Review by a German commission also found major benefits in patients who had not responded to prior treatment with other medications.
A German institute charged with evaluating the cost effectiveness of new drugs found that treatment with simeprevir is beneficial for some treatment-naïve patients with hepatitis C, as well for some relapsed and nonresponding patients, but that the drug offered no additional advantage for patients coinfected with HIV.
The country’s Institute for Quality and Efficiency in Health Care (IQWiG) examined whether simeprevir offers added benefit over comparable existing therapy as part of an early benefit assessment mandated by German law. In May, Medivir, a Swedish coporate partner of Janssen, was granted European approval to market simeprevir (Olysio) for the treatment of genotypes 1 and 4 chronic hepatitis C virus (HCV) infection to be administered with or without ribavirin and pegylated interferon.
Hepatitis C is a bloodborne virus that can severely damage the liver and lead to cirrhosis, cancer of the liver, and a need for transplants in some patients. Health officials estimate that up to 150 million people worldwide are chronically infected with HCV, which has six different genotypes and numerous sub strains, including genotype 1b, common in Europe, and genotype 1a, common to the United States.
Major added benefits for nonresponders
Simeprevir was found to have major added benefits for nonresponders compared to telaprevir in adults with chronic HCV genotype 1 infection, according to a release on the findings issued by IQWiG. Findings were based on results of a study provided by the drug manufacturer in which both drugs were used as comparators as part of triple therapy in combination with peginterferon alfa and ribavirin.
While serious side effects and early discontinuations due to side effects happened with both drugs, they were found to be less frequent in patients treated with simeprevir, as were skin and gastrointestinal disorders. “Overall, an indication of major added benefit can be derived from the positive effects” the release stated.
Added benefit for treatment-naïve and relapsed patients
The institute also found indications of added benefit for people with HCV genotype 1 who were either treatment naïve or who had received successful treatment but later relapsed. Treatment consisted of simeprevir or placebo in combination with peginterferon alfa and ribavirin.
For treatment-naive patients with HCV genotype 1, study results indicated that some who took simeprevir had fewer side effects while fatigue and global health status improved more than the comparator. For relapsed patients with HCV genotype 1, simeprevir treatment showed an increased likelihood of being virus-free after the treatment. However it is unclear how often the drug can actually prevent liver cancer, the release states.
The institute found that there was insufficient data to assess benefit of simeprevir in patients with HCV genotype 4 and those with genotype 1 who are coinfected with HIV. The group’s assessment is part of the procedure to assist the Federal Joint Committee also known as the G-BA in regulating pricing and insurance reimbursement of the drug throughout Germany’s health care system.