Mid-stage trial notes efficacy in investigational hepatitis C treatment

CORK, Ireland Patients with chronic genotype 1 hepatitis C fared better when given an investigational drug developed by Johnson & Johnson division Tibotec and Vertex Pharmaceuticals than when given the standard therapy after they had failed previous treatments, according to results of a mid-stage trial published Thursday.

The results of the 453-patient, phase 2 “PROVE3” trial, published in the New England Journal of Medicine, found that regimens based on the drug telaprevir worked better than other drugs at keeping the virus undetectable in the bloodstream. Patients who achieve undetectability of the virus, also known as sustained virologic response, or SVR, are considered cured. The current standard of care for patients is Genentech’s Pegasys (peginterferon alfa-2a) combined with Merck & Co.’s Rebetol (ribavirin), which also is available as a generic.

“People with HCV who fail to achieve SVR after initial treatment typically don’t succeed when they are re-treated,” study investigator and Hannover, Germany-based Hepatology and Endocrinology Medical School professor Michael Manns said. “This study shows that telaprevir may provide a much-needed new therapeutic option for patients undergoing a second round of treatment.”

The patients were divided into four groups: 115 who took telaprevir, Pegasys and ribavirin for three months followed by Pegasys and ribavirin with placebo for another three; 113 who took telaprevir, Pegasys and ribavirin for six months followed by Pegasys and ribavirin alone for another six; 111 who took telaprevir and Pegasys for six months; and a control group of 114 who took Pegasys, ribavirin and placebo for six months, followed by Pegasys and ribavirin for another six.

Those who took telaprevir and ribavirin together achieved SVR at rates of more than 50%, compared with 24% and 14% in the telaprevir with Pegasys group and the control group, respectively. Among patients who had previously relapsed, those who took telaprevir, Pegasys and ribavirin had SVR rates of 69% to 76%, compared with 42% and 20% in the non-ribavirin and control groups, respectively. Among patients who had not responded to previous therapies, those who took all three drugs had SVR rates of 38% to 39%, compared with 11% in the non-ribavirin group and 9% in the control group.

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