Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection

A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01826981

Enrollment

359

Registered

2013-04-09

Start date

2013-04-30

Completion date

2015-05-31

Last updated

2018-11-16

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

Conditions

Chronic Hepatitis C

Brief summary

The purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic hepatitis C virus (HCV) infection.

Interventions

DRUGLDV/SOF

Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily

DRUGSOF

SOF 400 mg tablet administered orally once daily

DRUGRBV

Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

DRUGPeg-IFN

pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly

DRUGGS-9669

GS-9669 500 mg (2 × 250 mg tablet) administered orally once daily

DRUGVEL

Velpatasvir (VEL) tablet(s) administered orally 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 1, 2, 3, or 6 HCV infection * Cirrhosis determination; a liver biopsy may be required * Screening laboratory values within defined thresholds * Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion criteria

* Pregnant or nursing female or male with pregnant female partner * Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers) * Chronic use of systemic immunosuppressive agents * History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	Posttreatment Week 12	SVR12 is defined as HCV RNA \< lower limit of quantification (LLOQ) at 12 weeks after stopping study treatment.
Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)	Up to 24 weeks plus 30 days	—

Secondary

Measure	Time frame	Description
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Weeks 1 and 2	—
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	Posttreatment Weeks 2, 4, 8, and 24	—
For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20)	Posttreatment Weeks 16 and 20	—
Percentage of Participants With On-treatment Virologic Failure	Up to Posttreatment Week 24	On-treatment virologic failure was defined as: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Percentage of Participants Experiencing Viral Relapse	Up to Posttreatment Week 24	Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.

Countries

New Zealand

Participant flow

Recruitment details

Participants were enrolled at a total of 2 study sites in New Zealand. The first participant was screened on 3 April 2016. The last study visit occurred on 25 May 2015.

Pre-assignment details

446 participants were screened.

Participants by arm

Arm	Count
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.	19
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study	10
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis	25
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis	26
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection	25
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection	26
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection	25
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection	50
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis	20
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic) SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection	27
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic) SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection	24
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic) SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection	27
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic) SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection	26
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study	20
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection) LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection	8
Total	358

Withdrawals & dropouts

Period	Reason	FG001	FG004	FG005	FG006	FG007	FG008	FG009	FG010	FG011	FG012	FG013
Overall Study	Adverse Event	0	1	0	0	0	0	0	0	0	0	0
Overall Study	Enrolled/Randomized but Not Treated	0	0	0	0	1	0	0	0	0	0	0
Overall Study	Lack of Efficacy	1	5	0	0	8	7	0	1	0	0	3
Overall Study	Lost to Follow-up	0	1	1	0	1	0	1	1	1	1	0
Overall Study	Upper G-I Haemorrhage	0	0	0	0	0	0	0	0	0	0	1
Overall Study	Withdrew Consent	0	0	0	1	1	0	0	0	1	0	1

Baseline characteristics

Characteristic	Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)	Total	Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)	Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)	Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)	Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)	Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)	Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)	Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)	Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)	Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)	Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)	Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)	Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease	Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)	Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
Age, Continuous	55 Years STANDARD_DEVIATION 6.1	50.7 Years STANDARD_DEVIATION 9.44	53 Years STANDARD_DEVIATION 6.9	54 Years STANDARD_DEVIATION 7	47 Years STANDARD_DEVIATION 10.3	50 Years STANDARD_DEVIATION 10.2	47 Years STANDARD_DEVIATION 7.9	48 Years STANDARD_DEVIATION 7.9	56 Years STANDARD_DEVIATION 5.5	52 Years STANDARD_DEVIATION 8.2	51 Years STANDARD_DEVIATION 13.9	48 Years STANDARD_DEVIATION 9.2	43 Years STANDARD_DEVIATION 10.2	55 Years STANDARD_DEVIATION 6.7	56 Years STANDARD_DEVIATION 5.3	49 Years STANDARD_DEVIATION 12.5
Cirrhosis Status No	18 participants	251 participants	6 participants	6 participants	26 participants	27 participants	24 participants	27 participants	0 participants	28 participants	23 participants	20 participants	21 participants	9 participants	7 participants	9 participants
Cirrhosis Status Yes	1 participants	107 participants	2 participants	14 participants	0 participants	0 participants	0 participants	0 participants	20 participants	22 participants	2 participants	6 participants	4 participants	17 participants	18 participants	1 participants
HCV Genotype 1b with possible mixed infection with Genotype 4	0 participants	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	1 participants	0 participants
HCV Genotype Genotype 1a	16 participants	86 participants	6 participants	9 participants	0 participants	0 participants	0 participants	0 participants	18 participants	0 participants	0 participants	0 participants	0 participants	22 participants	15 participants	0 participants
HCV Genotype Genotype 1a with possible 6 (subtypes c - l)	1 participants	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	0 participants
HCV Genotype Genotype 1b	2 participants	19 participants	2 participants	0 participants	0 participants	0 participants	0 participants	0 participants	2 participants	0 participants	0 participants	0 participants	0 participants	4 participants	9 participants	0 participants
HCV Genotype Genotype 3	0 participants	7 participants	0 participants	0 participants	0 participants	0 participants	1 participants	2 participants	0 participants	3 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants
HCV Genotype Genotype 3a	0 participants	215 participants	0 participants	10 participants	26 participants	27 participants	22 participants	25 participants	0 participants	46 participants	0 participants	25 participants	24 participants	0 participants	0 participants	10 participants
HCV Genotype Genotype 3k	0 participants	1 participants	0 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
HCV Genotype Genotype 6a or 6b	0 participants	8 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	8 participants	0 participants	0 participants	0 participants	0 participants	0 participants
HCV Genotype Genotype 6 (subtypes c - l)	0 participants	17 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	17 participants	0 participants	0 participants	0 participants	0 participants	0 participants
HCV Genotype Indeterminate genotype. Sequencing indicates GT3a	0 participants	1 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
HCV Genotype Indeterminate pattern. Sequencing indicates GT3k	0 participants	1 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
HCV Genotype Missing	0 participants	1 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	0 participants	0 participants
HCV RNA	6.3 log 10 IU/mL STANDARD_DEVIATION 0.51	6.2 log 10 IU/mL STANDARD_DEVIATION 0.76	6.0 log 10 IU/mL STANDARD_DEVIATION 10.9	6.0 log 10 IU/mL STANDARD_DEVIATION 0.48	6.2 log 10 IU/mL STANDARD_DEVIATION 0.92	6.0 log 10 IU/mL STANDARD_DEVIATION 0.71	6.3 log 10 IU/mL STANDARD_DEVIATION 0.69	5.9 log 10 IU/mL STANDARD_DEVIATION 0.86	6.0 log 10 IU/mL STANDARD_DEVIATION 0.48	6.3 log 10 IU/mL STANDARD_DEVIATION 0.76	6.7 log 10 IU/mL STANDARD_DEVIATION 0.67	6.3 log 10 IU/mL STANDARD_DEVIATION 0.87	6.3 log 10 IU/mL STANDARD_DEVIATION 0.88	6.1 log 10 IU/mL STANDARD_DEVIATION 0.69	6.5 log 10 IU/mL STANDARD_DEVIATION 0.39	6.5 log 10 IU/mL STANDARD_DEVIATION 0.63
HCV RNA Category < 800,000	3 IU/mL	102 IU/mL	2 IU/mL	6 IU/mL	7 IU/mL	11 IU/mL	10 IU/mL	14 IU/mL	5 IU/mL	15 IU/mL	2 IU/mL	6 IU/mL	9 IU/mL	9 IU/mL	2 IU/mL	1 IU/mL
HCV RNA Category >= 800,000	16 IU/mL	256 IU/mL	6 IU/mL	14 IU/mL	19 IU/mL	16 IU/mL	14 IU/mL	13 IU/mL	15 IU/mL	35 IU/mL	23 IU/mL	20 IU/mL	16 IU/mL	17 IU/mL	23 IU/mL	9 IU/mL
IL28b Status CC	4 participants	145 participants	7 participants	7 participants	14 participants	15 participants	6 participants	10 participants	7 participants	18 participants	20 participants	15 participants	9 participants	4 participants	6 participants	3 participants
IL28b Status CT	12 participants	159 participants	1 participants	7 participants	10 participants	11 participants	15 participants	13 participants	6 participants	27 participants	5 participants	6 participants	10 participants	19 participants	12 participants	5 participants
IL28b Status TT	3 participants	54 participants	0 participants	6 participants	2 participants	1 participants	3 participants	4 participants	7 participants	5 participants	0 participants	5 participants	6 participants	3 participants	7 participants	2 participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants	1 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	0 participants
Race/Ethnicity, Customized Asian	0 participants	32 participants	1 participants	0 participants	0 participants	1 participants	0 participants	1 participants	1 participants	3 participants	22 participants	1 participants	1 participants	0 participants	1 participants	0 participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants	34 participants	4 participants	1 participants	6 participants	3 participants	2 participants	5 participants	2 participants	5 participants	0 participants	1 participants	1 participants	1 participants	2 participants	1 participants
Race/Ethnicity, Customized Not Hispanic or Latino	19 participants	358 participants	8 participants	20 participants	26 participants	27 participants	24 participants	27 participants	20 participants	50 participants	25 participants	26 participants	25 participants	26 participants	25 participants	10 participants
Race/Ethnicity, Customized Other	1 participants	13 participants	0 participants	1 participants	0 participants	3 participants	2 participants	1 participants	0 participants	2 participants	0 participants	1 participants	1 participants	1 participants	0 participants	0 participants
Race/Ethnicity, Customized White	18 participants	278 participants	3 participants	18 participants	19 participants	20 participants	20 participants	20 participants	17 participants	40 participants	3 participants	23 participants	22 participants	24 participants	22 participants	9 participants
Sex: Female, Male Female	6 Participants	124 Participants	2 Participants	2 Participants	15 Participants	10 Participants	6 Participants	10 Participants	3 Participants	11 Participants	9 Participants	15 Participants	12 Participants	11 Participants	10 Participants	2 Participants
Sex: Female, Male Male	13 Participants	234 Participants	6 Participants	18 Participants	11 Participants	17 Participants	18 Participants	17 Participants	17 Participants	39 Participants	16 Participants	11 Participants	13 Participants	15 Participants	15 Participants	8 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
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	17 / 19	10 / 10	24 / 25	24 / 26	24 / 25	23 / 26	21 / 25	43 / 50	19 / 20	17 / 20	6 / 8	18 / 27	18 / 24	22 / 27	21 / 26
serious Total, serious adverse events	0 / 19	0 / 10	1 / 25	0 / 26	4 / 25	0 / 26	1 / 25	1 / 50	2 / 20	3 / 20	0 / 8	1 / 27	0 / 24	0 / 27	0 / 26

Outcome results

Primary

Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

Time frame: Up to 24 weeks plus 30 days

Population: Safety Analysis Set

Arm	Measure	Value (NUMBER)
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)	Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)	0 Percentage of participants
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)	Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)	0 Percentage of participants
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)	Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)	4.0 Percentage of participants
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease	Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)	0 Percentage of participants
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)	Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)	4.0 Percentage of participants
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)	Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)	0 Percentage of participants
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)	Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)	0 Percentage of participants
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)	Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)	2.0 Percentage of participants
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)	Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)	0 Percentage of participants
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)	0 Percentage of participants
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)	4.2 Percentage of participants
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)	0 Percentage of participants
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)	3.8 Percentage of participants
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)	Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)	5.0 Percentage of participants
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)	Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)	0 Percentage of participants

Primary

Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 is defined as HCV RNA \< lower limit of quantification (LLOQ) at 12 weeks after stopping study treatment.

Time frame: Posttreatment Week 12

Population: Full analysis set: Participants who were randomized and received at least 1 dose of study drug.

Arm	Measure	Value (NUMBER)
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)	Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	100 percentage of participants
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)	Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	90 percentage of participants
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)	Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	100 percentage of participants
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease	Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	100 percentage of participants
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)	Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	64.0 percentage of participants
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)	Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	100 percentage of participants
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)	Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	96.0 percentage of participants
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)	Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	82.0 percentage of participants
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)	Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	65.0 percentage of participants
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	100 percentage of participants
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	87.5 percentage of participants
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	96.3 percentage of participants
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	100.0 percentage of participants
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)	Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	75 percentage of participants
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)	Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	100 percentage of participants

Secondary

For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20)

Time frame: Posttreatment Weeks 16 and 20

Population: Full Analysis Set included the participants who were randomized into Cohort 6 and received at least one dose of study drug.

Arm	Measure	Group	Value (NUMBER)
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)	For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20)	SVR16	100 percentage of participants
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)	For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20)	SVR20	100 percentage of participants

Secondary

Percentage of Participants Experiencing Viral Relapse

Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.

Time frame: Up to Posttreatment Week 24

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

Arm	Measure	Value (NUMBER)
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)	Percentage of Participants Experiencing Viral Relapse	0 percentage of participants
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)	Percentage of Participants Experiencing Viral Relapse	10.0 percentage of participants
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)	Percentage of Participants Experiencing Viral Relapse	0 percentage of participants
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease	Percentage of Participants Experiencing Viral Relapse	0 percentage of participants
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)	Percentage of Participants Experiencing Viral Relapse	33.3 percentage of participants
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)	Percentage of Participants Experiencing Viral Relapse	0 percentage of participants
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)	Percentage of Participants Experiencing Viral Relapse	4.0 percentage of participants
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)	Percentage of Participants Experiencing Viral Relapse	16.3 percentage of participants
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)	Percentage of Participants Experiencing Viral Relapse	35.0 percentage of participants
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants Experiencing Viral Relapse	0 percentage of participants
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants Experiencing Viral Relapse	8.7 percentage of participants
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants Experiencing Viral Relapse	0 percentage of participants
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants Experiencing Viral Relapse	0 percentage of participants
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)	Percentage of Participants Experiencing Viral Relapse	15.0 percentage of participants
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)	Percentage of Participants Experiencing Viral Relapse	0 percentage of participants

Secondary

Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)

Time frame: Posttreatment Weeks 2, 4, 8, and 24

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

Arm	Measure	Group	Value (NUMBER)
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR8	100.0 percentage of participants
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR4	100.0 percentage of participants
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR24	100.0 percentage of participants
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR2	100.0 percentage of participants
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR2	100.0 percentage of participants
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR8	90.0 percentage of participants
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR4	100.0 percentage of participants
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR24	90.0 percentage of participants
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR8	100.0 percentage of participants
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR24	100.0 percentage of participants
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR4	84.0 percentage of participants
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR2	100.0 percentage of participants
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR24	100.0 percentage of participants
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR2	100.0 percentage of participants
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR4	92.3 percentage of participants
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR8	100.0 percentage of participants
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR24	64.0 percentage of participants
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR2	72.0 percentage of participants
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR8	64.0 percentage of participants
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR4	95.8 percentage of participants
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR4	88.5 percentage of participants
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR2	100.0 percentage of participants
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR24	100.0 percentage of participants
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR8	100.0 percentage of participants
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR8	96.0 percentage of participants
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR4	96.0 percentage of participants
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR24	96.0 percentage of participants
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR2	100.0 percentage of participants
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR24	82.0 percentage of participants
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR2	90.0 percentage of participants
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR4	96.0 percentage of participants
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR8	82.0 percentage of participants
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR4	75.0 percentage of participants
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR2	95.0 percentage of participants
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR8	65.0 percentage of participants
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR24	65.0 percentage of participants
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR24	100.0 percentage of participants
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR4	96.3 percentage of participants
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR8	100.0 percentage of participants
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR2	100.0 percentage of participants
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR8	87.5 percentage of participants
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR24	87.5 percentage of participants
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR4	95.7 percentage of participants
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR2	87.5 percentage of participants
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR4	92.3 percentage of participants
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR8	96.3 percentage of participants
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR24	96.3 percentage of participants
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR2	96.3 percentage of participants
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR2	100.0 percentage of participants
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR24	100.0 percentage of participants
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR8	100.0 percentage of participants
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR4	96.2 percentage of participants
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR2	95.0 percentage of participants
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR4	75.0 percentage of participants
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR8	80.0 percentage of participants
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR24	75.0 percentage of participants
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR4	87.5 percentage of participants
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR24	100.0 percentage of participants
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR8	100.0 percentage of participants
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)	SVR2	100.0 percentage of participants

Secondary

Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

Time frame: Week 10

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

Arm	Measure	Value (NUMBER)
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0 percentage of participants
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0 percentage of participants
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0 percentage of participants
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0 percentage of participants
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0 percentage of participants
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0 percentage of participants
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0 percentage of participants
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	98.0 percentage of participants
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0 percentage of participants
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0 percentage of participants
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0 percentage of participants

Secondary

Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

Time frame: Weeks 1 and 2

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

Arm	Measure	Group	Value (NUMBER)
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 2	63.2 percentage of participants
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 1	15.8 percentage of participants
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 2	50.0 percentage of participants
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 1	30.0 percentage of participants
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 1	4.0 percentage of participants
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 2	44.0 percentage of participants
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 2	53.8 percentage of participants
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 1	11.5 percentage of participants
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 1	20.0 percentage of participants
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 2	64.0 percentage of participants
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 2	61.5 percentage of participants
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 1	11.5 percentage of participants
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 1	12.0 percentage of participants
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 2	56.0 percentage of participants
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 2	52.0 percentage of participants
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 1	12.0 percentage of participants
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 1	0 percentage of participants
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 2	25.0 percentage of participants
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 1	33.3 percentage of participants
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 2	70.4 percentage of participants
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 1	4.2 percentage of participants
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 2	66.7 percentage of participants
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 2	65.4 percentage of participants
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 1	26.9 percentage of participants
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 1	19.2 percentage of participants
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 2	69.2 percentage of participants
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 1	15.0 percentage of participants
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 2	45.0 percentage of participants
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 1	12.5 percentage of participants
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 2	75.0 percentage of participants

Secondary

Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

Time frame: Weeks 4, 6, and 8

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

Arm	Measure	Group	Value (NUMBER)
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 6	100.0 percentage of participants
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 4	100.0 percentage of participants
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 8	100.0 percentage of participants
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 4	100.0 percentage of participants
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 6	100.0 percentage of participants
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 8	100.0 percentage of participants
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 6	100.0 percentage of participants
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 4	84.0 percentage of participants
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 8	100.0 percentage of participants
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 8	100.0 percentage of participants
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 4	92.3 percentage of participants
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 6	100.0 percentage of participants
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 4	95.8 percentage of participants
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 8	100.0 percentage of participants
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 6	100.0 percentage of participants
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 6	100.0 percentage of participants
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 4	88.5 percentage of participants
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 8	100.0 percentage of participants
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 8	100.0 percentage of participants
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 4	96.0 percentage of participants
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 6	96.0 percentage of participants
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 6	100.0 percentage of participants
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 4	96.0 percentage of participants
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 8	100.0 percentage of participants
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 4	75.0 percentage of participants
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 6	100.0 percentage of participants
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 8	100.0 percentage of participants
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 6	100.0 percentage of participants
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 4	96.3 percentage of participants
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 8	100.0 percentage of participants
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 6	100.0 percentage of participants
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 4	95.7 percentage of participants
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 8	100.0 percentage of participants
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 8	100.0 percentage of participants
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 6	100.0 percentage of participants
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 4	92.3 percentage of participants
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 6	100.0 percentage of participants
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 4	96.2 percentage of participants
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 8	100.0 percentage of participants
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 4	75.0 percentage of participants
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 8	90.0 percentage of participants
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 6	90.0 percentage of participants
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 6	100.0 percentage of participants
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 8	100.0 percentage of participants
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 4	87.5 percentage of participants

Secondary

Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

Time frame: Week 12

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

Arm	Measure	Value (NUMBER)
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0 percentage of participants
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0 percentage of participants
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0 percentage of participants
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0 percentage of participants
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0 percentage of participants
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0 percentage of participants
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0 percentage of participants
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	98.0 percentage of participants
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0 percentage of participants
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0 percentage of participants
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	100.0 percentage of participants

Secondary

Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

Time frame: Weeks 16, 20, and 24

Population: Full Analysis Set

Arm	Measure	Group	Value (NUMBER)
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 16	100.0 percentage of participants
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 20	100.0 percentage of participants
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)	Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment	Week 24	100.0 percentage of participants

Secondary

Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)

Time frame: Up to Posttreatment Week 24

Population: Full Analysis Set

Arm	Measure	Value (NUMBER)
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)	Percentage of Participants With On-treatment Virologic Failure	0 percentage of participants
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)	Percentage of Participants With On-treatment Virologic Failure	0 percentage of participants
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)	Percentage of Participants With On-treatment Virologic Failure	0 percentage of participants
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease	Percentage of Participants With On-treatment Virologic Failure	0 percentage of participants
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)	Percentage of Participants With On-treatment Virologic Failure	0 percentage of participants
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)	Percentage of Participants With On-treatment Virologic Failure	0 percentage of participants
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)	Percentage of Participants With On-treatment Virologic Failure	0 percentage of participants
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)	Percentage of Participants With On-treatment Virologic Failure	0 percentage of participants
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)	Percentage of Participants With On-treatment Virologic Failure	0 percentage of participants
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With On-treatment Virologic Failure	0 percentage of participants
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With On-treatment Virologic Failure	0 percentage of participants
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With On-treatment Virologic Failure	0 percentage of participants
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)	Percentage of Participants With On-treatment Virologic Failure	0 percentage of participants
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)	Percentage of Participants With On-treatment Virologic Failure	0 percentage of participants
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)	Percentage of Participants With On-treatment Virologic Failure	0 percentage of participants

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026

Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20)

Percentage of Participants Experiencing Viral Relapse

Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)

Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

Percentage of Participants With On-treatment Virologic Failure