Added Benefit for Hepatitis C Treatment Not Proven

Data for daclatasvir not suitable to prove added benefit.

Hepatitis C virus (HCV) drug daclatasvir was not found to offer an added benefit over the appropriate comparator therapy in a recent study.

In an evaluation of the drug’s dossier conducted by German health officials, data from the manufacturer for hepatitis C genotype 1 patients without cirrhosis of the liver and patients with HCV genotype 4 was found to be unsuitable to prove an added benefit.

Daclatasvir seeks to limit the reproduction of HCV by interfering with viral DNA replication. It is believed that if sustained virologic response is achieved for a prolonged duration, the risk of secondary disease is reduced.

Daclatasvir is typically utilized in combination with sofosbuvir, in triple therapy with sofosbuvir and ribavirin, or in triple therapy with peginterferon alfa to enhance the immune system and ribavirin. The duration of treatment varies among certain patient groups with a typical length of 12 to 48 weeks.

The options for comparator therapy are combination treatment with peginterferon alfa and ribavirin or triple therapy comprised of peginterferon alfa and ribavirin with a protease inhibitor (boceprevir or telaprevir).

Federal Joint Committee specifications list different appropriate comparator therapies for each of 6 different HCV subindications. In both treatment-naive and treatment-experienced adults with chronic HCV genotype 1 infection without cirrhosis, both dual therapy and triple therapy is specified as an appropriate comparator therapy.

In 4 other subindications, daclatasvir was to be compared only with dual therapy in treatment-naive HCV patients with genotype 1 and cirrhosis; patients with HCV genotype 1 and additional HIV infection; patients with HCV genotype 3 infection with compensated cirrhosis; and in patients with HCV genotype 4 infection.

Data was only presented by the manufacturer for treatment-naive adults with chronic HCV genotype 1 infection without cirrhosis and for patients with HCV genotype 4 infection.

Short of proper studies to allow for direct comparison, an indirect evaluation for HCV genotype 1 patients without cirrhosis was included by the manufacturer with a goal of providing a historical comparison with individual arms of different studies. The analysis sought illustrate the superiority of daclatasvir versus the triple therapy, but the manufacturer failed to meet the requirements for the dossier.

Additionally, the inclusion and exclusion criteria for the studies that were included was insufficient, as at least one relevant study was not included. The dossier also lacked suitable data for treatment-naive HCV genotype 4 patients, according to the Institute for Quality and Efficiency in Health Care.