Clinical trial NCT01808248: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-03-11
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
measure: Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
timeFrame: Posttreatment Weeks 4 and 24
measure: Percentage of Participants Experiencing On-treatment Virologic Failure
timeFrame: Up to 12 weeks
measure: Percentage of Participants Experiencing Viral Relapse
timeFrame: Up to Posttreatment Week 24
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
Study officials:
affiliation: Gilead Sciences
name: Rob Hyland
role: STUDY_DIRECTOR
References: