Lambda/Daclatasvir/Ribavirin for treatment of HCV/HIV co-infection
Research type
Research Study
Full title
Phase 3 open label study evaluating the efficacy and safety of pegylated interferon lambda-1a, in combination with ribavirin and daclatasvir, for treatment of chronic HCV infection with treatment naïve genotypes 1, 2, 3 or 4 in subjects co-infected with HIV
IRAS ID
131972
Contact name
Sanjay Bhagani
Contact email
Sponsor organisation
Bristol-Myers Squibb
Eudract number
2012-003280-22
Research summary
The purpose of this study is to evaluate the safety and effectiveness of investigational treatments, peg-interferon lambda-1a (Lambda) and daclatasvir (DCV), combined with ribavirin (RBV) in controlling the Hepatitis C Virus (HCV) in patients who are also infected with the Human Immunodeficiency Virus (HIV).
The ‘standard of care’ therapy for HCV/HIV co-infected patients involves treatment with a combination of peg-interferon Alfa (Alfa) and RBV.
Lambda is part of the same class of interferon drugs as Alfa and is being studied for the treatment of HCV. Lambda and Alfa bind to cells differently, and one goal of the study is to evaluate whether there may be less side effects associated with the investigational Lambda treatment.
Daclatasvir is part of a new class of “direct-acting antiviral” (DAA) drugs being studied in combination with Alfa and RBV in the treatment of HCV. DAA drugs have been shown to have specific activity against HCV in vitro. Studying DAA drugs with Lambda and RBV could help determine if such treatments for HCV are effective.
There are 7 major variations of HCV, known as genotypes 1 to 7. This study looks just at patients with genotypes 1, 2, 3 and 4.
Everyone in the study will receive the same 3 medications (DCV, Lambda and RBV). Based on the patient’s HCV genotype, they will be assigned to one of two treatment groups:
Group A: Patients with genotype 2 or 3 and who have never taken any medications for their HCV infection will receive treatment for 24 weeks.
Group B: Patients with genotype1 or 4 and who have never taken any medications for their HCV infection will receive treatment for 24 or 48 weeks.
Globally, 300 patients will be treated, commencing in May 2013. In the UK, recruitment is expected to commence in August 2013. The study is funded by Bristol-Myers Squibb.REC name
London - Dulwich Research Ethics Committee
REC reference
13/LO/0830
Date of REC Opinion
8 Jul 2013
REC opinion
Further Information Favourable Opinion