Clinical and Patient-Reported Outcomes of Direct-Acting Antivirals for the Treatment of Chronic Hepatitis C Among Patients on Opioid Agonist Treatment: A Real-world Prospective Cohort Study
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Clinical and Patient-Reported Outcomes of Direct-Acting Antivirals for the Treatment of Chronic Hepatitis C Among Patients on Opioid Agonist Treatment: A Real-world Prospective Cohort Study. / Schulte, Bernd; Schmidt, Christiane S; Manthey, Jakob; Strada, Lisa; Christensen, Stefan; Cimander, Konrad; Görne, Herbert; Khaykin, Pavel; Scherbaum, Norbert; Walcher, Stefan; Mauss, Stefan; Schäfer, Ingo; Verthein, Uwe; Rehm, Jürgen; Reimer, Jens.
in: OPEN FORUM INFECT DI, Jahrgang 7, Nr. 8, 08.2020, S. 317.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Clinical and Patient-Reported Outcomes of Direct-Acting Antivirals for the Treatment of Chronic Hepatitis C Among Patients on Opioid Agonist Treatment: A Real-world Prospective Cohort Study
AU - Schulte, Bernd
AU - Schmidt, Christiane S
AU - Manthey, Jakob
AU - Strada, Lisa
AU - Christensen, Stefan
AU - Cimander, Konrad
AU - Görne, Herbert
AU - Khaykin, Pavel
AU - Scherbaum, Norbert
AU - Walcher, Stefan
AU - Mauss, Stefan
AU - Schäfer, Ingo
AU - Verthein, Uwe
AU - Rehm, Jürgen
AU - Reimer, Jens
N1 - © The Author(s) 2020. Published by Oxford University Press on behalf of Infectious Diseases Society of America.
PY - 2020/8
Y1 - 2020/8
N2 - Background: Patient-reported outcomes (PROs) can help to reduce uncertainties about hepatitis C virus (HCV) treatment with direct-acting antivirals (DAAs) among people who inject drugs and increase treatment uptake in this high-risk group. Besides clinical data, this study analyzed for the first time PROs in a real-world sample of patients on opioid agonist treatment (OAT) and HCV treatment with DAAs.Methods: HCV treatment data including virological response, adherence, safety, and PROs of 328 German patients on OAT were analyzed in a pragmatic prospective cohort study conducted from 2016 to 2018. Clinical effectiveness was defined as sustained virological response (SVR) at week 12 after end of treatment and calculated in per-protocol (PP) and intention-to-treat (ITT) analyses. Changes over time in PROs on health-related quality of life, physical and mental health, functioning, medication tolerability, fatigue, concentration, and memory were analyzed by repeated-measures analyses of variances (ANOVAs).Results: We found high adherence and treatment completion rates, a low number of mainly mild adverse events, and high SVR rates (PP: 97.5% [n = 285]; ITT: 84.5% [n = 328]). Missing SVR data in the ITT sample were mainly caused by patients lost to follow-up after treatment completion. Most PROs showed statistically significant but modest improvements over time, with more pronounced improvements in highly impaired patients.Conclusions: This real-world study confirms that DAA treatment among OAT patients is feasible, safe, and effective. PROs show that all patients, but particularly those with higher somatic, mental, and social burden, benefit from DAA treatment.
AB - Background: Patient-reported outcomes (PROs) can help to reduce uncertainties about hepatitis C virus (HCV) treatment with direct-acting antivirals (DAAs) among people who inject drugs and increase treatment uptake in this high-risk group. Besides clinical data, this study analyzed for the first time PROs in a real-world sample of patients on opioid agonist treatment (OAT) and HCV treatment with DAAs.Methods: HCV treatment data including virological response, adherence, safety, and PROs of 328 German patients on OAT were analyzed in a pragmatic prospective cohort study conducted from 2016 to 2018. Clinical effectiveness was defined as sustained virological response (SVR) at week 12 after end of treatment and calculated in per-protocol (PP) and intention-to-treat (ITT) analyses. Changes over time in PROs on health-related quality of life, physical and mental health, functioning, medication tolerability, fatigue, concentration, and memory were analyzed by repeated-measures analyses of variances (ANOVAs).Results: We found high adherence and treatment completion rates, a low number of mainly mild adverse events, and high SVR rates (PP: 97.5% [n = 285]; ITT: 84.5% [n = 328]). Missing SVR data in the ITT sample were mainly caused by patients lost to follow-up after treatment completion. Most PROs showed statistically significant but modest improvements over time, with more pronounced improvements in highly impaired patients.Conclusions: This real-world study confirms that DAA treatment among OAT patients is feasible, safe, and effective. PROs show that all patients, but particularly those with higher somatic, mental, and social burden, benefit from DAA treatment.
U2 - 10.1093/ofid/ofaa317
DO - 10.1093/ofid/ofaa317
M3 - SCORING: Journal article
C2 - 32875003
VL - 7
SP - 317
JO - OPEN FORUM INFECT DI
JF - OPEN FORUM INFECT DI
SN - 2328-8957
IS - 8
ER -