FDA approves boceprevir, the first new hepatitis C drug in 20 years
The Food and Drug Administration on Friday approved marketing of the Merck drug boceprevir, the first new drug for hepatitis C in 20 years. The agency is still considering approval of a similar drug, telaprevir, and is expected to approve it soon as well. Both drugs are members of a new class of hepatitis drugs called protease inhibitors, which block a key enzyme required by the virus to replicate. They are expected to convert hepatitis C from a debilitating disease into a manageable condition for the majority of people infected with the virus. Boceprevir, which will be marketed by Merck under the brand name Victrelis, is approved only for use in conjunction with the current hepatitis C drugs, peginterferon-alpha and ribavirin.
In two clinical trials reported in March in the New England Journal of Medicine, researchers found that boceprevir nearly doubled the number of patients who achieved what is known as a sustained virologic response -- in effect, a cure -- in patients with new hepatitis C infections. It tripled the response rate in those for whom prior therapy had failed. The drug is approved for both applications.
In patients with new infections, the combination of boceprevir, peginterferon-alpha and ribavirin produced a sustained virologic suppression in as many as 66% of patients, compared with a response of only 38% in patients who received only peginterferon-alpha and ribavirin. Among patients in which previous therapies had failed, the combination produced a 59% response in one group and a 66% response in a second group, compared with a 21% response rate in those who received the current therapy.
Side effects of the combination therapy include fatigue, anemia, nausea, headache and taste distortion.
Merck has not yet said what the pills will cost consumers, but the wholesale cost to distributors will be $1,100 per week. Wahtever the cost, it will be on top of the current $28,000 per year for peginterferon-alpha and ribavirin. Insurance companies are expected to pay for it, however, because the drug is so effective.
