Prognostic factors and early predictability of sustained viral response with peginterferon alfa-2a (40KD)

• Published in: Journal of hepatology Vol. 37; no. 4; pp. 500 - 506
• Main Authors: Lee, Samuel S, Heathcote, E.Jenny, Reddy, K.Rajender, Zeuzem, Stefan, Fried, Michael W, Wright, Teresa L, Pockros, Paul J, Häussinger, Dieter, Smith, Coleman I, Lin, Amy, Pappas, Stephen C
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier B.V 01.10.2002; Elsevier
• Subjects: Adult; Antiviral Agents - administration & dosage; Biological and medical sciences; Female; Genotype; Hepacivirus - genetics; Hepacivirus - growth & development; Hepatitis C; Hepatitis C virus RNA; Hepatitis C, Chronic - diagnosis; Hepatitis C, Chronic - drug therapy; Hepatitis C, Chronic - virology; Humans; Immunomodulators; Interferon alfa-2a; Interferon alpha-2; Interferon-alpha - administration & dosage; Male; Medical sciences; Peginterferon alfa-2a (40KD); Pegylated interferon; Pharmacology. Drug treatments; Polyethylene Glycols - administration & dosage; Predictability; Predictive Value of Tests; Prognosis; Prognostic factors; Recombinant Proteins; RNA, Viral - analysis; Viral kinetics; Virus Replication - drug effects; Interferon alfa-2a; Hepatitis C virus RNA; Viral kinetics; Pegylated interferon; Predictability; Peginterferon alfa-2a (40KD); Hepatitis C; Prognostic factors; Human; Viremia; Treatment efficiency; Hepatic disease; Peginterferon; Infection; Chronic; Decrease; Immunotherapy; Viral disease; Treatment withdrawal; Digestive diseases; Interferon; Predictive factor; Viral hepatitis C
• ISSN: 0168-8278; 1600-0641
• DOI: 10.1016/S0168-8278(02)00211-8

Background/Aims: Baseline factors and early decline in serum hepatitis C virus RNA are predictive of sustained virological response to interferon therapy in patients with chronic hepatitis C. We evaluated the prognostic value of baseline factors and early viral RNA among patients treated with peginterferon alfa-2a (40KD). Methods: Data were pooled from three randomized trials involving 814 patients treated with peginterferon alfa-2a (40KD) (90, 135, or 180 μg). Stepwise and multiple logistic regression identified independent baseline factors associated with response. Receiver operating characteristic curves for both absolute values and log 10 decline in viral RNA at 4, 8, 12 and 24 weeks of therapy were created. Results: Independent prognostic factors for sustained virological response included viral genotype non-1, low pretreatment viral load, age (<40 years), no cirrhosis and body weight (<85 kg). In addition, alanine aminotransferase quotient (>3) and histological activity index score (>10) were also independently prognostic. Receiver operating characteristic curves showed that detectable or less than 2-log 10 decline in viral RNA at week 12 predicted sustained virological non-response (negative predictive value is 98%). Conclusions: In patients with chronic hepatitis C treated with peginterferon alfa-2a (40KD), the decision to continue or stop treatment can be made as early as week 12.