[Sequential combination therapy with prednisone, lamivudine and interferon alfa-2b for HBeAg-positive chronic hepatitis B].
BACKGROUND
Despite the development of potent, new antiviral drugs, the percentage of HBeAg seroconversion is approximately 35%. Immunosuppression before antiviral administration has recently been investigated with contradictory results. We evaluated the safety and efficacy of lamivudine and interferon alfa-2b with prior immunosuppression with prednisone in patients with HBeAg-positive chronic hepatitis B (CHB).


METHODS
A randomized controlled study was conducted in a sample of 44 patients with HBeAg-positive CHB and persistently elevated alanine transferase (ALT) levels. The patients were distributed into two groups: 22 patients received prednisone 40 mg daily for 4 weeks, followed by 2 weeks without treatment, and lamivudine 150 mg daily for 4 weeks; lamivudine plus interferon alfa 2b (10 MIU every other day) was then administered for 24 weeks followed by continuous lamivudine 150 mg daily to complete 58 weeks. A further 22 patients received the same treatment regimen and duration, but without prednisone.


RESULTS
Virologic response defined as HBeAg seroconversion plus a decrease of serum HBV DNA < 105 copies/ml 24 weeks after concluding the treatment was observed in 68% of the patients receiving previous immunosuppression compared with 54% of the control group (p = 0.26). Forty-five percent of patients with prednisone priming showed histologic improvement compared with 23% of the control group (p = 0.10). A significant proportion of patient with previous immunosuppression showed improvement in necroinflammatory activity (45% vs 23%) and fibrosis (50 vs 23%) compared with the control group.


CONCLUSIONS
Virologic response was clinically, but not statistically, superior in the group with prednisone priming. Histologic improvement was notable in the group with previous immunosuppression.
Vilar Gómez
Eduardo
E
Servicio de Hepatología. Instituto Nacional de Gastroenterología. La Habana. Cuba.
Grá Oramas
Bienvenido
B
Arús Soler
Enrique
E
Ruenes Domech
Caridad
C
Dávila González
Yudith
Y
D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use*; D006513:Hepatitis B e Antigens / Q000097:blood; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D007165:Immunosuppression Therapy; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000627:therapeutic use*; D011994:Recombinant Proteins
D000998:Antiviral Agents; D005938:Glucocorticoids; D006513:Hepatitis B e Antigens; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D019259:Lamivudine; D011241:Prednisone