Clinical and patient reported outcomes of direct-acting antivirals for the treatment of chronic hepatitis C among patients in opioid agonist treatment: A real-world prospective cohort study

Bernd Schulte, Christiane S Schmidt, Jakob Manthey, Lisa Strada, Stefan Christensen, Konrad Cimander, Herbert Görne, Pavel Khaykin, Norbert Scherbaum, Stefan Walcher, Stefan Mauss, Ingo Schäfer (+3 others)
2020 Open Forum Infectious Diseases  
Background Patient reported outcomes (PRO) can help to reduce uncertainties about hepatitis C (HCV) treatment with direct-acting antivirals (DAA) among people who inject drugs and increase the treatment uptake in this high-risk group. Besides clinical data, this study analysed for the first time PRO in a real-world sample of patients in opioid agonist treatment (OAT) and HCV treatment with DAAs. Methods HCV treatment data including virological response, adherence, safety and PRO of 328 German
more » ... tients in OAT were analysed in a pragmatic prospective cohort study during 2016-2018. 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 PRO on health-related quality of life, physical and mental health, functioning and medication tolerability, fatigue, concentration and memory were analysed by repeated-measure analyses of variances (ANOVA). Results We found high adherence as well as 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 PRO 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. PRO show that all patients, but particularly those with higher somatic, mental and social burden, benefit from DAA treatment.
doi:10.1093/ofid/ofaa317 pmid:32875003 pmcid:PMC7452367 fatcat:wuuq26rw6rbkjczaevt7hy6ae4