Monday, November 1, 2010

HCV Tx Cuts Deaths Post-Transplant/AASLD

By Michael Smith, North American Correspondent, MedPage TodayPublished: October 31, 2010Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco.

BOSTON -- After a liver transplant, successful treatment for hepatitis C significantly reduces the risk of death, researchers reported here.

The finding, from a retrospective analysis of nearly 500 patients from 12 Italian liver transplant centers, suggests that antiviral treatment should be "strongly pursued," according to Maria Rendina, MD, of the University of Bari in Bari, Italy and colleagues.

Many physicians are reluctant to treat the recurrent disease aggressively because of a perceived lack of clinical effect and because of frequent adverse events, Rendina said at the annual meeting of the American Association for the Study of Liver Diseases.

But in this study population, she said, the lack of a sustained virologic response (SVR) -- defined as undetectable viral RNA 24 weeks after the end of treatment -- was "significantly and independently" associated with a threefold increased risk of death.

All told, Rendina's group studied outcomes for 464 consecutive liver transplant patients who were treated after their hepatitis C recurred. Over a median follow-up of six years, Rendina said, 35% of the patients achieved an SVR and most maintained the response throughout the study period.

But mortality was significantly lower among those with an SVR. In addition, she noted:

Only 10% of those who were successfully treated died, including only one from liver-related causes.
In contrast, 34% of those who did not achieve an SVR died, including 89 (or 28%) from liver-related causes.
The difference was significant at P=0.001, but there was no significant difference in the rate of death from non-liver related causes.

Rendina said univariate analysis showed that older donor age, diabetes, having viral genotypes one or four, and lack of an SVR were all significant risk factors for death.

In a multivariate analysis, the lack of an SVR was associated with a significant hazard ratio for death of 3.3, she added.

Rendina noted that current treatments for hepatitis C (interferon, whether pegylated or standard, combined with ribavirin) are difficult to tolerate -- indeed, she reported 26% of the patients in the current analysis stopped treatment.

"New antivirals are urgently needed," she said.

The findings "extend the whole idea that if you have an SVR you actually improve mortality," according to Arun Sanyal, MD, of Virginia Commonwealth University Medical Center in Richmond, Va. Sanyal, president of AASLD, who was not part of the study.

Sanyal said data from the nontransplant population -- some presented at this meeting -- show that an SVR is associated with lower risk of death.

The Italian study, he said, shows that "post-transplant, if you knock the virus out then it really has a huge impact on liver-related death."

Taken together, the data "makes a really compelling case than an SVR really does represent a cure," Sanyal added.

The study may increase interest in treating more post-transplant patients, he commented, although the question of when to treat remains up in the air.

Rendina did not report any external support for the study. She said she had no financial disclosures.

Primary source: American Association for the Study of Liver Diseases
Source reference:
Rendina M, et al "SVR to antiviral therapy is highly protective against liver -- related death in patients with HCV recurrence on the graft after liver transplantation (LT)" AASLD 2010; Abstract 4.

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