A randomized controlled trial of pegylated interferon α-2a (40 KD) or interferon α-2a plus ribavirin and amantadine vs interferon α-2a and ribavirin in treatment-naïve patients with chronic hepatitis C

A. Mangia, G. L. Ricci, M. Persico, N. Minerva, V. Carretta, D. Bacca, M. Cela, M. Piattelli, M. Annese, G. Maio, D. Conte, V. Guadagnino, V. Pazienza, D. Festi, F. Spirito, A. Andriulli

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Abstract

We determined whether triple therapy comprising amantadine (AMA), ribavirin (RBV) and either peginterferon (PEG-IFN) α-2a or conventional IFN α-2a would improve sustained virological response (SVR) rates over dual therapy with IFN α-2a and RBV in patients with chronic HCV infection. A total of 362 treatment-naïve patients were randomized to 48 weeks of treatment with: PEG-IFN α-2a 180 μg/week (group A) or IFN α-2a 3 MU tiw (groups B and C). All patients received RBV 1000 or 1200 mg/day and those in groups A and B received AMA 200 mg/day, SVR was defined as an undetectable HCV RNA after 24 weeks of untreated follow-up. At the end of therapy, 74.4% (95% CI 0.66-0.82) of patients in group A were HCV RNA-negative compared with 42.5% (95% CI 0.33-0.50) of those in group B(P = 0.0001) and 48.8% (95% CI 0.40-0.56) of those in group C. SVR was achieved in a significantly greater proportion of patients in group A compared with groups B and C: 65.3% (95% CI 0.53-0.56), 33.3% (95% CI 0.25-0.41) and 44.6% (95% CI 0.36-0.53; P = 0.0001) respectively. In patients with genotype 1. SVR rates were 55.2, 22.8 and 28.8% with the three regimens respectively. Factors independently associated with SVR were HCV genotype 2 or 3, therapy with PEG-IFN, female gender and age. In treatment-naïve patients with chronic hepatitis C, triple therapy with PEG-IFN α-2a. RBV and AMA produces higher SVR than dual or triple therapy with conventional IFN α-2a.

Original languageEnglish
Pages (from-to)292-299
Number of pages8
JournalJournal of Viral Hepatitis
Volume12
Issue number3
DOIs
Publication statusPublished - May 2005

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Amantadine
Ribavirin
Chronic Hepatitis C
Interferons
Randomized Controlled Trials
Therapeutics
Genotype
RNA

Keywords

  • Amantadine
  • Chronic hepatitis C
  • Interferon α-2a
  • Peginterferon α-2a
  • Ribavirin
  • Therapy

ASJC Scopus subject areas

  • Hepatology
  • Virology

Cite this

A randomized controlled trial of pegylated interferon α-2a (40 KD) or interferon α-2a plus ribavirin and amantadine vs interferon α-2a and ribavirin in treatment-naïve patients with chronic hepatitis C. / Mangia, A.; Ricci, G. L.; Persico, M.; Minerva, N.; Carretta, V.; Bacca, D.; Cela, M.; Piattelli, M.; Annese, M.; Maio, G.; Conte, D.; Guadagnino, V.; Pazienza, V.; Festi, D.; Spirito, F.; Andriulli, A.

In: Journal of Viral Hepatitis, Vol. 12, No. 3, 05.2005, p. 292-299.

Research output: Contribution to journalArticle

Mangia, A. ; Ricci, G. L. ; Persico, M. ; Minerva, N. ; Carretta, V. ; Bacca, D. ; Cela, M. ; Piattelli, M. ; Annese, M. ; Maio, G. ; Conte, D. ; Guadagnino, V. ; Pazienza, V. ; Festi, D. ; Spirito, F. ; Andriulli, A. / A randomized controlled trial of pegylated interferon α-2a (40 KD) or interferon α-2a plus ribavirin and amantadine vs interferon α-2a and ribavirin in treatment-naïve patients with chronic hepatitis C. In: Journal of Viral Hepatitis. 2005 ; Vol. 12, No. 3. pp. 292-299.
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abstract = "We determined whether triple therapy comprising amantadine (AMA), ribavirin (RBV) and either peginterferon (PEG-IFN) α-2a or conventional IFN α-2a would improve sustained virological response (SVR) rates over dual therapy with IFN α-2a and RBV in patients with chronic HCV infection. A total of 362 treatment-na{\"i}ve patients were randomized to 48 weeks of treatment with: PEG-IFN α-2a 180 μg/week (group A) or IFN α-2a 3 MU tiw (groups B and C). All patients received RBV 1000 or 1200 mg/day and those in groups A and B received AMA 200 mg/day, SVR was defined as an undetectable HCV RNA after 24 weeks of untreated follow-up. At the end of therapy, 74.4{\%} (95{\%} CI 0.66-0.82) of patients in group A were HCV RNA-negative compared with 42.5{\%} (95{\%} CI 0.33-0.50) of those in group B(P = 0.0001) and 48.8{\%} (95{\%} CI 0.40-0.56) of those in group C. SVR was achieved in a significantly greater proportion of patients in group A compared with groups B and C: 65.3{\%} (95{\%} CI 0.53-0.56), 33.3{\%} (95{\%} CI 0.25-0.41) and 44.6{\%} (95{\%} CI 0.36-0.53; P = 0.0001) respectively. In patients with genotype 1. SVR rates were 55.2, 22.8 and 28.8{\%} with the three regimens respectively. Factors independently associated with SVR were HCV genotype 2 or 3, therapy with PEG-IFN, female gender and age. In treatment-na{\"i}ve patients with chronic hepatitis C, triple therapy with PEG-IFN α-2a. RBV and AMA produces higher SVR than dual or triple therapy with conventional IFN α-2a.",
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T1 - A randomized controlled trial of pegylated interferon α-2a (40 KD) or interferon α-2a plus ribavirin and amantadine vs interferon α-2a and ribavirin in treatment-naïve patients with chronic hepatitis C

AU - Mangia, A.

AU - Ricci, G. L.

AU - Persico, M.

AU - Minerva, N.

AU - Carretta, V.

AU - Bacca, D.

AU - Cela, M.

AU - Piattelli, M.

AU - Annese, M.

AU - Maio, G.

AU - Conte, D.

AU - Guadagnino, V.

AU - Pazienza, V.

AU - Festi, D.

AU - Spirito, F.

AU - Andriulli, A.

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N2 - We determined whether triple therapy comprising amantadine (AMA), ribavirin (RBV) and either peginterferon (PEG-IFN) α-2a or conventional IFN α-2a would improve sustained virological response (SVR) rates over dual therapy with IFN α-2a and RBV in patients with chronic HCV infection. A total of 362 treatment-naïve patients were randomized to 48 weeks of treatment with: PEG-IFN α-2a 180 μg/week (group A) or IFN α-2a 3 MU tiw (groups B and C). All patients received RBV 1000 or 1200 mg/day and those in groups A and B received AMA 200 mg/day, SVR was defined as an undetectable HCV RNA after 24 weeks of untreated follow-up. At the end of therapy, 74.4% (95% CI 0.66-0.82) of patients in group A were HCV RNA-negative compared with 42.5% (95% CI 0.33-0.50) of those in group B(P = 0.0001) and 48.8% (95% CI 0.40-0.56) of those in group C. SVR was achieved in a significantly greater proportion of patients in group A compared with groups B and C: 65.3% (95% CI 0.53-0.56), 33.3% (95% CI 0.25-0.41) and 44.6% (95% CI 0.36-0.53; P = 0.0001) respectively. In patients with genotype 1. SVR rates were 55.2, 22.8 and 28.8% with the three regimens respectively. Factors independently associated with SVR were HCV genotype 2 or 3, therapy with PEG-IFN, female gender and age. In treatment-naïve patients with chronic hepatitis C, triple therapy with PEG-IFN α-2a. RBV and AMA produces higher SVR than dual or triple therapy with conventional IFN α-2a.

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