High rates of progressive hepatic functional deterioration whether lamivudine therapy is continued or discontinued after emergence of a lamivudine-resistant mutant: a prospective randomized controlled study.

Background. The management of patients with lamivudine-resistant mutants remains challenging, and no clear evidence has been presented concerning the discontinuation of lamivudine. Methods. Seventy-four patients with lamivudine-resistant mutants were prospectively enrolled and randomized; 37 patients continued (group A) and 37 patients discontinued lamivudine therapy (group B). The median follow-up was 20 months. Results. Serum albumin levels were reduced and prothrombin time was prolonged in both groups versus baseline (P = 0.015 and 0.045, respectively). Four patients in group A (10.8%) and six in group B (16.2%) experienced hepatitis flare, but the difference was not significant (P > 0.05). Multivariate analyses identified a younger age as a risk factor for hepatitis flare (P = 0.021). Seven (18.9%) decompensations occurred in group A and five (13.5%) in group B, which was not a significant difference (P > 0.05). Multivariate analyses revealed higher alanine aminotransferase and a lower platelet count as risk factors for hepatic decompensation (P = 0.001 and 0.001, respectively). The patients whose platelet count was <65000/μl experienced hepatic decompensations more frequently (50%) than those with platelet counts >65 000/μl (13.2%) during follow-up (P = 0.05). Conclusions. The clinical course of group B was not significantly different from that of group A. Therefore, the discontinuation of lamivudine may be a feasible option when other antiviral agents active against lamivudine-resistant mutants are unavailable. [ABSTRACT FROM AUTHOR]