Viral blips during long-term treatment with standard or double dose lamivudine in HBe antigen negative chronic hepatitis B.
OBJECTIVE
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.


CONCLUSIONS
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.
Stornaiuolo
Gianfranca
G
Department of Infectious Diseases, Second University of Naples, Via Cotugno 1, c/o Osp. Gesu e Maria, Naples 80135, Italy.
Stanzione
Maria
M
Brancaccio
Giuseppina
G
Cuomo
Gianluca
G
Precone
Vincenza
V
Di Biase
Sebastiano
S
Felaco
Francesca-M
FM
Piccinino
Felice
F
Gaeta
Giovanni-B
GB
D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D004279:DNA, Viral / Q000097:blood; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood*; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016133:Polymerase Chain Reaction; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use*
D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine; D000410:Alanine Transaminase