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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01808248
• Other study ID #: GS-US-334-0151
• Status: Completed
• Phase: Phase 2
• First received: March 1, 2013
• Last updated: September 5, 2014
• Start date: February 2013
• Est. completion date: December 2013

Study information

• Verified date: September 2014
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
• PEG
Peginterferon alfa 2a (PEG) 180 µg administered once weekly by subcutaneous injection
• RBV
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)

Locations

Country	Name	City	State
United States	Alamo Medical Research	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Posttreatment Week 12	No
Primary	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.	Up to 12 weeks	No
Secondary	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.	Posttreatment Weeks 4 and 24	No
Secondary	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	Up to 12 weeks	No
Secondary	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.	Up to Posttreatment Week 24	No

External Links

•   Drug Information available for:
•   Hepatitis
•   Hepatitis A
•   Hepatitis C
•   Medicine Plus
•   PEGINTERFERON ALFA-2A
•   Ribavirin
•   U.S. FDA Resources