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Advisory panel likes new hepatitis C drugs, which could expand options

April 29, 2011|By Marissa Cevallos, HealthKey
  • Two new drugs to treat patients with chronic hepatitis C received unanimous backing from an FDA advisory panel this week.
Two new drugs to treat patients with chronic hepatitis C received unanimous… (Ricardo DeAratanha / Los…)

Two new drugs to treat hepatitis C got strong – that is, unanimous – backing this week from an advisory panel to the FDA. Both are meant to be given in combination with standard therapy and, together, offer new options for people with the virus.

One drug, boceprevir, manufactured by Merck, has been shown in clinical trials to roughly double the number of patients who suppress the hepatitis C virus to undetectable levels — a “viral cure” — when compared to those who undergo regular therapy alone. 

The other drug, telaprevir, developed by Vertex, has achieved a 75% cure rate when administered to previously untreated patients as part of combination therapy. 

The panel’s decisions don’t guarantee FDA approval, but the FDA tends to follow the panel’s recommendations.

Again, these drugs don’t replace standard therapy, which has unpleasant side effects. In clinical trials, both drugs were used in addition to pegylated-interferon and ribavirin —  treatments that can give patients a laundry list of flu-like symptoms, such as fever and fatigue.

Still, the week’s news is still good for hepatitis C sufferers, which may number 4 million in the U.S.

Some patients respond better to one medication than another, so more options — even though side effects haven’t been ameliorated — is a good thing. 

healthkey@tribune.com

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