Real-world effectiveness and safety of glecaprevir/pibrentasvir therapy in patients with chronic hepatitis C virus infection in Switzerland
AIM OF THE STUDY
In the era of pangenotypic treatment regimens against hepatitis C virus (HCV) infection, data from postmarketing observational studies are crucial to better understand the treatment patterns used in specific countries and treatment outcomes under real-life conditions. We report data from Switzerland from an ongoing, multinational postmarketing observational study on the pangenotypic treatment regimen of glecaprevir (GLE; NS3/4A protease inhibitor) and pibrentasvir (PIB; NS5A inhibitor), coformulated as GLE/PIB.
Adults infected with chronic HCV genotypes 1–6 were eligible to participate in the postmarketing observational study if they started GLE/PIB at the treating physician’s discretion. The primary objective was to evaluate the effectiveness of GLE/PIB based on sustained virological response 12 weeks after completion of treatment (SVR12); secondary outcomes included patient-reported outcomes (Fatigue Severity Scale, Work Productivity and Activity Impairment Questionnaire, Pictorial Representation of Illness and Self Measure tool) and safety data.
In Switzerland, 109 patients were enrolled, and 107 patients received ≥1 dose GLE/PIB (94.4% non-cirrhotic; 43.9%/14.0%/29.0%/13.1% GT1/GT2/GT3/GT4; 89.7% treatment-naïve; 91.6% assigned to an 8-week GLE/PIB regimen). Overall, 95 of 98 patients with sufficient follow-up data (96.9%) achieved SVR12 (95% confidence interval [CI] 91.4% to 99.0%), and 91.6% in the safety population (including six non-virological failures). The three treatment failures were due to relapse. All three failures were GT3, without cirrhosis and treatment naïve. Patient-reported outcomes improved as well. GLE/PIB was well tolerated with no serious adverse events and no adverse events leading to discontinuation or interruption of GLE/PIB treatment.
These real-world effectiveness and safety data of GLE/PIB in patients from Switzerland were consistent with those seen in the multinational registration trials. (Trial registration number: Clinicaltrials.gov: NCT03303599.)
- World Health Organization. Global Hepatitis Report. 2017. Available from: www.who.int/hepatitis/publications/global-hepatitis-report2017/en/. Accessed 2020 March 04.
- Stanaway JD, Flaxman AD, Naghavi M, Fitzmaurice C, Vos T, Abubakar I, et al. The global burden of viral hepatitis from 1990 to 2013: findings from the Global Burden of Disease Study 2013. Lancet. 2016;388(10049):1081–8. doi:.https://doi.org/10.1016/S0140-6736(16)30579-7
- Swiss Hepatitis. Strategy 2014 – 2030 Process Paper. Version 4, 2019 January. Available from: https://www.hepatitis-schweiz.ch/files/Dokumente/PDF/Process_Paper_14_02_2019.pdf. Accessed 2020 March 04.
- Pawlotsky J, Negro F, Aghemo A, Berenguer M, Dalgard O, Dusheiko G, et al.; European Association for the Study of the Liver. Electronic address: firstname.lastname@example.org; European Association for the Study of the Liver. EASL Recommendations on Treatment of Hepatitis C 2018. J Hepatol. 2018;69(2):461–511. doi:.https://doi.org/10.1016/j.jhep.2018.03.026
- Carrion AF, Martin P. Glecaprevir + pibrentasvir for treatment of hepatitis C. Expert Opin Pharmacother. 2018;19(4):413–9. doi:.https://doi.org/10.1080/14656566.2018.1444030
- Zeuzem S, Foster GR, Wang S, Asatryan A, Gane E, Feld JJ, et al. Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection. N Engl J Med. 2018;378(4):354–69. doi:.https://doi.org/10.1056/NEJMoa1702417
- Puoti M, Foster GR, Wang S, Mutimer D, Gane E, Moreno C, et al. High SVR12 with 8-week and 12-week glecaprevir/pibrentasvir therapy: An integrated analysis of HCV genotype 1-6 patients without cirrhosis. J Hepatol. 2018;69(2):293–300. doi:.https://doi.org/10.1016/j.jhep.2018.03.007
- Kwo PY, Poordad F, Asatryan A, Wang S, Wyles DL, Hassanein T, et al. Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis. J Hepatol. 2017;67(2):263–71. doi:.https://doi.org/10.1016/j.jhep.2017.03.039
- Bruggmann P. Hepatitis C epidemiology in Switzerland and the role of general practitioners [Die Hepatitis-C-Epidemiologie in der Schweiz und die Rolle der Grundversorgung]. Praxis (Bern). 2016;105:885–9. doi:.https://doi.org/10.1024/1661-8157/a002424
- Zahnd C, Brezzi M, Bertisch B, et al. Situationsanalyse zu Hepatitis B und C in der Schweiz 2017. Schweizerische Eidgenossenschaft, Bundesamt für Gesundheit. Available from: https://www.bag.admin.ch/bag/de/home/das-bag/publikationen/forschungsberichte/forschungsberichte-uebertragbare-krankheiten/situationsanalyse-hepatitis.html. Accessed 2020 March 04.
- Swiss Federal Office of Public Health. Hepatitis C. Schweizerische Eidgenossenschaft, Bundesamt für Gesundheit. Available from: https://www.bag.admin.ch/bag/de/home/krankheiten/krankheiten-im-ueberblick/hepatitis-c.html. Accessed 2020 March 04.
- SwissMedic [Internet]. Switzerland: Maviret Product Information 2018. Available from: http://www.swissmedicinfo.ch/. Accessed 2020 March 04.
- Büchi S, Buddeberg C, Klaghofer R, Russi EW, Brändli O, Schlösser C, et al. Preliminary validation of PRISM (Pictorial Representation of Illness and Self Measure) - a brief method to assess suffering. Psychother Psychosom. 2002;71(6):333–41. doi:.https://doi.org/10.1159/000065994
- Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993;4(5):353–65. doi:.https://doi.org/10.2165/00019053-199304050-00006
- Reilly Associates. Work Productivity and Activity Impairment Index (WPAI). 2002. Available from: http://www.reillyassociates.net/Index.html. Accessed 2020 March 04.
- Rosa K, Fu M, Gilles L, Cerri K, Peeters M, Bubb J, et al. Validation of the Fatigue Severity Scale in chronic hepatitis C. Health Qual Life Outcomes. 2014;12(1):90. doi:.https://doi.org/10.1186/1477-7525-12-90
- Blach S, Zeuzem S, Manns M, Altraif I, Duberg A, Muljono D, et al., Polaris Observatory HCV Collaborators. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. Lancet Gastroenterol Hepatol. 2017;2(3):161–76. doi:.https://doi.org/10.1016/S2468-1253(16)30181-9
- Moradpour D, Fehr J, Semela D, et al. Treatment of Chronic Hepatitis C –Update SASL-SSI Expert Opinion Statement 2018 August. Available from: https://sasl.unibas.ch/guidelines/SASL-SSI_EOS_Aug2018.pdf. Accessed 2020 March 04.
- SwissMedic [Internet]. Switzerland: Epclusa Product Information, 2019. Available from: http://www.swissmedicinfo.ch/. Accessed 2020 March 04.
- D’Ambrosio R, Pasulo L, Puoti M, Vinci M, Schiavini M, Lazzaroni S, et al.; NAVIGATORE-Lombardia Study Group. Real-world effectiveness and safety of glecaprevir/pibrentasvir in 723 patients with chronic hepatitis C. J Hepatol. 2019;70(3):379–87. doi:.https://doi.org/10.1016/j.jhep.2018.11.011
- Berg T, Naumann U, Stoehr A, Sick C, John C, Teuber G, et al. Real-world effectiveness and safety of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C infection: data from the German Hepatitis C-Registry. Aliment Pharmacol Ther. 2019;49(8):1052–9. doi:.https://doi.org/10.1111/apt.15222
- Aghemo A, Bourgois S, Gschwantler M, et al. Real-world health care resource utilization and quality of life (QoL) with G/P treatment: A pooled analysis from post-marketing observational studies. Abstract. J Hepatol 2019; 70(Suppl N1S):e228. Poster presented at: International Liver Congress 2019, Vienna. 10–14 April 2019. 1.