage of Participants With Virologic Failure	On-treatment virologic failure	0.0 percentage of participants
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE	Percentage of Participants With Virologic Failure	Viral relapse	0.0 percentage of participants
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE	Percentage of Participants With Virologic Failure	On-treatment virologic failure	0.0 percentage of participants
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN	Percentage of Participants With Virologic Failure	On-treatment virologic failure	0.0 percentage of participants
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN	Percentage of Participants With Virologic Failure	Viral relapse	0.0 percentage of participants
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE	Percentage of Participants With Virologic Failure	On-treatment virologic failure	0.0 percentage of participants
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE	Percentage of Participants With Virologic Failure	Viral relapse	0.0 percentage of participants
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN	Percentage of Participants With Virologic Failure	On-treatment virologic failure	0.0 percentage of participants
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN	Percentage of Participants With Virologic Failure	Viral relapse	8.0 percentage of participants
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis	Percentage of Participants With Virologic Failure	On-treatment virologic failure	0.0 percentage of participants
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis	Percentage of Participants With Virologic Failure	Viral relapse	30.0 percentage of participants
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis	Percentage of Participants With Virologic Failure	On-treatment virologic failure	0.0 percentage of participants
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis	Percentage of Participants With Virologic Failure	Viral relapse	0.0 percentage of participants
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN	Percentage of Participants With Virologic Failure	On-treatment virologic failure	0.0 percentage of participants
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN	Percentage of Participants With Virologic Failure	Viral relapse	20.0 percentage of participants
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac	Percentage of Participants With Virologic Failure	Viral relapse	0.0 percentage of participants
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac	Percentage of Participants With Virologic Failure	On-treatment virologic failure	0.0 percentage of participants
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN	Percentage of Participants With Virologic Failure	Viral relapse	32.0 percentage of participants
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN	Percentage of Participants With Virologic Failure	On-treatment virologic failure	0.0 percentage of participants

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026

Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3

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Brief summary

Detailed description

Related papers

Interventions

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Study design

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Inclusion criteria

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Design outcomes

Primary

Secondary

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Participant flow

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Participants by arm

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Baseline characteristics

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Outcome results

Percentage of Participants Who Experienced Adverse Events

Change From Baseline in HCV RNA at Week 12

Change From Baseline in HCV RNA at Week 6

Change From Baseline in HCV RNA at Week 8

Percentage of Participants With HCV RNA < LOD at Week 12

Percentage of Participants With HCV RNA < LOD at Week 6

Percentage of Participants With HCV RNA < LOD at Week 8

Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)

Percentage of Participants With Virologic Failure