Abstract
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.
| Original language | English |
|---|---|
| Pages (from-to) | 478-483 |
| Number of pages | 6 |
| Journal | Journal of Hepatology |
| Volume | 40 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Mar 2004 |
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Keywords
- Amantadine
- Chronic hepatitis C
- Interferon
- Meta-analysis
- Randomized clinical trials
- Therapy
ASJC Scopus subject areas
- Gastroenterology
Cite this
Combination therapy with amantadine and interferon in naïve patients with chronic hepatitis C : Meta-analysis of individual patient data from six clinical trials. / Mangia, Alessandra; Leandro, Gioacchino; Helbling, Beat; Renner, Eberhard L.; Tabone, Marco; Sidoli, Laura; Caronia, Simona; Foster, Graham R.; Zeuzem, Stephan; Berg, Thomas; Di Marco, Vito; Cino, Nicolina; Andriulli, Angelo.
In: Journal of Hepatology, Vol. 40, No. 3, 03.2004, p. 478-483.Research output: Contribution to journal › Article
}
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
UR - http://www.scopus.com/inward/record.url?scp=10744224044&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=10744224044&partnerID=8YFLogxK
U2 - 10.1016/j.jhep.2003.11.002
DO - 10.1016/j.jhep.2003.11.002
M3 - Article
VL - 40
SP - 478
EP - 483
JO - Journal of Hepatology
JF - Journal of Hepatology
SN - 0168-8278
IS - 3
ER -