The Lancet has featured results from the two phase III regulatory trials (QUEST-1 and QUEST-2) of simeprevir, an oral once daily HCV NS3/4A serine protease inhibitor. Both studies used the same study design and reported similar results; sustained virological response at 12 weeks with the simeprevir regimen was significantly higher than that with the control regimen of placebo, peginterferon alfa, and ribavirin. Simeprevir was generally well tolerated in both studies with a similar adverse event profile to the peginterferon and ribavirin group.
A related commentary discusses the place in therapy for HCV adding that despite the apparent advantages, little is known about this regimen in patients in whom viral eradication is more difficult to achieve, such as black patients and those with cirrhosis, as these subgroups were not adequately represented in the QUEST trials.
In the UK, simeprevir (Olysio™) is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (genotypes 1 and 4) in adult patients. The recommended dosage is one capsule of 150mg once daily for 12 weeks. NICE is currently evaluating simeprevir for the treatment of genotype 1 or 4 chronic hepatitis C; guidance publication is expected in January 2015.