Twelve weeks of Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir) plus ribavirin boasted a nearly perfect cure rate among highly treatment-experienced cirrhotic people with genotype 1 of hepatitis C virus, MedPage Today reports. The cure rate was almost identical to that achieved through treating the same demographic with 24 weeks of just Harvoni. Researchers conducted a double-blind Phase II trial of 155 HCV-positive people with cirrhosis, all of whom had failed at least two previous attempts at cure. Results were presented at the Annual Meeting of the American Association for the Study of Liver Diseases in Boston.

The participants were randomly assigned to receive either Harvoni plus a placebo for ribavirin for 24 weeks, or 12 weeks of a placebo for all three drugs (including the ledipasvir and sofosbuvir that make up Harvoni) followed by 12 weeks of Harvoni plus ribavirin.

One participant in the ribavirin arm left the study because of an adverse side effect experienced during the 12-week placebo period. And another participant who was randomized to receive ribavirin was instead treated with just Harvoni for 24 weeks.

Seventy-four of 77 participants (96 percent) in the 12-week ribavirin group achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure). Seventy-five of the 77 participants (97 percent) in the 24-week Harvoni arm were cured. Thus, adding ribavirin to Harvoni allowed the treatment length to be cut in half with essentially the same results.

Between 87 percent and 96 percent of the participants experienced at least one adverse side effect, although most of them were mild. One person in the ribavirin arm experienced a serious adverse side effect: anemia that was attributed to ribavirin.

When comparing the placebo phase of the ribavirin arm with the Harvoni group, the only statistically significant side effects among those taking Harvoni were headache and fatigue.

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