Chronic Hepatitis C Clinical Trial
Official title:
Phase 2a Study of Boceprevir for the Treatment of Genotype 6 Hepatitis C
The purpose of this study is to evaluate the antiviral efficacy of Boceprevir-based therapy
for the treatment of genotype 6 chronic hepatitis C infection.
Boceprevir has recently been approved for the treatment of genotype 1 chronic hepatitis C
infection. Recent in vitro studies suggest similar efficacy against genotype 6 chronic
hepatitis C infection.
The investigators therefore hypothesise that:
i) Boceprevir is a potent inhibitor of genotype 6 hepatitis C replication in vivo.
ii) Boceprevir in combination with pegylated interferon-alpha and ribavirin for 24 weeks
will cure a high proportion of patients chronically infected with genotype 6 chronic
hepatitis C infection.
Genotype 6 HCV (HCV-6) is common in parts of South-East Asia, in particular Vietnam. There
is a small but growing population of immigrant patients with chronic HCV-6 in Australia. The
current standard-of-care treatment (SOC) for chronic HCV-6 infection is peg-interferon-α
(PEG-IFN) and ribavirin (RBV) therapy for 48 weeks. The available data evaluating treatment
outcome suggests that SVR rates are intermediate between those of HCV-1 and HCV-2/3. There
is a medical need for novel therapies that might increase SVR rates and/or allow shortened
treatment duration.
Boceprevir is a novel HCV NS3 protease inhibitor, and boceprevir-based triple therapy has
recently been approved for the treatment of HCV-1. Boceprevir also appears to have some
antiviral effect against HCV-2 and HCV-3 in vivo. Boceprevir has not been used to treat
patients with chronic HCV-6 infection. Recent in vitro data have demonstrated that
boceprevir has an antiviral effect against HCV-6.
The investigators are therefore undertaking an investigator-initiated proof-of-concept pilot
study of boceprevir-based therapy for the treatment of patients chronically infected with
HCV-6.
The study population will consist of a representative group of 30 adult patients who are
chronically infected with genotype 6 HCV. All patients will be of Asian background, will be
non-cirrhotic, and will carry a "good response" IL28B genotype (C/C for rs12979860). The
patients will be recruited from the outpatient clinics of 4 Hepatology units in Melbourne,
Australia, represented by the principal and associate investigators.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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