Treatment of chronic hepatitis B with the sequential administration of interferon and lamivudine.
OBJECTIVE
Interferon monotherapy has been shown to induce a sustained viral response in 30-40% of patients with HbeAg-positive chronic hepatitis B infection. Similarly, lamivudine monotherapy causes HBeAg seroconversion in less than 20% of patients treated for one year. This study aims to assess the efficacy and safety of the sequential administration of interferon alfa-2a plus lamivudine to patients with chronic hepatitis B in comparison to lamivudine monotherapy.


METHODS
Sixty-one patients with HbeAg-positive chronic hepatitis B infection and raised ALT were randomized to receive either interferon Alfa-2a, 4.5 million units daily for 16 weeks plus lamivudine 100 mg daily starting from week 5 and continuing for 48 weeks (Group A, n = 32) or lamivudine monotherapy for 48 weeks (Group B; n = 29). Patients were followed for 48 weeks after completion of therapy.


RESULTS
HBeAg seroconversion to anti-HB +ve was observed in 2 (6.2%) patients in Group A. Both patients remained HBeAg negative and HBV-DNA negative throughout the follow-up phase. None of the group B patients seroconverted at the end of therapy or during follow-up (P = NS). All group A patients experienced at least one side effect and as a result, one dropped out. All group B patients completed the study without side effects.


CONCLUSIONS
The sequential administration of interferon plus lamivudine was not superior to lamivudine monotherapy for the treatment of chronic hepatitis B and was associated with more side effects.
Hasan
Fuad
F
Department of Medicine, Faculty of Medicine, Kuwait University, P.O. Box 24923, Safat 13110, Kuwait. fuad@hsc.kuniv.edu.kw
al-Khaldi
Jameela
J
Asker
Haifa
H
Varghese
Rosh
R
Siddique
Iqbal
I
al-Shammali
Mohammed
M
al-Kalaoui
Maher
M
al-Nakib
Basil
B
D000293:Adolescent; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004279:DNA, Viral / Q000097:blood; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006510:Hepatitis B Antibodies / Q000097:blood; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000235:genetics / Q000276:immunology; D019694:Hepatitis B, Chronic / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D019259:Lamivudine / Q000008:administration & dosage* / Q000009:adverse effects; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D016896:Treatment Outcome
D000998:Antiviral Agents; D004279:DNA, Viral; D006510:Hepatitis B Antibodies; D006513:Hepatitis B e Antigens; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D019259:Lamivudine