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Lamivudine, Entecavir Both Improved Prognosis in Hepatitis B-Related Acute-on-Chronic Liver Failure: Presented at AASLD

By Cheryl Lathrop

BOSTON -- November 2, 2009 -- Both entecavir and lamivudine significantly improved the survival of patients with early- to midstage acute-on-chronic liver failure (ACLF) related to hepatitis B virus (HBV) after at least 1 month of treatment, researchers noted here at the Liver Meeting 2009, the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). There was no significant difference between the 2 treatments (P = .723).

Jinhua Hu, Liver Failure Treatment and Research Center, Beijing, China, and colleagues reported findings from this prospective, controlled, parallel-group efficacy trial at a poster session here on October 31.

The primary endpoint was time to disease progression, defined as the first occurrence of either death related to liver disease or liver transplantation. Cumulative survival was assessed through both the study and the follow-up. Therapeutic efficacy was evaluated in week 4.

"Improved" status was defined as one of the following: the clinical manifestation was improved, serum TBil (total bilirubin) decreased by more than 50% with no further decrease of prothrombin activity, or prothrombin activity increased by 10% with no further increase of TBil. "Unchanged" status was defined as failure to achieve the specified endpoint "improved" indices or death.

The majority (78.3%) of patients in this study had HBV C genotype. No significant difference was observed between the 2 treatment groups for age, baseline key biochemical indices, DNA level, or Model for End-Stage Liver Disease (MELD) scores.

After screening, 237 patients with HBV-related ACLF were randomised (1:1:1 ratio) to receive basic treatment, lamivudine (100 mg/day) + basic treatment, or entecavir (0.5 mg/day) + basic treatment. Basic treatment included strict bed rest, nutritional support, an intravenous drip of liver-protective drugs (hepatocyte growth-promoting factors, glutathione, or N-acetylcysteine), an intravenous drip of human serum albumin and fresh plasma, a subcutaneous injection of thymosin alpha 1, and prevention of various complications.

The number of patients completing the study was 207 (basic = 66, lamivudine = 70, entecavir = 71).

At week 4, "improved" status was achieved by 34.84% of the subjects in the basic-treatment-only group, 58.57% in the lamivudine group, and 59.15% in the entecavir group (P = .029). The survival rates at 4 weeks were 86.36% in the basic-treatment-only group, 87.14% in the lamivudine group, and 88.73% in the entecavir group.

After a long-term follow-up (25 months), however, the cumulative survival rates of patients with lamivudine (P = .045) or entecavir (P = .04) antiviral treatments were significantly higher than those without antiviral treatment.

[Presentation title: Lamivudine and Entecavir Significantly Improved the Prognosis of Early- and Mid-Stage Hepatitis B-Related Acute-on-Chronic Liver Failure -- A Prospective, Randomized, Open and Parallel Controlled Clinical Trial. Abstract 247]

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