title: Adherence to ribavirin in chronic hepatitis C patients on antiviral treatment: Results from a randomized controlled trial using real-time medication monitoring.
abstract: 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.
authors: Department of Gastroenterology and Hepatology, University Medical Center of Utrecht, P.O. Box 85500, 3508 GA Utrecht, The Netherlands.
authors: Lotte G
authors: LG
authors: van Vlerken
authors: Department of Gastroenterology and Hepatology, University Medical Center of Utrecht, P.O. Box 85500, 3508 GA Utrecht, The Netherlands; Department of Internal Medicine and Infectious Diseases, University Medical Center of Utrecht, Utrecht, The Netherlands.
authors: Faydra I
authors: FI
authors: Lieveld
authors: Department of Gastroenterology and Hepatology, University Medical Center of Utrecht, P.O. Box 85500, 3508 GA Utrecht, The Netherlands.
authors: Suzanne
authors: S
authors: van Meer
authors: Department of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht University Medical Center, Maastricht, The Netherlands.
authors: Ger H
authors: GH
authors: Koek
authors: Department of Gastroenterology and Hepatology, Free University Medical Center, Amsterdam, The Netherlands.
authors: Karin M J
authors: KM
authors: van Nieuwkerk
authors: Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, The Netherlands.
authors: Pieter
authors: P
authors: Friederich
authors: Department of Internal Medicine and Infectious Diseases, University Medical Center of Utrecht, Utrecht, The Netherlands.
authors: Joop E
authors: JE
authors: Arends
authors: Department of Gastroenterology and Hepatology, University Medical Center of Utrecht, P.O. Box 85500, 3508 GA Utrecht, The Netherlands; Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.
authors: Peter D
authors: PD
authors: Siersema
authors: Department of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.
authors: David M
authors: DM
authors: Burger
authors: Department of Gastroenterology and Hepatology, University Medical Center of Utrecht, P.O. Box 85500, 3508 GA Utrecht, The Netherlands. Electronic address: k.j.vanerpecum@umcutrecht.nl.
authors: Karel J
authors: KJ
authors: van Erpecum
mesh_terms: D000998:Antiviral Agents / Q000097:blood / Q000627:therapeutic use*; D016903:Drug Monitoring / Q000295:instrumentation*; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D009842:Oligopeptides / Q000627:therapeutic use; D011392:Proline / Q000031:analogs & derivatives / Q000627:therapeutic use; D012254:Ribavirin / Q000097:blood / Q000627:therapeutic use*
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D009842:Oligopeptides; D012254:Ribavirin; C486464:telaprevir; C512204: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; D011392:Proline