WASHINGTON – Federal health officials said Tuesday a highly anticipated hepatitis C drug from Vertex Pharmaceuticals successfully treats the majority of patients with the virus in less time than older medicines that have been used for 20 years.
The Food and Drug Administration posted its review of Vertex's telaprevir ahead of a meeting Thursday where outside experts will vote on the benefits of the experimental drug. On Wednesday the experts will review a similar drug from Merck & Co. Inc.
Both new drugs work by blocking the enzyme protease, which allows the hepatitis virus to reproduce. The new approach represents a breakthrough from older medicines, which are designed to help boost the immune system to fight hepatitis.
Like HIV drugs, the new drugs will be prescribed as part of a cocktail with the two older drugs to help lower viral levels.
"A drug like telaprevir does an amazing job clearing the virus, but there's a small portion that is just intrinsically less responsive and it's the job of the older drugs to clear up that mess that's left behind," said Dr. Cailla Graham, Vertex's vice president for global medical affairs.
The current two-drug treatment for the virus cures only about 40% of people and causes side effects like nausea, fatigue and vomiting.
FDA scientists said 79% of first-time hepatitis C patients taking telaprevir and the older medicines were cured, compared to 46% of those taking the older medications alone, according to Vertex's studies. Among patients who had already been treated for hepatitis C once, 65% achieved a cure after taking telaprevir, compared with 17% of those taking the older medications.
In general, telaprevir's cure rates are higher than those seen with Merck's boceprevir. The two drugs are expected to compete in a multibillion dollar global market. Read more>>