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

• Published in: Journal of digestive diseases Vol. 16; no. 5; pp. 286 - 292
• Main Authors: Gonen, Can, Gunduz, Feyza, Doganay, Levent, Enc, Feruze Y, Yegin, Ender G, Ahishali, Emel, Erdem, Emrullah, Sokmen, Mehmet, Tuncer, Ilyas, Ozdogan, Osman
• Format: Journal Article
• Language: English
• Published: Australia Blackwell Publishing Ltd 01-05-2015; Wiley Subscription Services, Inc
• Subjects: Adult; Aged; Aged, 80 and over; Antiretroviral drugs; Antiviral Agents - therapeutic use; Deoxyribonucleic acid; DNA; DNA, Viral; early response; Female; Health risk assessment; Hepatitis B virus; Hepatitis B virus - drug effects; Hepatitis B, Chronic - drug therapy; Humans; lamivudine; Lamivudine - therapeutic use; Liver Function Tests; Male; Middle Aged; resistance; Retrospective Studies; Treatment Failure; Treatment Outcome; viral load; Viremia - drug therapy; Young Adult; viral load; early response; hepatitis B virus; resistance; lamivudine
• ISSN: 1751-2972; 1751-2980
• DOI: 10.1111/1751-2980.12237

Objective
Low baseline viremia and an early treatment response predict the best outcomes in hepatitis B virus (HBV)‐infected patients treated with nucleoside analogues with low barriers to resistance. The aim of this study was to assess the long‐term results and effectiveness of lamivudine in patients with low baseline viremia and early virological treatment response.
Methods
In this multicenter, real‐life setting study, 111 antiviral‐naive patients with low baseline viremia (HBV DNA <107 copies/mL) plus an early virological response (HBV DNA <300 copies/mL at week 24) treated with lamivudine were enrolled. The primary end‐point was treatment failure, defined as the re‐emergence of detectable viremia or at least a 1 log increase in HBV DNA, resulting in a titer of ≥300 copies/mL with lamivudine treatment after week 24, which required treatment modification.
Results
Altogether 111 patients, including 78 non‐cirrhotic and 33 cirrhotic patients, were included in the study. Treatment failure occurred in 30.8% of the non‐cirrhotic patients over a median follow‐up period of 32.5 months, and the 1‐, 2‐, 3‐, 4‐ and 5‐year treatment failure rates were 6.5%, 14.0%, 31.4%, 39.6% and 43.1%, respectively. Treatment failure occurred in 28.8% of the whole group. There were no differences between the cirrhotic and non‐cirrhotic patients.
Conclusions
Lamivudine treatment had a high treatment modification rate in patients with low baseline viremia and early virological response over a long‐term follow‐up in a real‐life setting. The pretreatment and on‐treatment favorable characteristics found in the studies with telbivudine appeared to be inapplicable to lamivudine.