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Sofosbuvir: Indication of added benefit for specific patients
Date:5/2/2014

The drug sofosbuvir has been available since January 2014 as a treatment for chronic hepatitis C infection. 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 whether the new drug offers added benefit in comparison with the appropriate comparator therapy.

The dossier submitted by the drug manufacturer provides indications of added benefit for non-pretreated patients infected with the virus of genotype 2. However, the extent cannot be quantified. There were no suitable data in the dossier for patients who are infected with other virus types (genotype 1 and 3 to 6) or who are coinfected with HIV.

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 increases. Sofosbuvir inhibits the reproduction of hepatitis C viruses and is administered in addition to the drugs peginterferon alfa and ribavirin, which are already on the market; in certain cases it is administered in addition to ribavirin alone. According to the approval, treatment duration differs for the individual patient groups.

The dual combination of peginterferon alfa and ribavirin is the current treatment standard; in genotype 1, this also applies to a triple combination with boceprevir or telaprevir (triple therapy) in most patients.

The Federal Joint Committee (G-BA) therefore specified peginterferon alfa and ribavirin as appropriate comparator therapy, and, in genotype 1, triple therapy as additional option.

No adequate analyses for most virus types

The manufacturer presented no adequate analyses for infection with type 1 and type 3 to 6 viruses and for HIV coinfection. It analysed results
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Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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