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Boceprevir: Indication of added benefit for specific patients
Date:12/9/2011

The active ingredient boceprevir has been available since the middle of 2011 as a treatment for chronic hepatitis C of genotype 1. In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined to establish whether boceprevir offers added benefit in comparison with the previous standard therapy. According to this assessment, the dossier submitted by the pharmaceutical company provides indications of added benefit for patients who have not yet developed liver cirrhosis. However, the extent of this added benefit cannot be classified.

The pharmaceutical company provided no data - or inadequate data - for two other indications - patients with liver cirrhosis and patients for whom prior treatment was totally ineffective (zero response to prior interferon-based therapy) - and therefore added benefit for these patients is not proven.

An addition to previous standard drug therapy

Hepatitis C viruses attack the liver and can trigger inflammation there. If this becomes chronic, cirrhosis can develop and liver function progressively deteriorates. Moreover, the risk of liver cancer (hepatocellular carcinoma, HCC) increases. Boceprevir (trade name Victrelis, manufacturer MSD Sharp & Dohme) inhibits the reproduction of hepatitis C viruses. Experts assume that if no viruses are detectable in the blood over a sustained period after treatment (sustained virological response, SVR), the risk of secondary disease is reduced.

Boceprevir is administered in addition to the active ingredients peginterferon alfa and ribavirin, which are already on the market. In accordance with the approval status, different patient groups are treated for different periods, as was allowed for in the assessment. The dual combination of peginterferon alfa and ribavirin has been the standard therapy and this was compared wi
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Contact: Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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