麻豆传媒

BARCELONA -- Even the sickest patients with hepatitis C (HCV) might be able to avoid some of the severe consequences of the disease if they are treated with the new direct-acting antiviral agents, a researcher said here.

After such therapy, about a third of patients on a list for a liver transplant had their status "inactivated" because of clinical improvement, and about two-thirds of those were eventually taken off the list entirely, according to of the Niguarda hospital in Milan, Italy.

It will take more follow-up to see if such patients can permanently avoid transplant, he told reporters at the annual.

But he told 麻豆传媒 later that he thinks about 80% of those delisted will be able to avoid transplant "for good."

The study is "very timely" as more and more of the new agents come on the market, commented , of Hôpital Beaujon in the Paris suburb of Clichy and secretary-general of the European Association of the Study of the Liver (EASL), which organizes the meeting.

Castera told 麻豆传媒 the study begins to fill a key information gap -- what is the "point of no return" before an HCV cure does little or nothing to reduce the need for a transplant?

All of the new direct-acting antiviral agents are remarkably effective in improving the clinical picture in patients with decompensated cirrhosis, Belli said, but it has not been clear what effect that might have on the need for transplant.

To find out, he and his colleagues collected baseline data on 134 consecutive patients with decompensated cirrhosis -- but without hepatocellular carcinoma -- who were listed for liver transplant at 11 European centers between February 2014 and February 2015.

Of those, 103 were treated with one or two direct-acting agents (depending on location, some countries only had one available) and 31 were not treated, mainly because their treating physicians thought they were too close to transplant.

The primary endpoint of the analysis was the probability of inactivation, followed by delisting, he noted.

Sixty weeks after starting treatment, 33% of the treated patients were inactivated and 62% of those inactivated so far have been delisted, although six more might be taken off the list soon.

The median time to delisting was 48 weeks.

Of the 21 delisted patients, Belli said, all showed regression in signs of hepatic decompensation -- all were without hepatic encephalopathy and 16 had no ascites and were off diuretics.

All had a score (MELD) of less than 15, and 19 of the 21 had seen that score improve by more than three points during treatment.

A key secondary endpoint was predictors of inactivation. Belli said analysis suggests three criteria: Changes 24 weeks after the start of therapy in MELD score, Child-Pugh status, and albumin.

The researchers also found that among the 67 patients who were not inactivated, the median baseline MELD score was 16 and did not change. But among the 34 who were inactivated, the median was 14 at baseline and dropped to nine for a difference that was significant (P<0.0001).

In addition, Child-Pugh scores fell in both groups from 10 to 9 and from 9 to 7 among non-inactivated and inactivated patients respectively. But the two-point different in the latter group was significant (P<0.0001).

Finally, albumin levels improved significantly (P<0.0002) by 0.5 grams per deciliter of urine among the inactivated patients, while remaining roughly stable among those who were not inactivated.

While the issue is important today, it is likely to go away soon, Belli told 麻豆传媒. As the new agents become more widely used, more patients will be treated early in the disease course, avoiding the transplant list entirely, he said.

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