Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon (POSITRON)

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C

Treatments: Drug: SOF; Drug: Placebo to match SOF; Drug: RBV; Drug: Placebo to match RBV

Study type: Interventional

Funder types: Industry

Identifiers

NCT01542788

GS-US-334-0107

Details and patient eligibility

About

This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to match SOF+placebo to match RBV. Randomization was stratified by presence/absence of cirrhosis. Approximately 20% of participants may have had evidence of cirrhosis at screening.

Full description

Participants who were randomized to the placebo arm and completed all scheduled study procedures were eligible to receive active SOF+RBV in open-label Study GS-US-334-0109.

Participants who do not achieve sustained virologic response (SVR) were eligible for enrollment in the Sequence Registry Study GS-US-248-0123. The purpose of the Sequence Registry Study is to monitor the persistence of resistant mutations for up to 3 years.

Participants who achieved SVR were eligible for enrollment in the SVR Registry Study GS-US-248-0122. The purpose of the SVR Registry Study is to evaluate durability of SVR for up to 3 years after treatment.

Enrollment: 278 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infection with HCV genotype 2 or 3

• Cirrhosis determination

• Subject meets one of the following classifications:

  1. IFN unwilling
  2. IFN ineligible
  3. IFN intolerant

• Screening laboratory values within defined thresholds

• Subject 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 an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B 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 subject treatment, assessment or compliance with the protocol
• Excessive alcohol ingestion or significant drug abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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278 participants in 2 patient groups, including a placebo group

SOF+RBV

Experimental group

Description:

Participants were randomized to receive SOF+RBV for 12 weeks.

Treatment:

Drug: RBV

Drug: SOF

Placebo

Placebo Comparator group

Description:

Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks.

Treatment:

Drug: Placebo to match RBV

Drug: Placebo to match SOF