Action Points
Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
Note that this retrospective study suggests that liver transplant outcomes have improved since the advent of the direct-acting agent era, particularly among those with HCV infection.
Be aware that patient-level data on who received DAAs was not available for this analysis.
CHICAGO — The advent of direct-acting anti-hepatitis C agents (DAAs) appears to have improved both patient and graft survival after liver transplant, a researcher said here.
In almost all cases, patients with chronic hepatitis C (HCV) who undergo liver transplant see the virus quickly recur, with rapid progression to fibrosis and cirrhosis, according to Nyan Latt, MD, of the Mayo Clinic in Jacksonville, Fla.
But the new DAAs can cure HCV in most patients and halt that process, with the possibility of a beneficial impact on both survival of the transplanted organ and patients themselves, Latt said at Digestive Disease Week, co-sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.
Treatment with DAAs is indicated for all transplant patients with recurrence, Latt said, and the therapy seems likely to change survival rates.
To examine the issue, he and colleagues looked back over some 3,575 liver transplant patients at two centers over three time periods — before 2006, from 2006 through 2010, and after 2010.
The time periods were chosen to allow comparison of HCV and non-HCV transplant recipients with enough follow-up in the DAA era — post 2010 — to allow calculation of five-year survival rates, Latt said.
They also allowed the sample sizes in each era to be roughly the same, he said.
All told, 1,437, or 40%, of the patients, had HCV.
The researchers expected to see a gradual improvement in outcomes over time, reflecting better medical and surgical care, with a differential between those with and without an HCV diagnosis, he added.
And indeed, for graft survival, that’s pretty much what they saw.
For instance, five-year graft survival among non-HCV patients rose from 71.9% to 82% from the earliest era to the most recent time, increases that were paralleled but somewhat higher for one- and three-year survival.
Among HCV patients the pattern was similar: 66.6% rising to 81.8%, with slightly higher numbers associated with shorter follow-up.
In both groups, the trend was significant at P=0.001.
For patient survival, the picture was different:
There were no significant improvements among the non-HCV group, with five-year rates rising slightly from 77.9% to 83.2%
But among those with HCV, the five-year rates did not change markedly in the first two eras — 75.8% and 76.2%, respectively — but then jumped significantly in the DAA era to 83.7%
In other words, Latt said, patient survival in the DAA era was comparable for patients with and without HCV.
However, the study had two important flaws, commented Richard Sterling, MD, of Virginia Commonwealth University in Richmond, Va., who was not part of the study but who moderated the session at which it was presented.
The first is the way the time periods were set up. In order to get five-year data, Latt and colleagues started their DAA era after 2010, when the earliest of such agents came on the market.
But those agents, Sterling told MedPage Today, were protease inhibitors that still needed to be given with pegylated interferon and ribavirin. Interferon- and ribavirin-free drugs did not appear until 2014 and later and it is possible that outcomes using them would have been different from those seen with the first DAAs.
He said it would have been better to hold off on the analysis until there was enough data to yield five-year graft and patient survival rates for interferon- and ribavirin-free regimens.
“We need to wait another two or three years in order to have the five-year DAA-only data,” he said.
The other important flaw, he said, is that Latt and colleagues don’t yet have data on how patients in their latest era were actually treated. “Did 20 get treated [with DAAs] or 300?” he asked.
The assumption is that most got DAA therapy and therefore did better, Sterling said, “but he can’t show that.”
The study had no external support. Latt said the authors had no disclosures.
Sterling disclosed relationships with Salix, Bayer, ViiV, Baxter, Pfizer, AbbVie, Gilead, Merck, BMS, and Roche/Genentech.
Reviewed by F. Perry Wilson, MD, MSCE Assistant Professor, Section of Nephrology, Yale School of Medicine and Dorothy Caputo, MA, BSN, RN, Nurse Planner
2017-05-09T13:00:00-0400