Efficacy of PTX+IFN Alpha+ RBV on Hepatitis C Virus Coinfected HIV Patients
Status:
Unknown status
Trial end date:
2016-03-01
Target enrollment:
Participant gender:
Summary
Current Hepatitis C virus (HCV) treatment consists of the combination of interferon alpha 2a
(IFN-alpha 2a) plus ribavirin (RBV) and it provides sustained virologic responses (SVR) on 54
to 56% on HCV monoinfected patients and this response is even lower on HIV-HCV coinfected
patients. A previous study on HCV monoinfected patients showed that the addition of
pentoxyfylline (PTX) to a treatment scheme based on interferon-alfa and ribavirin increased
SVR on 25%, although it is not known if the same effect is to be obtained in HCV-HIV
coinfected patients.
On the other hand, other factors such as host genetics, have proved to influence treatment
response on HCV infected patients. The best described genetic factor so far is the
interleukin 28B (IL28B) polymorphism rs12979860, where a cytosine-cytosine (CC) genotype
provides an almost twice increase on SVR than the rest of the genotypes.
Therefore, this is a randomized, double blind study to assess the efficacy of pentoxyfylline
addition to a treatment scheme based on interferon-alfa and ribavirin in chronic HCV genotype
1, co-infected HIV-1 positive subjects, considering the IL28B polymorphism rs12979860.
HIV-HCV coinfected subjects currently receiving Highly active antiretroviral therapy (HAART),
with at least 8 months on undetectable HIV viral load and T helper cells count of 200 or
higher will be included. Patients will be randomized on one of two groups:
- Group A: IFN alpha 2a + RBV + PTX
- Group B: IFN alpha 2a + RBV + placebo
Patients will be followed for primary outcome during 72 (for rapid responders) or 96 weeks
(for non rapid responses). Outcome measures will be the following:
- SVR rate 24 weeks after the end of treatment
- Grade of Hepatic fibrosis from baseline to the end of treatment, measured by transient
elastography and the AST to platelet ratio index (APRI index)
- IL28B rs12979860 genotype
The study hypothesis is that the addition of PTX to a treatment scheme based on IFN-alfa2a
and RBV in chronic HCV genotype 1, co-infected HIV-1 positive subjects will improve SVR rate
and fibrosis progression irrespectively of IL28B rs12979860 genotype.
Phase:
Phase 4
Details
Lead Sponsor:
Centro Universitario de Ciencias de la Salud, Mexico