Sovaldi/Daklinza slow response may not impact SVR in liver transplant

SAN FRANCISCO — Slow virological response occurred in 47% of patients treated with Sovaldi and Daklinza for HCV recurrence after liver transplantation, according to findings presented at The Liver Meeting 2015.

“Slow response has no impact on SVR rate, regardless of treatment duration,” Vincent Leroy, MD, of the department of gastroenterology at CHU Grenoble in La Tronche, France, said during his presentation. “These results support the use of conventional treatment regimens.”

Leroy and colleagues aimed to determine factors that predict slow response to Sovaldi (sofosbuvir, Gilead Sciences) and Daklinza (daclatasvir, Bristol Myers Squibb) with or without ribavirin for 12 or 24 weeks.

The analysis included 188 liver transplantation recipients with HCV in the per protocol population. Clinicians treated 118 patients without ribavirin and 70 with ribavirin.

The researchers assessed HCV RNA levels at weeks 0, 2, 4, 8 and 12 of treatment, and then at end of treatment and at 4 and 12 weeks’ follow up.

“The objective was to evaluate the main patient characteristics, including immunosuppression regimen, that are predictive factors of slow virological response,” Leroy said. “Genotype 1 was predominant, followed by genotypes 3 and 4.”

At week 4, 53% of patients had the lower limit of quantification of 15 IU/ml. This increased to 87% by week 8, 95% by week 12, 100% by week 24, 99% by the end of treatment and 99% by follow-up week 4.

“In the multivariate analysis, we wanted to identify dependent factors associated with slow virologic response,” Leroy said.

Use of mycophenolate mofetil at baseline was a key factor that predicted slow response (P = .0378), along with fibrosis stage (P = .0219) and viral load at baseline (P = .0017). Leukocytes and aspartate aminotransferase at baseline also predicted slow response.

The researchers also looked at the relationship between viral kinetics and SVR12. They assessed 22 patients who received 12 weeks of treatment. The response rate at 2, 4, 8 and 12 weeks was 100% in this group.

Leroy noted that there were two relapses in the 24-week treatment group. One occurred at follow-up week 4 and one at follow-up week 12. There was one breakthrough at week 8. – by Rob Volansky

Reference:

Herve C, et al. Abstract 3. Presented at: The Liver Meeting; Nov. 13-17, 2015; San Francisco.

Disclosures: Leroy reports financial relationships with AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen Therapeutics and MSD. Please see the full study for a list of all other authors’ relevant financial disclosures.