Clinical trial NCT02074514: Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic HCV Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2014-02-28
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
measure: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
timeFrame: Posttreatment Weeks 4 and 24
measure: Percentage of Participants With Virologic Failure and Viral Relapse
timeFrame: Up to Posttreatment Week 24
Other outcomes:
Locations:
city: Hyderabad
country: India
state: Andhra Pradesh
city: New Delhi
country: India
state: Delhi
city: New Delhi
country: India
state: Delhi
city: Surat
country: India
state: Gujarat
city: Gurgaon
country: India
state: Haryana
city: Kochi
country: India
state: Kerala
city: Mumbai
country: India
state: Maharashtra
city: Ludhiana
country: India
state: Punjab
city: Jaipur
country: India
state: Rajasthan
city: Coimbatore
country: India
state: Tamil Nadu
city: Lucknow
country: India
state: Uttarpradesh
city: Kolkata
country: India
state: West Bengal
city: Chandigarh
country: India
Study officials:
affiliation: Gilead Sciences
name: Kathryn Kersey, MSc
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Shah 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.
citation: Shah 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.