Delisting HCV-infected Liver Transplant Candidates Who Improved After Viral Eradication

Outcome 2 Years After Delisting

Giovanni Perricone; Christophe Duvoux; Marina Berenguer; Paolo A. Cortesi; Carmen Vinaixa; Rita Facchetti; Chiara Mazzarelli; Susanne-Rasoul Rockenschaub; Silvia Martini; Cristina Morelli; Sara Monico; Riccardo Volpes; Georges-Philippe Pageaux; Stefano Fagiuoli; Luca S. Belli; for the European Liver and Intestine Transplant Association (ELITA)

Disclosures

Liver International. 2018;38(12):2170-2177. 

In This Article

Methods

The primary ELITA cohort1 comprised one hundred and three consecutive liver transplant candidates on the waiting list, with DC and HCC negative, who were treated with second-generation DAAs between February 2014 and February 2015. An additional group of 39 consecutive patients were added to the original cohort and were treated from March 2015 through June 2015. All patients were followed up until 31 December 2017. Eleven European Centres participated in this study. Inclusion and exclusion criteria were the same as in the preliminary report.[1] The primary study endpoints were clinical outcomes (survival, HCC development, clinical deterioration and relisting) in the delisted patients.

Criteria for Delisting

Although the timing of delisting was left to the discretion of the treating physician, it was agreed that patients would be delisted if the following goals could be achieved: 1. Sustained Virological Response (SVR), 2. regression of Hepatic Encephalopathy (HE) and of ascites 3. MELD score below 15. Low doses of diuretics (up to furosemide 25 mg QD and aldactone antagonist 100 mg QD) at delisting were considered acceptable. It was also agreed that patients would be listed as 'inactive position' on the waiting list for a period of at least 3–6 months prior to delisting to confirm the stable clinical status. Patients who were not delisted maintained the priority driven by their MELD score.

Statistical Analysis

Descriptive statistical analysis was performed where data are expressed as median (interquartile range, IQR). Categorical variables were compared with the Chi-square test or 2-sided Fisher's exact test, continuous variables were analysed by Wilcoxon's rank-sum test as appropriate. Cumulative incidence curves for delisting were constructed considering time to delisting and time to LT and time to death as competing risks.[5] Time to delisting, time to LT and time to death were measured from the date of treatment start. All analyses were performed using SAS software (version 9·4; SAS Institute Inc., Cary, NC). A P-value < .05 was considered to be statistically significant. Ethical approval was not sought as the study utilized data provided in the course of normal patient care and no patient-identifiable data were collected.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....