Phase 2 Completed N=379 Randomized Treatment

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

Hepatitis C

Source: ClinicalTrials.gov NCT01858766 ↗

Enrolled (actual)

379

Serious AEs

1.9%

Results posted

Sep 2016

Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 96.3; 100.0; 90.9; 100.0 percentage of participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	96.3; 100.0; 90.9; 100.0; 92.6; 92.6	—
PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	0; 0; 1.8; 0; 0; 0	—
SECONDARY Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	96.3; 100.0; 90.9; 100.0; 92.6; 100.0	—
SECONDARY Percentage of Participants With Virologic Failure	3.7; 0; 0; 0; 7.4; 7.4	—

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT01858766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.