Peginterferon alfa-2b and ribavirin for 12 vs. 24 weeks in HCV genotype 2 or 3

Alessandra Mangia, Rosanna Santoro, Nicola Minerva, Giovanni L. Ricci, Vito Carretta, Marcello Persico, Francesco Vinelli, Gaetano Scotto, Donato Bacca, Mauro Annese, Mario Romano, Franco Zechini, Fernando Sogari, Fulvio Spirito, Angelo Andriulli

Research output: Contribution to journalArticle

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Abstract

BACKGROUND: We hypothesized that in patients with hepatitis C virus (HCV) genotype 2 or 3 in whom HCV RNA is not detectable after 4 weeks of therapy, 12 weeks of treatment is as effective as 24 weeks. METHODS: A total of 283 patients were randomly assigned to a standard 24-week regimen of peginterferon alfa-2b at a dose of 1.0 μg per kilogram weekly plus ribavirin at a dose of 1000 mg or 1200 mg daily, on the basis of body weight. Of these, 70 patients were assigned to the 24-week regimen (standard-duration group) and 213 patients to a variable regimen (variable-duration group) of 12 or 24 weeks, depending on whether tests for HCV RNA were negative or positive at week 4. The primary end point was HCV that was not detectable by polymerase-chain-reaction (PCR) assay 24 weeks after the completion of therapy. RESULTS: In the standard-duration group, 45 (64 percent) patients had HCV that was not detectable by PCR assay at week 4, as compared with 133 (62 percent) in the variable-duration group (difference [the rate in the standard-duration group minus that in the variable-duration group], 2 percent; 95 percent confidence interval, -11 to 15 percent). Fifty-three patients (76 percent) in the standard-duration group and 164 patients (77 percent) in the variable-duration group had a sustained virologic response (difference, -1 percent; 95 percent confidence interval, -13 to 10 percent). Fewer patients in the variable-duration group receiving the 12-week regimen had adverse events and withdrew than in the group receiving the 24-week regimen (P=0.045). The rate of relapse (defined as HCV not detectable at the end of treatment but detectable at the end of follow-up) was 3.6 percent in the standard-duration group and 8.9 percent in the variable-duration group (P=0.16). Overall, the rate of sustained virologic response was 80 percent among patients with HCV genotype 2 and 66 percent among those with genotype 3 (P

Original languageEnglish
Pages (from-to)2609-2617
Number of pages9
JournalNew England Journal of Medicine
Volume352
Issue number25
DOIs
Publication statusPublished - Jun 23 2005

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Ribavirin
Hepacivirus
Genotype
RNA
Confidence Intervals
peginterferon alfa-2b
Polymerase Chain Reaction
Therapeutics
Body Weight
Recurrence

ASJC Scopus subject areas

  • Medicine(all)

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Peginterferon alfa-2b and ribavirin for 12 vs. 24 weeks in HCV genotype 2 or 3. / Mangia, Alessandra; Santoro, Rosanna; Minerva, Nicola; Ricci, Giovanni L.; Carretta, Vito; Persico, Marcello; Vinelli, Francesco; Scotto, Gaetano; Bacca, Donato; Annese, Mauro; Romano, Mario; Zechini, Franco; Sogari, Fernando; Spirito, Fulvio; Andriulli, Angelo.

In: New England Journal of Medicine, Vol. 352, No. 25, 23.06.2005, p. 2609-2617.

Research output: Contribution to journalArticle

Mangia, A, Santoro, R, Minerva, N, Ricci, GL, Carretta, V, Persico, M, Vinelli, F, Scotto, G, Bacca, D, Annese, M, Romano, M, Zechini, F, Sogari, F, Spirito, F & Andriulli, A 2005, 'Peginterferon alfa-2b and ribavirin for 12 vs. 24 weeks in HCV genotype 2 or 3', New England Journal of Medicine, vol. 352, no. 25, pp. 2609-2617. https://doi.org/10.1056/NEJMoa042608
Mangia, Alessandra ; Santoro, Rosanna ; Minerva, Nicola ; Ricci, Giovanni L. ; Carretta, Vito ; Persico, Marcello ; Vinelli, Francesco ; Scotto, Gaetano ; Bacca, Donato ; Annese, Mauro ; Romano, Mario ; Zechini, Franco ; Sogari, Fernando ; Spirito, Fulvio ; Andriulli, Angelo. / Peginterferon alfa-2b and ribavirin for 12 vs. 24 weeks in HCV genotype 2 or 3. In: New England Journal of Medicine. 2005 ; Vol. 352, No. 25. pp. 2609-2617.
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AU - Santoro, Rosanna

AU - Minerva, Nicola

AU - Ricci, Giovanni L.

AU - Carretta, Vito

AU - Persico, Marcello

AU - Vinelli, Francesco

AU - Scotto, Gaetano

AU - Bacca, Donato

AU - Annese, Mauro

AU - Romano, Mario

AU - Zechini, Franco

AU - Sogari, Fernando

AU - Spirito, Fulvio

AU - Andriulli, Angelo

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