Lamivudine Treatment Failure Risks in Chronic Hepatitis B Patients with Low Viral Load

Abstract

Aim: To analyze the risk factors of lamivudine treatment failure (LTF) for the long-term use in patients with low viral load (LVL). Material and Methods: In this multicenter study, 548 antiviral naïve noncirrhotic adult patients with LVL (for HBeAg+ patients HBV DNA <10⁹ copies/ml and for HBeAg- patients HBV DNA <10⁷ copies/ml) were enrolled. As a control group, 46 lamivudine-initiated patients with high viral load (HVL) were included. Primary outcome was switching to or adding on another antiviral drug as a consequence of primary nonresponse, partial response, viral breakthrough or adverse events. Secondary outcomes included LTF rates at 1, 2, 3, 4 and 5 years and LTF-related viral and host factors. Results: Among 594 patients, 294 had to change lamivudine at the follow-up. Primary nonresponse, partial response, viral breakthrough or adverse events frequencies were 6.8, 1.6, 64.5 and 0.1%, respectively. Five-year LTF rates were 61.3 and 84.2% in patients with LVL and HVL, respectively. Among patients with LVL, patients with <100,000 copies/ml and ≥100,000 copies/ml had 54.8 and 67.3% LTF rates at the end of the 5th year, respectively. Logistic regression analysis of risk factors showed HBeAg+, hepatic activity index, HBV DNA, virological response at 6 months and duration of follow-up were independent predictors for LTF (p values were 0.001, 0.008, 0.003, 0.020 and 0.003, respectively). Conclusion: Similar to patients with HVL, first-line lamivudine therapy is not efficient for long-term use in patients with LVL. LTF risk is so high even in the absence of worse predictive factors.

High treatment modification rates with lamivudine therapy in HBV‐infected patients with low baseline viremia and early virological response: A multicenter study

“…reported that 13% of the patients who achieved complete viral suppression (HBV DNA < 200 copies/mL) with continuous lamivudine treatment developed viral resistance over a median follow‐up period of 12 months . In a recent multicenter study the lamivudine treatment failure rate was examined in 548 non‐cirrhotic patients (85% HBeAg‐negative) with a low viral load (for HBeAg‐positive patients, HBV DNA <10 9 copies/mL and for HBeAg‐negative patients, HBV DNA <10 7 copies/mL). A cut‐off value of <400 copies/mL was defined as early virological response.…”

“…Data have been scarce on the long‐term outcomes of treatment with lamivudine for patients with low baseline viremia plus an early virological response. A recent study showed there was a 5‐year treatment failure rate of 61.3% with lamivudine therapy among patients with a low pretreatment viral load (HBV DNA <10 7 and <10 9 copies/mL for patients with negative and positive hepatitis B e antigen [HBeAg], respectively) . The aim of this study was to assess the long‐term results and effectiveness of lamivudine treatment for patients with low pretreatment viremia and an early virological response to treatment.…”