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

Journal Article

BACKGROUND: 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). AIMS: To assess the association of initial viral kinetics during albIFN therapy with baseline factors and SVR prediction. METHODS: 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. RESULTS: 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 <4.2 log(10) IU/ml or first-phase decline >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). CONCLUSIONS: First-phase viral decline with albIFN/RBV was predictive of SVR in this study and may be modulated in part by IR.

Full Text

Duke Authors

Cited Authors

  • Neumann, AU; Bain, VG; Yoshida, EM; Patel, K; Pulkstenis, E; Subramanian, GM

Published Date

  • October 2009

Published In

Volume / Issue

  • 29 / 9

Start / End Page

  • 1350 - 1355

PubMed ID

  • 19291180

Pubmed Central ID

  • 19291180

Electronic International Standard Serial Number (EISSN)

  • 1478-3231

Digital Object Identifier (DOI)

  • 10.1111/j.1478-3231.2009.02005.x

Language

  • eng

Conference Location

  • United States