Dasabuvir (trade name Exviera) and the fixed-dose drug combination ombitasvir/paritaprevir/ritonavir (trade name Viekirax) have been available since January 2015 for the treatment of adults with chronic hepatitis C infection. The German Institute for Quality and Efficiency in Health Care (IQWiG) had examined their added benefit in a dossier assessment completed in April 2015.

In an addendum, the Institute now assessed study data subsequently submitted by the drug manufacturer in the commenting procedure. According to the findings, the results of an indirect comparison show a hint of an added benefit of both drugs also in pretreated patients with genotype 1b infection without cirrhosis. The extent of this added benefit is non-quantifiable.

Both dasabuvir and ombitasvir/paritaprevir/ritonavir are only approved in combination with further drugs, including dasabuvir plus ombitasvir/paritaprevir/ritonavir. Since the Summaries of Product Characteristics recommend partly different treatment regimens both for these two drugs and for the respective comparator therapies, there are different patient groups for the benefit assessment, which mainly differ in type of virus, pretreatment and stage of disease.

The Federal Joint Committee (G-BA) specified either dual therapy (peginterferon plus ribavirin) or triple therapy, i. e. a combination of a protease inhibitor with peginterferon and ribavirin, as appropriate comparator therapies.

For more details, go to: https://www.iqwig.de/en/press/press-releases/press-releases/dasabuvir-and-ombitasvir/paritaprevir/ritonavir-hint-of-added-benefit-in-further-patients.6757.html