Overall, 38 (28.6%) subjects had some hypersensitivity manifestation. Only 36 (27.1%) of the subjects recovered spontaneously
without liver transplantation (Tables 4 and 5). Of the remaining 97 subjects, 56 (42.1% of the cohort) underwent liver transplantation with excellent results within the study 3-week capture period (four deaths, FK866 concentration 92.9% survived), giving an overall survival of 66.2% (88 subjects). Another 17 subjects were listed but died without receiving transplantation, i.e., 23.3% wait-list mortality. Whereas 73 (54.9%) subjects were listed for liver transplantation, 24 (18.0%) were not, because of medical, psychosocial, or other contraindications. Nontransplant mortality was 30.8% (41 subjects). By univariate analysis, the baseline factors significantly associated with a good outcome were lower coma grades, bilirubin, INR, creatinine, and MELD scores, but not age, gender, BMI, blood pressure, drug class, type of DILI reaction, or liver
enzyme elevation (Table 4). Subjects undergoing transplantation were younger on average by 7 to 9 years, than those who recovered spontaneously or died, respectively (Table 4). Among the 20 subjects ≥60 years and eight ≥65 years, transplant-free survival (six out of 20, or 30%, and two out of eight, or 25%, respectively) was comparable to the whole cohort. Few older subjects underwent transplantation (four of 20 ≥60 years, and one of eight ≥65 years) but all survived. Consequently,
nontransplant death rates were high in this older subset (50% ≥60 years and Dabrafenib in vitro 63% ≥65 years), compared to the whole cohort (30.9%). Transplant-free survivors were significantly learn more less jaundiced (median bilirubin 12.6 mg/dL; IQR, 5.2-24.1) than those who died or underwent transplantation (20.5 and 23.3 mg/dL, respectively). Subjects who did not undergo transplantation who died had worse renal compromise (median creatinine 2.1 mg/dL) than survivors who did not undergo transplantation (1.1 mg/dL) and subjects undergoing transplantation (1.0 mg/dL). When transplant-free survival was compared to transplantation and death combined (Table 5), creatinine did not differ between the groups. The worst INRs were seen in transplant subjects. Though all MELD scores were high, median MELD scores were lowest for the transplant-free survivors (29.0), intermediate for transplant recipients (32.5), and highest for the nontransplant deaths (36.0), but not statistically so. NAC treatment was slightly more frequently associated with spontaneous survival (38.6%) than with transplantation (34.1%) and nontransplantation death (27.3%), respectively. Transplant-free survival (compared to transplantation or death) was greater with (38.6%) than without NAC (21.4%), without regard to coma grade (Table 5). There were too few subjects to permit conclusions about the interaction between NAC and coma grade, as reported in the NAC trial.