Two new drugs for hepatitis C

The FDA has approved two new drugs for the treatment of hepatitis C — the first new drugs to be approved in years. The approvals came within days of each other, pitting the two drugs (and their companies' marketing departments) against each other in this multibillion dollar market. Both drugs are protease inhibitors and both have similar indications. First to be approved was Merck's boceprevir (Victrelis), which is indicated for adults with hepatitis C who still have some liver function and who either have not been treated previously with drug therapy or who have failed drug therapy. Boceprevir is approved for use in combination with peginterferon alpha and ribavirin. The approval was based on two phase 3 clinical trials of 1500 adults in which two-thirds of patients in the boceprevir, interferon, and ribavirin treatment group experienced a significantly increased sustained virologic response at 24 weeks compared to 38% with interferon and ribavirin alone. Boceprevir is taken orally three times a day with food. The second drug approved was Vertex Pharmaceutical's telaprevir (Incivek), which also was approved for patients with hepatitis C who either have not received interferon-based drug therapy or who have not responded adequately to prior therapies. Telaprevir is also approved for use with peginterferon alpha and ribavirin. Approval was based on three phase 3 clinical trials of over 2000 adults. In previously untreated patients, 79% of patients in the telaprevir group experienced a sustained viral response compared to 46% for standard treatment. Most patients experienced virologic response at 24 weeks suggesting that treatment times may be reduced from 48 weeks to 24 weeks. Telaprevir is also taken orally three times a day with food. Both drugs are approved to treat genotype-1, the most common form of hepatitis C and the most difficult to treat. The drugs have similar side effects, which include anemia and serious rashes. Several other drug manufacturers have similar drugs in the pipeline with approval expected within the next year or two. It is estimated that about 170 million people worldwide and 3.2 million Americans are infected with chronic hepatitis C, which is the most common cause of progressive liver disease leading to liver transplant. Telaprevir is expected to cost nearly $50,000 per treatment course, while bocepavir is expected to cost between $26,000 to $48,000 per treatment course depending on the duration.