HIV and Hepatitis.com Coverage of the
42nd EASL Conference
April 11 - 15, 2007, Barcelona, Spain
THE EUROPEAN ASSOCIATION FOR THE STUDY OF THE LIVER

HCV-796 Shows Antiviral Activity in Combination with Pegylated Interferon  

By Liz Highleyman

HCV-796 is a non-nucleoside HCV NS5B polymerase inhibitor under development by ViroPharma and Wyeth Pharmaceuticals. When used as monotherapy, it demonstrated antiviral activity against all HCV genotypes.

As reported at the 42nd Annual Meeting of the European Association for the Study of the Liver last month, researchers evaluated the antiviral activity, pharmacokinetics, and safety of HCV-796 when administered with pegylated interferon.

The study included 65 treatment-naive chronic hepatitis C patients, about two-thirds with genotype 1. Participants were randomly assigned to receive oral HCV-796 (100, 250, 500, or 1000 mg) or placebo twice daily for 14 days, in combination with 1.5 mcg/kg pegylated interferon alfa-2b (PegIntron) administered one day before HCV-796 initiation and at Day 7; no subjects received ribavirin.

Results

  • At all doses tested, HCV-796 plus PegIntron reduced plasma HCV viral load more than PegIntron monotherapy.
  • At Day 14, mean HCV RNA reductions were 3.3-3.5 logs in the HCV-796 arms, compared with vs 1.6 logs in the PegIntron monotherapy arm.
  • Among genotype 1 patients, the respective viral load reductions were 2.6-3.2 logs and 1.3 logs.
  • For those with non-1 genotypes, the respective reductions were 3.5-4.8 logs and 2.6 logs.
  • 70%-92% of subjects in the HCV-796 arms achieved viral load reductions of 2 logs or greater at Day 14, compared with 40% of those on interferon monotherapy.
  • 30%-33% of all patients (13%-17% of those with genotype 1) who received HCV-796 doses of 250 mg or higher achieved undetectable HCV RNA (< 50 IU/mL) by Day 14.
  • Pharmacokinetic parameters for HCV-796 administered with PegIntron were generally similar to those observed when HCV-796 was used alone.
  • HCV-796 was generally well tolerated.
  • No dose-limiting side effects related to HCV-796 were observed at any tested dose.

Conclusion

“The combination of HCV-796 and [PegIntron] provides antiviral activity across multiple HCV genotypes that is greater than either agent used alone,” the researchers concluded. “Clinical studies of more long-term administration are needed to determine if these effects are durable.”

ViroPharma Incorporated, Exton, PA; Wyeth Research, Collegeville, PA; Northwest Kinetics, Tacoma, WA; Center For Clinical Trials Research, University of Florida, Gainesville, FL.

05/01/07
Sources

SA Villano, D Raible, D Harper, and others. Antiviral activity of the non-nucleoside polymerase inhibitor, HCV-796, in combination with pegylated inetrferon alfa-2b in treatmen-naive patients with chronic HCV. 42nd Annual Meeting of the European Association for the Study of the Liver. Barcelona, Spain. April 11-15, 2007.

ViroPharma (via PR Newswire). ViroPharma Announces Presentation of Additional HCV-796 Data at Meeting of the European Association for the Study of the Liver. Press release. April 13, 2007.

 

 





























HOME