FDA Panel Backs 2 Hepatitis C Drugs
Advisory Panel Recommends Approval of Telaprevir and Boceprevir to Treat Hepatitis C
Praise From the FDA Panel continued...
”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.
Other classes of antiviral drugs for HCV are expected to come up for FDA approval in the next few years. Robert Conslavo, a spokesman for Merck, likened the new drugs to AZT, the first widely used antiviral drug that revolutionized treatment of HIV and AIDS.
The drugs could for the first time give doctors a way to treat a certain genetic subtype of HCV that until now had proven difficult to treat. About 75% of patients carry HCV genotype 1, the virus that is most likely to mount resistance to ribavirin. Both telaprevir and boceprevir appear particularly effective at targeting HCV genotype 1.
New Drug Drawbacks
Amid all the excitement, though, there were caveats. Telaprevir and boceprevir must be taken in addition to ribavirin and interferon. That would make the already complicated treatment course for hepatitis C even more complex and requiring the care of experienced specialists.
In addition, more than half of patients taking telaprevir in clinical trials developed often widespread skin rashes. In about one in 14 patients, the rash was so severe patients stopped taking their treatments.
Both drugs can also increase the risk of anemia, already a side effect of concern in patients on available medications. In most cases they must be taken every eight hours with fatty food, a potentially difficult prospect for patients already feeling sick.
“These treatments are still going to be difficult for patients,” said Martha Saly, director of the National Viral Hepatitis Roundtable, a consortium of non-profit and industry groups. Still, “it will be monumental what we can do with these new treatments."
Experts Thursday urged the FDA to label telaprevir with warnings for patients and doctors about the risk of severe rash. Patients should be warned not to stop their treatment if a rash develops, they said.
Federal rules require the FDA to make a decision on both drugs before the end of May. The agency doesn’t have to follow advisory panel decisions, though it usually does.