Daklinza, Sovaldi show efficacy in genotype 3

SAN FRANCISCO — A challenging group of patients with hepatitis C virus genotype 3 responded favorably to Daklinza and Sovaldi with or without ribavirin, according to findings presented at The Liver Meeting 2015.

“In this real life clinical setting, daclatasvir, sofosbuvir and ribavirin achieved high SVR rates in HCV genotype 3 patients at high risk of hepatic decompensation or death,” Tania M. Welzel, MD, of Universitätsklinikum der Johann Wolfgang Goethe University in Frankfurt, Germany, said in her presentation.

Welzel reported results for 101 patients treated with 60 mg of Daklinza (daclatasvir, Bristol Myers Squibb) plus 400 mg of Sovaldi (sofosbuvir, Gilead) daily, with or without ribavirin in a European compassionate use program. There were 62 patients treated with daclatasvir and sofosbuvir and 40 patients treated with daclatasvir, sofosbuvir and ribavirin. It was recommended that patients be treated for 24 weeks.

Eligible participants had a high risk of decompensation or death. The cohort was 85% cirrhotic, 57% with Child B or C cirrhosis and included eight transplant recipients.

“These were patients with urgent need,” Welzel said.

Welzel presented safety data for all 102 patients and efficacy data for 82 patients.

The overall response rate was 87%, with 88% of patients in the ribavirin arm and 86% of the non-ribavirin arm showing a response. One breakthrough occurred, as did six relapses, one discontinuation due to an adverse event and three deaths.

Among cirrhotics, the response rates exceeded 80% in all groups except patients with Child C cirrhosis, according to Welzel.

The lowest response rate in any group was 71%, which occurred in patients in the ribavirin arm who were treated for 12 weeks.

Among patients treated for 24 weeks, those receiving ribavirin reached a 92% response rate, while those without ribavirin responded at 86%.

The response rates for treatment-experienced patients were 82% in the ribavirin group and 81% in the non-ribavirin group.

Serious adverse events occurred in 21% of patients. Most of the adverse events leading to discontinuation were related to underlying liver disease, according to Welzel.

“Improvements in liver function were observed. The regimen was generally safe and well tolerated,” she said. – by Rob Volansky

Reference:

Welzel TM, et al. Abstract 37. Presented at: The Liver Meeting; Nov. 13-17, 2015; San Francisco.

Disclosures: Welzel reports being on the advisory committee or review panels of Abbvie, BMS, Boehringer-Ingelheim, Gilead, Janssen and Novartis.