title: Lamivudine treatment is beneficial in patients with severely decompensated cirrhosis and actively replicating hepatitis B infection awaiting liver transplantation: a comparative study using a matched, untreated cohort.
abstract: Uncontrolled studies have suggested a beneficial effect of lamivudine in patients with decompensated cirrhosis caused by replicating hepatitis B virus (HBV). We analyzed the outcome of lamivudine treatment in 23 consecutive patients with severely decompensated HBV-cirrhosis defined as a Child-Pugh-Turcotte (CPT) score of > or =10, and compared with a historical untreated control group of 23 patients matched for age, gender, and baseline CPT score. Significant clinical response, defined as a decrease in the CPT score by > or =3 points, was observed in 14 of 23 (60.9%) treated patients versus none of the controls (P <.0001). The median change in CPT scores was -3.0 (range, -6 to +3) in the treated group versus +1.0 in the controls (range, -1 to +2) (P =.016). Orthotopic liver transplantation (OLT) was performed in 34.8% of treated patients (median, 3.5; range, 1-32 months), versus 73.9% of controls (median, 3.0; range, 1-14 months) (P =.04). Excluding transplanted patients, there were no deaths in the treated group versus 6 deaths in the control group (P =.009). Time to death or OLT was significantly longer in treated patients than in controls (P <.001). Two patients developed lamivudine resistance after 9 and 12 months, respectively. Our results suggest that lamivudine significantly improves hepatic function in over half of the patients with decompensated cirrhosis and replicating HBV, and may confer a survival advantage. However, the small sample size and the use of a retrospective control cohort preclude drawing definitive conclusions. Expedited OLT remains the only viable treatment for lamivudine nonresponders.
authors.affiliation: Department of Medicine, Division of Gastroenterology, University of California, San Francisco, CA 94143-0538, USA. yaofyk@itsa.ucsf.edu
authors.forename: F Y
authors.initials: FY
authors.lastname: Yao
authors.forename: N A
authors.initials: NA
authors.lastname: Terrault
authors.forename: C
authors.initials: C
authors.lastname: Freise
authors.forename: L
authors.initials: L
authors.lastname: Maslow
authors.forename: N M
authors.initials: NM
authors.lastname: Bass
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015331:Cohort Studies; D004279:DNA, Viral / Q000097:blood; D004351:Drug Resistance; D005260:Female; D006509:Hepatitis B / Q000150:complications* / Q000821:virology*; D006515:Hepatitis B virus / Q000235:genetics; D006801:Humans; D019259:Lamivudine / Q000009:adverse effects / Q000627:therapeutic use*; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000503:physiopathology / Q000601:surgery / Q000821:virology*; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016019:Survival Analysis; D014779:Virus Replication; D014850:Waiting Lists
chemical_list: D004279:DNA, Viral; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine