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

Lotte G van Vlerken; Faydra I Lieveld; CMJ van Nieuwkerk; Suzanne van Meer; Ger H Koek; Pieter Friederich; Joop E Arends; Peter D Siersema; David M Burger; Karel J van Erpecum

doi:10.1016/j.clinre.2015.12.014

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

Lotte G van Vlerken
, Faydra I Lieveld
, CMJ van Nieuwkerk
, Suzanne van Meer
, Ger H Koek
, Pieter Friederich
, Joop E Arends
, Peter D Siersema
, David M Burger
, Karel J van Erpecum

Department of Gastroenterology and Hepatology, University Medical Center of Utrecht, P.O. Box 85500, 3508 GA Utrecht, The Netherlands.
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.
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht University Medical Center, Maastricht, The Netherlands.
Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, The Netherlands.
Department of Internal Medicine and Infectious Diseases, University Medical Center, Utrecht, The Netherlands.
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.
Department of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.
Department of Gastroenterology and Hepatology, University Medical Center of Utrecht, P.O. Box 85500, 3508 GA Utrecht, The Netherlands. Electronic address: [email protected].

Research output: Contribution to journal › Article › Academic › peer-review

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.

Original language	English
Pages (from-to)	622-630
Number of pages	9
Journal	Clinics and research in hepatology and gastroenterology
Volume	40
Issue number	5
DOIs	https://doi.org/10.1016/j.clinre.2015.12.014
Publication status	Published - Nov 2016

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SDG 3 Good Health and Well-being

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10.1016/j.clinre.2015.12.014

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van Vlerken, L. G., Lieveld, F. I., van Nieuwkerk, CMJ., van Meer, S., Koek, G. H., Friederich, P., Arends, J. E., Siersema, P. D., Burger, D. M., & van Erpecum, K. J. (2016). Adherence to ribavirin in chronic hepatitis C patients on antiviral treatment: Results from a randomized controlled trial using real-time medication monitoring. Clinics and research in hepatology and gastroenterology, 40(5), 622-630. https://doi.org/10.1016/j.clinre.2015.12.014

@article{2fff5147be3043ae840498f4c5c154c6,

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

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.",

author = "\{van Vlerken\}, \{Lotte G\} and Lieveld, \{Faydra I\} and \{van Nieuwkerk\}, CMJ and \{van Meer\}, Suzanne and Koek, \{Ger H\} and Pieter Friederich and Arends, \{Joop E\} and Siersema, \{Peter D\} and Burger, \{David M\} and \{van Erpecum\}, \{Karel J\}",

year = "2016",

month = nov,

doi = "10.1016/j.clinre.2015.12.014",

language = "English",

volume = "40",

pages = "622--630",

journal = "Clinics and research in hepatology and gastroenterology",

issn = "2210-7401",

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}

van Vlerken, LG, Lieveld, FI, van Nieuwkerk, CMJ, van Meer, S, Koek, GH, Friederich, P, Arends, JE, Siersema, PD, Burger, DM & van Erpecum, KJ 2016, 'Adherence to ribavirin in chronic hepatitis C patients on antiviral treatment: Results from a randomized controlled trial using real-time medication monitoring', Clinics and research in hepatology and gastroenterology, vol. 40, no. 5, pp. 622-630. https://doi.org/10.1016/j.clinre.2015.12.014

Adherence to ribavirin in chronic hepatitis C patients on antiviral treatment: Results from a randomized controlled trial using real-time medication monitoring. / van Vlerken, Lotte G; Lieveld, Faydra I; van Nieuwkerk, CMJ et al.
In: Clinics and research in hepatology and gastroenterology, Vol. 40, No. 5, 11.2016, p. 622-630.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Adherence to ribavirin in chronic hepatitis C patients on antiviral treatment

T2 - Results from a randomized controlled trial using real-time medication monitoring

AU - van Vlerken, Lotte G

AU - Lieveld, Faydra I

AU - van Nieuwkerk, CMJ

AU - van Meer, Suzanne

AU - Koek, Ger H

AU - Friederich, Pieter

AU - Arends, Joop E

AU - Siersema, Peter D

AU - Burger, David M

AU - van Erpecum, Karel J

PY - 2016/11

Y1 - 2016/11

N2 - 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.

AB - 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.

U2 - 10.1016/j.clinre.2015.12.014

DO - 10.1016/j.clinre.2015.12.014

M3 - Article

SN - 2210-7401

VL - 40

SP - 622

EP - 630

JO - Clinics and research in hepatology and gastroenterology

JF - Clinics and research in hepatology and gastroenterology

IS - 5

ER -

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

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