Post-transplant sofosbuvir/simeprevir regimen effective, well tolerated

BOSTON — An all-oral antiviral regimen of sofosbuvir and simeprevir was associated with high sustained virologic response regardless of the addition of ribavirin in patients with hepatitis C virus genotype 1 infection after liver transplant.

“Our objective was to report our multicenter experience for sofosbuvir and simeprevir with or without ribavirin for 12 weeks in terms of tolerability, safety and efficacy,” Surakit Pungpapong, MD, a transplant hepatologist and an associate professor of medicine at the Mayo Clinic in Jacksonville, Fla., said during a presentation at The Liver Meeting.

Researchers enrolled 109 post-transplant patients with HCV genotype 1 infection who were followed for a median of 23 weeks; 62% of patients had genotype 1a. End-of-treatment response data were available on 101 patients, 90 patients were assessed for SVR4 and 66 were assessed for SVR12.

Therapy was initiated a median of 29 months after liver transplantation.

Intention-to-treat analysis indicated an end-of-treatment response rate of 98%. SVR4 was 92% and SVR12 was 91%.

“Ribavirin did not impact these outcomes. All responses were above 90%,” Pungpapong said.

In patients with genotype 1a, fibrosis stage F3 or F4 was associated with significantly lower SVR12 compared with F0 to F2 (64% vs. 97%; P=.01), Pungpapong said.

“On the other hand, degree of fibrosis did not impact SVR12 rates in patients with genotype 1b infection,” he said.

All but two patients achieved undetected HCV RNA at a median of 4 weeks. The treatment groups did not differ with regard to time to undetected RNA, according to Pungpapong.

“Minimal dose adjustments of immunosuppressive agent were required during treatment,” he said. “No immunosuppressive-related adverse events were reported.” The immunosuppressive agent was tacrolimus in 99 patients, cyclosporine in nine patients and sirolimus in one patient.

Reported events were mild, and included fatigue, hyperbilirubinemia, nausea and headache. Two patients developed serious adverse events. – by Rob Volansky

For more information:

Pungpapong S. Abstract 9. Presented at: The Liver Meeting; Nov. 7-11, 2014; Boston.

Disclosure: Pungpapong reports receiving grant/research support from Bristol-Myers Squibb and Gilead. See the abstract for the other researchers’ relevant financial disclosures.