Lamivudine monotherapy and lamivudine plus interferon alpha combination therapy in HBeAg negative chronic hepatitis B not responding to previous interferon alpha monotherapy.
OBJECTIVE
To investigate the efficacy of the combined therapy of lamivudine (LAM) plus alpha interferon (IFN) and LAM monotherapy in HBeAg negative chronic hepatitis B (CHB) patients who were unresponsive to previous IFN monotherapy, and the incidence of YMDD mutations.


METHODS
Forty-five HBeAg negative patients were enrolled in this study. 24 of these were treated with LAM (100 mg/day, PO, for 24 months) alone (group 1) and 21 with combined therapy (IFN-alpha-2b, 10 MU, tiw, SC, for 6 months plus LAM 100 mg/day, PO, for 24 months) (group 2). Normal alanine aminotransferase values and negativity of HBV DNA (molecular hybridization; Digene, USA) were accepted as treatment response. YMDD variants were analyzed at the end of treatment or when clinical breakthrough was observed (Inno-Lipa Innogenetic kit, Belgium).


RESULTS
End of follow-up response rate was 29.2%, by ITT in group 1, 19% in group 2 (p > 0.05). Histological activity index was statistically decreased by LAM monotherapy as compared to combination therapy. YMDD mutation rates were 59% in group 1, 62.5% in group 2 (p > 0.05).


CONCLUSIONS
Additional IFN-alpha therapy to LAM in HBeAg negative CHB not responding to previous IFN-alpha monotherapy does not increase the response rate compared to LAM monotherapy and does not also decrease the incidence of YMDD mutations.
Akyuz
Filiz
F
(1) Department of Gastroenterohepatology, Istanbul University, Istanbul Medical Faculty. filizakyuz@hotmail.com
Kaymakoglu
Sabahattin
S
Demir
Kadir
K
Aksoy
Nevzat
N
Karaca
Cetin
C
Danalioglu
Ahmet
A
Onel
Derya
D
Badur
Selim
S
Besisik
Fatih
F
Cakaloglu
Yilmaz
Y
Okten
Atilla
A
D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D004279:DNA, Viral / Q000032:analysis; D004359:Drug Therapy, Combination; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood*; D006515:Hepatitis B virus / Q000235:genetics / Q000302:isolation & purification; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D019259:Lamivudine / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009154:Mutation; D011994:Recombinant Proteins
D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D019259:Lamivudine