Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection

A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Naive Subjects With Chronic HCV Infection

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01858766

Enrollment

379

Registered

2013-05-21

Start date

2013-04-30

Completion date

2014-08-31

Last updated

2018-11-14

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

Conditions

Hepatitis C

Keywords

Hepatitis, HCV Genotype 1, HCV Genotype 2, HCV Genotype 3, HCV Genotype 4, HCV Genotype 5, HCV Genotype 6, treatment naive

Brief summary

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus (HCV) infection.

Interventions

DRUGSOF

400 mg tablet administered orally once daily

DRUGVEL

Tablet administered orally once daily

DRUGRBV

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)

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 HCV infection * Body mass index (BMI) ≥ 18 kg/m\^2 * HCV RNA ≥ 10000 IU/mL at screening * Use of highly effective contraception methods if female of childbearing potential or sexually active male * Must not have cirrhosis

Exclusion criteria

* Current or prior history of clinically significant illness other than HCV * Screening ECG with clinically significant abnormalities * Prior exposure to HCV specific direct acting antiviral agent * Prior treatment of HCV with interferon or ribavirin * Pregnant or nursing female or male with pregnant female partner * Chronic liver disease of non-HCV etiology * Hepatitis B * Active drug abuse * Use of any prohibited concomitant medications

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	Posttreatment Week 12	SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	Up to 12 weeks	—

Secondary

Measure	Time frame	Description
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	Posttreatment Weeks 4 and 24	SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Percentage of Participants With Virologic Failure	Up to Posttreatment Week 24	Virologic failure was defined as: * On-treatment virologic failure: * 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) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.

Countries

Puerto Rico, United States

Participant flow

Recruitment details

Participants were enrolled at study sites in the United States. The first participant was screened on 22 April 2013. The last study visit occurred on 12 August 2014.

Pre-assignment details

469 participants were screened.

Participants by arm

Arm	Count
SOF+VEL 25 mg 12 Weeks (GT1) SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)	27
SOF+VEL 100 mg 12 Weeks (GT1) SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)	28
SOF+VEL 25 mg 12 Weeks (GT2) SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)	11
SOF+VEL 100 mg 12 Weeks (GT2) SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)	10
SOF+VEL 25 mg 12 Weeks (GT3) SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)	27
SOF+VEL 100 mg 12 Weeks (GT3) SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)	27
SOF+VEL 25 mg 12 Weeks (GT4) SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)	7
SOF+VEL 100 mg 12 Weeks (GT4) SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)	7
SOF+VEL 25 mg 12 Weeks (GT5) SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)	1
SOF+VEL 25 mg 12 Weeks (GT6) SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)	4
SOF+VEL 100 mg 12 Weeks (GT6) SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)	5
SOF+VEL 25 mg 8 Weeks (GT1) SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)	30
SOF+VEL 25 mg + RBV 8 Weeks (GT1) SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)	30
SOF+VEL 100 mg 8 Weeks (GT1) SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)	29
SOF+VEL 100 mg + RBV 8 Weeks (GT1) SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)	31
SOF+VEL 25 mg 8 Weeks (GT2) SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)	26
SOF+VEL 25 mg + RBV 8 Weeks (GT2) SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)	25
SOF+VEL 100 mg 8 Weeks (GT2) SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)	26
SOF+VEL 100 mg + RBV 8 Weeks (GT2) SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)	26
Total	377

Withdrawals & dropouts

Period	Reason	FG000	FG002	FG004	FG005	FG007	FG011	FG012	FG013	FG014	FG015	FG016	FG017	FG018
Overall Study	Death	0	1	0	0	0	0	0	0	0	0	0	0	0
Overall Study	Lack of Efficacy	1	0	1	2	0	3	5	3	5	5	2	3	3
Overall Study	Lost to Follow-up	0	0	0	1	2	1	0	0	3	1	1	0	1
Overall Study	Randomized but Never Treated	0	0	0	1	0	0	0	0	0	0	0	1	0
Overall Study	Withdrew Consent	0	0	0	0	0	1	0	0	0	0	0	0	0

Baseline characteristics

Characteristic	SOF+VEL 25 mg 12 Weeks (GT1)	Total	SOF+VEL 100 mg + RBV 8 Weeks (GT2)	SOF+VEL 100 mg 8 Weeks (GT2)	SOF+VEL 25 mg + RBV 8 Weeks (GT2)	SOF+VEL 25 mg 8 Weeks (GT2)	SOF+VEL 100 mg + RBV 8 Weeks (GT1)	SOF+VEL 100 mg 8 Weeks (GT1)	SOF+VEL 25 mg + RBV 8 Weeks (GT1)	SOF+VEL 25 mg 8 Weeks (GT1)	SOF+VEL 100 mg 12 Weeks (GT6)	SOF+VEL 25 mg 12 Weeks (GT6)	SOF+VEL 25 mg 12 Weeks (GT5)	SOF+VEL 100 mg 12 Weeks (GT4)	SOF+VEL 25 mg 12 Weeks (GT4)	SOF+VEL 100 mg 12 Weeks (GT3)	SOF+VEL 25 mg 12 Weeks (GT3)	SOF+VEL 100 mg 12 Weeks (GT2)	SOF+VEL 25 mg 12 Weeks (GT2)	SOF+VEL 100 mg 12 Weeks (GT1)
Age, Continuous	49 years STANDARD_DEVIATION 11.4	52 years STANDARD_DEVIATION 11.3	51 years STANDARD_DEVIATION 9.4	54 years STANDARD_DEVIATION 10.8	54 years STANDARD_DEVIATION 11.5	52 years STANDARD_DEVIATION 10.8	52 years STANDARD_DEVIATION 13.8	55 years STANDARD_DEVIATION 9.6	53 years STANDARD_DEVIATION 8.5	50 years STANDARD_DEVIATION 10.7	54 years STANDARD_DEVIATION 9.3	57 years STANDARD_DEVIATION 4.8	53 years	56 years STANDARD_DEVIATION 5.5	51 years STANDARD_DEVIATION 16.1	50 years STANDARD_DEVIATION 12.7	52 years STANDARD_DEVIATION 10.8	53 years STANDARD_DEVIATION 12.6	42 years STANDARD_DEVIATION 14.6	49 years STANDARD_DEVIATION 12.2
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants	39 Participants	5 Participants	7 Participants	2 Participants	3 Participants	1 Participants	2 Participants	1 Participants	4 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants	5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants	338 Participants	21 Participants	19 Participants	23 Participants	23 Participants	30 Participants	27 Participants	29 Participants	26 Participants	5 Participants	4 Participants	1 Participants	6 Participants	7 Participants	26 Participants	25 Participants	10 Participants	10 Participants	23 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
HCV Genotype Genotype 1a	22 participants	142 participants	0 participants	0 participants	0 participants	0 participants	25 participants	24 participants	25 participants	25 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	21 participants
HCV Genotype Genotype 1b	5 participants	32 participants	0 participants	0 participants	0 participants	0 participants	6 participants	5 participants	5 participants	5 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	6 participants
HCV Genotype Genotype 1g	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	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants
HCV Genotype Genotype 2	0 participants	124 participants	26 participants	26 participants	25 participants	26 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	10 participants	11 participants	0 participants
HCV Genotype Genotype 3	0 participants	54 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	27 participants	27 participants	0 participants	0 participants	0 participants
HCV Genotype Genotype 4	0 participants	14 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	7 participants	7 participants	0 participants	0 participants	0 participants	0 participants	0 participants
HCV Genotype Genotype 5	0 participants	1 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	0 participants
HCV Genotype Genotype 6	0 participants	9 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	5 participants	4 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
HCV RNA	6.4 log10 IU/mL STANDARD_DEVIATION 0.6	6.5 log10 IU/mL STANDARD_DEVIATION 0.75	6.7 log10 IU/mL STANDARD_DEVIATION 0.57	6.5 log10 IU/mL STANDARD_DEVIATION 0.74	6.6 log10 IU/mL STANDARD_DEVIATION 0.8	6.4 log10 IU/mL STANDARD_DEVIATION 0.87	6.6 log10 IU/mL STANDARD_DEVIATION 0.55	6.3 log10 IU/mL STANDARD_DEVIATION 0.85	6.5 log10 IU/mL STANDARD_DEVIATION 0.63	6.5 log10 IU/mL STANDARD_DEVIATION 0.69	6.7 log10 IU/mL STANDARD_DEVIATION 0.88	6.1 log10 IU/mL STANDARD_DEVIATION 0.89	7.0 log10 IU/mL	5.8 log10 IU/mL STANDARD_DEVIATION 0.55	6.2 log10 IU/mL STANDARD_DEVIATION 0.58	6.2 log10 IU/mL STANDARD_DEVIATION 0.74	6.4 log10 IU/mL STANDARD_DEVIATION 1.09	6.7 log10 IU/mL STANDARD_DEVIATION 0.78	6.5 log10 IU/mL STANDARD_DEVIATION 0.74	6.4 log10 IU/mL STANDARD_DEVIATION 0.74
HCV RNA Category < 800,000 IU/mL	4 participants	74 participants	2 participants	5 participants	4 participants	6 participants	3 participants	8 participants	5 participants	5 participants	1 participants	1 participants	0 participants	4 participants	2 participants	6 participants	9 participants	1 participants	2 participants	6 participants
HCV RNA Category ≥ 800,000 IU/mL	23 participants	303 participants	24 participants	21 participants	21 participants	20 participants	28 participants	21 participants	25 participants	25 participants	4 participants	3 participants	1 participants	3 participants	5 participants	21 participants	18 participants	9 participants	9 participants	22 participants
IL28b Status CC	8 participants	135 participants	7 participants	9 participants	13 participants	9 participants	9 participants	13 participants	10 participants	9 participants	5 participants	1 participants	1 participants	2 participants	2 participants	13 participants	12 participants	2 participants	1 participants	9 participants
IL28b Status CT	16 participants	196 participants	14 participants	14 participants	9 participants	14 participants	18 participants	13 participants	16 participants	14 participants	0 participants	3 participants	0 participants	2 participants	5 participants	12 participants	13 participants	8 participants	8 participants	17 participants
IL28b Status Missing	0 participants	3 participants	2 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
IL28b Status TT	3 participants	43 participants	3 participants	3 participants	3 participants	3 participants	4 participants	3 participants	4 participants	7 participants	0 participants	0 participants	0 participants	3 participants	0 participants	1 participants	2 participants	0 participants	2 participants	2 participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants	6 participants	1 participants	0 participants	0 participants	2 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	1 participants	1 participants	0 participants	0 participants	0 participants
Race/Ethnicity, Customized Asian	0 participants	7 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	4 participants	2 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants
Race/Ethnicity, Customized Black or African American	4 participants	35 participants	0 participants	2 participants	2 participants	2 participants	5 participants	5 participants	3 participants	4 participants	0 participants	0 participants	0 participants	1 participants	2 participants	0 participants	4 participants	0 participants	0 participants	1 participants
Race/Ethnicity, Customized Other	0 participants	3 participants	0 participants	0 participants	0 participants	0 participants	2 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
Race/Ethnicity, Customized White	23 participants	326 participants	25 participants	24 participants	23 participants	22 participants	24 participants	24 participants	27 participants	26 participants	1 participants	2 participants	1 participants	5 participants	5 participants	26 participants	22 participants	10 participants	11 participants	25 participants
Sex: Female, Male Female	13 Participants	159 Participants	16 Participants	14 Participants	8 Participants	11 Participants	15 Participants	13 Participants	12 Participants	14 Participants	1 Participants	0 Participants	0 Participants	3 Participants	1 Participants	10 Participants	9 Participants	3 Participants	5 Participants	11 Participants
Sex: Female, Male Male	14 Participants	218 Participants	10 Participants	12 Participants	17 Participants	15 Participants	16 Participants	16 Participants	18 Participants	16 Participants	4 Participants	4 Participants	1 Participants	4 Participants	6 Participants	17 Participants	18 Participants	7 Participants	6 Participants	17 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
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	38 / 77	45 / 77	27 / 56	43 / 55	22 / 55	36 / 57
serious Total, serious adverse events	2 / 77	1 / 77	3 / 56	1 / 55	0 / 55	0 / 57

Outcome results

Primary

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Time frame: Up to 12 weeks

Population: Safety Analysis Set

Arm	Measure	Value (NUMBER)
SOF+VEL 25 mg 12 Weeks (GT1)	Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	0 percentage of participants
SOF+VEL 100 mg 12 Weeks (GT1)	Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	0 percentage of participants
SOF+VEL 25 mg 12 Weeks (GT2)	Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	1.8 percentage of participants
SOF+VEL 100 mg 12 Weeks (GT2)	Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	0 percentage of participants
SOF+VEL 25 mg 12 Weeks (GT3)	Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	0 percentage of participants
SOF+VEL 100 mg 12 Weeks (GT3)	Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	0 percentage of participants

Primary

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

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

Time frame: Posttreatment Week 12

Population: Full Analysis Set: participants randomized into the study and received at least 1 dose of study drug.

Arm	Measure	Value (NUMBER)
SOF+VEL 25 mg 12 Weeks (GT1)	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	96.3 percentage of participants
SOF+VEL 100 mg 12 Weeks (GT1)	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	100.0 percentage of participants
SOF+VEL 25 mg 12 Weeks (GT2)	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	90.9 percentage of participants
SOF+VEL 100 mg 12 Weeks (GT2)	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	100.0 percentage of participants
SOF+VEL 25 mg 12 Weeks (GT3)	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	92.6 percentage of participants
SOF+VEL 100 mg 12 Weeks (GT3)	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	92.6 percentage of participants
SOF+VEL 25 mg 12 Weeks (GT4)	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	100.0 percentage of participants
SOF+VEL 100 mg 12 Weeks (GT4)	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	85.7 percentage of participants
SOF+VEL 25 mg 12 Weeks (GT5)	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	100.0 percentage of participants
SOF+VEL 25 mg 12 Weeks (GT6)	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	100.0 percentage of participants
SOF+VEL 100 mg 12 Weeks (GT6)	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	100.0 percentage of participants
SOF+VEL 25 mg 8 Weeks (GT1)	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	86.7 percentage of participants
SOF+VEL 25 mg + RBV 8 Weeks (GT1)	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	83.3 percentage of participants
SOF+VEL 100 mg 8 Weeks (GT1)	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	89.7 percentage of participants
SOF+VEL 100 mg + RBV 8 Weeks (GT1)	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	80.6 percentage of participants
SOF+VEL 25 mg 8 Weeks (GT2)	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	76.9 percentage of participants
SOF+VEL 25 mg + RBV 8 Weeks (GT2)	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	88.0 percentage of participants
SOF+VEL 100 mg 8 Weeks (GT2)	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	88.5 percentage of participants
SOF+VEL 100 mg + RBV 8 Weeks (GT2)	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	88.5 percentage of participants

Secondary

Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

Time frame: Posttreatment Weeks 4 and 24

Population: Full Analysis Set

Arm	Measure	Group	Value (NUMBER)
SOF+VEL 25 mg 12 Weeks (GT1)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4	96.3 percentage of participants
SOF+VEL 25 mg 12 Weeks (GT1)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR24	92.6 percentage of participants
SOF+VEL 100 mg 12 Weeks (GT1)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR24	100.0 percentage of participants
SOF+VEL 100 mg 12 Weeks (GT1)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4	100.0 percentage of participants
SOF+VEL 25 mg 12 Weeks (GT2)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR24	90.9 percentage of participants
SOF+VEL 25 mg 12 Weeks (GT2)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4	90.9 percentage of participants
SOF+VEL 100 mg 12 Weeks (GT2)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4	100.0 percentage of participants
SOF+VEL 100 mg 12 Weeks (GT2)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR24	100.0 percentage of participants
SOF+VEL 25 mg 12 Weeks (GT3)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR24	92.6 percentage of participants
SOF+VEL 25 mg 12 Weeks (GT3)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4	92.6 percentage of participants
SOF+VEL 100 mg 12 Weeks (GT3)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR24	92.6 percentage of participants
SOF+VEL 100 mg 12 Weeks (GT3)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4	100.0 percentage of participants
SOF+VEL 25 mg 12 Weeks (GT4)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR24	100.0 percentage of participants
SOF+VEL 25 mg 12 Weeks (GT4)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4	100.0 percentage of participants
SOF+VEL 100 mg 12 Weeks (GT4)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4	85.7 percentage of participants
SOF+VEL 100 mg 12 Weeks (GT4)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR24	85.7 percentage of participants
SOF+VEL 25 mg 12 Weeks (GT5)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4	100.0 percentage of participants
SOF+VEL 25 mg 12 Weeks (GT5)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR24	100.0 percentage of participants
SOF+VEL 25 mg 12 Weeks (GT6)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4	100.0 percentage of participants
SOF+VEL 25 mg 12 Weeks (GT6)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR24	100.0 percentage of participants
SOF+VEL 100 mg 12 Weeks (GT6)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR24	100.0 percentage of participants
SOF+VEL 100 mg 12 Weeks (GT6)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4	100.0 percentage of participants
SOF+VEL 25 mg 8 Weeks (GT1)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4	86.7 percentage of participants
SOF+VEL 25 mg 8 Weeks (GT1)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR24	86.7 percentage of participants
SOF+VEL 25 mg + RBV 8 Weeks (GT1)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4	83.3 percentage of participants
SOF+VEL 25 mg + RBV 8 Weeks (GT1)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR24	83.3 percentage of participants
SOF+VEL 100 mg 8 Weeks (GT1)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4	93.1 percentage of participants
SOF+VEL 100 mg 8 Weeks (GT1)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR24	89.7 percentage of participants
SOF+VEL 100 mg + RBV 8 Weeks (GT1)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4	87.1 percentage of participants
SOF+VEL 100 mg + RBV 8 Weeks (GT1)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR24	80.6 percentage of participants
SOF+VEL 25 mg 8 Weeks (GT2)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR24	76.9 percentage of participants
SOF+VEL 25 mg 8 Weeks (GT2)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4	88.5 percentage of participants
SOF+VEL 25 mg + RBV 8 Weeks (GT2)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR24	88.0 percentage of participants
SOF+VEL 25 mg + RBV 8 Weeks (GT2)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4	88.0 percentage of participants
SOF+VEL 100 mg 8 Weeks (GT2)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4	92.3 percentage of participants
SOF+VEL 100 mg 8 Weeks (GT2)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR24	88.5 percentage of participants
SOF+VEL 100 mg + RBV 8 Weeks (GT2)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR24	88.5 percentage of participants
SOF+VEL 100 mg + RBV 8 Weeks (GT2)	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4	88.5 percentage of participants

Secondary

Percentage of Participants With Virologic Failure

Virologic failure was defined as: * On-treatment virologic failure: * 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) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.

Time frame: Up to Posttreatment Week 24

Population: Full Analysis Set

Arm	Measure	Value (NUMBER)
SOF+VEL 25 mg 12 Weeks (GT1)	Percentage of Participants With Virologic Failure	3.7 percentage of participants
SOF+VEL 100 mg 12 Weeks (GT1)	Percentage of Participants With Virologic Failure	0 percentage of participants
SOF+VEL 25 mg 12 Weeks (GT2)	Percentage of Participants With Virologic Failure	0 percentage of participants
SOF+VEL 100 mg 12 Weeks (GT2)	Percentage of Participants With Virologic Failure	0 percentage of participants
SOF+VEL 25 mg 12 Weeks (GT3)	Percentage of Participants With Virologic Failure	7.4 percentage of participants
SOF+VEL 100 mg 12 Weeks (GT3)	Percentage of Participants With Virologic Failure	7.4 percentage of participants
SOF+VEL 25 mg 12 Weeks (GT4)	Percentage of Participants With Virologic Failure	0 percentage of participants
SOF+VEL 100 mg 12 Weeks (GT4)	Percentage of Participants With Virologic Failure	0 percentage of participants
SOF+VEL 25 mg 12 Weeks (GT5)	Percentage of Participants With Virologic Failure	0 percentage of participants
SOF+VEL 25 mg 12 Weeks (GT6)	Percentage of Participants With Virologic Failure	0 percentage of participants
SOF+VEL 100 mg 12 Weeks (GT6)	Percentage of Participants With Virologic Failure	0 percentage of participants
SOF+VEL 25 mg 8 Weeks (GT1)	Percentage of Participants With Virologic Failure	10.0 percentage of participants
SOF+VEL 25 mg + RBV 8 Weeks (GT1)	Percentage of Participants With Virologic Failure	16.7 percentage of participants
SOF+VEL 100 mg 8 Weeks (GT1)	Percentage of Participants With Virologic Failure	10.3 percentage of participants
SOF+VEL 100 mg + RBV 8 Weeks (GT1)	Percentage of Participants With Virologic Failure	16.1 percentage of participants
SOF+VEL 25 mg 8 Weeks (GT2)	Percentage of Participants With Virologic Failure	23.1 percentage of participants
SOF+VEL 25 mg + RBV 8 Weeks (GT2)	Percentage of Participants With Virologic Failure	8.0 percentage of participants
SOF+VEL 100 mg 8 Weeks (GT2)	Percentage of Participants With Virologic Failure	11.5 percentage of participants
SOF+VEL 100 mg + RBV 8 Weeks (GT2)	Percentage of Participants With Virologic Failure	11.5 percentage of participants

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

Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection

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Brief summary

Related papers

Interventions

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Study design

Eligibility

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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 Who Permanently Discontinued Any Study Drug Due to an Adverse Event

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

Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

Percentage of Participants With Virologic Failure