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FDA Considers Expanded Use of HCV Drugs

April 30, 2010

ROCKVILLE, Md. -- The FDA heard public testimony Friday on establishing a compassionate use program that would allow severely ill hepatitis C (HCV) patients access to investigational, direct-acting antiviral agents.

One of the current treatments for HCV -- pegylated interferon alfa-2a and ribavirin (Rebetol) -- is highly toxic with a response rate of about 50%, clinical data show. That number is much lower in real-world cases, according to a number of physicians who testified during the public hearing.

The FDA understands current treatment options are not good enough, an official said. "Current control of hepatitis C is not working," said Peter Lurie, MD, of the FDA's Office of the Commissioner.

Friday's meeting was called in response to a petition by groups seeking access to the drugs for individuals often excluded from clinical trials.
Clinical trials are only open to a small subset of real-world HCV patients, noted Diana Sylvestre, MD, who treats HCV-infected intravenous drug users in the San Francisco area. Yet, there are many HCV patients who cannot tolerate current treatments, she said.

Her patients are rarely accepted into clinical trials, she said, because of their drug use, comorbidities, and mental illnesses.

Other patient populations who might benefit from expanded access include those with cirrhosis, HIV, or hemophilia; those awaiting transplant or post-transplant patients who have a recurrence of HCV; and African Americans and Hispanics.

Several physicians urged special consideration for minority patients, who are disproportionately left out of clinical trials. A recent study confirmed that members of ethnic minorities do not fare as well as expected with current HCV treatments.

The FDA instituted compassionate use programs in the 1970s and such drugs as trastuzumab (Herceptin), bevacizumab (Avastin), and erlotinib (Tarceva) have all been made available before formal FDA approval under an expanded access protocol.

One major expanded access program involved breakthrough HIV therapies in the '90s. "Anecdotally, the results were so striking," said Jeffrey Murray, MD, deputy director of the FDA's antiviral products division. "They did save lives."

Murray noted that the FDA is working on a guidance document on the use of direct-acting antiviral agents, which should be released sometime this year.
If approved, an expanded access program could be applied to several novel HCV treatments currently in clinical trials.

One of the most advanced is the protease inhibitor telaprevir from Vertex and Johnson & Johnson.

Results from a phase II trial showed that when telaprevir was added to pegylated interferon alfa-2a and ribavirin among patients who hadn't responded to treatment, the virus was significantly more likely to be eradicated.  


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