The dossier assessment is a procedural part of the Reform of the Market for Medicinal Products Act, overseen by the Federal Joint Committee (G-BA). The G-BA conducts a commenting procedure once the dossier assessment is complete and then determines the extent of the added benefit determined by the Institute for Quality and Efficacy in Health Care (IQWiG).
The current assessment was based on the MALACHITE I and II clinical studies, where patients with HCV genotype 1a or 1b without cirrhosis were dosed with Exviera (dasabuvir, AbbVie) in combination with Viekirax (ombitasvir/paritaprevir/ritonavir, AbbVie) with or without ribavirin, and compared with patients treated with a combination of Incivek (telaprevir, Vertex), pegylated interferon and ribavirin, according to the release.
Ten patient groups were examined in the overall assessment, according to the release, but added benefit was only observed for genotype 1a treatment-naive patients and patients who relapsed after previous successful therapy, and treatment-naive patients with genotype 1b. Among these groups, data showed SVR rates in favor of the combination treatment.
The assessment also contained information on health-related quality of life and found that dasabuvir had an advantage for the duration of treatment, but only in certain genotype 1a and 1b treatment-naive patients and not treatment-experienced patients with genotype 1a, the release said.
In terms of adverse events, the assessment did not prove greater or lesser harm of the therapies on the patients. However, the IQWiG did notice an indication of lesser harm in treatment-naive patients with genotype 1b and treatment-experienced patients with genotype 1a.
Ombitasvir/paritaprevir/ritonavir in combination with dasabuvir was approved by the European Commission in January for HCV genotypes 1 and 4 and is now available in certain areas of Europe, including the UK.
Ombitasvir/paritaprevir/ritonavir in combination with dasabuvir, known as Viekira Pak (AbbVie) in the U.S., was approved by the FDA in December 2014 for treating patients with HCV genotype 1 infection and cirrhosis. – by Melinda Stevens