Background: An early virological response to interferon-alpha treatment is a strong predictor of sustained response, but it has never been exploited to stratify patients in clinical trials. Aim: To evaluate the efficacy of amantadine plus interferon-a compared with interferon-alpha alone in naive patients with chronic hepatitis C who were randomized on the basis of the early virological response to interferon-alpha. Methods: One hundred and eighty-one patients received recombinant interferon-alpha2a (3 MU three times weekly) for 2 months and 164 were evaluated for early (i.e. month 2) virological response. Hepatitis C virus (HCV) RNA-negative patients (n = 66) were randomized to receive 3 MU of interferon-alpha three times weekly, with or without amantadine (200 mg/day); HCV RNA-positive patients (n = 98) were randomized to receive 6 MU of interferon-alpha three times weekly, with or without amantadine (200 mg/day). HCV RNA-positive patients at 6 months discontinued treatment, and all others completed 12 months. Results: At month 6, HCV RNA-negative patients made up 54.2% of the interferon + amantadine group and 42.0% of the monotherapy group (P = 0.07). At month 12, HCV RNA-negative patients made up 38.5% of the interferon + amantadine group and 28.4% of the monotherapy group (N.S.). The sustained virological response rates were 21.6% and 20.9%, respectively (N.S.). Conclusion: The addition of amantadine does not enhance the sustained virological response to interferon-a in naive patients with chronic hepatitis C; however, an additive effect of amantadine occurs in the first 6 months, mainly in patients without an early response to monotherapy. Early response to interferon-alpha is a strong predictor of sustained virological response.

Angelico, M., Cepparulo, M., Angelico, F., Francioso, S., Barlattani, A., Di Candilo, F., et al. (2004). A randomized controlled trial of amantadine plus interferon-alpha 2a vs. interferon-alpha 2a alone in naive patients with chronic hepatitis C randomized according to the early virological response to interferon-alpha 2a monotherapy. ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 19(3), 339-347 [10.1111/j.1365-2036.2004.01843.x].

A randomized controlled trial of amantadine plus interferon-alpha 2a vs. interferon-alpha 2a alone in naive patients with chronic hepatitis C randomized according to the early virological response to interferon-alpha 2a monotherapy

ANGELICO, MARIO;BARLATTANI, ALBERTA;
2004

Abstract

Background: An early virological response to interferon-alpha treatment is a strong predictor of sustained response, but it has never been exploited to stratify patients in clinical trials. Aim: To evaluate the efficacy of amantadine plus interferon-a compared with interferon-alpha alone in naive patients with chronic hepatitis C who were randomized on the basis of the early virological response to interferon-alpha. Methods: One hundred and eighty-one patients received recombinant interferon-alpha2a (3 MU three times weekly) for 2 months and 164 were evaluated for early (i.e. month 2) virological response. Hepatitis C virus (HCV) RNA-negative patients (n = 66) were randomized to receive 3 MU of interferon-alpha three times weekly, with or without amantadine (200 mg/day); HCV RNA-positive patients (n = 98) were randomized to receive 6 MU of interferon-alpha three times weekly, with or without amantadine (200 mg/day). HCV RNA-positive patients at 6 months discontinued treatment, and all others completed 12 months. Results: At month 6, HCV RNA-negative patients made up 54.2% of the interferon + amantadine group and 42.0% of the monotherapy group (P = 0.07). At month 12, HCV RNA-negative patients made up 38.5% of the interferon + amantadine group and 28.4% of the monotherapy group (N.S.). The sustained virological response rates were 21.6% and 20.9%, respectively (N.S.). Conclusion: The addition of amantadine does not enhance the sustained virological response to interferon-a in naive patients with chronic hepatitis C; however, an additive effect of amantadine occurs in the first 6 months, mainly in patients without an early response to monotherapy. Early response to interferon-alpha is a strong predictor of sustained virological response.
Pubblicato
Rilevanza internazionale
Articolo
Sì, ma tipo non specificato
Settore MED/12 - Gastroenterologia
English
Con Impact Factor ISI
amantadine; recombinant alpha2a interferon; virus RNA; adult; aged; anemia; article; chronic hepatitis; clinical trial; controlled clinical trial; controlled study; depression; drug efficacy; drug safety; female; flu like syndrome; hepatitis C; Hepatitis C virus; human; human tissue; insomnia; irritability; major clinical study; male; neutropenia; priority journal; randomized controlled trial; side effect; virology; Adolescent; Adult; Aged; Amantadine; Antiviral Agents; Drug Combinations; Female; Hepatitis C, Chronic; Humans; Interferon Alfa-2a; Interferon Alfa-2b; Male; Middle Aged; Treatment Outcome
Angelico, M., Cepparulo, M., Angelico, F., Francioso, S., Barlattani, A., Di Candilo, F., et al. (2004). A randomized controlled trial of amantadine plus interferon-alpha 2a vs. interferon-alpha 2a alone in naive patients with chronic hepatitis C randomized according to the early virological response to interferon-alpha 2a monotherapy. ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 19(3), 339-347 [10.1111/j.1365-2036.2004.01843.x].
Angelico, M; Cepparulo, M; Angelico, F; Francioso, S; Barlattani, A; Di Candilo, F; Della Vecchiai, R; Demelia, L; De Sanctis, G; Gentile, S; Grieco, A; Parruti, G; Sabusco, G; Tarquini, L; Tosti, A; Zaru, S
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2108/29708
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