Drugs in Development for Viral Hepatitis

Abstract

The approval of the first direct-acting antiviral (DAA) drugs for treatment of hepatitis C virus (HCV) is anticipated in 2011. Due to the promise that these compounds, telaprevir and boceprevir, may improve sustained viral response (SVR) rates up to 75% in treatment-naive or relapse genotype 1 (G1) patients, there will likely be widespread use of these drugs in the US and EU. Unfortunately, this also creates the potential for misuse of these new drugs for multiple reasons such as poor understanding of treatment populations, inadequate viral assay testing, poor adverse effect management and lack of monitoring for antiviral resistance. In an effort to avoid the casual or incorrect use of these newmedications, the American Association for The Study of Liver Diseases (AASLD) introduced a new programme to their 2010 meeting, the Viral Hepatitis Debrief. The purpose of the debrief is to move the field forward by immediately synthesizing new data from the annual meeting into a reasonable set of guidelines for clinicians who will be using these drugs. Topics in the debrief include changes in pre-treatment diagnostic testing, lessons from the phase III trials presented at themeeting,monitoring for resistance during treatment, combinations of small molecules, treatment of special populations, expanded access programmes (EAPs), what will be different in 2011 and, lastly, what issues remain unclear.