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ANRS CO23 CULPIT: Sovaldi, daclatasvir well tolerated in transplant, recurrence

VIENNA — Regimens containing Sovaldi and daclatasvir were efficacious and well tolerated in a cohort of patients with recurrence of hepatitis C virus after liver transplantation, according to data presented at the 2015 International Liver Congress.

Audrey Coilly, MD, of AP-HP Hopital Paul Brousse, University of Paris-Sud, Institut National de la Santé et Recherche Médicale in Villejuif, Paris, said that HCV recurrence in transplant patients used to be a major issue. “Access to new [direct-acting antivirals] revolutionizes the prognosis of these patients,” she said.

Audrey Coilly

Eligible participants were treated between July 2013 and November 2014 and the final analysis included 130 patients. There were 75 patients treated with Sovaldi (sofosbuvir, Gilead Sciences) and daclatasvir (Bristol-Myers Squibb) and 55 patients treated with sofosbuvir, daclatasvir and ribavirin.

“About 50% of the cohort was previously exposed to treatment,” Coilly said. The majority of patients had genotype 1 disease, specifically genotype 1b. There were also patients with genotype 3, 4 and 5 disease.”

Results of a kinetic analysis indicated that the time to undetectability was 5.7 weeks, according to Coilly.

Although SVR12 rates were 67% for patients treated with sofosbuvir, daclatasvir and ribavirin for 12 weeks, rates were 100% for those treated without ribavirin for 12 weeks and higher than 90% for all patients treated for 24 weeks.

“There was no significant difference between treatment-naive patients and previous treatment failures,” Coilly said. SVR12 rates were higher than 90% for these groups.

Genotype and fibrosis stage also did not impact SVR12 rates.

“Most patients improved in terms of MELD score,” Coilly said.  

The adverse event rate during treatment was 23%. One patient died during treatment and one patient died 6 weeks after treatment due to hepatocellular carcinoma recurrence.

Anemia was reported in 37.7% of the cohort. Other hematological events included neutropenia and thrombocytopenia, but these events were infrequent.

“Half of the patients had to change immunosuppressive drugs during treatment,” Coilly said.

“The combination of sofosbuvir and daclatasvir was highly effective,” she added. “Ribavirin does not seem to be mandatory.”

There were no drug-drug interactions, but clinicians should pay attention to renal function, according to Coilly. – by Rob Volanksy

For More Information:

Coilly A, et al. Abstract G18. Presented at: International Liver Congress; April 22-26, 2015; Vienna.

Disclosure: Coilly reports sponsored lectures with Astellas, Bristol-Myers-Squibb, Gilead, Janssen, Merck Sharp & Dohme, Novartis and Roche.