In many ways, 2009 brought significant changes to viral hepatitis with promising new drug development and increased national advocacy. In terms of drug development, the treatment pipeline for hepatitis C (HCV) is very robust. Two protease inhibitors, telaprevir and bocepravir, are in final Phase 3 studies and if approved this year, will add an adjunct therapy to the standard of care (pegylated interferon + ribavirin) for HCV mono-infected individuals. Over 50 new therapies from several classes -- including HCV inhibitors, anti-inflammatory drugs, immunomodulators, new interferon drugs and vaccines -- are all in early and mid-stage studies. Advocates, including Project Inform, have also pushed for the development of studies in people living with both HCV and HIV, which will follow results from mono-infection studies, but pose new challenges for a more difficult to treat population.
The year also heralded the announcement of a strategy called Specifically Targeted Antiviral Therapy for hepatitis C (STAT-C), which is attempting to effectively treat HCV without using pegylated interferon and ribavirin. If this strategy proves effective it may usher in a new era of HCV treatment since pegylated interferon and ribavirin are highly toxic and not effective in everyone.
In any case, HCV drug development is complex and the offering of so many clinical studies of different drugs from so many different classes presents unique challenges to the field. However, these challenges will eventually pay off for people who need new HCV treatments . It is extremely encouraging to see the motivation and interest in the research. For more information on the status of hepatitis C clinical studies, go to www.HCVadvocate.org or www.clinicaltrials.gov.
Advocacy efforts are building through the Viral Hepatitis and Liver Cancer Control and Prevention Act of 2009 bill that was introduced at the same time as the AASLD meeting in Boston last fall. Advocates have worked for years for legislation to increase funding for testing, care and treatment of HCV. Project Inform has also joined with Treatment Action Group and other hepatitis C advocates nationally to create a Hepatitis C Treatment Issues Committee which will work to monitor the abundant drug development. We have learned significant lessons through the years of HIV drug development that are likely to support HCV drug development.