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

Gilead Sciences127 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

127

Conditions

Hepatitis C

Interventions

SOFDRUG

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

RBVDRUG

Ribavirin (RBV) tablets administered orally in a divided daily dose using weight-based dosing (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (16)

Central Clinical Hospital of the Russian Academy of Sciences

Moscow, Russia

Central Scientific and Research Institute of Epidemiology of Rospotrebnadzor

Moscow, Russia

Outcomes

Primary Outcomes

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.

Time frame: Posttreatment Week 12

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.

Time frame: Up to 24 weeks

Secondary Outcomes

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.

Time frame: Posttreatment Weeks 4 and 24

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)

Time frame: Up to 24 weeks

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.

Time frame: Up to Posttreatment Week 12

Data from ClinicalTrials.gov

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