Megan Brooks

November 16, 2009

November 16, 2009 (Boston, Massachusetts) — Patients with hepatitis B virus (HBV) waitlisted for liver transplantation face a lower probability of receiving a transplant and a higher probability of dying without a transplant than patients with other diagnoses and similar Model for End-Stage Liver Disease (MELD) scores, according to research reported during a plenary presentation here at The Liver Meeting 2009: American Association for the Study of Liver Diseases 60th Annual Meeting.

"This was especially true in patients with end-stage liver disease who did not have hepatocellular carcinoma and in patients of Asian and Pacific Island race," study presenter W. Ray Kim, MD, from the Division of Gastroenterology and Hepatology at the Mayo Clinic College of Medicine in Rochester, Minnesota, told meeting attendees.

All adult primary liver transplant candidates waitlisted between 1995 and 2006 were divided into 5 categories: HBV (n = 2235), hepatitis C virus (HCV; n = 35,178), cholestatic liver disease (n = 7758), acute liver disease (ALD; n = 12,584), and other diagnoses (n = 18.952).

Across the groups, ages were similar; there was a male preponderance in the HBV, HCV, and ALD groups; and, as expected, Asian/Pacific Island race was over-represented in the HBV group (38%). Fifteen percent of HBV patients had hepatocellular carcinoma.

During the 24 months after waitlist registration, the probability of death was 22% for ALD patients and the probability of transplantation was 53%; the remaining patients were apparently still waiting for transplantation, Dr. Kim reported. "For HCV, cholestatic liver disease, and other diagnoses, the trends are very similar. They roughly overlap," he noted.

The picture, however, was very different for HBV patients, Dr. Kim said. "At 24 months after registration on the waitlist, HBV patients had 42% mortality probability, compared with about 20% for other diagnoses; the probability of transplant was only 25% for HBV patients, compared with over 50% for other diagnoses."

The hazard ratio (risk for death) for HBV patients on the waitlist was 1.8 (95% confidence interval [CI], 1.7 - 2.0). These differences persisted when the data were broken down by era. In the most recent era (2003 to 2006), HBV patients were more than twice as likely to die on the waitlist as non-HBV patients, the study team reported.

Taking into account the MELD score at registration did not negate the higher risk for death in patients with HBV infection (hazard ratio, 1.8; 95% CI, 1.5 - 2.2). "This suggests that hepatitis B patients are not benefiting from the MELD system," Dr. Kim reported during his presentation. It seems, he said, that HBV patients are "disadvantaged in the current allocation system."

"There may be a biological basis for the poor outcome of HBV patients waitlisted for liver transplant," Dr. Kim said, "such as acute deterioration associated with HBV flare that cannot be saved with antiviral therapy. We do have effective antivirals but they are unable to reverse hepatic decompensation when applied too late."

Session moderator Marina Berenguer, MD, from the Hepatogastroenterology Service, Hospital Universitario La Fe, Valencia, Spain, who was not involved in the study, told Medscape Gastroenterology that the poorer outcome of waitlisted HBV patients "is something that is being seen more recently, as opposed to years ago, despite the fact that we are giving them antiviral drugs, and we need to know why."

"What are they dying from? The HBV patients typically have cancer and the cancers are quite aggressive. The problem might be that they are on the waiting list and their cancers are growing, so I think we need data on cancers in these patients," she offered.

Dr. Kim reports serving as a consultant/advisor to Bristol-Myers Squibb, Gilead Sciences, Roche, and Romark. Dr. Berenguer has disclosed no relevant financial relationships.

The Liver Meeting 2009: American Association for the Study of Liver Diseases (AASLD) 60th Annual Meeting: Abstract 3. Presented November 1, 2009.