FDA Approves Merck’s New Drug Victrelis For Treatment Of Hepatitis C
The U.S. Food and Drug Administration (FDA) announced late yesterday that it has approved Victrelis for the treatment of hepatitis C.
Victrelis (boceprevir), which will be marketed by the U.S. pharmaceutical company Merck, is approved for use in combination with the current standard of treatment for hepatitis C, peginterferon alfa (Pegasys or PegIntron) plus Ribavirin (Copegus, Rebetol).
“This is an exciting day for physicians and patients because Victrelis is the first major advancement for the treatment of chronic hepatitis C approved in a decade,” said Dr. Bruce Bacon, professor of internal medicine at Saint Louis University School of Medicine and one of the Victrelis clinical trial leaders, in a Merck press release.
“Compared to current standard therapy, Victrelis can significantly increase a patient’s chance of achieving undetectable levels of the virus, thereby obtaining an SVR [sustained virologic response]. For many patients, Victrelis may allow for a shorter total duration of treatment,” he added.
The approval is based on clinical trial results showing that Victrelis increased cure rates for hepatitis C – called a sustained virologic response, or SVR – from around 40 percent to about 65 percent (see related AIDS Beacon news).
Hepatitis C is a Liver Disease caused by the hepatitis C virus (HCV). If untreated, infection with HCV can cause damage and scarring to the liver, liver cancer, and eventually liver failure. Once the liver fails, a liver transplant is necessary for a patient to survive. Some people who are infected can spontaneously clear the virus themselves; the rest need treatment with antiviral drugs.
Victrelis has been approved for use in adults with hepatitis C who have never been treated or who have previously failed treatment. It may be taken even by patients who have cirrhosis (scarring and poor liver function caused by advanced liver disease).
Victrelis has not yet been approved for people with HIV-HCV co-infection. Merck is currently conducting clinical trials to evaluate the drug’s safety and efficacy in people who are infected with both HIV and HCV (see related AIDS Beacon news).
The approved dosing schedule for Victrelis, as anticipated, is somewhat complicated. Most patients taking Victrelis will undergo response-guided therapy. Under this model, the length of treatment varies depending on how well a patient responds to the drugs.
Treatment-naïve patients will receive four weeks of standard treatment (ribavirin plus peginterferon alfa), then 24 weeks of standard treatment plus Victrelis (for a 28 week total treatment length). However, if patients still have detectable HCV levels after eight weeks of Victrelis, treatment is extended with an additional eight weeks of Victrelis, then 12 weeks of just peginterferon alfa plus ribavirin (for a total treatment length of 48 weeks).
Patients who have been treated previously for hepatitis C will receive four weeks of standard treatment, then 32 weeks of standard treatment plus Victrelis (for a 36 week total treatment length). If patients still have detectable HCV levels after eight weeks of Victrelis, treatment is extended with an additional 12 weeks of peginterferon alfa plus ribavirin after finishing Victrelis (for a total treatment length of 48 weeks).
Patients who have cirrhosis will take peginterferon alfa and ribavirin for four weeks, followed by 44 weeks of Victrelis, peginterferon alfa, and ribavirin.
If HCV is still detectable after 24 weeks, Merck recommends discontinuing treatment with all three drugs. Victrelis is taken three times daily with food, every seven to nine hours, in the form of four 200 mg pills.
Merck stated in its press release that it will start shipping Victrelis to pharmacies within a week. The company will also add Victrelis to its patient assistance program, which provides free medications to people who are uninsured and who meet income requirements (annual income of no more than $43,320 for an individual). Victrelis will cost $1,100 per week, or between about $26,000 and $48,000 for an entire course of therapy.
Victrelis is one of two new hepatitis C drugs currently being evaluated by the FDA. Victrelis and telaprevir, which will be marketed by Vertex Pharmaceuticals and Johnson & Johnson, are both HCV protease inhibitors, which work by inhibiting HCV replication in the body. The FDA is expected to announce its decision on telaprevir’s potential approval within the next two weeks.
May 18, 2011