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

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
SOF
RBV
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

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

Inclusion Criteria:

  • Confirmed chronic genotype 1 or 3 HCV infection
  • HCV treatment-naive
  • Individuals will have cirrhosis status assessment; liver biopsy may be required.
  • Screening laboratory values within predefined thresholds
  • Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

  • Pregnant or nursing female or male with pregnant female partner
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Contraindication to ribavirin therapy
  • Excessive alcohol ingestion as defined by protocol
  • History of solid organ transplantation
  • Current or prior history of clinical hepatic decompensation
  • History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol

Sites / Locations

  • Central Clinical Hospital of the Russian Academy of Sciences
  • Central Scientific and Research Institute of Epidemiology of Rospotrebnadzor
  • Central Scientific Research Institution of Gastroenterology of Moscow Healthcare Department
  • City Clinical Hospital 24
  • Clinical Diagnostics and Research Center of Federal Bedgetary Institution
  • Infectious Clinical Hospital No. 1
  • Institute of Nutrition of Academy of Sciences
  • Institution of Healthcare of Sverdlovsk Region
  • Institution of High Professional Education First Moscow State Medical University
  • Institution of Tumen Region
  • Krasnoyarsk Regional Center for Prevention and Control of AIDS and Infectious Diseases
  • Scientific Research Institution of Emergency Care n.a. N.V. Sclifosovskiy of Moscow
  • Stavropol State Medical University of Ministry of Healthcare
  • Medical Military Academy n.a. S.M. Kirov
  • Saint-Petersburg Center for Prevention and Control of AIDS and Infectious Diseases
  • Medical Company Hepatolog

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SOF+RBV 16 Weeks

SOF+RBV 24 Weeks

Arm Description

SOF+RBV for 16 weeks

SOF+RBV for 24 weeks

Outcomes

Primary Outcome Measures

Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.

Secondary Outcome Measures

Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Percentage of Participants Experiencing On-treatment Virologic Failure
On-treatment virologic failure was defined as 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)
Percentage of Participants Experiencing Virologic Relapse
Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.

Full Information

First Posted
July 2, 2013
Last Updated
May 7, 2015
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01896193
Brief Title
Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection
Official Title
A Phase 3b, Multicenter, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naïve Adults With Genotype 1 and 3 Chronic HCV Infection.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
June 2014 (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 plus ribavirin administered for 16 weeks and 24 weeks in participants with chronic genotype 1 (GT1) or genotype 3 (GT3) hepatitis C virus (HCV) infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
SOF+RBV 16 Weeks
Arm Type
Experimental
Arm Description
SOF+RBV for 16 weeks
Arm Title
SOF+RBV 24 Weeks
Arm Type
Experimental
Arm Description
SOF+RBV for 24 weeks
Intervention Type
Drug
Intervention Name(s)
SOF
Other Intervention Name(s)
Sovaldi®, PSI-7977, GS-7977
Intervention Description
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RBV
Intervention Description
Ribavirin (RBV) tablets administered orally in a divided daily dose using weight-based dosing (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
Description
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Time Frame
Posttreatment Week 12
Title
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Description
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Description
SVR4 and SVR 24 were 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 Experiencing On-treatment Virologic Failure
Description
On-treatment virologic failure was defined as 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)
Time Frame
Up to 24 weeks
Title
Percentage of Participants Experiencing Virologic Relapse
Description
Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Time Frame
Up to Posttreatment Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed chronic genotype 1 or 3 HCV infection HCV treatment-naive Individuals will have cirrhosis status assessment; liver biopsy may be required. Screening laboratory values within predefined thresholds Use of two effective contraception methods if female of childbearing potential or sexually active male Exclusion Criteria: Pregnant or nursing female or male with pregnant female partner Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) Contraindication to ribavirin therapy Excessive alcohol ingestion as defined by protocol History of solid organ transplantation Current or prior history of clinical hepatic decompensation History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Kersey, MSc
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Central Clinical Hospital of the Russian Academy of Sciences
City
Moscow
Country
Russian Federation
Facility Name
Central Scientific and Research Institute of Epidemiology of Rospotrebnadzor
City
Moscow
Country
Russian Federation
Facility Name
Central Scientific Research Institution of Gastroenterology of Moscow Healthcare Department
City
Moscow
Country
Russian Federation
Facility Name
City Clinical Hospital 24
City
Moscow
Country
Russian Federation
Facility Name
Clinical Diagnostics and Research Center of Federal Bedgetary Institution
City
Moscow
Country
Russian Federation
Facility Name
Infectious Clinical Hospital No. 1
City
Moscow
Country
Russian Federation
Facility Name
Institute of Nutrition of Academy of Sciences
City
Moscow
Country
Russian Federation
Facility Name
Institution of Healthcare of Sverdlovsk Region
City
Moscow
Country
Russian Federation
Facility Name
Institution of High Professional Education First Moscow State Medical University
City
Moscow
Country
Russian Federation
Facility Name
Institution of Tumen Region
City
Moscow
Country
Russian Federation
Facility Name
Krasnoyarsk Regional Center for Prevention and Control of AIDS and Infectious Diseases
City
Moscow
Country
Russian Federation
Facility Name
Scientific Research Institution of Emergency Care n.a. N.V. Sclifosovskiy of Moscow
City
Moscow
Country
Russian Federation
Facility Name
Stavropol State Medical University of Ministry of Healthcare
City
Moscow
Country
Russian Federation
Facility Name
Medical Military Academy n.a. S.M. Kirov
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Saint-Petersburg Center for Prevention and Control of AIDS and Infectious Diseases
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Medical Company Hepatolog
City
Samara
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
27376706
Citation
Isakov V, Zhdanov K, Kersey K, Svarovskaia E, Massetto B, Zhu Y, Knox SJ, Bakulin I, Chulanov V. Efficacy of sofosbuvir plus ribavirin in treatment-naive patients with genotype-1 and -3 HCV infection: results from a Russian Phase IIIb study. Antivir Ther. 2016;21(8):671-678. doi: 10.3851/IMP3065. Epub 2016 Jul 4.
Results Reference
derived

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

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