August 18, 2016
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DAA therapy may reduce number of LT candidates

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Patients with hepatitis C virus, but without hepatocellular carcinoma treated with direct-acting antiviral agents saw lower MELD scores and improved liver function, enabling some of them to be removed from the liver transplant list.

“This study shows for the first time that DAAs may lead to a remarkable clinical improvement allowing the delisting of one patient out of five,” Luca S. Belli, MD, of the department of gastroenterology and hepatology at the Niguarda Hospital in Milan, Italy, and colleagues wrote in the Journal of Hepatology.

Luca S. Belli

In this retrospective study, researchers studied 103 patients listed consecutively for LT in 11 European locations between February 2014 and February 2015. Through a competing risk analysis of inactivated and delisted patients, researchers discovered the collective frequency was 15.5% and 0% at 24 weeks, 27.6% and 10.3% at 48 weeks and 33.3% and 19.2% at 60 weeks. MELD score improved by 3.4 points in the patients (n = 34) who were inactivated and 62% of those (n = 21) were delisted after further improvement, according to Belli and colleagues.

The researchers stratified study participants according to baseline MELD: those less than 16, those between 16 and 20, and those greater than 20. Those in the lowest baseline MELD group inactivated at a rate of 27.3% with less than a 2-point change in MELD but 100% with a greater than 4-point change. But only two patients who entered the study with a MELD greater than 20 were delisted despite achieving a greater than 4-point change in MELD.

In a related editorial, Gregory T. Everson, MD, FACP, director of the hepatology section, University of Colorado School of Medicine, addressed this.

Gregory T. Everson, MD

Gregory T. Everson

“The rate of inactivation and delisting in the Belli study may not be translatable to all transplant centers,” Everson wrote. “In fact, many U.S. centers don’t currently list liver candidates until MELD [greater than] 20. If the Belli study is correct, and MELD [greater than] 20 is too sick to inactivate or delist, then the newly listed U.S. candidates for liver transplantation will not be activated or delisted after [sustained virologic response].”
Belli’s group noted patients taking DAA may not continue to see health improvements for the rest of their lives.

“We suggest designing long-term multinational observational studies on patients who have been listed for decompensated [HCV] cirrhosis and subsequently delisted because of clinical improvement,” Belli and researchers wrote. – by Janel Miller

Disclosure: Belli reports receiving grant/research support from Gilead, AbbVie and BMS as well as contributing to the Gilead consulting/advisory board. Please see the full study for a list of all other authors’ relevant financial disclosures.