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World J Gastroenterol. Nov 14, 2007; 13(42): 5642-5647
Published online Nov 14, 2007. doi: 10.3748/wjg.v13.i42.5642
Viral blips during long-term treatment with standard or double dose lamivudine in HBe antigen negative chronic hepatitis B
Gianfranca Stornaiuolo, Maria Stanzione, Giuseppina Brancaccio, Gianluca Cuomo, Vincenza Precone, Sebastiano Di Biase, Francesca M Felaco, Felice Piccinino, Giovanni B Gaeta
Gianfranca Stornaiuolo, Giuseppina Brancaccio, Gianluca Cuomo, Vincenza Precone, Giovanni B Gaeta, Viral Hepatitis Unit, Department of Infectious Diseases, Second University, Naples, Italy
Maria Stanzione, Francesca M Felaco, Felice Piccinino, Infectious Disease Unit, Department of Infectious Diseases, Second University, Naples, Italy
Sebastiano Di Biase, Merigen, Laboratory of Molecular Biology, Naples, Italy
Author contributions: All authors contributed equally to the work.
Correspondence to: Giovanni B Gaeta, Professor, Viral Hepatitis Unit, Department of Infectious Diseases, Second University of Naples, Via Cotugno 1, c/o Osp. Gesù e Maria, Naples 80135, Italy. giovannib.gaeta@unina2.it
Telephone: +39-81-5666208
Received: April 24, 2007
Revised: June 15, 2007
Accepted: August 23, 2007
Published online: November 14, 2007
Abstract

AIM: To evaluate safety and effect on hepatitis B virus (HBV) suppression of a long-term treatment with lamivudine (LAM) at standard (100 mg/d) or double (200 mg/d) dose in chronic hepatitis B.

METHODS: This was a case study with matched controls (1:3) in patients with chronic hepatitis B with anti-HBe antibodies.

RESULTS: Twelve patients received LAM 200 mg/d and 35 LAM 100 mg/d, for a median of 28 mo. A primary response (PR; i.e., negative HBV-DNA with Amplicor assay) was achieved in 100% of LAM-200 patients and 83% of LAM-100 patients. A virological breakthrough occurred in 16.7 and 24.7%, respectively, of the PR-patients, with the appearance of typical LAM resistance mutations in all but one patient. Viremia blips (i.e., transient HBV-DNA below 80 IU/mL in patients who tested negative at Amplicor assay) were detected using a real time polymerase chain reaction (PCR) and occurred in seven out of nine patients with subsequent BT and in four out of 32 patients with end-of-study response (77.7% vs 12.5%; P = 0.001) at chi-square test). At the end of the study, 51.4% of LAM-100 patients and 83.3% of LAM-200 patients had remained stably HBV-DNA negative. Double-dose LAM was well tolerated.

CONCLUSION: Long-term treatment of anti-HBe positive chronic hepatitis B with double dose lamivudine causes a more profound and stable viral suppression as compared to conventional treatment.

Keywords: Lamivudine; Hepatitis B; Chronic; Hepatitis; Polymerase chain reaction