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Reuters Health Information (2013-04-23): New AbbVie drugs cure hepatitis C at eight weeks

Drug & Device Development

New AbbVie drugs cure hepatitis C at eight weeks

Last Updated: 2013-04-23 11:47:29 -0400 (Reuters Health)

(Reuters) - A combination of five oral drugs being tested by AbbVie Inc cured at least 88% of new patients with hepatitis C after only eight weeks of treatment, without raising significant safety issues, researchers said on Tuesday.

Patients in the ongoing Aviator study have the most common, but hardest to treat, genotype 1 variation of the infectious virus. They received the protease inhibitor ABT-450, whose effect was boosted by ritonavir; the polymerase inhibitor ABT-333, and the NS5A inhibitor ABT-267. They also received ribavirin.

The latest findings also showed that 96% of patients taking the five medicines for 12 weeks eliminated the virus, as assessed by blood tests 24 weeks after they stopped treatment. If the virus is undetectable 24 weeks after completing treatment, a patient is considered cured.

The latest results were deemed little different than the 99% sustained virologic response (SVR) rate reported in October, for patients evaluated 12 weeks after completing 12 weeks of the five-drug treatment regimen.

"We are pleased that the data remain consistent and robust," said Dr. Kris Kowdley, who is presenting the data this week at a meeting of the European Association for the Study of the Liver (EASL) in Amsterdam.

"The data confirm that the 12-week treatment appears to be optimal, but certainly we are still very pleased with ... data for the eight-week treatment," Dr. Kowdley said in an interview.

AbbVie is racing Gilead Sciences Inc to be first to market an all-oral treatment for hepatitis C, as companies work to eliminate difficult-to-tolerate interferon from the regimen, while raising cure rates and shortening treatment duration.

Current hepatitis C treatments take either 24 or 48 weeks.

Dr. Kowdley, director of the Liver Center of Excellence at Virginia Mason Medical Center in Seattle, said the trial also showed impressive results among patients who had failed to benefit from earlier therapy.

The cure rate after 12 weeks of treatment was 93% for those patients, called null responders, assessed both 12 weeks and 24 weeks after completion of their drug regimens. That compared with a cure rate of 95% for patients treated for 24 weeks, and then assessed 24 weeks after treatment stopped.

AbbVie said the safety of the tested drugs was similar to that seen in results presented last year. Of the 247 patients evaluated, serious side effects were seen in four patients (1.6%), while seven patients had liver enzyme elevations that could be a sign of toxicity.

Less serious side effects seen in more than 10% of patients included headache, fatigue, nausea, insomnia and diarrhea.

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