Adherence to ribavirin in chronic hepatitis C patients on antiviral treatment: Results from a randomized controlled trial using real-time medication monitoring

Clin Res Hepatol Gastroenterol. 2016 Nov;40(5):622-630. doi: 10.1016/j.clinre.2015.12.014. Epub 2016 Feb 8.

Abstract

Background and objective: Adherence is essential in antiviral therapy for chronic hepatitis C. We investigated the effect of real-time medication monitoring on adherence to ribavirin.

Methods: In this randomized controlled trial, patients in the intervention group received a medication dispenser that monitored ribavirin intake real-time during 24 weeks PEG-interferon/ribavirin±boceprevir or telaprevir. Patients in the control group received standard-of-care. Adherence was also measured by pill count.

Results: Seventy-two patients were assigned to either intervention (n=35) or control groups (n=37). Median adherence by pill count was 96% (range: 43%-100%) with 30 (94%) of patients exhibiting≥80% adherence. Perfect adherence (i.e. 100%) was similar in intervention and control groups: 22 (85%) vs. 15 (75%) (P=0.47). Adherences by real-time medication monitoring and by pill count did not correlate (R=0.19, P=0.36). No predictors of poor adherence could be identified. Ribavirin trough levels after 8 weeks (median: 2.4 vs. 2.7mg/L, P=0.30) and 24 weeks (median: 3.0 vs. 3.0mg/L, P=0.69), and virological responses did not differ between intervention and control groups.

Conclusions: Adherence to ribavirin during PEG-interferon containing therapy in chronic hepatitis C is high. Real-time medication monitoring did not influence adherence to ribavirin, plasma ribavirin levels or virological responses.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Antiviral Agents / blood
  • Antiviral Agents / therapeutic use*
  • Drug Monitoring / instrumentation*
  • Female
  • Hepatitis C, Chronic / drug therapy*
  • Humans
  • Interferon-alpha / therapeutic use
  • Male
  • Medication Adherence*
  • Middle Aged
  • Oligopeptides / therapeutic use
  • Proline / analogs & derivatives
  • Proline / therapeutic use
  • Ribavirin / blood
  • Ribavirin / therapeutic use*

Substances

  • Antiviral Agents
  • Interferon-alpha
  • 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