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

Primary Purpose

Chronic HCV Infection

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sofosbuvir
RBV
PEG
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic HCV Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Sofosbuvir+RBV+PEG 12 weeks

Sofosbuvir+RBV 12 weeks

Sofosbuvir+RBV 16 weeks

Sofosbuvir+RBV 24 Weeks

Arm Description

Participants with genotype 1 or 6 will receive sofosbuvir+RBV+Peg-IFNα-2a for 12 weeks.

Participants with genotype 1, 2 or 6 will receive sofosbuvir+RBV for 12 weeks.

Participants with genotype 1, 6 will receive sofosbuvir+RBV for 16 weeks.

Participants with genotype 1, 3, or 6 will receive sofosbuvir+RBV for 24 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
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.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Secondary Outcome Measures

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

Full Information

First Posted
November 26, 2013
Last Updated
August 11, 2017
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02021643
Brief Title
Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
December 10, 2013 (Actual)
Primary Completion Date
August 12, 2016 (Actual)
Study Completion Date
November 3, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic HCV Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
687 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sofosbuvir+RBV+PEG 12 weeks
Arm Type
Experimental
Arm Description
Participants with genotype 1 or 6 will receive sofosbuvir+RBV+Peg-IFNα-2a for 12 weeks.
Arm Title
Sofosbuvir+RBV 12 weeks
Arm Type
Experimental
Arm Description
Participants with genotype 1, 2 or 6 will receive sofosbuvir+RBV for 12 weeks.
Arm Title
Sofosbuvir+RBV 16 weeks
Arm Type
Experimental
Arm Description
Participants with genotype 1, 6 will receive sofosbuvir+RBV for 16 weeks.
Arm Title
Sofosbuvir+RBV 24 Weeks
Arm Type
Experimental
Arm Description
Participants with genotype 1, 3, or 6 will receive sofosbuvir+RBV for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir
Other Intervention Name(s)
Sovaldi®, GS-7977, PSI-7977
Intervention Description
Sofosbuvir 400 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RBV
Other Intervention Name(s)
Ribasphere®
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
PEG
Other Intervention Name(s)
Pegasys®
Intervention Description
Pegylated interferon alfa-2a (Peg-IFNα-2a) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Description
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.
Time Frame
Posttreatment Week 12
Title
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Description
SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Time Frame
Posttreatment Weeks 4 and 24
Title
Percentage of Participants With On-Treatment Virologic Failure
Description
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment.
Time Frame
Up to 24 weeks
Title
Percentage of Participants With Viral Relapse
Description
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.
Time Frame
Up to Posttreatment Week 24
Title
Change From Baseline in HCV RNA (log10 IU/mL)
Time Frame
Up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
City
Beijing
Country
China
City
Chongqing
Country
China
City
Fujian
Country
China
City
Guangdong
Country
China
City
Guangxi
Country
China
City
Hainan
Country
China
City
Hebei
Country
China
City
Hubei
Country
China
City
Hunan
Country
China
City
Jiangxi
Country
China
City
Jilin
Country
China
City
Jin'an
Country
China
City
Liaoyang
Country
China
City
Shanghai
Country
China
City
Sichuan
Country
China
City
Yunnan
Country
China
City
Zhejiang
Country
China
City
Hong Kong
Country
Hong Kong
City
Sha Tin
Country
Hong Kong
City
Incheon
State/Province
Gyeonggi-do
Country
Korea, Republic of
City
Seongnam-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
City
Ansan-si
Country
Korea, Republic of
City
Bucheon-si
Country
Korea, Republic of
City
Busan
Country
Korea, Republic of
City
Daegu
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Chang-hua
Country
Taiwan
City
Kaohsiung
Country
Taiwan
City
Keelung
Country
Taiwan
City
Taichung
Country
Taiwan
City
Tainan
Country
Taiwan
City
Taipei
Country
Taiwan
City
Taoyuan
Country
Taiwan
City
Hanoi
Country
Vietnam
City
Ho Chi Minh City
Country
Vietnam

12. IPD Sharing Statement

Citations:
PubMed Identifier
26503414
Citation
Lai CL, Wong VW, Yuen MF, Yang JC, Knox SJ, Mo H, Han LL, Brainard DM, Chan HL. Sofosbuvir plus ribavirin for the treatment of patients with chronic genotype 1 or 6 hepatitis C virus infection in Hong Kong. Aliment Pharmacol Ther. 2016 Jan;43(1):96-101. doi: 10.1111/apt.13429. Epub 2015 Oct 26.
Results Reference
result
PubMed Identifier
26864153
Citation
Ahn SH, Lim YS, Lee KS, Paik SW, Lee YJ, Jeong SH, Kim JH, Yoon SK, Yim HJ, Tak WY, Han SY, Yang JC, Mo H, Mathias A, Han L, Knox SJ, Brainard DM, Kim YJ, Byun KS, Kim YS, Heo J, Han KH. A phase 3b study of sofosbuvir plus ribavirin in treatment-naive and treatment-experienced Korean patients chronically infected with genotype 2 hepatitis C virus. J Viral Hepat. 2016 May;23(5):358-65. doi: 10.1111/jvh.12499. Epub 2016 Feb 10.
Results Reference
result
PubMed Identifier
26835876
Citation
Kao JH, Chien RN, Chang TT, Peng CY, Hu TH, Lo GH, Wang HY, Chen JJ, Yang JC, Knox SJ, Han L, Mo H, Mathias A, Brainard DM, Sheen IS, Hsu YC, Chu CJ, Chuang WL. A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection. Liver Int. 2016 Aug;36(8):1101-7. doi: 10.1111/liv.13082. Epub 2016 Mar 23.
Results Reference
result

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

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