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Boceprevir (Victrelis°). In triple-drug combination: virological advantage in chronic hepatitis C

FEATURED REVIEW  In chronic hepatitis C caused by genotype 1 virus, adding boceprevir to the standard combination of peginterferon alfa + ribavirin markedly increases the rate of sustained virological response, with acceptable adverse effects. Thus, the addition of boceprevir to standard therapy is justified, but evaluation must continue to determine long-term clinical outcomes.
Full review (4 pages) available for download by subscribers.

Abstract

  • Standard treatment for patients with genotype 1 chronic hepatitis C consists of a combination of peginterferon alfa and ribavirin, taken for 24 to 48 weeks.
     
  • Boceprevir, a drug that inhibits the hepatitis C virus NS3/4A serine protease, is now authorised in the European Union as an adjunct to this standard treatment.
     
  • In clinical trials, addition of boceprevir did not increase efficacy when the peginterferon alfa-2b + ribavirin combination reduced viral load during the first 4 weeks of treatment.
     
  • A double-blind, randomised trial including 1097 previously untreated patients showed that adding boceprevir after 4 weeks of peginterferon alfa- 2b + ribavirin combination therapy increased the rate of sustained virological response compared with adding placebo after 44 weeks of triple-agent therapy (66.1% versus 37.7%).
     
  • In early responders, the rates of sustained virological response were similar after 24 weeks and 44 weeks of triple-agent therapy.
     
  • After failure of standard therapy, a double-blind randomised trial in 403 patients showed that a new 44-week course of treatment induced a significantly higher rate of sustained virological response when boceprevir was added rather than placebo (66% versus 21%). In early responders, the rates of sustained virological response were not reduced by shortening treatment duration to 32 weeks.
     
  • The main adverse effect of adding boceprevir was an increased incidence of haematological disorders, including anaemia (48% versus 28% with placebo add-on), neutropenia (23% versus 18%), and thrombocytopenia (32% versus 14%).
     
  • Boceprevir is a potent inhibitor of cytochrome P450 isoenzyme CYP3A4; clinically relevant pharmacokinetic interactions can be thus anticipated when boceprevir is combined with drugs that have a narrow therapeutic margin.
     
  • Boceprevir therapy involves taking 4 capsules 3 times daily for 24 to 32 weeks.
     
  • In practice, adding boceprevir to the peginterferon alfa + ribavirin combination is justified both for first-line treatment and after failure of standard treatment. The impact of the added virological efficacy on morbidity and mortality remains to be determined.  
     

©Prescrire 1 April 2012

"Boceprevir. In triple-drug combination: virological advantage in chronic hepatitis C" Prescrire Int 2012; 21 (126): 89-92. (Pdf, subscribers only)
Download the full review.
Pdf, subscribers only

See also:

Telaprevir and hepatitis C. 
After boceprevir, if necessary
Prescrire Int 2012:
21 (126): 93-96.
Pdf, subscribers only