IQWiG finds added benefit of Exviera plus Viekirax in pretreated patients with genotype 1b hepatitis C- AbbVie
The German Institute for Quality and Efficiency in Health Care (IQWiG) has re-examined the added benefit of Exviera plus Viekirax (dasabuvir/ombitasvir/paritaprevir/ritonavir), from Abbvie, for the treatment of adults with chronic hepatitis C infection in an addendum to the original dossier assessment completed in April 2015. In the addendum, the Institute has now assessed study data subsequently submitted by the manufacturer, based on two randomized controlled trials: The first study (PEARL II) compared dasabuvir plus ombitasvir/paritaprevir/ritonavir with dasabuvir plus ombitasvir/paritaprevir/ritonavir plus ribavirin. The second study (MALACHITE II) compared the latter combination with triple therapy.
The comparison showed a statistically significant difference in favour of dasabuvir plus ombitasvir/paritaprevir/ritonavir in “sustained virologic response” (SVR). A hint of an added benefit can be derived from this for one further group: pretreated patients infected with genotype 1b virus who have not (yet) developed cirrhosis. The extent of this added benefit cannot be quantified, however. It remains unclear in how many patients in whom the virus is no longer detectable, late complications, and liver cancer in particular, can actually be prevented.
In the dossier assessment from May 2015, IQWiG had determined an indication of a non-quantifiable added benefit of dasabuvir and ombitasvir/paritaprevir/ritonavir in a total of three patient groups: pretreated and treatment-naive patients with genotype 1a infection and treatment-naive patients with genotype 1b. Pretreated patients with genotype 1b now form the fourth group. The limitation that the patients have not yet developed cirrhosis applies to all four groups. The data still do not show an advantage for the remaining groups of patients, but these populations are comparably small. Overall, IQWiG now sees an added benefit in approximately 90% of the patients for whom the two drugs are approved. The extent of this added benefit is non-quantifiable.
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