Early liver transplant for severe alcohol-related hepatitis was associated with increased risk for post-transplant alcohol relapse compared with standard transplantation, according to study findings published in The Lancet Gastroenterology & Hepatology.
For the analysis, researchers conducted a prospective, nonrandomized, noninferiority, controlled trial, called QuickTrans (ClinicalTrials.gov Identifier: NCT01756794), at 19 hospitals in France and Belgium between 2012 and 2016. The rate of alcohol consumption up to 2 years after liver transplant was assessed among patients with severe alcohol-related hepatitis who did not respond to medical treatment. Patients were assigned to receive early transplant (n=102), standard transplant (n=129), or no transplant (n=47) on the basis of a score (Lille model) comprising social and addiction criteria. Early transplant recipients were not required to have 6 months of alcohol abstinence, as is standard in France. Outcomes were compared with a nontransplant historical control cohort (n=428) in which case and control participants were matched in a 1:1 ratio. Primary outcomes for early vs standard transplantation included the noninferiority of a 2-year rate of alcohol relapse after transplantation and using the alcohol timeline follow back method plus a prespecified noninferiority margin of 10%.
The 68 and 93 patients in the early and standard transplantation cohorts had a median age of 54 (IQR, 46-59) and 56 (IQR, 52-60) years; 68% and 73% were men; 79% and 67% had ascites; 18% and 12% encephalopathy; and pre-transplant alcohol consumption was 12 (IQR, 8-20) and 0 units per day, respectively.
In the 2 years after transplantation, alcohol relapse occurred among 34% of the early and 25% of the standard transplant groups. Noninferiority of early transplantation was not achieved (absolute difference, 9.1%; 95% CI, -¥ to 21.1; P =.45). Similar results for high alcohol intake were observed, in which 22% and 5% of the early and standard group had high alcohol consumption (relative risk [RR], 4.10; 95% CI, 1.56-10.75).
At 2 years, 10% of the early cohort and 12% of the standard cohort died, indicating no difference in the 2-year survival rate (hazard ratio [HR], 0.87; 95% CI, 0.33-2.26).
The early transplant candidates and patients who were not eligible for transplantation were aged 55 (IQR, 45-59) and 53 (IQR, 46-59) years; 68% and 68% were men; 71% and 70% had ascites; and 18% and 18% had encephalopathy, respectively.
Among all candidates for the early transplant, 28% died compared with 70% of the patients who were ineligible for transplantation. This indicated that ineligibility was associated with poorer survival (HR, 0.27; 95% CI, 0.16-0.47).
Compared with the historical cohort, the early transplant cohort had improved 2-year survival (70.6% vs 18.2%; HR, 0.21; 95% CI, 0.13-0.32).
This study may have been limited by using the Lille model for stratifying patients, which has not been externally validated.
Overall, the study authors concluded that “the present study did not establish the
noninferiority of early liver transplantation for severe alcohol-related hepatitis with regards to alcohol relapse after transplantation, and confirms the important survival benefit related to early liver transplantation for severe alcohol-related hepatitis.”
Louvet A, Labreuche J, Moreno C, et al. Early liver transplantation for severe alcohol-related hepatitis not responding to medical treatment: a prospective controlled study. Lancet Gastroenterol Hepatol. Published online February 21, 2022. doi:10.1016/S2468-1253(21)00430-1