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SATURN: Simeprevir, Daclatasvir Show Efficacy in Transplant Population
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VIENNA — Post-transplant patients responded favorably to treatment with Olysio and daclatasvir plus ribavirin, according to findings presented at the 2015 International Liver Congress.
Xavier Forns, MD, of Institut d'Investigacions Biomèdiques August Pi i Sunyer and Centro de Investigación Biomédica en Red in Barcelona, Spain, and colleagues investigated once daily Olysio (simeprevir 150 mg and 60 mg, Janssen) and daclatasvir (Bristol Myers-Squibb) plus 1 g/day to 1.2 g/day ribavirin for 24 weeks in a cohort of patients with recurrent genotype 1b disease who had undergone liver transplantation. The cohort included treatment-naive and treatment-experienced patients who were being treated with immunosuppressive therapy.
The study included two parts. Patients with METAVIR F1-F2 receiving cyclosporine or tacrolimus comprised one part of the patient population (n = 21) while those with F1-F4 receiving tacrolimus comprised the second part of the study group (n =14).
Week 4 treatment response was 71% in the first group and 64% in the second. Week 12 responses were 95% for the first group and 100% for the second. At end of treatment and then at 4 weeks after treatment, responses rates were similar: 90% for the first group and 93% for the second group.
Anemia was the most frequently occurring adverse event, which was reported in 62% of the overall cohort. Asthenia occurred in 38% of patients in the low METAVIR group. Anemia also occurred in 21% of those in the high METAVIR group.
Serious adverse events occurred in 24% of patients in the low METAVIR group and 14% of those in the high METAVIR group.
There were two discontinuations in the first group and none in the second. Forns reported grade 3 or 4 hemoglobin decreases of less than 10% in both groups, while hyperbilirubinemia occurred in 33% of patients in the first group and 36% of those in the second.
“Simeprevir with daclatasvir plus ribavirin led to a significant on-treatment response in post-[orthotopic liver transplantation] patients on immunosuppressive therapy,” Forns said, and added that this regimen should be studied further in post-transplantation populations.
For more information:
Forns X, et al. Abstract O004. Presented at: International Liver Congress; April 22-26, 2015; Vienna.
Disclosure: Forns reports receiving grants from Janssen and being a consultant for Abbvie, Gilead and Janssen.