Impact of Immunosuppressants on HCV SVR in Post-Transplant Patients
SAN FRANCISCO, CA—Cyclosporine (CyA) immunosuppression does not affect hepatitis C virus (HCV) response to ledipasvir/sofosbuvir (LDV/SOF) + ribavirin (RBV) treatment among liver-transplantation patients, according to authors of a post-hoc analysis reported at the The Liver Meeting® 2015.
Lead study author Tania M. Welzel, MD, of the Department of Medicine, JW Goethe University Hospital in Frankfurt am Main, Germany, and coauthors reported, “Among liver transplant recipients treated with LDV/SOF + RBV, similar rapid declines in HCV RNA were observed irrespective of whether patients received CyA or TAC [tacrolimus] for immunosuppression.”
CyA and TAC are the two most commonly used immunosuppressants following liver transplantation, Dr. Welzel noted. “CyA suppresses HCV replication in vitro and its use may be associated with a higher SVR [sustained virologic response] rate in patients receiving interferon-based HCV therapy,” he explained.
To determine if the immunosuppressive regimen impacts viral decline or relapse rates after liver transplantation, Dr. Welzel and coauthors conducted a post-hoc analysis of data from the SOLAR-1 (NCT01938430) and SOLAR-2 (NCT02010255) clinical studies, in which patients received LDV/SOF + RBV for 12 or 24 weeks.
“On-treatment and post-treatment HCV RNA measurements from liver transplantation patients who received CyA or TAC were compared,” Dr. Welzel explained. “Patients who took both or neither of the immunosuppressants were excluded.” Endpoints included HCV RNA undetectable <LLOQ (lower limit of quantification) and HCV RNA <LLOQ at Weeks 2, 4, and 6.
Of 405 post-transplantation patients included in the post-hoc analysis, 309 (76%) had received TAC and 96 (24%) had received CyA, Dr. Welzel reported. “The number of patients with decompensated disease receiving TAC and CyA was 73 (24%) and 22 (23%) respectively,” Dr. Welzel reported. “Median, Q1, and Q3 baseline HCV RNA values were similar among patients receiving TAC and CyA.”
Results showed rapid HCV RNA suppression across all treatment groups. SVR rates were 100% for patients in the CyA group and 93% for patients in the TAC group. The difference may be due in part to more deaths that occurred in the TAC group (n=13) vs. CyA (n=0).
Researchers noted no statistically-significant difference in the relapse rates and similar overall safety of LDV/SOF + RBV in patients coadministered CyA or TAC.