Overview

This trial has been completed.

Condition chronic hcv infection
Treatments sofosbuvir, rbv, pegifnα
Phase phase 3
Sponsor Gilead Sciences
Start date December 2013
End date August 2016
Trial size 687 participants
Trial identifier NCT02021643, GS-US-334-0115

Summary

This study will evaluate the safety and efficacy of sofosbuvir+ribavirin (RBV), +/- pegylated interferon, in treatment-naive and treatment-experienced adults with chronic genotype 1, 2, 3 or 6 HCV infection.

The study will be conducted in China, Hong Kong (HK), Korea, Taiwan, and Vietnam. Participants will be enrolled in the study for 12, 16, or 24 weeks of treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants with genotype 2 will receive sofosbuvir+RBV for 12 weeks.
sofosbuvir Sovaldi®
Sofosbuvir 400 mg tablet administered orally once daily
rbv Ribasphere®
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
(Experimental)
Participants with genotype 1, 3, or 6 will receive sofosbuvir+RBV for 16 weeks.
sofosbuvir Sovaldi®
Sofosbuvir 400 mg tablet administered orally once daily
rbv Ribasphere®
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
(Experimental)
Participants with genotype 1, 3, or 6 will receive sofosbuvir+RBV for 24 weeks.
sofosbuvir Sovaldi®
Sofosbuvir 400 mg tablet administered orally once daily
rbv Ribasphere®
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
(Experimental)
Participants with genotype 1 or 6 will receive sofosbuvir+RBV+PegIFNα for 12 weeks.
sofosbuvir Sovaldi®
Sofosbuvir 400 mg tablet administered orally once daily
rbv Ribasphere®
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
pegifnα
Pegylated interferon alfa-2a (PegIFNα) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week

Primary Outcomes

Measure
Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)
time frame: Posttreatment Week 12
Proportion of participants permanently discontinuing study drug(s) due to an adverse event (AE)
time frame: Up to 24 weeks

Secondary Outcomes

Measure
Proportion of participants with: HCV RNA < LLOQ at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)
time frame: Posttreatment Weeks 4 and 24
Proportion of participants experiencing viral breakthrough
time frame: Up to 24 weeks
Proportion of participants experiencing viral relapse
time frame: Up to Posttreatment Week 24
Change from baseline in HCV RNA (log10 IU/mL)
time frame: Up to 24 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Key Inclusion Criteria: - Willing and able to provide written informed consent - HCV RNA ≥ 10^4 IU/mL at screening - HCV treatment-naive (HCV genotype 1, 2, 3 or 6), defined as no prior exposure to any interferon (IFN), RBV, or other approved or experimental HCV-specific direct-acting antiviral agent, or HCV treatment-experienced (HCV genotype 1, 2, 3, or 6 only) with medical records that include sufficient detail of prior treatment with IFN to allow for categorization of prior response as either IFN Intolerant, non-responder, or experiences viral breakthrough or relapse - HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy Key Exclusion Criteria: - Current or prior history of any clinically-significant illness (other than HCV) - Pregnant or nursing female or male with pregnant female partner - Chronic liver disease of a non-HCV etiology - Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Additional Information

Official title A Phase 3b, Multicenter, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin (± Pegylated Interferon) in Subjects With Chronic Genotype 1, 2, 3 and 6 HCV Infection
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.