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)

Phase 2

Withdrawn

• Conditions: Hepatitis C
• Interventions: Drug: Daclatasvir; Drug: Sofosbuvir

• Registration Number: NCT02556086
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-15
• Study First Submitted QC: 2015-09-21
• Study First Posted: 2015-09-22
• Status Verified: 2015-11
• Study Start: 2015-12
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-01-20
• Primary Completion: 2016-06
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with SVR12	Post treatment follow-up week 12	SVR12 rate defined as HCV RNA \< LLOQ target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects infected with HCV/HIV-1 coinfection genotype 1-4

Secondary Outcome Measures

Name	Time	Method
Treatment safety measured by the number of incidence of serious adverse event (SAEs), discontinuations due to adverse event (AEs), Grade 3/4 AEs and Grade 3/4 clinical laboratory abnormalities through the end of treatment	Approximately 2 years
Proportion of subjects receiving cART who experience HIV virologic failure	Approximately 2 years
Sustained virologic response (SVR12) rate	Approximately 2 years	SVR12 rate defined as HCV RNA \< lower limit of quantification (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects infected with HCV/HIV-1 coinfection, by individual genotype (1-4)
Proportion of subjects receiving cART who maintain HIV virologic suppression	Approximately 2 years
Proportion of subjects who achieve HCV RNA < LLOQ-TD/TND at each of the following Weeks: 1, 2, 4, 6, 8, EOT, post-treatment Week 4 in subjects on the 8-week regimen of DCV/SOF	Approximately 2 years
Proportion of subjects who achieve HCV RNA < LLOQ TND at each of the following Weeks: 1, 2, 4, 6, 8, end of treatment (EOT), in subjects on the 8-week regimen of DCV/SOF	Approximately 2 years

Trial Locations

Locations (1)

Local Institution; 🇫🇷 Pessac, France