TY - JOUR
T1 - Lamivudine and 24 weeks of lamivudine/interferon combination therapy for hepatitis B e antigen-positive chronic hepatitis B in interferon nonresponders
AU - Schiff, Eugene R.
AU - Dienstag, Jules L.
AU - Karayalcin, Selim
AU - Grimm, Ian S.
AU - Perrillo, Robert P.
AU - Husa, Petr
AU - De Man, R. A.
AU - Goodman, Zachary
AU - Condreay, Lynn D.
AU - Crowther, Lynn M.
AU - Woessner, Mary A.
AU - McPhillips, Penny J.
AU - Brown, Nathaniel A.
PY - 2003/6/1
Y1 - 2003/6/1
N2 - Background/Aims: Lamivudine is effective in treatment-naive patients with chronic hepatitis B, but its role in interferon nonresponders has not been described. We assessed lamivudine treatment, with or without added interferon, in patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B who had failed interferon therapy previously. Methods: Patients were randomized to lamivudine (100 mg) or placebo for 52 weeks or to a 24-week regimen of lamivudine plus interferon. Primary treatment comparisons were at week 52, with a 16-week posttreatment follow-up period. Measurements included histology (primary endpoint), HBeAg response, normalization of alanine aminotransferase, reduction of hepatitis B virus (HBV) DNA, and safety. Results: Among 238 patients, histologic response was significantly more common in patients treated with lamivudine (52 versus placebo 25%, P = 0.002) or the combination regimen (32%, P = 0.01). HBeAg loss was also more common with lamivudine (33 versus 13 versus 21%), as were virologic and alanine aminotransferase responses. Among 28 subjects with HBeAg loss/seroconversion, 71% had durable responses 16 weeks posttreatment. Conclusions: Lamivudine for 52 weeks is as effective in interferon nonresponders as in previously reported treatment-naive patients; however, a combination of lamivudine for 24 weeks and interferon for 16 weeks was not effective in this population.
AB - Background/Aims: Lamivudine is effective in treatment-naive patients with chronic hepatitis B, but its role in interferon nonresponders has not been described. We assessed lamivudine treatment, with or without added interferon, in patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B who had failed interferon therapy previously. Methods: Patients were randomized to lamivudine (100 mg) or placebo for 52 weeks or to a 24-week regimen of lamivudine plus interferon. Primary treatment comparisons were at week 52, with a 16-week posttreatment follow-up period. Measurements included histology (primary endpoint), HBeAg response, normalization of alanine aminotransferase, reduction of hepatitis B virus (HBV) DNA, and safety. Results: Among 238 patients, histologic response was significantly more common in patients treated with lamivudine (52 versus placebo 25%, P = 0.002) or the combination regimen (32%, P = 0.01). HBeAg loss was also more common with lamivudine (33 versus 13 versus 21%), as were virologic and alanine aminotransferase responses. Among 28 subjects with HBeAg loss/seroconversion, 71% had durable responses 16 weeks posttreatment. Conclusions: Lamivudine for 52 weeks is as effective in interferon nonresponders as in previously reported treatment-naive patients; however, a combination of lamivudine for 24 weeks and interferon for 16 weeks was not effective in this population.
KW - Chronic hepatitis
KW - Hepatitis B
KW - Hepatitis B e antigen
KW - Interferon
KW - Interferon nonresponder
KW - Lamivudine
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U2 - 10.1016/S0168-8278(03)00076-X
DO - 10.1016/S0168-8278(03)00076-X
M3 - Article
C2 - 12763376
AN - SCOPUS:0038025291
VL - 38
SP - 818
EP - 826
JO - Journal of Hepatology
JF - Journal of Hepatology
SN - 0168-8278
IS - 6
ER -