Safety, Tolerability, and Efficacy of Asunaprevir and Daclatasvir in Subjects Coinfected With HIV-HCV
Status:
Completed
Trial end date:
2016-11-01
Target enrollment:
Participant gender:
Summary
Chronic hepatitis C virus (HCV) infection is a major public health problem with an estimated
180 million people infected worldwide. In the United States an estimated 4.1 million people
are infected and HCV is the principal cause of death from liver disease and leading
indication for liver transplantation. Within HIV/HCV co-infected patients, liver disease due
to Hepatitis C progresses even more rapidly. While combination of ribavirin (RBV) and
pegylated interferon (PEG) in combination with boceprevir/telaprevir is the currently
recommended therapy for chronic HCV infection and has superior cure rates compared to PEG+RBV
alone in HCV monoinfected patients, treatment is still associated with a high incidence of
adverse events (AEs), discontinuations and poor cure rates in several populations. Within the
HIV/HCV co-infected population treatment for HCV remains complicated given drug interactions
between anti-retrovirals and HCV protease inhibitors, in addition to the extensive
side-effects due to PEG +RBV alone. Recent studies have demonstrated that the use of a
combination of anti-virals which target HCV without interferon (IFN) can cure HCV, without
additional toxicities. These novel therapies that do not rely on an IFN backbone may
additionally enhance cure rates in HIV/HCV co-infected, a population which has historically
been difficult to cure.
The findings from this study will aid in the understanding of antiviral and host responses
and determinants of response to an IFN free regimen in HIV/HCV co-infected patients.
Phase:
Phase 2
Details
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborators:
Bristol-Myers Squibb National Institute of Allergy and Infectious Diseases (NIAID)