Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection
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
1 other identifier
interventional
687
5 countries
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2013
Typical duration for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2013
CompletedStudy Start
First participant enrolled
December 10, 2013
CompletedFirst Posted
Study publicly available on registry
December 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 3, 2016
CompletedResults Posted
Study results publicly available
February 20, 2018
CompletedFebruary 20, 2018
August 1, 2017
2.7 years
November 26, 2013
August 11, 2017
August 11, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Up to 24 weeks
Secondary Outcomes (4)
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Posttreatment Weeks 4 and 24
Percentage of Participants With On-Treatment Virologic Failure
Up to 24 weeks
Percentage of Participants With Viral Relapse
Up to Posttreatment Week 24
Change From Baseline in HCV RNA (log10 IU/mL)
Up to 24 weeks
Study Arms (4)
Sofosbuvir+RBV+PEG 12 weeks
EXPERIMENTALParticipants with genotype 1 or 6 will receive sofosbuvir+RBV+Peg-IFNα-2a for 12 weeks.
Sofosbuvir+RBV 12 weeks
EXPERIMENTALParticipants with genotype 1, 2 or 6 will receive sofosbuvir+RBV for 12 weeks.
Sofosbuvir+RBV 16 weeks
EXPERIMENTALParticipants with genotype 1, 6 will receive sofosbuvir+RBV for 16 weeks.
Sofosbuvir+RBV 24 Weeks
EXPERIMENTALParticipants with genotype 1, 3, or 6 will receive sofosbuvir+RBV for 24 weeks.
Interventions
Sofosbuvir 400 mg tablet administered orally once daily
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)
Pegylated interferon alfa-2a (Peg-IFNα-2a) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (35)
Unknown Facility
Beijing, China
Unknown Facility
Chongqing, China
Unknown Facility
Fujian, China
Unknown Facility
Guangdong, China
Unknown Facility
Guangxi, China
Unknown Facility
Hainan, China
Unknown Facility
Hebei, China
Unknown Facility
Hubei, China
Unknown Facility
Hunan, China
Unknown Facility
Jiangxi, China
Unknown Facility
Jilin, China
Unknown Facility
Jin’an, China
Unknown Facility
Liaoyang, China
Unknown Facility
Shanghai, China
Unknown Facility
Sichuan, China
Unknown Facility
Yunnan, China
Unknown Facility
Zhejiang, China
Unknown Facility
Hong Kong, Hong Kong
Unknown Facility
Shatin, Hong Kong
Unknown Facility
Incheon, Gyeonggi-do, South Korea
Unknown Facility
Seongnam-si, Gyeonggi-do, South Korea
Unknown Facility
Ansan-si, South Korea
Unknown Facility
Bucheon-si, South Korea
Unknown Facility
Busan, South Korea
Unknown Facility
Daegu, South Korea
Unknown Facility
Seoul, South Korea
Unknown Facility
Chang-hua, Taiwan
Unknown Facility
Kaohsiung City, Taiwan
Unknown Facility
Keelung, Taiwan
Unknown Facility
Taichung, Taiwan
Unknown Facility
Tainan, Taiwan
Unknown Facility
Taipei, Taiwan
Unknown Facility
Taoyuan District, Taiwan
Unknown Facility
Hanoi, Vietnam
Unknown Facility
Ho Chi Minh City, Vietnam
Related Publications (3)
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.
PMID: 26503414RESULTAhn 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.
PMID: 26864153RESULTKao 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.
PMID: 26835876RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2013
First Posted
December 27, 2013
Study Start
December 10, 2013
Primary Completion
August 12, 2016
Study Completion
November 3, 2016
Last Updated
February 20, 2018
Results First Posted
February 20, 2018
Record last verified: 2017-08