Predicting sustained virological responses in chronic hepatitis C patients treated with peginterferon alfa-2a (40 KD)/ribavirin

• Published in: Journal of hepatology Vol. 43; no. 3; pp. 425 - 433
• Main Authors: Ferenci, Peter, Fried, Michael W., Shiffman, Mitchell L., Smith, Coleman I., Marinos, George, Gonçales, Fernando L., Häussinger, Dieter, Diago, Moises, Carosi, Giampero, Dhumeaux, Daniel, Craxì, Antonio, Chaneac, Monique, Reddy, K. Rajender
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier B.V 01.09.2005; Elsevier
• Subjects: Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiviral agents; Antiviral Agents - therapeutic use; Biological and medical sciences; Chronic hepatitis C; Dose-Response Relationship, Drug; Drug Therapy, Combination; Hepatitis B virus - drug effects; Hepatitis C, Chronic - drug therapy; Human viral diseases; Humans; Immunomodulators; Infectious diseases; Interferon-alpha - therapeutic use; Medical sciences; Peginterferon alfa-2a (40 KD); Pharmacology. Drug treatments; Polyethylene Glycols - therapeutic use; Predictability; Probability; Recombinant Proteins; Retrospective Studies; Ribavirin; Ribavirin - therapeutic use; RNA, Viral - analysis; Sustained virological response; Treatment; Treatment Outcome; Viral diseases; Viral hepatitis; Viral Load; Viral hepatitis; Chronic hepatitis C; Treatment; Predictability; Peginterferon alfa-2a (40 KD); Sustained virological response; Ribavirin; Antineoplastic agent; Human; Cytokine; Hepatic disease; Infection; Immunomodulator; Interferon alpha 2a; Peginterferon alfa-2a; Viral disease; Digestive diseases; Antiviral; Pegylated form; Viral hepatitis C
• ISSN: 0168-8278; 1600-0641
• DOI: 10.1016/j.jhep.2005.04.009

Prediction of sustained virological response (SVR) during treatment would allow clinicians to identify patients most likely to benefit from therapy. Retrospective analysis of data from 1121 adults with chronic hepatitis C treated for 48 weeks with peginterferon alfa-2a (40 KD) 180 μg/week plus placebo or ribavirin (1000/1200 mg/day), or interferon alfa-2b 3 MIU three times/week plus ribavirin in a randomized, multinational, study. 67% of patients treated with peginterferon alfa-2a (40 KD)/ribavirin with early virological responses (HCV RNA negative or ≥2 log 10 decrease) at week 12 had SVRs at week 72 (HCV RNA <50 IU/mL). The negative predictive value (NPV) was 97%. The probability of an SVR increased with the rapidity of HCV RNA suppression. The highest SVR rates were achieved in patients with rapid virological responses at week 4, but the corresponding NPV (74%) is too low for a decision criterion. In patients with early virological responses by week 12, the SVR rate was ≈20% lower in those who received <80% compared with patients who received ≥80% of the planned ribavirin dose. Early, sustained suppression of HCV replication portends an SVR. Cessation of treatment may be contemplated in patients without a ≥2 log 10 reduction in HCV RNA after 12 weeks.