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Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3

Primary Purpose

Hepatitis C

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

SOF

PEG

RBV

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring HCV genotype 2 (GT-2), HCV genotype 3 (GT-3), HCV, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, Treatment-Naïve, GS-7977, Ribavirin, RBV, Peginterferon Alfa 2a, PEG, Additional relevant MeSH terms:, Hepatitis, Hepatitis A, Hepatitis, Chronic, Hepatitis C, Hepatitis C, Chronic, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, Virus Diseases, Enterovirus Infections, Picornaviridae Infections, RNA Virus Infections, Flaviviridae Infections, Peginterferon alfa-2a, Interferon-alpha, Antiviral Agents, Anti-Infective Agents, Therapeutic Uses, Pharmacologic Actions, Antimetabolites, Molecular Mechanisms of Pharmacological Action, Immunologic Factors, Physiological Effects of Drugs

Eligibility Criteria

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

Inclusion Criteria:

Infection with genotype 2 or 3 HCV infection
Cirrhosis determination
Individual is treatment-experienced
Screening laboratory values within defined thresholds
Individual has not been treated with any investigational drug or device within 30 days of the Screening visit
Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

Prior exposure to a direct-acting antiviral drug targeting the HCV NS5B polymerase
Pregnant or nursing female or male with pregnant female partner
Current or prior history of clinical hepatic decompensation
History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment, or compliance with the study protocol
Excessive alcohol ingestion or significant drug abuse

Sites / Locations

Alamo Medical Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SOF+PEG+RBV

Arm Description

Participants will receive SOF+PEG+RBV for 12 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, < 15 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 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 SVR24 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: Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment

Percentage of Participants Experiencing Viral Relapse

Viral relapse was defined as having HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.

Full Information

NCT ID

NCT01808248

First Posted

March 1, 2013

Last Updated

September 5, 2014

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01808248

Brief Title

Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3

Official Title

A Phase 2, Open-Label Study of Sofosbuvir in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gilead Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12 weeks in participants with chronic genotype 2 or 3 hepatitis C virus (HCV) infection who have previously failed prior treatment with an interferon-based regimen.

6. Conditions and Keywords

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

Hepatitis C

Keywords

HCV genotype 2 (GT-2), HCV genotype 3 (GT-3), HCV, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, Treatment-Naïve, GS-7977, Ribavirin, RBV, Peginterferon Alfa 2a, PEG, Additional relevant MeSH terms:, Hepatitis, Hepatitis A, Hepatitis, Chronic, Hepatitis C, Hepatitis C, Chronic, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, Virus Diseases, Enterovirus Infections, Picornaviridae Infections, RNA Virus Infections, Flaviviridae Infections, Peginterferon alfa-2a, Interferon-alpha, Antiviral Agents, Anti-Infective Agents, Therapeutic Uses, Pharmacologic Actions, Antimetabolites, Molecular Mechanisms of Pharmacological Action, Immunologic Factors, Physiological Effects of Drugs

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SOF+PEG+RBV

Arm Type

Experimental

Arm Description

Participants will receive SOF+PEG+RBV for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

SOF

Other Intervention Name(s)

Sovaldi®, GS-7977, PSI-7977

Intervention Description

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

Intervention Type

Drug

Intervention Name(s)

PEG

Intervention Description

Peginterferon alfa 2a (PEG) 180 μg administered once weekly by subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

RBV

Intervention Description

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)

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, < 15 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 discontinuing any study drug due to an adverse event was summarized.

Time Frame

Up to 12 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 SVR24 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

Time Frame

Up to 12 weeks

Title

Percentage of Participants Experiencing Viral Relapse

Description

Time Frame

Up to Posttreatment Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Infection with genotype 2 or 3 HCV infection Cirrhosis determination Individual is treatment-experienced Screening laboratory values within defined thresholds Individual has not been treated with any investigational drug or device within 30 days of the Screening visit Use of highly effective contraception methods if female of childbearing potential or sexually active male Exclusion Criteria: Prior exposure to a direct-acting antiviral drug targeting the HCV NS5B polymerase Pregnant or nursing female or male with pregnant female partner Current or prior history of clinical hepatic decompensation History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment, or compliance with the study protocol Excessive alcohol ingestion or significant drug abuse

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rob Hyland

Organizational Affiliation

Gilead Sciences

Official's Role

Study Director

Facility Information:

Facility Name

Alamo Medical Research

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78215

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.nlm.nih.gov/medlineplus/

Description

Medicine Plus

URL

http://www.nlm.nih.gov/medlineplus/hepatitis.html

Description

Hepatitis

URL

http://www.nlm.nih.gov/medlineplus/hepatitisa.html

Description

Hepatitis A

URL

http://www.nlm.nih.gov/medlineplus/hepatitisc.html

Description

Hepatitis C

URL

http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp

Description

Drug Information available for:

URL

http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0036791045&QV1=RIBAVIRIN

Description

Ribavirin

URL

Description

PEGINTERFERON ALFA-2A

URL

http://clinicaltrials.gov/ct2/info/fdalinks

Description

U.S. FDA Resources

Learn more about this trial

Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3

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