Megan Brooks

November 02, 2009

November 2, 2009 (Boston, Massachusetts) — After orthotopic liver transplantation for hepatitis C virus (HCV), extending antiviral therapy for 52 weeks after a first HCV-negative result leads to low relapse rates, according to research reported here during an oral presentation at The Liver Meeting 2009: American Association for the Study of Liver Diseases (AASLD) 60th Annual Meeting.

"In patients responding slowly to antiviral therapy following orthotopic liver transplant, the 'stop rules' at weeks 12 and 24 should be reconsidered," lead investigator Kimberly Brown, MD, head of the Division of Gastroenterology at the Henry Ford Hospital in Detroit, Michigan, and colleagues report in their meeting abstract.

In an interview with Medscape Gastroenterology just prior to her presentation, Dr. Brown said: "There are some data in the pretransplant population that, if you extend antiviral therapy, you reduce relapse rates, especially in patients who are responding slowly. The purpose of our study was to extend therapy to see if we could do that in a posttransplant population, and the results suggest that we could."

The study involved 241 consecutive patients who underwent orthotopic liver transplant from 1999 to 2006 for HCV. Patients were offered therapy if they tested positive for HCV RNA, had recurrent HCV with at least stage 1 fibrosis, and had stable immunosuppression for at least 3 months.

Patients received either nonpegylated interferon 3 times weekly or pegylated interferon in combination with ribavirin in standard doses. Treatment was continued for 52 weeks after patients became HCV-negative.

According to Dr. Brown, of the 241 patients, 66 were treated, 22 achieved sustained virologic response, and only 2 (8%) relapsed. "A relapse rate of 8% is quite a bit lower than the 30% that is commonly cited in the literature," she told Medscape Gastroenterology.

She also noted that patients who achieved sustained virologic response were more likely to have had extended treatment than those who did not (97.5 vs 59.9 weeks; P < .014).

Moreover, "35% of the patients who went on to have a sustained virologic response actually became virus-negative after week 24," Dr. Brown said. "This suggests that even if patients are positive at 24 weeks, there is still a 35% chance that they can achieve sustained viral clearance."

Stuart C. Gordon, MD, also from the Department of Gastroenterology and Transplant Surgery at the Henry Ford Hospital, but who was not involved in the study, said: "These are very provocative data that challenge a lot of long-held paradigms. The standard of care has always taught us that failure to achieve viral negativity by 24 weeks is the end of the line. This study shows that this is not the case."

"In light of these findings, our preconceived notions about antiviral therapy need to be re-explored," he concluded.

The study was funded by Henry Ford Health System in Detroit, Michigan. Dr. Brown and Dr. Gordon have disclosed no relevant financial relationships.

The Liver Meeting 2009: American Association for the Study of Liver Diseases (AASLD) 60th Annual Meeting: Abstract 187. Presented November 2, 2009.

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