May 04, 2015
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Retreatment of HCV patients with DAAs demonstrates high SVR rates

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Research presented at the 2015 International Liver Congress may be the first to demonstrate a high sustained virologic response rate in patients with hepatitis C virus infection who were retreated with direct-acting antiviralsafter previously failing therapy with these newer regimens.

“[Direct-acting antivirals (DAAs)] have dramatically improved the treatment of hepatitis C, but retreatment strategies for patients who have failed to achieve sustained virologic response (SVR) with combination DAAs have not been studied,” Eleanor M.P. Wilson, MD, of the Critical Care Medicine Department at the NIH, and colleagues wrote.

The phase 2a trial included 34 HCV monoinfected patients (median age, 60.5 years; 82% men; 85% black) with early stage (F0-F2) liver fibrosis. Nearly three-quarters of those studied were infected with HCV genotype 1a.

Eleanor M.P. Wilson

Thirty-two patients completed therapy with 12 weeks of a fixed-dosed combination of ledipasvir and Sovaldi (sofosbuvir; Gilead Sciences). The patients previously had been treated with a short course of either ledipasvir or sofosbuvir in combination with GS-9451 (Gilead) and/or GS-9669 (Gilead).

Wilson and colleagues reported SVR12 rates of 90% in the intention-to-treat analysis and 96% in the per protocol analysis.

“Prior to initial therapy, 22 patients had variants consistent with high levels of resistance (> 20 fold) in NS5A, and all but one patient completing therapy went on to achieve SVR12,” according to the researchers. “Our data shows that there are good prospects for the retreatment of patients failing short course combination DAA therapy, and this may have a role in the future treatment strategies of hepatitis C.” – by David Jwanier