April 28, 2011 -- A major advance for treating hepatitis C is likely headed to market after government advisors backed two new drugs this week.
Studies suggest the drugs could as much as double the effectiveness of current treatments for the potentially fatal liver disease. That could improve prospects for tens of thousands of patients and may bring thousands of more chronic sufferers into treatment, experts say.
An expert panel unanimously recommended Thursday that the FDA approve a new drug called telaprevir, saying it effectively cuts the level of hepatitis C virus (HCV) in the bloodstream of infected patients. The decision comes on the heels of another unanimous vote Wednesday backing a similar drug called boceprevir.
As many as 3.9 million Americans are infected with HCV, though up to three-quarters of them don’t know it. Millions of Americans were infected with HCV because of tainted blood products in the 1990s and earlier. Today, sharing of needles by users of illicit drugs is a major source of infection.
Hepatitis C is a major cause of cirrhosis, a potentially fatal liver wasting disease. It is also a risk factor for liver cancer.
Telaprevir, made by Vertex Pharmaceuticals, and boceprevir, made by Merck, are both part of a new class of anti-HCV drugs known as protease inhibitors. Like similar medications already used against HIV, the drugs suppress HCV by disrupting the reproduction of the virus.
Most HCV patients now face months of treatment with ribavirin and interferon, which are used to boost the immune system. The treatment is complicated, expensive, fraught with side effects, and requires close attention from doctors and patients.
But data from both Vertex and Merck suggest the new protease inhibitors could increase treatment effectiveness from about 40% now to nearly 80%, on average. Clinical trials submitted by the companies suggested the drugs can also shorten the length of treatment from a year to as little as 24 weeks.
Praise From the FDA Panel
The results prompted high praise rarely heard by the FDA’s scientific advisors.
“I started pinching myself, saying, ‘Is it really possible I’m looking at numbers like this?’ Because it really is unbelievable,” said Victoria Cargill, MD, director of minority research at the National Institutes of Health’s Office of AIDS Research and the panel’s chair.
”For those of us who’ve been in the field, thisis a very exciting moment,” said Lawrence S. Feldman, MD, a professor of medicine at Harvard Medical School and a member of the panel.
Several company officials and advisors referred to the drugs as the first potential cure for hepatitis C.
“I am thrilled by today’s decision,” said Camilla Graham, MD, the vice president for global medical affairs for Vertex.