Hep C Trial Shows Best Chance for Non-Responders

Hep C Trial Shows Best Chance for Non-Responders
May 08, 2009

Following a year long trial of Vertex's oral protease inhibitor, telaprevir's high success rate in clearing Hepatitis C from previous non-responders has landed it in the final stretch for FDA approval.

Vertex’s Hepatitis C Drug Helps Sickest Patients Get Relief

By Michelle Fay Cortez and Lisa Rapaport

April 25 (Bloomberg) -- Vertex Pharmaceuticals Inc.’s experimental hepatitis C drug telaprevir wiped out signs of the infection in half of patients with hard-to-treat forms of the disease in a yearlong study.

The Prove 3 trial, presented at the European Association for the Study of the Liver in Copenhagen, found adding the drug to Roche Holding AG’s Pegasys and Copegus improved response to therapy. The study also showed Copegus is essential. Researchers left it out of one arm of the trial in an effort to reduce side effects, and netted lower patient response as well.

The study tracked 453 patients who failed to benefit from previous treatment or suffered a relapse after therapy, giving them few treatment options. Fifty-two percent of those who got therapy including telaprevir for 48 weeks experienced a sustained response -- with no signs of the virus that causes hepatitis C -- compared with 14 percent of those given the Roche drugs alone.

“Previously treated patients who didn’t achieve sustained viral response represent the hardest to treat patient population in physicians’ practices,” said lead investigator Michael Manns, director of gastroenterology, hepatology and endocrinology at the Medical School of Hannover, Germany, in a statement. “This represents an exciting potential medical advance.”

The study, from the second of three phases needed for regulatory approval, was funded by Vertex and its partner, New Brunswick, New Jersey-based Johnson & Johnson.

Final Stage Testing

Studies from the final stage needed for U.S. Food and Drug Administration approval are under way, and should be completed in the first half of next year, said Robert Kauffman, senior vice president of clinical development at Cambridge, Massachusetts-based Vertex, in a telephone interview.

“These are unprecedented results, with the highest sustained viral response rates ever reported,” Kauffman said.

Few patients relapse months after they finish treatment, suggesting a potential cure for those who respond, he said.

“You want to follow patients over the long term just to be sure,” he said. “Based on everything we know, we’re optimistic these patients will maintain their responses.”

Telaprevir is an oral protease inhibitor, which works by targeting an enzyme the virus needs to replicate. The Roche drugs work by an indirect method, bolstering the patient’s immune system and their own ability to fight off the disease.

170 Million Infected

About 170 million worldwide, and 3.4 million in the U.S., have hepatitis C, a liver disease that is spread mainly through contact with the blood of infected patients, according to the World Health Organization. Symptoms include stomach pain, fever and fatigue, and can increase the risk of cirrhosis and death.

“Vertex’s long-term growth story looks more secure with each HCV conference we attend,” Thomas J. Russo, an analyst at Robert W. Baird in Chicago, wrote in an April 24 note to clients.

To contact the reporters on this story: Michelle Fay Cortez in London at mcortez@bloomberg.net; Lisa Rapaport in New York at Lrapaport1@bloomberg.net.

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Posted by Editors at May 8, 2009 02:31 PM