Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection
A Phase 3b, Multi-Center, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naïve Adults With Chronic Genotype 1 or 3 Hepatitis C Virus Infection
1 other identifier
interventional
117
1 country
13
Brief Summary
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + ribavirin (RBV) in treatment-naive adults with chronic genotype 1 or 3 hepatitis C virus (HCV) infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2014
13 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
February 26, 2014
CompletedFirst Posted
Study publicly available on registry
February 28, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedResults Posted
Study results publicly available
October 25, 2016
CompletedOctober 25, 2016
September 1, 2016
1.5 years
February 26, 2014
September 2, 2016
September 2, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 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 (2)
Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Posttreatment Weeks 4 and 24
Percentage of Participants With Virologic Failure and Viral Relapse
Up to Posttreatment Week 24
Study Arms (2)
Sofosbuvir+RBV 16 weeks
EXPERIMENTALParticipants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 16 weeks.
Sofosbuvir+RBV 24 weeks
EXPERIMENTALParticipants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 24 weeks.
Interventions
400 mg tablet administered orally once daily
200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Eligibility Criteria
You may qualify if:
- HCV RNA ≥10\^4 IU/mL at screening
- Confirmed chronic HCV genotype 1 or 3 infection
- HCV treatment naive
- Approximately 30% of individuals may have compensated cirrhosis at screening
You may not qualify if:
- Any other chronic liver disease
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Current or prior history of clinical hepatic de-compensation
- Contraindication to RBV therapy, e.g., history of clinically significant hemoglobinopathy (sickle cell disease, thalassemia).
- Chronic use of systemically administered immunosuppressive agents
- History of solid organ transplantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (13)
Unknown Facility
Hyderabad, Andhra Pradesh, 500 004, India
Unknown Facility
Chandigarh, Chandigarh, 160012, India
Unknown Facility
Surat, Gujarat, 395002, India
Unknown Facility
Gurgaon, Haryana, 122 001, India
Unknown Facility
Kochi, Kerala, 682040, India
Unknown Facility
Mumbai, Maharashtra, 400012, India
Unknown Facility
New Delhi, National Capital Territory of Delhi, 110029, India
Unknown Facility
New Delhi, National Capital Territory of Delhi, 110070, India
Unknown Facility
Ludhiana, Punjab, 141001, India
Unknown Facility
Jaipur, Rajasthan, 302004, India
Unknown Facility
Coimbatore, Tamil Nadu, 641 005, India
Unknown Facility
Lucknow, Uttar Pradesh, 226014, India
Unknown Facility
Kolkata, West Bengal, 700 020, India
Related Publications (3)
Shah S, Acharya SK, Mehta R., Kapoor D, Duseja A, Koshy A, et al. (2016) "Sofosbuvir Plus Ribavirin in the Treatment of Chronic HCV Infection in India." Hepatol Int. 10 (Suppl 1): S15.
RESULTShah S, Chowdhury A, Mehta R, Kapoor D, Duseja A, Koshy A, et al. Sofosbuvir plus Ribavirin Results in High SVR4 Rates in Patients with Chronic HCV Genotype 1 or 3 Infection in India (Poster L-47). 56th Annual Conference of Indian Society of Gastroenterology; 2015, November, 19-22 Indore, India.
RESULTShah SR, Chowdhury A, Mehta R, Kapoor D, Duseja A, Koshy A, Shukla A, Sood A, Madan K, Sud R, Nijhawan S, Pawan R, Prasad M, Kersey K, Jiang D, Svarovskaia E, Doehle B, Kanwar B, Subramanian M, Acharya SK, Sarin S. Sofosbuvir plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 or 3 infection in India. J Viral Hepat. 2017 May;24(5):371-379. doi: 10.1111/jvh.12654. Epub 2016 Dec 9.
PMID: 27933698DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Kathryn Kersey, MSc
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
February 26, 2014
First Posted
February 28, 2014
Study Start
March 1, 2014
Primary Completion
September 1, 2015
Study Completion
November 1, 2015
Last Updated
October 25, 2016
Results First Posted
October 25, 2016
Record last verified: 2016-09