TY - JOUR
T1 - Combination therapy with amantadine and interferon in naïve patients with chronic hepatitis C
T2 - Meta-analysis of individual patient data from six clinical trials
AU - Mangia, Alessandra
AU - Leandro, Gioacchino
AU - Helbling, Beat
AU - Renner, Eberhard L.
AU - Tabone, Marco
AU - Sidoli, Laura
AU - Caronia, Simona
AU - Foster, Graham R.
AU - Zeuzem, Stephan
AU - Berg, Thomas
AU - Di Marco, Vito
AU - Cino, Nicolina
AU - Andriulli, Angelo
PY - 2004/3
Y1 - 2004/3
N2 - Background/Aims: In chronic hepatitis C, clinical trials evaluating the efficacy of amantadine (AMA) and interferon (INF) compared to INF monotherapy, have produced conflicting results. We performed a meta-analysis of the individual patient's data from previous studies. Methods: Nine hundred and seventy-two patients from six European centres were evaluated by means of individual patient meta-analysis, using mixed models with centres and the centre-treatment interaction fitted as random variables. Results: At the end of therapy, virological responses were 38.5% (95% CI 34.1-42.8) after INF and AMA, and 29.5% (95% CI 25.5-33.6) after INF alone (P=0.003). Sustained response occurred in 111 (23.1%; 95% CI 19.3-20.2) and 85 patients (17.3%; 95% CI 14.0-20.7), respectively (P=0.03). Even accounting for the centre effect, therapy with AMA and INF was more effective than IFN alone (P=0.029). When genotypes and viraemia levels were combined, the response rate after combination therapy doubled that observed with IFN alone in all subgroups, except those with low viraemia and genotypes 2 or 3. Conclusions: In chronic hepatitis C, therapy with AMA and INF is effective and may be an alternative to INF and ribavirin in patients who cannot tolerate ribavirin.
AB - Background/Aims: In chronic hepatitis C, clinical trials evaluating the efficacy of amantadine (AMA) and interferon (INF) compared to INF monotherapy, have produced conflicting results. We performed a meta-analysis of the individual patient's data from previous studies. Methods: Nine hundred and seventy-two patients from six European centres were evaluated by means of individual patient meta-analysis, using mixed models with centres and the centre-treatment interaction fitted as random variables. Results: At the end of therapy, virological responses were 38.5% (95% CI 34.1-42.8) after INF and AMA, and 29.5% (95% CI 25.5-33.6) after INF alone (P=0.003). Sustained response occurred in 111 (23.1%; 95% CI 19.3-20.2) and 85 patients (17.3%; 95% CI 14.0-20.7), respectively (P=0.03). Even accounting for the centre effect, therapy with AMA and INF was more effective than IFN alone (P=0.029). When genotypes and viraemia levels were combined, the response rate after combination therapy doubled that observed with IFN alone in all subgroups, except those with low viraemia and genotypes 2 or 3. Conclusions: In chronic hepatitis C, therapy with AMA and INF is effective and may be an alternative to INF and ribavirin in patients who cannot tolerate ribavirin.
KW - Amantadine
KW - Chronic hepatitis C
KW - Interferon
KW - Meta-analysis
KW - Randomized clinical trials
KW - Therapy
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U2 - 10.1016/j.jhep.2003.11.002
DO - 10.1016/j.jhep.2003.11.002
M3 - Article
C2 - 15123363
AN - SCOPUS:10744224044
VL - 40
SP - 478
EP - 483
JO - Journal of Hepatology
JF - Journal of Hepatology
SN - 0168-8278
IS - 3
ER -