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Reuters Health Information (2010-05-25): Telaprevir achieves 75% rate of sustained HCV response: study

Drug & Device Development

Telaprevir achieves 75% rate of sustained HCV response: study

Last Updated: 2010-05-25 19:38:35 -0400 (Reuters Health)

NEW YORK (Reuters) - Telaprevir, a hepatitis C treatment being developed by Vertex Pharmaceuticals Inc, led to a 75% rate of sustained viral response (SVR) in a pivotal trial of previously untreated patients, the company said on Tuesday.

The results from the first late-stage phase III study of telaprevir came in at the high end of expectations for an SVR rate of 70% to 75%, with slightly lower discontinuation rates due to side effects than previously seen.

Seventy-five percent of patients who received 12 weeks of telaprevir in combination with current standard treatment of pegylated interferon and ribavirin, followed by either 12 or 36 weeks of standard treatment, had an SVR.

That compared with a 44% SVR rate for patients who received the usual 48-week regimen of the standard drugs.

"I think it is a bellwether day for hepatitis C drug development. It's really impressive to see a 75% SVR rate in a phase 3 pivotal trial," said drug industry analyst Geoffrey Porges, of the company Sanford Bernstein.

Telaprevir is in a race with a similar drug called boceprevir being developed by Merck & Co.

Data from two more phase III trials of telaprevir, including results in patients who failed with previous treatment, is expected in the third quarter. The first boceprevir late-stage data will be released later this year.

Through mid-stage studies, most analysts have said the Vertex drug as superior.

In a third arm of the phase III study, 69% of patients who received the telaprevir combination for just eight weeks followed by either 16 or 40 weeks of the standard drugs achieved SVR, Vertex said.

There has been great hope for this new class of antiviral drugs for serious liver disease because of the potential for significantly higher cure rates and the possibility of cutting the duration that the standard drugs must be taken.

"These results show that 75% of patients in the 12-week telaprevir arm achieved a viral cure, with the majority receiving only 24 weeks of therapy, marking what we believe may be a potentially dramatic improvement in the future treatment of hepatitis C," Vertex Chief Medical Officer Robert Kauffman said in a statement.

Several drugmakers, including Vertex, are working on next generation drugs with the hope they could be combined with treatments like telaprevir and eliminate the need for interferon altogether.

Telaprevir discontinuation rates due to adverse events were a bit lower than those seen in Phase II studies.

The discontinuation rate was 6.9% in the 12-week telaprevir arm, 7.7% in the 8-week arm and 3.6% with the standard drugs alone.

Viral relapse rates were much lower in the telaprevir arms of the study: 8.6% among patients who received 12 weeks, 9.5% for those who got the Vertex drug for 8 weeks, and 28% with standard therapy.

"The results highlight that telaprevir-based combination regimens may increase viral eradication rates and shorten treatment time for many patients," Dr. Ira Jacobson from Weill Cornell Medical College and a researcher for the study, said in a statement.

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