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Promising findings for therapeutic hepatitis C vaccine TG4040
Liz Highleyman, 2012-05-09 11:00:00
An investigational hepatitis C virus (HCV) therapeutic vaccine significantly improved the likelihood of sustained response to interferon-based therapy, according to a proof-of-concept study reported at the 47th International Liver Congress (EASL 2012) last month in Barcelona.
Interferon-based therapy and new direct-acting antiviral agents are not able to cure all patients with chronic hepatitis C. But the fact that some people respond very well to therapy – and that some are able to spontaneously clear HCV without treatment – suggests it may be possible to further boost the natural immune response to the virus.
Heiner Wedemeyer, from Hannover Medical School in Germany, and colleagues conducted a Phase 2 study of TG4040, a therapeutic vaccine being developed by the French company Transgene that is designed to stimulate immunity against HCV when combined with interferon. TG4040 is a recombinant vaccinia poxvirus (MVA) vaccine containing sequences encoding the NS3, NS4 and NS5B proteins from genotype 1b HCV.
The open-label HCVac trial included 153 treatment-naive genotype 1 chronic hepatitis C patients; about 80% had subtype 1b. Most were white men and the average age was about 43 years. Approximately 25% had the favorable IL28B CC gene pattern associated with good interferon response. About 10% of people who received TG404 had advanced fibrosis (stage F3), compared with only one person in the standard therapy control group.
Participants were randomly allocated (2:2:1) into three treatment arms. All received standard-of-care (SOC) pegylated interferon alfa-2a (Pegasys) plus ribavirin for 48 weeks. In addition, the first group received six injections of TG4040 beginning four weeks after treatment initiation (SOC lead-in), the second group started TG4040 12 weeks before beginning pegylated interferon/ribavirin (TG4040 lead-in), and the control arm did not receive TG4040.
The primary endpoint was complete early virological response (cEVR) 12 weeks after starting pegylated interferon/ribavirin.
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