The drug combination of ledipasvir and sofosbuvir (trade name Harvoni) has been available since November 2014 for the treatment of chronic hepatitis C infection. The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether this new drug offers an added benefit over the appropriate comparator therapy.

IQWiG found a hint a non-quantifiable added benefit for two out of seven patient groups in total: in an infection with genotype 1 hepatitis C virus (HCV) when previous therapies had been unsuccessful, and when previously untreated patients have not yet developed cirrhosis of the liver. The data showed an advantage in sustained virologic response (SVR): Almost all patients were free of the virus after the Treatment.

IQWiG examined the added benefit separately for a total of seven patient groups, which were categorized according to genotype of the virus (1, 3, or 4), stage of the disease and previous treatment.

The drug manufacturer presented no direct comparative studies, but so-called historical comparisons. In a historical comparison, data from different studies, in which at least one of the treatments to be compared was tested, are compared.

However, these kinds of results are susceptible to bias for several reasons. Conclusions on the (added) benefit can therefore generally only be derived when the effect differences are so large that they cannot be explained by the bias alone (“dramatic effect”). Due to the reduced certainty of conclusions, no more than a hint can be derived from these kinds of data, but no indication or even proof.

For more details, go to: https://www.iqwig.de/en/press/press-releases/press-releases/ledipasvir-plus-sofosbuvir-hint-of-added-benefit-in-certain-patients.6610.html