Reassessing the Role for Lamivudine in Chronic Hepatitis B Infection: A Four-Year Cohort Analysis

Abstract

The data supporting the use of antiviral agents other than lamivudine in the management of patients with hepatitis B virus (HBV) infection are based on highly selected clinical trial populations that may not be representative of typical HBV-infected populations encountered in many clinics. Despite its limitations, however, lamivudine is relatively inexpensive and widely available and, in carefully selected patients, can still be successfully used to achieve long-term HBV suppression. This study investigated the long-term effectiveness of lamivudine in an adherent, frequently monitored, noninvestigational HBV-infected cohort.BACKGROUND/OBJECTIVES: Lamivudine is readily available and inexpensive. Guidelines recommend other antiviral medications because they achieve superior virological suppression with less resistance. These data are based on clinical trial populations and may not be representative of typical hepatitis B virus (HBV) populations. The authors assessed lamivudine in maintaining long-term viral suppression in an adherent, frequently monitored, noninvestigational HBV-infected population.METHODS: All HBV patients (n=369) between 2000 and 2010 were evaluated in a retrospective, single-centre study. Virological response was defined by complete suppression of HBV DNA (<400 copies/mL) and was assessed at six to 12 month intervals over four years. Enzymatic and serological outcomes, as well as treatment failures were assessed.RESULTS: Forty-seven patients (36 men; mean age 44 years, mean alanine aminotransferase level 123 U/L; METAVIR stage 3/4 [n=21], treatment naive [n=41]) received lamivudine 100 mg to 300 mg daily. The mean pretreatment viremia was 5.19 log₁₀ copies/mL, and was above the limit of detection (>6.91 log₁₀ copies/mL) in 11 patients (23%). The mean (± SD) dosing duration was 32±22 months. Virological suppression was achieved in 45 (96%) patients. Mean viremia declined to 3.06 log₁₀ copies/mL (n=27) and 2.68 log₁₀ copies/mL (n=18) at 12 and 48 months, respectively, with 78% and 88% with undetectable viremia at these time points, respectively. The mean alanine aminotransferase level declined to 31 U/L and 36 U/L at 12 and 48 months, respectively. Seven of 13 (54%) hepatitis B e antigen-positive patients seroconverted. The treatment failure rate was 11%.CONCLUSIONS: In a selected group of HBV patients, successful long-term viremia suppression was achieved with low treatment failure rates. With strict dosing adherence and monitoring for virological breakthrough, sustained virological suppression can be reliably achieved with lamivudine in carefully selected patients.