The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined whether Incivek/Incivo (telaprevir), from J&J Janssen Cilag, offers an added benefit for patients with Hepatitis C compared to conventional therapy. The assessment finds that the drug offers advantages in various groups of patients with chronic Hepatitis C infection of genotype 1. The available studies provide proof, indications or "hints" of an added benefit, but that the probability and extent of this benefit varies.
From 3 studies investigated, different results for morbidity were shown for treatment-naïve patients without cirrhosis, depending on the viral load in the blood at the start of treatment. Proof of an added benefit of telaprevir was only determined for patients with a high viral load. However, the extent of the added benefit is unquantifiable. For treatment-naïve patients without cirrhosis, the data also provide proof and an indication of greater harm due to the adverse effects "anaemia" and "rash" respectively. However, overall this doesn't alter overall the conclusions as these side effects were nearly exclusively classified as "not serious".
In contrast, for treatment-naïve patients without cirrhosis who have a low viral load at baseline, the data provide an indication of lesser benefit of telaprevir versus the comparator therapy. This is due to the fact that an added benefit regarding SVR is not proven, so that only the harmful effects are taken into account. There were different results shown for patients in whom treatment had so far been unsuccessful: here the data only provide a "hint" of an added benefit. Finally in patients with cirrhosis who relapsed, IQWiG concluded that overall an added benefit is not proven for this patient group.