August 13, 2018
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Resistance Did Not Affect SVR Rates in Trials of Vosevi for HCV

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Baseline resistance associated substitutions did not impact sustained virologic response among direct-acting antiviral-experienced patients who underwent hepatitis C therapy with Vosevi for 12 weeks, according to a recently published study.

“In contrast to the prior studies of regimens targeting two distinct HCV proteins, the presence of NS3, NS5A and/or NS5B NI RASs did not affect treatment outcome in DAA-experienced patients including those who were previously treated with NS5A inhibitors upon treatment with [Vosevi] for 12 weeks in phase 3 trials,” Christoph Sarrazin, MD, from the Goethe University Hospital in Frankfurt, Germany, and colleagues wrote.

Sarrazin and colleagues’ review included data from the POLARIS-1 and POLARIS-4 studies of Vosevi (sofosbuvir/velpatasvir/voxilaprevirfor, Gilead Sciences), which included patients with HCV genotype 1 through 6.

SVR rates were 96.8% or higher for patients with either or both NS3 and NS5A RASs and 97.7% or higher for patients without RASs, which was not significantly different.

In a subanalysis of patients who had experience with earlier generation pegylated interferon therapy, the researchers found SVR rates of 95.1% or higher among patients with NS3 RASs.

Additionally, despite RAS position among patients with NS5A RASs, patients achieved SVR rates of 97% or higher.

“NS5A inhibitors are a common component of DAA regimens and more recently developed agents have demonstrated pangenotypic activity,” Sarrazin and colleagues wrote. “These results show that daily treatment with the single-tablet regimen of [Vosevi] for 12 weeks is highly effective for a broad range of DAA-experienced patients infected with HCV of any genotype regardless the presence of RASs.” – by Talitha Benenett

Disclosure: Sarrazin reports he has received research or grant support from Abbott, Achillion, Astra, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Janssen, Merck Sharp & Dohme, Qiagen, Roche and Siemens. Please see the full study for the other authors’ relevant financial disclosures.