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Oral Regimen for Hepatitis C Shows Promise in NIH Trial

Side effects minimized with combination therapy in hard-to-treat patients (August 28)

In a study of an all-oral drug regimen, a majority of volunteers with liver damage caused by hepatitis C virus (HCV) infection were cured following a 6-month course of therapy that combined an experimental drug, sofosbuvir, with the licensed antiviral drug ribavirin. The results showed that the regimen was highly effective in clearing the virus and was well tolerated in a group of patients who historically have had unfavorable prognoses.

Findings from the phase II trial appear in the Aug. 28 issue of the Journal of the American Medical Association (JAMA).

The new study involved 60 volunteers with genotype-1 HCV, which tends to be less responsive to interferon-based treatment. Fifty of the 60 participants were African-American.

The study was divided into two parts. The first part enrolled 10 people with mild or moderate liver fibrosis. Volunteers received oral ribavirin at a dosage based on their weight along with sofosbuvir, also in pill form, taken daily for 6 months.

Nine volunteers completed the course of therapy. Virus was undetectable in all nine volunteers 12 weeks after the end of therapy and continued to be undetectable when they were tested again 24 weeks after completing therapy.

The second part of the trial enrolled 50 volunteers, 13 of whom had serious liver damage. Twenty-five received ribavirin based on their weight, and 25 received a low dose (600 mg/day) of the drug. All received sofosbuvir.

At 4, 12, and 24 weeks after the end of treatment, volunteers were tested for the presence of HCV. HCV levels were undetectable in 24 of the volunteers in the weight-based arm when treatment ended. Of those, 17 continued to have undetectable virus levels 24 weeks later and were considered cured of infection. In the low-dose arm, three volunteers dropped out of the study. Of the remaining 22 patients, all responded to the treatment, but only 12 were considered cured at 24 weeks after the end of treatment.

Sources: JAMA; August 28, 2013; and NIH; August 27, 2013.

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