HIV Infections Clinical Trial
Official title:
Pegylated Interferon Alfa-2a Versus Emtricitabine / Tenofovir +/- Pegylated Interferon Alfa-2a for the Treatment of Chronic HBe-Ag Positive Hepatitis B Infection in HIV-Coinfected Patients - the PEGPLUS Trial
The efficacy of pegylated interferons in the treatment of chronic hepatitis B has shown
superior results to standard of care in patients only infected with hepatitis B. The
efficacy of pegylated interferon for the treatment of chronic hepatitis B in HIV-coinfected
patients is not known at present.
The purpose of this study is to evaluate the efficacy of pegylated interferon in the
treatment of chronic hepatitis B in HIV-infected individuals.
Apart from evaluating the efficacy of pegylated interferon therapy in this setting as such,
i.e. in patients without present or future need of highly active antiretroviral therapy
(HAART) for HIV-infection, there is a second purpose of this study, to investigate whether
combination treatment of HBV-infection may be superior to pegylated interferon therapy
alone.
Therefore patients without need of HAART are offered pegylated interferon alfa-2a over 48
weeks. Patients who require HAART are offered emtricitabine / tenofovir DF containing HAART
over 72 weeks PLUS pegylated interferon alfa-2a over 48 weeks vs. emtricitabine / tenofovir
DF containing HAART over 72 weeks WITHOUT pegylated interferon-alfa-2a.
Even though the generated data on standard interferon for the treatment of chronic
HBV-infection in HIV-coinfected patients appears not promising at the moment, it is however
the only treatment with a curative intention. Trials with pegylated interferon in the
treatment of chronic HBV-infection in monoinfected patients with pegylated interferons
showed higher efficacy than standard of care and when compared to historic data higher
efficacy compared to non-pegylated interferon. This suggests in parallel a higher efficacy
in the treatment of chronic hepatitis B in HIV-coinfected as well. At the same time,
analysis suggested a further benefit when pegylated interferon therapy was prolonged beyond
24 weeks to 48 weeks as the elimination of HBV-DNA from serum appeared to continue beyond 24
weeks. Looking again at data from chronic hepatitis C infection, it is well known that the
elimination kinetics of HCV-RNA in HIV-coinfected patients is slower compared to
HCV-monoinfected patients, clearly suggesting rationale to offer 48 weeks pegylated
interferon for the treatment of chronic hepatitis B to HIV-coinfected patients as well.
Parallel to the above said there are several other factors suggesting a positive effect of a
combination treatment with nucleoside / nucleotide analogues active against HBV and
interferon. Therefore patients in need for antiretroviral therapy with CD4-cells above
200/µl will be randomized to either PegIFN as part of a combination treatment with FTC and
TDF or to FTC / TDF combination therapy alone. Patients receiving HAART will also receive a
third active antiretroviral HIV-drug, either a non-nucleoside analogue (NNRTI) or a protease
inhibitor (PI), at the choice of the investigator. A non-divergent antiretroviral therapy
solely based on nucleoside analogues will not be allowed in this trial.
The objective of this study is to assess the efficacy (HBV-DNA < 5x10³ copies/ml, loss of
HBe-Ag, HBe-seroconversion) and safety (adverse events, serious adverse events) of PegIFN
for 48 weeks, to that of PegIFN for 48 weeks plus TDF and FTC containing HAART, to that of
TDF and FTC containing HAART for 72 weeks.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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