Positive and negative prediction of sustained virologic response at weeks 2 and 4 of treatment with albinterferon alfa-2b or peginterferon alfa-2a in treatment-naïve patients with genotype 1, chronic hepatitis C

Avidan U. Neumann, Stephen Pianko, Stefan Zeuzem, Eric M. Yoshida, Yves Benhamou, Moshe Mishan, John G. McHutchison, Erik Pulkstenis, G. Mani Subramanian

Research output: Contribution to journalArticle

Abstract

Background/Aims: Albinterferon alfa-2b is a novel, long-acting, fusion polypeptide that is dosed q2wk or q4wk. The predictive value of early virologic response during albinterferon alfa-2b or peginterferon alfa-2a treatment was investigated in interferon-naïve patients with genotype 1, chronic hepatitis C. Methods: Four hundred and fifty-eight patients were randomized to: albinterferon 900 or 1200 μg q2wk, or 1200 μg q4wk, or peginterferon 180 μg qwk. HCV RNA was measured by real-time PCR. A linear exhaustive search algorithm was used to determine the best SVR prediction algorithm in the per-protocol population (n = 368), with inclusion of key ITT analyses to assess impact. Results: SVR rate: 54-67% (P = NS between arms). Rapid initial virologic response rate at week 2 (RIVR; viral decline >2 log10 IU/mL) was 32-50% and gave rise to positive predictive value of 88-97% for SVR. No initial virologic response at week 4 (NIVR; viral decline 10 IU/mL; viral load >5.5 log10 IU/mL) demonstrated a 100% negative predictive value for SVR. A sequential prediction algorithm based on viral kinetics at weeks 2 and 4 identified four prediction groups that reliably predicted SVR, positively or negatively, in 65-72% of patients. Conclusions: Improved SVR prediction was obtained by integrating absolute levels and reduction of HCV RNA at treatment week 2 and 4. Patients with RIVR had a high likelihood of achieving SVR.

Original languageEnglish (US)
Pages (from-to)21-28
Number of pages8
JournalJournal of Hepatology
Volume51
Issue number1
DOIs
Publication statusPublished - Jul 2009
Externally publishedYes

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Keywords

  • albIFN
  • Albinterferon alfa-2b
  • CHC
  • Chronic hepatitis C
  • HCV
  • Hepatitis C virus
  • Peginterferon
  • Sustained virologic response
  • SVR

ASJC Scopus subject areas

  • Hepatology

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