According to the results of two new clinical studies published in The Lancet, two new pill-only antiviral drug regimens for hepatitis C virus infection provide shorter and more effective treatment options with fewer side effects for most patients affected with the disease.
Chronic hepatitis C virus (HCV) infection affects about 150 million people around the world. This condition is a leading cause of cirrhosis and cancer of the liver. Currently the standard treatment for chronic HCV genotype 1 included a combination of three drugs: ribavirin, pegylated interferon, and a protease inhibitor. Used in association, these three drugs inhibit viral replication and increase the body’s immune response in order to eradicate the virus. This combination of drugs while effective poses a substantial financial burden, is cumbersome to administer and is associated with significant side effects.
In the current study 645 patients with HCV genotype 1b (which is not only the most common genotype in the USA, Europe, North Asia, Australia, and South America, but also one of the most difficult to treat) were treated with a 6-month course of treatment with a pair of oral DAAs asunaprevir and daclatasvir. A further 102 treatment-naïve patients formed a placebo control group. The treatment regimen was highly effective at clearing the virus and it was also well tolerated even in traditionally hard to treat patients. 90% of previously untreated patients and 82% who were intolerant to standard regimes, or who had been unsuccessfully treated with those, were cured. Characteristics such as gender, age, ethnic or having advanced liver disease generated no differences in response, at least none recognized as predictors of poor response to treatment.
The effectiveness and safety of 24 weeks of daclatasvir plus asunaprevir appears to represent a major improvement over the first generation of protease inhibitor based triple therapies for HCV genotype 1b infection. This new all-oral interferon and ribavirin-free combination could provide a more effective, safer, shorter, and simpler treatment option for those traditionally hard-to-cure patients with cirrhosis or those who have failed to respond to existing therapies.
Reference: Manns M, Pol S, Jacobson I, et al. All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study. The Lancet, Early Online Publication, 28 July 2014