Treatment with simeprevir (Olysio) was found to have added benefit over available comparator therapy in patients infected with hepatitis C virus (HCV) genotype 1 who have been untreated before or have relapsed after initially successful treatment.
In an early benefit assessment conducted by the German Institute for Quality and Efficiency in Health Care, researchers examined 3 available studies of simeprevir use in treatment-naïve patients with HCV genotype 1 infection, with or without cirrhosis of the liver. The patients received simeprevir or placebo in combination with peginterferon alfa and ribavirin.
Results and side effects varied by age, fibrosis score, and 2 molecular biological factors. Simeprevir was found to offer improvements on fatigue and global health status in relation to the comparator group, while certain patients reported fewer serious adverse events. No differences were found between the treatment groups in regard to mortality.
In patients who relapsed, simeprevir was found to increase the likelihood of being virus-free after the treatment, although it was unclear how frequently the drug can prevent liver cancer. In this patient group, the study found there to be an indication of a nonquantifiable added treatment benefit with simeprevir.
In patients who had unsuccessful prior HCV therapy, the group treated with simeprevir was found to have less frequent serious adverse events, less frequent skin and gastrointestinal disorders, and less frequent premature treatment discontinuations due to side effects.