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 <65 000/microl experienced hepatic decompensations more frequently (50%) than those with platelet counts >65 000/microl (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.
RCT Entities:
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 <65 000/microl experienced hepatic decompensations more frequently (50%) than those with platelet counts >65 000/microl (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.
Authors: Robert Perrillo; Hie-Won Hann; David Mutimer; Bernard Willems; Nancy Leung; William M Lee; Alison Moorat; Stephen Gardner; Mary Woessner; Eric Bourne; Carol L Brosgart; Eugene Schiff Journal: Gastroenterology Date: 2004-01 Impact factor: 22.682
Authors: Marion G Peters; H w Hann Hw; Paul Martin; E Jenny Heathcote; P Buggisch; R Rubin; M Bourliere; K Kowdley; C Trepo; D f Gray Df; M Sullivan; K Kleber; R Ebrahimi; S Xiong; Carol L Brosgart Journal: Gastroenterology Date: 2004-01 Impact factor: 22.682
Authors: Tatyana A Shamliyan; James R Johnson; Roderick MacDonald; Aasma Shaukat; Jian-Min Yuan; Robert L Kane; Timothy J Wilt Journal: J Gen Intern Med Date: 2011-01-04 Impact factor: 5.128