May 2, 2011
On Thursday, Vertex Pharmaceutical's new hepatitis C virus treatment gained unanimous support from an independent committee that advises the Food and Drug Administration on antiviral drugs. After a daylong hearing with stakeholders, the committee of medical experts voted 18-0 to recommend FDA approve telaprevir as a new HCV treatment. FDA typically follows the panel's advice and is scheduled to make a decision on May 23.
Over 3 million people in the United States have chronic HCV, and three-quarters are unaware of they are infected. Many acquired the blood-borne virus decades ago from drug use or through transfusions before HCV testing began in 1992.
Telaprevir is administered in combination with standard therapy: pegylated interferon and ribavirin. Of treatment-naïve HCV patients taking the telaprevir combination regimen, 79 percent achieved a sustained virologic response. Standard treatment alone against the same hardest-to-treat HCV strain typically achieves SVR in less than half of patients. Telaprevir works by blocking the protease enzyme HCV needs to replicate.
The panel concluded that telaprevir's risks, including rashes and anemia, were manageable. At least one panelist expressed disappointment that few clinical trial participants were African Americans -- a group representing a significant proportion of the HCV population, for whom treatment response rates are lower than average.
"It's a stunning achievement that we will be able to cure nearly 80 percent of [first-time] patients and nearly as many relapsers," said panelist Dr. Lawrence S. Friedman, head of the medicine department at Newton-Wellesley Hospital in Massachusetts.
"I think this is a long-awaited landmark day for patients with hepatitis C," said panelist Dr. Barbara H. McGovern of Tufts University School of Medicine in Boston.