Real-World Outcomes in Historically Underserved Patients with Chronic Hepatitis C Infection Treated with Glecaprevir/Pibrentasvir (June, 10.1007/s40121-021-00455-1, 2021)

被引:0
作者
Aghemo, Alessio [1 ,24 ]
Horsmans, Yves [2 ]
Bourgeois, Stefan [3 ]
Bondin, Mark [4 ]
Gschwantler, Michael [5 ,6 ]
Hofer, Harald [7 ]
Semmo, Nasser [8 ]
Negro, Francesco [9 ,27 ]
Zhang, Zhenzhen [4 ]
Marcinak, John [4 ]
Veitsman, Ella [10 ]
Hazzan, Rawi [11 ]
Mimidis, Konstantinos [12 ]
Goulis, Ioannis [13 ]
Marques, Nuno [14 ]
Flisiak, Robert [15 ]
Mazur, Wlodzimierz [16 ]
Roncero, Carlos [17 ,25 ,26 ]
Marra, Fiona [18 ]
Pageaux, Georges Philippe [19 ]
Asselah, Tarik [20 ,21 ]
Lampertico, Pietro [22 ,23 ]
机构
[1] Humanitas Univ, Dept Biomed Sci, Rozzano, Italy
[2] UCL, Clin Univ St Luc, Brussels, Belgium
[3] Stuivenberg ZNA, Antwerp, Belgium
[4] AbbVie Inc, N Chicago, IL USA
[5] Sigmund Freud Univ, Dept Internal Med 4, Wilhelminenspital, Vienna, Austria
[6] Sigmund Freud Univ, Vienna, Austria
[7] Klinikum Wels Grieskirchen, Dept Internal Med Gastroenterol & Hepatol, Wels, Austria
[8] Univ Bern, Dept BioMed Res Hepatol, Inselspital, CH-3010 Bern, Switzerland
[9] Univ Hosp, Div Gastroenterol & Hepatol, Geneva, Switzerland
[10] Liver Unit, Rambam Hlth Care Campus, Haifa, Israel
[11] Emek Med Ctr, Afula, Israel
[12] Democritus Univ Thrace, Sch Med, Dept Internal Med 1, Alexandroupolis, Greece
[13] Aristotle Univ Thessaloniki, Dept Internal Med 4, Thessaloniki, Greece
[14] Hosp Garcia Orta EPE, Infect Dis Serv, Almada, Portugal
[15] Med Univ Bialystok, Dept Infect Dis & Hepatol, Bialystok, Poland
[16] Med Univ Silesia, Clin Dept Infect Dis, Katowice, Poland
[17] Univ Salamanca Hlth Care Complex, Psychiat Serv, Salamanca, Spain
[18] Univ Liverpool, Hepatol Drug Interact Grp, Liverpool, Merseyside, England
[19] Ctr Hosp Univ CHU Montpellier, Dept Hepato Gastro Enterol, Montpellier 5, France
[20] Univ Paris, Hop Beaujon, AP HP, Dept Hepatol, Clichy, France
[21] Univ Paris, INSERM UMR 1149, Clichy, France
[22] Fdn IRCCS Ca Granda, Osped Maggiore Policlin, Policlin Div Gastroenterol & Hepatol CRC AM & A M, Ctr Liver Dis, Milan, Italy
[23] Univ Milan, Milan, Italy
[24] Humanitas Res Hosp IRCCS, Div Internal Med & Hepatol, Dept Gastroenterol, Via Manzoni 56, I-20089 Milan, Italy
[25] Univ Salamanca, Inst Biomed, Salamanca, Spain
[26] Univ Salamanca, Sch Med, Salamanca, Spain
[27] Univ Hosp, Div Clin Pathol, Geneva, Switzerland
关键词
Alcohol use disorder; Health-related quality of life; Hepatitis C; Illicit drugs; Psychiatric disorders;
D O I
10.1007/s40121-021-00529-0
中图分类号
R51 [传染病];
学科分类号
100401 ;
摘要
Introduction: Glecaprevir/pibrentasvir is approved for treating chronic hepatitis C virus (HCV) genotypes (GT) 1–6. We evaluated real-world effectiveness, safety, and patient-reported outcomes of glecaprevir/pibrentasvir in underserved patient populations, focusing on persons who use drugs infected with HCV. Methods: Data were pooled from nine countries (13 November 2017–31 January 2020). Patients had HCV GT1–6, with or without compensated cirrhosis, with or without prior HCV treatment and received glecaprevir/pibrentasvir consistent with local label at their physician’s discretion. Patients with prior direct-acting antiviral exposure were excluded from efficacy and quality-of-life analyses. The percentage of patients achieving sustained virologic response at post-treatment week 12 (SVR12) was assessed. Mean changes from baseline to SVR12 visit in 36-Item Short-Form Health Survey mental and physical component summary scores were reported. Safety was assessed in patients receiving at least one dose of glecaprevir/pibrentasvir. Results: Of 2036 patients, 1701 (83.5%) received 8-week glecaprevir/pibrentasvir. In 1684 patients with sufficient follow-up, SVR12 rates were 98.0% (1651/1684) overall, 98.1% (1432/1459) in 8-week treated patients, 97.0% (519/535) in persons who use drugs, and greater than 95% across subgroups. Mean changes from baseline in mental and physical component summary scores were 3.7 and 2.4, respectively. One glecaprevir/pibrentasvir-related serious adverse event was reported; six glecaprevir/pibrentasvir-related adverse events led to discontinuation. Conclusions: Glecaprevir/pibrentasvir was highly effective, well tolerated, and improved quality of life in HCV-infected persons who use drugs and other underserved patients. Trial Registration: These multinational post-marketing observational studies are registered with ClinicalTrials.gov, number NCT03303599. © 2021, The Author(s).
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页码:2223 / 2225
页数:3
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[1]  
Aghemo A, 2021, INFECT DIS THER, V10, P2203, DOI 10.1007/s40121-021-00455-1