A Phase 2b Evaluation of Daclatasvir/Sofosbuvir in Non-Cirrhotic Treatment Naive Subjects With Genotype 1, 2, 3 and 4 Chronic Hepatitis C Virus Coinfected With Human Immunodeficiency Virus (HIV-1)

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 2

Conditions: Hepatitis C

Treatments: Drug: Daclatasvir; Drug: Sofosbuvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02556086

2015-003467-12 (EudraCT Number)

AI444-378

Details and patient eligibility

About

The purpose of the study is to determine if combination therapy with daclatasvir (DCV) and sofosbuvir (SOF) for 8 weeks is safe and effective in patients who have never been treated previously without liver cirrhosis who are chronically infected with hepatitis C virus (HCV)/HIV-1 Coinfection genotype (GT) 1, 2, 3, 4 patients.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• HCV RNA < 2000000 IU/mL
• Never taken medication for HCV
• No Liver Cirrhosis
• No advanced fibrosis
• Body mass index(BMI) 18-40 kg/m^2
• Genotype 1-4

Exclusion Criteria:

• Infection with HCV other than GT-1, 2, 3 or GT-4 or subjects with mixed infections of any genotype
• Evidence of decompensated liver
• Subjects Infected with HIV 2
• Hepatitis B virus (HBV) coinfection
• Liver Cirrhosis
• Advanced fibrosis (F3-F4)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Daclatasvir + Sofosbuvir

Experimental group

Description:

Daclatasvir 30, 60, 90 mg tablet (dose is dependent on cART regimen) + Sofosbuvir 400 mg tablet oral dosing once daily for 8 weeks

Treatment:

Drug: Daclatasvir

Drug: Sofosbuvir