Real-world evidence of the effectiveness of ombitasvir-paritaprevir/r ± dasabuvir ± ribavirin in patients monoinfected with chronic hepatitis C or coinfected with human immunodeficiency virus-1 in Spain
Autoři:
José Manuel Sousa aff001; Mercedes Vergara aff002; Federico Pulido aff003; Gloria Sánchez Antolín aff004; Lander Hijona aff005; Fernando Carnicer aff006; Diego Rincón aff007; Javier Salmerón aff008; Beatriz Mateos-Muñoz aff009; Antoni Jou aff010; Benjamín Polo-Lorduy aff011; Ángel Rubín aff012; Ana Escarda aff013; Patricia Aguilar aff014; Teresa Aldamiz-Echevarría aff015; Luisa García-Buey aff016; José A. Carrión aff017; Manuel Hernández-Guerra aff018; Sonia Chimeno-Hernández aff019; Nuria Espinosa aff020; Rosa Mª Morillas aff021; Raúl J. Andrade aff022; Manuel Delgado aff023; Adolfo Gallego aff024; Marta Magaz aff025; José María Moreno-Planas aff026; Ángel Estébanez aff027; Mikel Rico aff028; Fernando Menéndez aff029; Blanca Sampedro aff030; Luís Morano aff031; Sonia Izquierdo aff032; José Manuel Zozaya aff033; Manuel Rodríguez aff034; Senador Morán-Sánchez aff035; Sara Lorente aff036; Ignacio Martín-Granizo aff037; Miguel Ángel Von-Wichmann aff038; Marcial Delgado aff039; Amanda Manzanares aff040
Působiště autorů:
Hepatology Department, Hospital Universitario Virgen del Rocío, Sevilla, Sevilla, Spain
aff001; Hepatology Unit, Digestive Disease Department, Parc Taulí Sabadell Hospital Universitari, Sabadell, Barcelona, Spain, CIBERehd, Instituto Carlos III, Madrid, Spain
aff002; HIV Unit, Hospital Universitario 12 de Octubre, imas12, Universidad Complutense de Madrid (UCM), Madrid, Spain
aff003; Hepatology Department, Hospital Universitario Río Hortega, Valladolid, Valladolid, Spain
aff004; Hepatology Department, Hospital Universitario Araba, Vitoria-Gasteiz, Álava, Spain
aff005; Hepatology Department, Hospital General Universitario de Alicante, Alicante, Alicante, Spain
aff006; Hepatology Department, Hospital General Universitario Gregorio Marañón, CIBERehd and (UCM), Madrid, Spain
aff007; Hepatology Department, Complejo Hospitalario Universitario de Granada, Granada, Granada, Spain
aff008; Hepatology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain
aff009; HIV Clinical Unit, Internal Medicine Department and Fundació de la Lluita contra la SIDA, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Barcelona, Spain
aff010; Hepatology Department, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain
aff011; Hepatology Department, Hospital Universitario y Politécnico de La Fe, Valencia, Valencia, Spain
aff012; Hepatology Department, Hospital Universitario Son Espases, Palma de Mallorca, Spain
aff013; Digestive System Clinical Unit, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Hospital Universitario Reina Sofía/Córdoba University, Córdoba, Spain
aff014; Infectious Diseases-HIV, Hospital General Universitario Gregorio Marañón (IiSGM), Madrid, Madrid, Spain
aff015; Hepatology Department, Hospital Universitario de La Princesa, Madrid, Spain
aff016; Liver Section, Gastroenterology Department, Hospital del Mar, IMIM (Hospital del Mar Medical Research Institute), UAB (Universitat Autonoma de Barcelona) Barcelona, Spain
aff017; Hepatology Department, Hospital Universitario de Canarias, La Laguna, Santa Cruz de Tenerife, Spain
aff018; Hepatology Department, Hospital Arnau de Vilanova, Valencia, Valencia, Spain
aff019; Clinical Unit of Infectious Diseases, Microbiology and Preventive Medicine, Infectious Diseases Research Group, Institute of Biomedicine of Seville (IBiS), University of Seville/CSIC,Sevilla, Spain
aff020; Liver Section, Department of Gastroenterology, Hospital Universitari Germans Trias i Pujol, IGTP, Badalona, Barcelona, Spain, and CIBEREHD
aff021; Unidad de Gestión Clínica de Aparato Digestivo, Instituto de Investigación Biomédica de Málaga-IBIMA, Hospital Universitario Virgen de la Victoria, Universidad de Málaga, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas CIBE
aff022; Hepatology Department, Complejo Hospitalario Universitario A Coruña, A Coruña, Spain
aff023; Hepatology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Barcelona, Spain
aff024; Hepatology Department, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain
aff025; Digestive System Department, Complejo Hospitalario Universitario de Albacete, Albacete, Spain
aff026; Hepatology Department, Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain
aff027; Infectious Diseases Unit, Hospital Universitario La Paz, Madrid, Spain
aff028; Hepatology Department, Hospital Universitario Basurto, Bilbao, Vizcaya, Spain
aff029; Hepatology Department, Hospital Galdakao, Galdakao, Vizcaya, Spain
aff030; Infectious Diseases Unit, Hospital Universitario Álvaro Cunqueiro, Vigo, Pontevedra, Spain
aff031; Hepatology Department, Hospital Clínico San Carlos, Madrid, Spain
aff032; Hepatology Department, Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain
aff033; Liver Unit, Division of Gastroenterology & Hepatology. Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
aff034; Hepatology Department, Hospital General Universitario Santa Lucía, Cartagena, Murcia, Spain
aff035; Hepatology Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Zaragoza, Spain
aff036; Department of Gastroenterology, Hospital Universitario Álvaro Cunqueiro, Vigo, Pontevedra, Spain
aff037; Infectious Diseases Unit, Hospital Universitario Donostia, Donostia, Gipuzkoa, Spain
aff038; Infectious Diseases Unit, Hospital Regional Universitario de Málaga, Málaga, Spain
aff039; AbbVie Spain, S.L.U., Madrid, Spain
aff040
Vyšlo v časopise:
PLoS ONE 14(11)
Kategorie:
Research Article
doi:
https://doi.org/10.1371/journal.pone.0225061
Souhrn
Aim
We describe the effectiveness and safety of the interferon-free regimen ombitasvir/paritaprevir/ritonavir plus dasabuvir with or without ribavirin (OBV/PTV/r ± DSV ± RBV) in a nationwide representative sample of the hepatitis C virus (HCV) monoinfected and human immunodeficiency virus-1/hepatitis C virus (HIV/HCV) coinfected population in Spain.
Material and methods
Data were collected from patients infected with HCV genotypes 1 or 4, with or without HIV-1 coinfection, treated with OBV/PTV/r ± DSV ± RBV at 61 Spanish sites within the initial implementation year of the first government-driven “National HCV plan.” Effectiveness was assessed by sustained virologic response at post-treatment week 12 (SVR12) and compared between monoinfected and coinfected patients using a non-inferiority margin of 5% and a 90% confidence interval (CI). Sociodemographic and clinical characteristics or patients and adverse events (AEs) were also recorded.
Results
Overall, 2,408 patients were included in the intention-to-treat analysis: 386 (16%) were patients with HIV/HCV. Patient selection reflected the real distribution of patients treated in each participating region in Spain. From the total population, 96.6% (95% CI, 95.8–97.3%) achieved SVR12. Noninferiority of SVR12 in coinfected patients was met, with a difference between monoinfected and coinfected patients of −2.2% (90% CI, −4.5% - 0.2%). Only genotype 4 was associated with non-response to OBV/PTV/r ± DSV ± RBV treatment (p<0.001) in the multivariate analysis. Overall, 286 patients (11.9%) presented AEs potentially related to OBV/PTV/r ± DSV, whereas 347 (29.0%) presented AEs potentially related to ribavirin and 61 (5.1%) interrupted ribavirin.
Conclusions
Our results confirm that OBV/PTV/r ± DSV ± RBV is effective and generally well tolerated in a representative sample of the HCV monoinfected and HCV/HIV coinfected population in Spain within the experience of a national strategic plan to tackle HCV.
Klíčová slova:
Cirrhosis – Co-infections – Fibrosis – Hepatitis C virus – HIV infections – Spain – Spanish people
Zdroje
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