Boceprevir or Telaprevir Based Triple Therapy against Chronic Hepatitis C in HIV Coinfection: Real-Life Safety and Efficacy

PLoS One. 2015 Apr 29;10(4):e0125080. doi: 10.1371/journal.pone.0125080. eCollection 2015.

Abstract

Background and aims: Clinical trials of therapy against chronic hepatitis C virus (HCV) infection including boceprevir (BOC) or telaprevir (TVR) plus pegylated interferon and ribavirin (PR) have reported considerably higher response rates than those achieved with PR alone. This study sought to evaluate the efficacy and safety of triple therapy including BOC or TVR in combination with PR in HIV/HCV-coinfected patients under real-life conditions.

Methods: In a multicentre study conducted in 24 sites throughout five European countries, all HIV/HCV-coinfected patients who initiated a combination of BOC or TVR plus PR and who had at least 60 weeks of follow-up, were analyzed. Sustained virologic response 12 weeks after the scheduled end of therapy date (SVR12) and the rate of discontinuations due to adverse events (AE) were evaluated.

Results: Of the 159 subjects included, 127 (79.9%) were male, 45 (34.4%) were treatment-naïve for PR and 60 (45.4%) showed cirrhosis. SVR12 was observed in 31/46 (67.4%) patients treated with BOC and 69/113 (61.1%) patients treated with TVR. Overall discontinuations due to AE rates were 8.7% for BOC and 8% for TVR. Grade 3 or 4 hematological abnormalities were frequently observed; anemia 7%, thrombocytopenia 17.2% and neutropenia 16.4%.

Conclusion: The efficacy and safety of triple therapy including BOC or TVR plus PR under real-life conditions of use in the HIV/HCV-coinfected population was similar to what is observed in clinical trials. Hematological side effects are frequent but manageable.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Coinfection / drug therapy
  • Coinfection / pathology
  • Drug-Related Side Effects and Adverse Reactions
  • Europe
  • Female
  • HIV / drug effects
  • HIV Infections / drug therapy*
  • HIV Infections / pathology
  • HIV Infections / virology
  • Hepacivirus / drug effects
  • Hepatitis C, Chronic / drug therapy*
  • Hepatitis C, Chronic / virology
  • Humans
  • Male
  • Middle Aged
  • Oligopeptides / administration & dosage*
  • Proline / administration & dosage
  • Proline / analogs & derivatives*
  • Ribavirin / administration & dosage
  • Treatment Outcome

Substances

  • Oligopeptides
  • Ribavirin
  • telaprevir
  • N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide
  • Proline

Grants and funding

This work was supported by the RD12/0017/0012 (RIS-HEP07 Study Group), the Ministerio de Sanidad y Servicios Sociales (grant number EC11-304), the Fundación Progreso y Salud, Consejería de Salud de la Junta de Andalucía (grant number PI-0492-2012) and the framework of the Swiss HIV Cohort Study, supported by the Swiss National Science Foundation (grant number 134277 and SHCS project number 688). K.N. is the recipient of a Miguel Servet research grant from the Instituto de Salud Carlos III (grant number CP13/00187). D.M. is a participant in the European AIDS Clinical Society Exchange Medical Programme. A.R.-J. is the recipient of a post-doctoral extension grant of the Fundación Progreso y Salud of the Junta de Andalucía (grant number RH-0024-2013). J.A.P is the recipient of an intensification grant from the Instituto de Salud Carlos III (grant number Programa-I3SNS).