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Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection

Primary Purpose

Chronic HCV Infection

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Sofosbuvir
RBV
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

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sofosbuvir+RBV 16 weeks

Sofosbuvir+RBV 24 weeks

Arm Description

Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 16 weeks.

Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 24 weeks.

Outcomes

Primary Outcome Measures

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.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Secondary Outcome Measures

Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Percentage of Participants With Virologic Failure and Viral Relapse
Virologic failure was defined as: On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.

Full Information

First Posted
February 26, 2014
Last Updated
September 2, 2016
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02074514
Brief Title
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

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
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sofosbuvir+RBV 16 weeks
Arm Type
Experimental
Arm Description
Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 16 weeks.
Arm Title
Sofosbuvir+RBV 24 weeks
Arm Type
Experimental
Arm Description
Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir
Other Intervention Name(s)
Sovaldi®, GS-7977, PSI-7977
Intervention Description
400 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RBV
Intervention Description
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)
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Description
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.
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 (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Description
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Time Frame
Posttreatment Weeks 4 and 24
Title
Percentage of Participants With Virologic Failure and Viral Relapse
Description
Virologic failure was defined as: On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Time Frame
Up to Posttreatment Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Kersey, MSc
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 004
Country
India
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122 001
Country
India
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682040
Country
India
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141001
Country
India
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302004
Country
India
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641 005
Country
India
City
Lucknow
State/Province
Uttarpradesh
ZIP/Postal Code
226014
Country
India
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700 020
Country
India
City
Chandigarh
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Citations:
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.
Results Reference
result
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.
Results Reference
result
PubMed Identifier
27933698
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.
Results Reference
derived

Learn more about this trial

Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection

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