'Real life' experience with sofosbuvir-based regimens after transplant shows promise

BOSTON — On-treatment response using sofosbuvir as the backbone of treatment for recurrent hepatitis C virus after liver transplantation appears promising in real-life patients, researchers reported at The Liver Meeting.

“There [are] limited data about the safety and effectiveness of sofosbuvir-based therapies in ‘real-life’ patients with HCV recurrence after liver transplantation,” Rohit Satoskar, MD, medical director of liver transplantation and clinical director of transplant hepatology at MedStar Georgetown University Hospital, and colleagues wrote in a study abstract presented here.

The researchers conducted a retrospective, multicenter study to evaluate sofosbuvir-containing regimens for safety and efficacy in this patient population. Ninety four patients were included. Most (88%) had HCV genotype 1 infection, 46% had advanced (stage F3-F4) and 71% were treatment experienced. The median time from transplant was 946 days.

One group of patients was treated with sofosbuvir (Sovaldi, Gilead), pegylated interferon (PEG-IFN) and ribavirin (RBV); a second group received sofosbuvir and simeprevir (Olysio, Janssen Therapeutics); a third group received sofosbuvir, simeprevir and RBV; and a fourth group received sofosbuvir and RBV. The treatment groups were balanced with regard to demographics, genotype, weight, fibrosis and laboratory parameters.

At week 4, undetectable HCV RNA was observed in 75% of patients who received sofosbuvir, PEG-IFN and RBV, 53% who received sofosbuvir and simeprevir, 67% who received sofosbuvir, simeprevir and RBV and 46% who received sofosbuvir and RBV. By week 12 of treatment, undetectable HCV RNA was achieved in 91% of the patients taking sofosbuvir and RBV and 100% of the patients of the other regimens who reached this timepoint, according to researchers.

“Of the people who relapsed in [the second group] with simeprevir and sofosbuvir, they were all people treated with 12 weeks of therapy vs. 24 weeks,” Adam Deising, MD, of the Transplant Institute, MedStar Georgetown University Hospital, told HCV Next. “Once the SVR12 data are tabulated from the entire population, we may have a better idea about the optimal length of treatment.”

About three-quarters of patients experienced adverse events including fatigue, musculoskeletal complaints, headache and nausea. No differences were reported between the groups in terms of frequency of adverse events.

Twenty two patients experienced serious adverse events. Patients who received RBV were more likely to experience a decrease of >2 in hemoglobin. The addition of PEG-IFN was associated with increased incidence of leukopenia (P<.0001) and thrombocytopenia (P=.002). Growth factors were required more frequently among patients treated with PEG-IFN and RBV (P=.005). Patients who received RBV required more frequent blood transfusions (P=.028).

“The vast majority of events were in patients who were on pegylated interferon or ribavirin,” Deising said.

Changes in dosing for immunosuppressive agents were not required in any of the treatment groups. – by Rob Volansky

For more information:

Satoskar R. Poster 694. Presented at: The Liver Meeting; Nov. 7-11, 2014; Boston.

Disclosure: The researchers report associations with companies including AbbVie, Bristol-Myers Squibb, Gilead and Janssen Therapeutics.