The Impact of Hepatitis C Virus Direct-Acting Antivirals on Patient-Reported Outcomes: A Dutch Prospective Cohort Study

• Published in: Infectious diseases and therapy Vol. 7; no. 3; pp. 373 - 385
• Main Authors: Kracht, Patricia A. M., Lieveld, Faydra I., Amelung, Linde M., Verstraete, Carina J. R., Mauser-Bunschoten, Eveline P., de Bruijne, Joep, Siersema, Peter D., Hoepelman, Andy I. M., Arends, Joop E., van Erpecum, Karel J.
• Format: Journal Article
• Language: English
• Published: Cheshire Springer Healthcare 01.09.2018; Springer; Springer Nature B.V
• Subjects: Analysis; Antiviral agents; Antiviral drugs; Biological response modifiers; Body mass index; Care and treatment; Clinical outcomes; Clinical trials; Cohort analysis; Dosage and administration; Drug therapy; Exercise; Health aspects; Hemophilia; Hepatitis; Hepatitis C; Hepatitis C virus; Infectious Diseases; Internal Medicine; Labor productivity; Medical research; Medicine; Medicine & Public Health; Medicine, Experimental; Original Research; Patient compliance; Patient outcomes; Prognosis; Protease inhibitors; Quality of life; Ribavirin; Netherlands; Adherence; Health-related quality of life; Karnofsky performance status; Hepatitis C virus; Beliefs about Medicines; Direct-acting antivirals
• ISSN: 2193-8229; 2193-6382
• DOI: 10.1007/s40121-018-0208-z

Introduction Pegylated interferon-based therapy for hepatitis C virus (HCV) negatively impacts nutritional state and patient-reported outcomes (PROs) such as health-related quality of life (HRQL). Clinical trials with direct-acting antivirals (DAAs) report significant PRO improvement but real-world data are still scarce. Methods Prospective cohort study recruiting HCV patients treated with DAAs in 2015–2016. Data at baseline, end of treatment (EOT) and 12 weeks thereafter (FU 12 ) included: patient-reported medication adherence; SF-36; Karnofsky Performance Status; paid labour productivity; physical exercise level; nutritional state [by body mass index (BMI) and Jamar hand grip strength (HGS)] and Beliefs about Medicines Questionnaire. Potential factors predicting these PROs were evaluated with multiple regression analysis. Results A total of 68 patients were enrolled: 85% male, median age 57 years, 80% genotype 1, 40% cirrhotics, 46% haemophilia. Both cure rate and patient-reported adherence were 97%. SF-36 Physical Component Summary did not change (43.2 ± 11.9, 44.9 ± 10.3 and 44.7 ± 10.9 at baseline, EOT and FU 12 , p  = 0.71). In contrast, SF-36 mental component summary (MCS) decreased transiently during therapy (49.2 ± 11.9, 44.6 ± 10.3 and 49.9 ± 12.6 at baseline, EOT and FU 12 , p  < 0.01). Concomitant ribavirin-use was the only independent predictor of decreased SF-36 MCS. BMI (25.7 ± 4.5 and 25.6 ± 4.4 at baseline and EOT, p  = 0.8) and Jamar HGS (39.7 ± 13.0, 37.4 ± 11.9 and 37.9 ± 13.8 at baseline, EOT and FU 12 , p  = 0.56) did not change. Conclusion Our study reveals concomitant ribavirin as the only independent predictor of transient decrease in SF-36 mental HRQL during DAA therapy. In contrast to interferon-based therapy, DAAs do not affect BMI or Jamar HGS.