A randomized controlled trial of lamivudine to treat acute hepatitis B.

Abstract

UNLABELLED:

The role of antivirals in patients with acute viral hepatitis B (AVH-B) has not been evaluated in controlled trials. The aim of this study was to evaluate the efficacy of lamivudine in patients with AVH-B. AVH-B patients with serum bilirubin of more than 5 mg/dL were randomized to receive either 100 mg of lamivudine daily for 3 months (group 1, n = 31) or placebo (group 2, n = 40). Patients were considered to have severe AVH-B if they fulfilled 2 of 3 criteria: (1) hepatic encephalopathy; (2) serum bilirubin > or = 10.0 mg/dL; and (3) international normalized ratio (INR) > or = 1.6. At week 4, HBV DNA levels were significantly lower (P = 0.037) in group 1 (median: 3.6721 log copies/mL) than group 2 (median: 4.2721 log copies/mL). Thereafter, HBV DNA levels were comparable in the 2 groups. The improvement in serum bilirubin, ALT, and INR values was similar in the 2 groups. Twenty-two patients (71%) in group 1 and 25 patients (62.5%) in group 2 had severe AVH-B. Results were similar when patients with severe AVH-B were analyzed separately. After 12 and 18 months, 93.5% and 92.5%, respectively, of patients in the lamivudine group and 96.7% and 97.5%, respectively, of patients in the placebo group lost HBsAg. There were no deaths in either group. After 1 year, 21 patients (67.7%) in group 1 and 34 patients (85%) in group 2 developed protective anti-HBs titers (P = 0.096). All HBeAg-positive patients in both groups lost e antigen and anti-HBe developed in 71% and 87.5% of patients in groups 1 and 2, respectively (P = 0.132).

CONCLUSION:

Though lamivudine causes a greater decrease in levels of HBV DNA, it does not cause significantly greater biochemical and clinical improvement as compared to placebo in patients with acute hepatitis B.

• Authors: M Kumar, S Satapathy, R Monga, K Das, S Hissar, C Pande, B C Sharma, S K Sarin
• Journal: Hepatology (Baltimore, Md.) (Hepatology) Vol. 45 Issue 1 Pg. 97-101 (Jan 2007) ISSN: 0270-9139 [Print] United States
• PMID: 17187417 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• DNA, Viral
• Hepatitis B e Antigens
• Reverse Transcriptase Inhibitors
• Lamivudine
• Bilirubin

Topics

• Acute Disease
• Adolescent
• Adult
• Aged
• Bilirubin (blood)
• Child
• DNA, Viral (metabolism)
• Female
• Hepatitis B (drug therapy, immunology, metabolism)
• Hepatitis B e Antigens (blood)
• Hepatitis B virus (genetics, immunology)
• Humans
• Immunocompetence (immunology)
• Lamivudine (adverse effects, therapeutic use)
• Male
• Middle Aged
• Reverse Transcriptase Inhibitors (adverse effects, therapeutic use)
• Treatment Outcome