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

Publication ,  Journal Article
Neumann, AU; Bain, VG; Yoshida, EM; Patel, K; Pulkstenis, E; Subramanian, GM
Published in: Liver Int
October 2009

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.

Duke Scholars

Published In

Liver Int

DOI

EISSN

1478-3231

Publication Date

October 2009

Volume

29

Issue

9

Start / End Page

1350 / 1355

Location

United States

Related Subject Headings

  • Ribavirin
  • Recombinant Proteins
  • RNA, Viral
  • Middle Aged
  • Male
  • Interferon-alpha
  • Interferon alpha-2
  • Insulin Resistance
  • Humans
  • Hepatitis C, Chronic
 

Citation

APA
Chicago
ICMJE
MLA
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Neumann, A. U., Bain, V. G., Yoshida, E. M., Patel, K., Pulkstenis, E., & Subramanian, G. M. (2009). Early prediction of sustained virological response at day 3 of treatment with albinterferon-alpha-2b in patients with genotype 2/3 chronic hepatitis C. Liver Int, 29(9), 1350–1355. https://doi.org/10.1111/j.1478-3231.2009.02005.x
Neumann, Avidan U., Vincent G. Bain, Eric M. Yoshida, Keyur Patel, Erik Pulkstenis, and G Mani Subramanian. “Early prediction of sustained virological response at day 3 of treatment with albinterferon-alpha-2b in patients with genotype 2/3 chronic hepatitis C.Liver Int 29, no. 9 (October 2009): 1350–55. https://doi.org/10.1111/j.1478-3231.2009.02005.x.
Neumann AU, Bain VG, Yoshida EM, Patel K, Pulkstenis E, Subramanian GM. Early prediction of sustained virological response at day 3 of treatment with albinterferon-alpha-2b in patients with genotype 2/3 chronic hepatitis C. Liver Int. 2009 Oct;29(9):1350–5.
Neumann, Avidan U., et al. “Early prediction of sustained virological response at day 3 of treatment with albinterferon-alpha-2b in patients with genotype 2/3 chronic hepatitis C.Liver Int, vol. 29, no. 9, Oct. 2009, pp. 1350–55. Pubmed, doi:10.1111/j.1478-3231.2009.02005.x.
Neumann AU, Bain VG, Yoshida EM, Patel K, Pulkstenis E, Subramanian GM. Early prediction of sustained virological response at day 3 of treatment with albinterferon-alpha-2b in patients with genotype 2/3 chronic hepatitis C. Liver Int. 2009 Oct;29(9):1350–1355.
Journal cover image

Published In

Liver Int

DOI

EISSN

1478-3231

Publication Date

October 2009

Volume

29

Issue

9

Start / End Page

1350 / 1355

Location

United States

Related Subject Headings

  • Ribavirin
  • Recombinant Proteins
  • RNA, Viral
  • Middle Aged
  • Male
  • Interferon-alpha
  • Interferon alpha-2
  • Insulin Resistance
  • Humans
  • Hepatitis C, Chronic