Boceprevir plus peginterferon/ribavirin for treatment of chronic hepatitis C in Russia

Abstract

Author contributions: Isakov V, Long J, Wahl J and Helmand FA designed the study; Isakov V, Nikitin I, Chulano V and Ogurtsov P enrolled patients; Isakov V, Lukyanova E, Long J and Helmand FA analyzed the data; Isakov V and Helmand FA wrote the first draft; all authors critically reviewed and approved the final draft of the paper.Supported by Merck & Co., Inc., Kenilworth, NJ, United States. Institutional review board statement:The protocol P08160 of the study registered at ClinicalTrials.gov with identifier NCT01425203 presented in the manuscript of Isakov V et al "Boceprevir plus peginterferon/ribavirin for treatment of chronic hepatitis C in Russia" was reviewed and approved by the Institute of Nutrition (Moscow, Russia) Institutional Review Board.Clinical trial registration statement: Protocol P08160 (The Effect of Boceprevir in Russian Participants Diagnosed with Chronic Hepatitis C Genotype 1) is registered at ClinicalTrials. gov (Identifier: NCT01425203).Informed consent statement: All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008. Informed consent was obtained from all patients included in the study.Conflict-of-interest statement: Isakov V has received research/ grant support from MSD, has served as a board member and or consultant for Abbvie, Vertex, Roche, Novartis, Janssen, and BristolMyers Squibb; has served on speakers' bureaus for BristolMyers Squibb, Janssen, Roche, and Novartis; and has received travel funding from BristolMyers Squibb and MSD Russia. Chulanov V has served on advisory boards for Roche, BristolMyers Squibb, Janssen, Novartis, and MSD Russia; has received research grants from BristolMyers Squibb; and has served on speakers' bureaus for BristolMyers Squibb, Roche, Janssen, Novartis, Gilead, AbbVie, and MSD. Ogurtsov P has served on advisory boards for ScheringPlough and delivered lectures on behalf of Abbott, Solvay, PRO.MED.CS Praha a.s., and Veropharm. Nikitin I has nothing to disclose. Lukyanova E, Long J, Wahl J and Helmond FA are current employees of Merck & Co., Inc., Kenilworth, NJ, United States. Abstract AIM: to evaluate addition of boceprevir to peginterferon/ribavirin (PR) in Russian patients with chronic hepatitis C virus (HCV).METHODS: treatment-naive (tN) and treatmentexperienced (tE) patients (who had failed prior treatment with PR for ≥ 12 wk) with chronic HCV genotype 1 infection were enrolled in this placebocontrolled, double-blind study. All patients initially received PR for 4 wk. Patients randomized to control treatment then received PR for an additional 44 wk. tN patients randomized to triple therapy received boceprevir (800 mg three times daily) plus PR for 24 wk and then further therapy according to treatment week 8 (tW8) HCV RNA levels. tE patients received boceprevir plus PR for 32 wk and then further therapy according to tW8 HCV RNA levels. treatment was discontinued for tN patients with detecta...

Acute Hepatitis C Virus Infection and Directly Acting Anti-Hepatitis C Virus Drugs

“…In the third study, boceprevir was added to peginterferon and ribavirin with 78% SVR rate [25]. The intolerability of the three combined drugs, the discouraging results, along with the high relapse rates determined on follow-up, was disappointing.…”