J Hepatol. 2012 Feb 15.
Source: http://www.ncbi.nlm.nih.gov/pubmed/22343167
HBV DNA suppression and HBsAg clearance in HBeAg negative chronic hepatitis
B patients on lamivudine therapy for over 5 years. Fasano M, Lampertico P,
Marzano A, Di Marco V, Niro GA, Brancaccio G, Marengo A, Scotto G,
Brunetto MR, Gaeta GB, Rizzetto M, Angarano G, Santantonio T. SourceClinic
of Infectious Diseases, University of Bari, Policlinico, Bari, Italy.
Abstract BACKGROUND & AIMS: In long-term responder patients, it is unclear
if lamivudine (LAM) monotherapy should be continued or switched to a
high-genetic-barrier analogue. This study aims at assessing LAM efficacy
over a 5-year period and the residual risk of drug resistance. The rate of
HBsAg clearance and LAM long-term safety profile were also evaluated.
METHODS: 191 patients with chronic HBeAg-negative hepatitis B successfully
treated with LAM monotherapy for at least 5 years were included.
Biochemical and virological tests were assessed every 3 months in all
patients and HBsAg quantification was performed in 45/191.
Reverse-transcriptase (RT) region was directly sequenced in virological
breakthrough patients. RESULTS: 191 patients (148 males, median age 53
years, 72 with compensated cirrhosis) responding to 60-month-LAM
monotherapy continued receiving LAM monotherapy beyond the initial 5 years
and were followed for an additional 36-month median period (range 1-108).
Virological response was maintained in 128/191 patients (67%) and HBsAg
clearance was observed in 15/128 (11.7%) after a 32-month median period
(range 1-65). The 63 remaining patients (33%) showed virological
breakthrough after a 15-month median treatment (range 1-78). RT region
analysis was performed in 38/63 breakthrough patients and LAM resistant
mutations were found in 37/38. No significant side effects were observed.
CONCLUSIONS: In long-term responder patients, continuation of LAM
monotherapy resulted in persistent viral suppression in most cases with
undetectable HBV DNA by real-time PCR; moreover, 11.7% of these patients
cleared HBsAg. Selection of LAM resistance, however, can still occur even
after successful long-term therapy, thus emphasizing the importance of a
careful virological monitoring.