S-Space College of Medicine/School of Medicine (의과대학/대학원) Internal Medicine (내과학전공) Journal Papers (저널논문_내과학전공)
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
- Kim, Yoon Jun; Kim, Byeong Gwan; Jung, Jun-Oh; Yoon, Jung-Hwan; Lee, Hyo-Suk
- Issue Date
- Springer Verlag
- J Gastroenterol. 2006 Mar;41(3):240-9.
- Adolescent; Adult; Aged; Alanine Transaminase/blood/drug effects; Bilirubin/blood; Biological Markers/blood; DNA, Viral/blood/drug effects; Disease Progression; Drug Resistance, Viral/*drug effects; Female; Follow-Up Studies; Hepatitis B e Antigens/blood/drug effects; Hepatitis B virus/drug effects/metabolism; Hepatitis B, Chronic/blood/drug therapy/epidemiology/virology; Humans; Korea/epidemiology; Lamivudine/adverse effects/*therapeutic use; Liver Failure/blood/*epidemiology/*physiopathology; Male; Middle Aged; Multivariate Analysis; Mutation/*drug effects; Platelet Count; Predictive Value of Tests; Prospective Studies; Prothrombin Time; Reverse Transcriptase Inhibitors/adverse effects/*therapeutic use; Risk Factors; Serum Albumin/drug effects/metabolism
- 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.
- 0944-1174 (Print)
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