PMID- 22343167
OWN - NLM
STAT- MEDLINE
DCOM- 20120917
LR  - 20131121
IS  - 1600-0641 (Electronic)
IS  - 0168-8278 (Linking)
VI  - 56
IP  - 6
DP  - 2012 Jun
TI  - HBV DNA suppression and HBsAg clearance in HBeAg negative chronic hepatitis B 
      patients on lamivudine therapy for over 5 years.
PG  - 1254-8
LID - 10.1016/j.jhep.2012.01.022 [doi]
AB  - BACKGROUND & AIMS: In long-term responder patients, it is unclear whether 
      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: One 
      hundred and ninety-one 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: One 
      hundred and ninety-one patients (148 males, median age 53 years, 72 with 
      compensated cirrhosis) responding to 60-month LAM monotherapy continued to 
      receive 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 emphasising the importance of a careful 
      virological monitoring.
CI  - Copyright (c) 2012 European Association for the Study of the Liver. Published by 
      Elsevier B.V. All rights reserved.
FAU - Fasano, Massimo
AU  - Fasano M
AD  - Clinic of Infectious Diseases, University of Bari, Policlinico, Bari, Italy.
FAU - Lampertico, Pietro
AU  - Lampertico P
FAU - Marzano, Alfredo
AU  - Marzano A
FAU - Di Marco, Vito
AU  - Di Marco V
FAU - Niro, Grazia Anna
AU  - Niro GA
FAU - Brancaccio, Giuseppina
AU  - Brancaccio G
FAU - Marengo, Andrea
AU  - Marengo A
FAU - Scotto, Gaetano
AU  - Scotto G
FAU - Brunetto, Maurizia Rossana
AU  - Brunetto MR
FAU - Gaeta, Giovanni Battista
AU  - Gaeta GB
FAU - Rizzetto, Mario
AU  - Rizzetto M
FAU - Angarano, Gioacchino
AU  - Angarano G
FAU - Santantonio, Teresa
AU  - Santantonio T
LA  - eng
PT  - Journal Article
DEP - 20120216
PL  - Netherlands
TA  - J Hepatol
JT  - Journal of hepatology
JID - 8503886
RN  - 0 (Antiviral Agents)
RN  - 0 (DNA, Viral)
RN  - 0 (Hepatitis B Surface Antigens)
RN  - 0 (Hepatitis B e Antigens)
RN  - 2T8Q726O95 (Lamivudine)
SB  - IM
CIN - J Hepatol. 2012 Jun;56(6):1219-20. PMID: 22406736
MH  - Adult
MH  - Aged
MH  - Antiviral Agents/*therapeutic use
MH  - DNA, Viral/*blood
MH  - Female
MH  - Hepatitis B Surface Antigens/*blood
MH  - Hepatitis B e Antigens/*blood
MH  - Hepatitis B, Chronic/*drug therapy/virology
MH  - Humans
MH  - Lamivudine/adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Real-Time Polymerase Chain Reaction/methods
MH  - Time Factors
EDAT- 2012/02/22 06:00
MHDA- 2012/09/18 06:00
CRDT- 2012/02/21 06:00
PHST- 2011/09/05 00:00 [received]
PHST- 2012/01/19 00:00 [revised]
PHST- 2012/01/23 00:00 [accepted]
PHST- 2012/02/21 06:00 [entrez]
PHST- 2012/02/22 06:00 [pubmed]
PHST- 2012/09/18 06:00 [medline]
AID - S0168-8278(12)00117-1 [pii]
AID - 10.1016/j.jhep.2012.01.022 [doi]
PST - ppublish
SO  - J Hepatol. 2012 Jun;56(6):1254-8. doi: 10.1016/j.jhep.2012.01.022. Epub 2012 Feb 
      16.