A new drug Boceprevir is going to be added to the already existing pegylated interferon injections and ribavirin pills in the treatment of dangerous Hepatitis C viral hepatitis.
This infection often lead to cirrhosis of liver and cancer of liver.
The new drug directly attacks the virus in contrast to the already existing drugs which help to boost immunity.
FDA Panel Endorses Boceprevir for Hepatitis C
SILVER SPRING, Md. -- An FDA advisory committee has voted unanimously to recommend approval of the investigational drug boceprevir (Victrelis), in combination with peginterferon and ribavirin, to treat hepatitis C genotype 1.
The panel was expected to endorse the drug -- and the FDA is expected to approve it -- since clinical trials showed that in the difficult-to-treat genotype 1 patients boceprevir yielded sustained virological response rates as high as 67%.
In contrast, the rate for patients getting the standard regimen of pegylated interferon injections and ribavirin pills was about 40%.
The drug is one of two hepatitis C virus (HCV) protease inhibitors that will be reviewed during the panel's two-day meeting this week. The other is telaprevir -- slated for review on Thursday -- which exhibited even higher sustained response rates than boceprevir.
Both boceprevir and telaprevir have attracted major buzz among physicians and patients on the basis of excellent-looking clinical trial results, most recently from two of boceprevir's pivotal studies published in the New England Journal of Medicine last month.
The core treatment regimen with boceprevir tested in the trials included a four-week lead-in period with peginterferon and ribavirin with boceprevir then added for 44 weeks. But some of the trials also included a regimen in which the duration of boceprevir treatment could be extended based on how well a patient was responding to treatment after eight and 24 weeks.
Until now, treatment has relied on boosting the immune system, rather than attacking the virus directly.
