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( Beat Müllhaupt ),( Paul Kwo ),( Kosh Agarwal ),( Christophe Duvoux ),( Francois Durand ),( Marcus Peck-Radosavljevic ),( Eric M. Yoshida ),( Leslie Lilly ),( Bernard Willems ),( Hugo Vargas ),( Prin 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1
Aims: The aim of this analysis is to evaluate outcomes in patients who underwent liver transplant after initiating treatment with ledipasvir (LDV)/sofosbuvir (SOF)+ribavirin (RBV) in the SOLAR-1 and SOLAR-2 trials. Methods: We combined data from the SOLAR-1 and SOLAR-2 studies, in which 7 groups of patients with HCV genotype (GT) 1 or 4 were randomized to receive 12 or 24 weeks of LDV/SOF+ RBV: patients without a transplant with 1) Child-Pugh-Turcotte (CPT) B or 2) CPT C cirrhosis; or transplanted patients with 3) no cirrhosis (F0 to F3), 4) CPT A, 5) CPT B or, 6) CPT C cirrhosis, or 7) fibrosing cholestatic hepatitis. Results: Seventeen patients underwent liver transplantation during the study. For all but one patient, this was the first liver transplant. Six were CPT B at screening (5 Group 1, 1 Group 5) and 11 were CPT C (Group 2). Median baseline MELD score was 17 (range 7-23), with the majority (11/17) having scores ≥15. Seven patients underwent transplant prior to completing their full course of treatment. All patients were HCV RNA <LLOQ at the time of liver transplant. All but one patient (94%, 16/17) maintained virologic response 12 weeks after transplant (pTVR12). All patients who achieved pTVR12 received at least 11 weeks of LDV/SOF+RBV. The one patient who did not achieve pTVR12 discontinued study drug on day 21 and underwent liver transplant the following day. Conclusions: Few patients with decompensated cirrhosis treated in the SOLAR studies underwent liver transplantation after initiating LDV/SOF+RBV therapy. For the 17 who did undergo transplant, 94% achieved pTVR12. The data suggest that 11 weeks of treatment prior to transplantation can prevent reinfection of the graft. Future studies are needed to assess the optimal timing and length of treatment in the peri-transplant setting.