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The cyclophilin inhibitor Debio 025 combined with PEG IFNalpha2a significantly reduces viral load in treatment-naïve hepatitis C patients.

AbstractUNLABELLED:
The anti-hepatitis C virus (HCV) effect and safety of three different oral doses of the cyclophilin inhibitor Debio 025 in combination with pegylated interferon-alpha2a (PEG IFN-alpha2a) were investigated in a multicenter, randomized, double-blind, placebo-controlled escalating dose-ranging phase II study in treatment-naïve patients with chronic hepatitis C. Doses of 200, 600, and 1,000 mg/day Debio 025 in combination with PEG IFN-alpha2a 180 microg/week for 4 weeks were compared with monotherapy with either 1,000 mg/day Debio 025 or 180 microg/week PEG IFN-alpha2a. In patients with genotypes 1 and 4, the 600- and 1,000-mg combination treatments induced a continuous decay in viral load that reached -4.61 +/- 1.88 and -4.75 +/- 2.19 log(10) IU/mL at week 4, respectively. In patients with genotypes 2 and 3, HCV RNA levels at week 4 were reduced by -5.91 +/- 1.11 and -5.89 +/- 0.43 log(10) IU/mL, respectively, with the same treatment regimens. Adverse events were comparable between treatment groups apart from a higher incidence of neutropenia associated with PEG IFN-alpha2a and an increased incidence of isolated hyperbilirubinemia at the highest dose of Debio 025 (1,000 mg/day).
CONCLUSION:
These results confirm that Debio 025 has a potent activity and an additive effect on HCV RNA reduction in genotype 1 and 4 patients at 600 and 1,000 mg/day when combined with PEG IFN-alpha2a.
AuthorsRobert Flisiak, Saya V Feinman, Maciej Jablkowski, Andrzej Horban, Wieslaw Kryczka, Małgorzata Pawlowska, Jenny E Heathcote, Giuseppe Mazzella, Carmen Vandelli, Valérie Nicolas-Métral, Pierre Grosgurin, Jorge S Liz, Pietro Scalfaro, Hervé Porchet, Raf Crabbé
JournalHepatology (Baltimore, Md.) (Hepatology) Vol. 49 Issue 5 Pg. 1460-8 (May 2009) ISSN: 1527-3350 [Electronic] United States
PMID19353740 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Antiviral Agents
  • Interferon alpha-2
  • Interferon-alpha
  • Recombinant Proteins
  • Polyethylene Glycols
  • Cyclosporine
  • peginterferon alfa-2a
  • alisporivir
Topics
  • Adult
  • Aged
  • Antiviral Agents (therapeutic use)
  • Cyclosporine (administration & dosage, adverse effects)
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Hepatitis C, Chronic (drug therapy)
  • Humans
  • Interferon alpha-2
  • Interferon-alpha (therapeutic use)
  • Male
  • Middle Aged
  • Polyethylene Glycols (therapeutic use)
  • Recombinant Proteins
  • Viral Load
  • Young Adult

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