Novel Hepatitis C Drug Shows Promise

Additional benefit from dasabuvir and combination of ombitasvir/paritaprevir/ritonavir found in pretreated genotype 1b hepatitis C patients without cirrhosis.

A novel hepatitis C drug combination that has already been approved in Europe has been found to offer an additional benefit for a specific group of patients.

An analysis by The German Institute for Quality and Efficiency in Health Care found dasabuvir (Exviera) and the fixed-dose drug combination of ombitasvir/paritaprevir/ritonavir (Viekirax) by AbbVie to show a hint of an added benefit in pretreated patients with genotype 1b infection without cirrhosis. The extent of the additional benefit is non-quantifiable, the study noted.

Both Exviera and Viekirax are used in combination with other drugs, including Exviera plus Viekirax. As such, researchers used different patient groups for the benefit assessment, with differences in type of virus, pretreatment, and stage of disease.

The drugs were evaluated based on 2 randomized controlled trials. The first study (PEARL II) compared Exviera plus Viekirax versus Exviera plus Viekirax with ribavirin. The second study (MALACHITE II) compared Exviera plus Viekirax plus ribavirin with triple therapy.

The comparison showed a statistically significant difference in sustained virologic response (SVR) in favor of Exviera plus Viekirax. The added benefit was derived for pretreated patients with genotype 1b hepatitis C who have not yet developed cirrhosis.

The study noted that it remains unclear how many patients no longer had detectable viral levels, late complications, and whether liver cancer could actually be prevented.

Earlier this year, researchers found a non-quantifiable added benefit from Exviera and Viekirax in 3 other patient groups, primarily justified by an SVR advantage shown in studies of direct comparisons.

These groups were pretreated and treatment-naive patients with genotype 1a infection and treatment-naive patients with genotype 1b. None of those patients have developed cirrhosis yet either, as well.