Meeting News Coverage

Sovaldi, velpatasvir, GS-9857 show efficacy in challenging populations

SAN FRANCISCO — A cohort including patients with genotype 3 disease demonstrated high SVR12 rates after treatment with Sovaldi, velpatasvir (or GS-5816), which targets NS5A and GS-9857, which targets NS3, according to findings presented at The Liver Meeting 2015.

“Eight weeks of treatment resulted in high SVR rates in historically difficult to treat populations,” Edward J. Gane, MD, of Auckland Clinical Studies in New Zealand, said in his presentation. “The new treatment paradigm is combining DAAs with different mechanisms of action not only to improve efficacy and prevent resistance but to shorten the duration of therapy across genotypes.”

Gane and colleagues investigated Sovaldi (sofosbuvir, Gilead Sciences), velpatasvir (GS-5816, Gilead Sciences), and GS-9857 (Gilead Sciences) in 82 patients divided into four cohorts. There were 17 patients with genotype 1 disease and cirrhosis who were treated for 8 weeks; 28 with genotype 1 and cirrhosis who failed previous therapy with a protease inhibitor and triple therapy who were treated for 8 weeks; 18 treatment-naive patients with genotype 3 disease who were treated for 6 weeks; and 19 treatment-experienced patients with genotype 3 disease who were treated for 8 weeks.

SVR12 rates were 100% for the patients with cirrhosis and genotype 1 treated for 8 weeks; 89% for the patients who failed other therapies; 83% for the naive patients treated for 6 weeks; and 100% for the experienced patients treated for 8 weeks.

Four of five patients who relapsed had baseline resistance-associated variants (RAVs). Overall, baseline NS5A RAVs were detected in 20 of 82 patients. The SVR12 rate was 90% among these patients. Among those without NS5A RAVs, 95% reached SVR12.

Response rates were 88% for patients with NS3 RAVs at baseline and 96% for those without this variant.

“Baseline RAVs reduced SVR rates among the protease inhibitor-experienced patients,” Gane said.

There were no serious treatment-related adverse events reported, and no discontinuations. Headache, fatigue, nausea and diarrhea were the most commonly reported events. They were generally mild and non-specific, according to Gane.

“We saw a few transient or isolated grade 3 elevations,” he said. “The regimen was generally well tolerated.” – by Rob Volansky

Reference:

Gane EJ, et al. Abstract 38. Presented at: The Liver Meeting; Nov. 13-17, 2015; San Francisco.

Disclosures: Gane reports being on the advisory committee or review panel for AbbVie, Achillion, Gilead Sciences, Janssen, Janssen Cilag, Merck, Novira and Tekmira; and speaking and teaching for AbbVie, Gilead Sciences and Merck.

SAN FRANCISCO — A cohort including patients with genotype 3 disease demonstrated high SVR12 rates after treatment with Sovaldi, velpatasvir (or GS-5816), which targets NS5A and GS-9857, which targets NS3, according to findings presented at The Liver Meeting 2015.

“Eight weeks of treatment resulted in high SVR rates in historically difficult to treat populations,” Edward J. Gane, MD, of Auckland Clinical Studies in New Zealand, said in his presentation. “The new treatment paradigm is combining DAAs with different mechanisms of action not only to improve efficacy and prevent resistance but to shorten the duration of therapy across genotypes.”

Gane and colleagues investigated Sovaldi (sofosbuvir, Gilead Sciences), velpatasvir (GS-5816, Gilead Sciences), and GS-9857 (Gilead Sciences) in 82 patients divided into four cohorts. There were 17 patients with genotype 1 disease and cirrhosis who were treated for 8 weeks; 28 with genotype 1 and cirrhosis who failed previous therapy with a protease inhibitor and triple therapy who were treated for 8 weeks; 18 treatment-naive patients with genotype 3 disease who were treated for 6 weeks; and 19 treatment-experienced patients with genotype 3 disease who were treated for 8 weeks.

SVR12 rates were 100% for the patients with cirrhosis and genotype 1 treated for 8 weeks; 89% for the patients who failed other therapies; 83% for the naive patients treated for 6 weeks; and 100% for the experienced patients treated for 8 weeks.

Four of five patients who relapsed had baseline resistance-associated variants (RAVs). Overall, baseline NS5A RAVs were detected in 20 of 82 patients. The SVR12 rate was 90% among these patients. Among those without NS5A RAVs, 95% reached SVR12.

Response rates were 88% for patients with NS3 RAVs at baseline and 96% for those without this variant.

“Baseline RAVs reduced SVR rates among the protease inhibitor-experienced patients,” Gane said.

There were no serious treatment-related adverse events reported, and no discontinuations. Headache, fatigue, nausea and diarrhea were the most commonly reported events. They were generally mild and non-specific, according to Gane.

“We saw a few transient or isolated grade 3 elevations,” he said. “The regimen was generally well tolerated.” – by Rob Volansky

Reference:

Gane EJ, et al. Abstract 38. Presented at: The Liver Meeting; Nov. 13-17, 2015; San Francisco.

Disclosures: Gane reports being on the advisory committee or review panel for AbbVie, Achillion, Gilead Sciences, Janssen, Janssen Cilag, Merck, Novira and Tekmira; and speaking and teaching for AbbVie, Gilead Sciences and Merck.

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