Role of simeprevir plasma concentrations in HCV treated patients with dermatological manifestations

Dig Liver Dis. 2017 Jun;49(6):705-708. doi: 10.1016/j.dld.2017.01.144. Epub 2017 Jan 17.

Abstract

Background and aims: Up till now the role of simeprevir plasma concentrations has not been described in treated patients affected by chronic hepatitis C and with dermatological side-effects. In this study, we have evaluated a possible relationship between plasma levels and the onset of skin complaints for the first time.

Methods: We report a clinical and pharmacokinetic analysis of 56 patients treated with simeprevir-based therapies.

Results: Simeprevir plasma concentrations were significantly related to dermatological side-effects at early time-points (P<0.001). In logistic regression, simeprevir concentrations at 1 week was the best predictive factor forskin symptoms (OR=1.901, 95%IC: 1.001-2.304; P=0.007).

Conclusion: Simeprevir plasma measurements could be a useful tool in a real-life clinical setting for prevention of dermatological symptoms.

Keywords: Dermatological side-effects; HCV; Pharmacokinetics; Simeprevir; Therapeutic drug monitoring.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • Antiviral Agents / blood
  • Antiviral Agents / pharmacokinetics
  • Drug Monitoring
  • Drug Therapy, Combination
  • Female
  • Hepacivirus
  • Hepatitis C, Chronic / blood*
  • Hepatitis C, Chronic / drug therapy*
  • Humans
  • Interferon-alpha / therapeutic use
  • Logistic Models
  • Male
  • Middle Aged
  • Prospective Studies
  • Ribavirin / therapeutic use
  • Simeprevir / adverse effects*
  • Simeprevir / blood*
  • Simeprevir / pharmacokinetics
  • Skin Diseases / chemically induced*
  • Treatment Outcome
  • Viral Load

Substances

  • Antiviral Agents
  • Interferon-alpha
  • Ribavirin
  • Simeprevir