Exviera, Viekirax combination added benefit for patients with HCV genotype 1b without cirrhosis

In an addendum from a previous manufacturer dossier assessment conducted by the Institute for Quality and Efficiency in Health Care in Germany, Exviera, when used in combination with Viekirax was deemed to have an added benefit of both drugs in patients with hepatitis C genotype 1b virus infection without cirrhosis, according to a press release.

The dossier assessment is a procedural part of the Act on the Reform of the Market for Medicinal Products, 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 Efficiency in Health Care (IQWiG).

According to the release, the manufacturer submitted data for an indirect comparison of treatments with Exviera (dasabuvir, AbbVie) in combination with Viekirax (ombitasvir/paritaprevir/ritonavir, AbbVie) with or without ribavirin. The comparison showed an added benefit, but “the extent of this added benefit cannot be quantified,” the release said.

Since dasabuvir and ombitasvir/paritaprevir/ritonavir are approved only when in combination with other drugs, different patient groups were used for the benefit assessment, which included patients with different types of the virus, stages of the disease and pre-treatment procedures, according to the release.

“This comparison was based on two randomized controlled trials,” the release stated. “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. Hence dasabuvir plus ombitasvir/paritaprevir/ritonavir plus ribavirin was suitable as a so-called common comparator.” In these two studies, the patients were similar, according to the release, so a comparison was “principally possible and suitable.” However, the results were “less informative than in a direct comparison.”

In terms of virologic response, the indirect comparison showed a significant difference in favor of the dasabuvir plus ombitasvir/paritaprevir/ritonavir regimen in a cohort of patients with HCV genotype 1b without cirrhosis. “A hint of added benefit” was seen in this group of patients for sustained virologic response, the release said, which was not seen in the earlier dossier assessment.

“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,” according to the release.

In the dossier assessment reported in May, IQWiG had determined an added benefit of dasabuvir and ombitasvir/paritaprevir/ritonavir in a total of three patient groups, which was primarily justified by an advantage in SVR and derived from studies of direct comparisons.

“The data still do not show an advantage for the remaining groups of patients. But these populations are comparably small,” the release said. “Overall, IQWiG now sees an added benefit in approximately 90% of the patients for whom the two drugs are approved.”

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.