Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection

August 11, 2017 updated by: Gilead Sciences

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

The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir (SOF)+ ribavirin (RBV), with or without Pegylated interferon alfa (Peg-IFNα-2a/ PEG)) in participants with chronic genotype (GT)-1, 2, 3, and 6 Hepatitis C virus (HCV) infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

687

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
      • Chongqing, China
      • Fujian, China
      • Guangdong, China
      • Guangxi, China
      • Hainan, China
      • Hebei, China
      • Hubei, China
      • Hunan, China
      • Jiangxi, China
      • Jilin, China
      • Jin'an, China
      • Liaoyang, China
      • Shanghai, China
      • Sichuan, China
      • Yunnan, China
      • Zhejiang, China
  • Hong Kong
      • Hong Kong, Hong Kong
      • Sha Tin, Hong Kong
  • Korea, Republic of
      • Ansan-si, Korea, Republic of
      • Bucheon-si, Korea, Republic of
      • Busan, Korea, Republic of
      • Daegu, Korea, Republic of
      • Seoul, Korea, Republic of
    • Gyeonggi-do
      • Incheon, Gyeonggi-do, Korea, Republic of
      • Seongnam-si, Gyeonggi-do, Korea, Republic of
  • Taiwan
      • Chang-hua, Taiwan
      • Kaohsiung, Taiwan
      • Keelung, Taiwan
      • Taichung, Taiwan
      • Tainan, Taiwan
      • Taipei, Taiwan
      • Taoyuan, Taiwan
  • Vietnam
      • Hanoi, Vietnam
      • Ho Chi Minh City, Vietnam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sofosbuvir+RBV+PEG 12 weeks
Participants with genotype 1 or 6 will receive sofosbuvir+RBV+Peg-IFNα-2a for 12 weeks.
Drug: RBV
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)
Other Names:
  • Ribasphere®
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: PEG
Pegylated interferon alfa-2a (Peg-IFNα-2a) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week
Other Names:
  • Pegasys®
Experimental: Sofosbuvir+RBV 12 weeks
Participants with genotype 1, 2 or 6 will receive sofosbuvir+RBV for 12 weeks.
Drug: RBV
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)
Other Names:
  • Ribasphere®
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Experimental: Sofosbuvir+RBV 16 weeks
Participants with genotype 1, 6 will receive sofosbuvir+RBV for 16 weeks.
Drug: RBV
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)
Other Names:
  • Ribasphere®
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Experimental: Sofosbuvir+RBV 24 Weeks
Participants with genotype 1, 3, or 6 will receive sofosbuvir+RBV for 24 weeks.
Drug: RBV
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)
Other Names:
  • Ribasphere®
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time Frame: Up to 24 weeks
Up to 24 weeks
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Time Frame: Posttreatment Week 12
SVR12 is defined as HCV RNA < the lower limit of quantification (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.
Posttreatment Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Time Frame: Posttreatment Weeks 4 and 24
SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Posttreatment Weeks 4 and 24
Percentage of Participants With On-Treatment Virologic Failure
Time Frame: Up to 24 weeks
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment.
Up to 24 weeks
Percentage of Participants With Viral Relapse
Time Frame: Up to Posttreatment Week 24
Viral relapse was 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.
Up to Posttreatment Week 24
Change From Baseline in HCV RNA (log10 IU/mL)
Time Frame: Up to 24 weeks
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2013

Primary Completion (Actual)

August 12, 2016

Study Completion (Actual)

November 3, 2016

Study Registration Dates

First Submitted

November 26, 2013

First Submitted That Met QC Criteria

December 20, 2013

First Posted (Estimate)

December 27, 2013

Study Record Updates

Last Update Posted (Actual)

February 20, 2018

Last Update Submitted That Met QC Criteria

August 11, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-334-0115

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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