A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3

Bristol-Myers Squibb

Overview

The purpose of this study is to determine if 8 weeks of Daclatasvir plus Sofosbuvir with or without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients without advanced fibrosis or liver cirrhosis who have never been treated previously.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Hepatitis C

Interventions

DaclatasvirDRUG

SofosbuvirDRUG

RibavirinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Genotype 3 * HCV RNA \< 2000000 IU/mL * Never taken HCV medication * Absence of advanced fibrosis or cirrhosis * Body mass index (BMI) 18-40 kg/m\^2 Exclusion Criteria: * Infection with HCV other than genotype 3 (GT3); Mixed infections of any genotype * Previously taken HCV medication * Liver Cirrhosis * Evidence of decompensated liver disease * HIV/ hepatitis B virus (HBV) coinfection

Locations (12)

Local Institution

Calgary, Alberta, Canada

Local Institution

Edmonton, Alberta, Canada

Local Institution

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

Proportion of subjects with sustained virologic response (SVR12) treated with Daclatasvir + Sofosbuvir (DCV+SOF)

SVR12 defined as HCV RNA \< LLOQ target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects treated with 8 weeks of DCV+SOF therapy or DCV+SOF+RBV therapy

Time frame: Post Treatment Follow up Week 12

Secondary Outcomes

Safety measured by number of incidence of deaths, serious adverse events (SAE)s, discontinuation due to adverse events (AE)s, Grade 3/4 AEs and Grade 3/4 laboratory abnormalities observed from clinical laboratory testing

Time frame: Approximately 1.5 years

Antiviral activity measured by the proportion of subjects who achieve HCV RNA < lower limit of quantification (LLOQ) - at during and after treatment in each treatment arm

Time frame: Post treatment follow up Week 24

Proportion of subjects with CC, CT or TT IL28B genotype who achieve SVR12 in each treatment arm

Time frame: Post Treatment Follow up Week 12

Data from ClinicalTrials.gov

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