Early prediction of sustained virological response at day 3 of treatment with albinterferon-alpha-2b in patients with genotype 2/3 chronic hepatitis C

• Published in: Liver international 2009-10, Vol.29 (9), p.1350-1355
• Main Authors: Neumann, Avidan U, Bain, Vincent G, Yoshida, Eric M, Patel, Keyur, Pulkstenis, Erik, Subramanian, G Mani
• Format: Article
• Language: English
• Subjects: Adult; Albumins - administration & dosage; Antiviral Agents - administration & dosage; Female; Genotype; Hepacivirus - classification; Hepatitis C, Chronic - drug therapy; Hepatitis C, Chronic - virology; Humans; Insulin Resistance; Interferon-alpha - administration & dosage; Male; Middle Aged; Recombinant Proteins; Ribavirin - administration & dosage; RNA, Viral - analysis
• ISSN: 1478-3231
• DOI: 10.1111/j.1478-3231.2009.02005.x

Albinterferon-alpha-2b (albIFN) is a long-acting fusion polypeptide composed of albumin and IFN-alpha-2b. In a phase 2 study of albIFN 1500 mug q2wk or q4wk in patients with genotype 2/3 chronic hepatitis C, albIFN demonstrated sustained virological response (SVR) rates of 62-77% (intent-to-treat population). To assess the association of initial viral kinetics during albIFN therapy with baseline factors and SVR prediction. In all, 43 patients were treated with albIFN 1500 mug (q2wk/q4wk) plus ribavirin (RBV) 800 mg/day for 24 weeks. Hepatitis C virus (HCV)-RNA levels were measured by real-time polymerase chain reaction, insulin resistance by homeostasis model assessment of insulin resistance (HOMA-IR) and serum albIFN levels by enyzme-linked immunosorbent assay. Prediction analysis was performed in a per protocol 28-patient subset who were > or =80% adherent to albIFN/RBV and had HCV-RNA levels measured at treatment day 3. Day-3 HCV-RNA level and first-phase viral decline as well as second-phase slope of viral decline were significantly associated with SVR. In adherent patients, 82.1% had a day-3 viral load 1.25 log(10) IU/ml, which was predictive of SVR, both positively (95.7%; sensitivity: 100%) and negatively (100%; specificity: 83.3%). As low first-phase decline was associated with a high pretreatment HOMA-IR index (P=0.004) and a low day-3 serum albIFN level (P=0.01). First-phase viral decline with albIFN/RBV was predictive of SVR in this study and may be modulated in part by IR.