First Evidence That Hep C Drugs Curb Liver Transplants

Kate Johnson

April 15, 2016

BARCELONA, Spain — Thanks to direct-acting antivirals that can cure the majority of patients with chronic hepatitis C virus, the need for liver transplantation in this population could be greatly reduced, according to the results of a new study.

In early data from 11 European liver transplant centers, almost 33% of hepatitis C patients with decompensated cirrhosis who were on a liver transplant list were placed on hold because of improvement after treatment with direct-acting antivirals. Eventually, 62% of these patients were delisted.

"With time, many more patients will be delisted," lead investigator Luca Belli, MD, from Niguarda Hospital in Milan, said here at the International Liver Congress 2016.

"I suspect around 80% of those who were inactivated will eventually be delisted," he told Medscape Medical News.

The study is "intriguing" and "one of the first to provide data on this issue," but should nevertheless be interpreted with caution, said Laurent Castera, MD, PhD, from Hôpital Beaujon in Clichy, France, who is vice-secretary of the European Association for the Study of the Liver.

"It's retrospective, with possible bias due to different policies at different centers, and there's lack of long-term follow-up," he told Medscape Medical News. "It's still interesting, it gives some ideas, but we have to be cautious."

The retrospective cohort study involved 134 consecutive patients with hepatitis C and decompensated cirrhosis who were on a wait list for liver transplantation. Of these, 103 patients were treated with direct-acting antivirals and 31 were not treated "because the physician thought they were too advanced," Dr Belli reported.

By 60 weeks, 34 of the treated patients (33%) had been inactivated, some as soon as 12 weeks after starting therapy, and 21 patients had been delisted (20%). The time between inactivation and delisting ranged from 24 to 36 weeks.

Although long-term follow-up is lacking for this cohort, "we suspect that, very likely, patients who have been delisted will stay well for good," said Dr Belli. Hpwever, "they are still at risk — low risk — of developing hepatocellular carcinoma, so we need longer follow-up."

The landscape of liver transplantation for hepatitis C is completely changing because of these new drugs.

Disease severity at baseline and improvement were predictors of inactivation and delisting.

Model for End-Stage Liver Disease (MELD) score at the start of therapy and changes in MELD and albumin after 12 weeks of therapy are predictive of inactivation and delisting, Dr Belli reported. "The lower the MELD score, the higher the chances of being inactivated and subsequently delisted."

Patients with a baseline MELD score of 16 to 20 were much less likely than those with a MELD score below 16 to be inactivated (hazard ratio [HR], 0.12; P < .0005). The same was true for patients with a MELD score above 20 (HR, 0.042; P < .0001).

Rates of inactivation were significantly better in patients with a median improvement in MELD score of 3.3 points than in those with slower improvement (P < .0001), as well as in patients with a median improvement in Child–Pugh score of 2 points (P < .0001) and in patients with a median improvement in albumin of 0.5 g/dL (P < .0002).

All patients who were inactivated also showed improvement in ascites and encephalopathy 24 weeks after the start of therapy, he added.

"The landscape of liver transplantation for hepatitis C is completely changing because of these new drugs," Dr Castera explained. "Now we achieve spectacular sustained viral response rates. We're going to cure most patients and hepatitis C recurrence will largely disappear."

Despite this, "5% to 15% of patients do not improve because they have reached the point of no return. People who are at an advanced state of cirrhosis probably are at highest risk of not improving," he added.

"We have to take into account that in real life, many of these patients have comorbidities. Some may also have excessive alcohol intake, or be overweight, and even though you cure the virus, they may still be at risk for other complications."

Dr Belli reports receiving grant and research support from Gilead, AbbVie, and BMS; and serving as a consultant or on the advisory board for Gilead. Dr Castera reports serving on the speaker's bureau for Echosens.

International Liver Congress (ILC) 2016: Abstract PS036. Presented April 14, 2016.

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