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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
dc.contributor.author | Manuel Sousa, Jose | |
dc.contributor.author | Vergara, Mercedes | |
dc.contributor.author | Pulido, Federico | |
dc.contributor.author | Sanchez Antolin, Gloria | |
dc.contributor.author | Hijona, Lander | |
dc.contributor.author | Carnicer, Fernando | |
dc.contributor.author | Rincon, Diego | |
dc.contributor.author | Salmeron, Javier | |
dc.contributor.author | Mateos-Munoz, Beatriz | |
dc.contributor.author | Jou, Antoni | |
dc.contributor.author | Polo-Lorduy, Benjamin | |
dc.contributor.author | Rubin, Angel | |
dc.contributor.author | Escarda, Ana | |
dc.contributor.author | Aguilar, Patricia | |
dc.contributor.author | Aldamiz-Echevarria, Teresa | |
dc.contributor.author | Garcia-Buey, Luisa | |
dc.contributor.author | Carrion, Jose A | |
dc.contributor.author | Hernandez-Guerra, Manuel | |
dc.contributor.author | Chimeno-Hernandez, Sonia | |
dc.contributor.author | Espinosa, Nuria | |
dc.contributor.author | Morillas, Rosa M feminine | |
dc.contributor.author | Andrade, Raul J | |
dc.contributor.author | Delgado Blanco, Manuel | |
dc.contributor.author | Gallego, Adolfo | |
dc.contributor.author | Magaz, Marta | |
dc.contributor.author | Moreno-Planas, Jose Maria | |
dc.contributor.author | Estebanez, Angel | |
dc.contributor.author | Rico, Mikel | |
dc.contributor.author | Menendez, Fernando | |
dc.contributor.author | Sampedro, Blanca | |
dc.contributor.author | Morano Amado, Luis | |
dc.contributor.author | Izquierdo, Sonia | |
dc.contributor.author | Zozaya, Jose Manuel | |
dc.contributor.author | Rodriguez, Manuel | |
dc.contributor.author | Moran-Sanchez, Senador | |
dc.contributor.author | Lorente, Sara | |
dc.contributor.author | Martín-Granizo Barrenechea, Ignacio | |
dc.contributor.author | Von-Wichmann, Miguel Angel | |
dc.contributor.author | Delgado, Marcial | |
dc.contributor.author | Manzanares, Amanda | |
dc.date.accessioned | 2022-01-25T12:15:13Z | |
dc.date.available | 2022-01-25T12:15:13Z | |
dc.date.issued | 2019 | |
dc.identifier.issn | 1932-6203 | |
dc.identifier.other | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6850697/pdf/pone.0225061.pdf | es |
dc.identifier.other | https://www.ncbi.nlm.nih.gov/pubmed/31714950 | es |
dc.identifier.uri | http://hdl.handle.net/20.500.11940/15893 | |
dc.description.abstract | 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. | en |
dc.language.iso | eng | es |
dc.rights | Atribución 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | * |
dc.subject.mesh | Drug Therapy | * |
dc.subject.mesh | Multivariate Analysis | * |
dc.subject.mesh | Middle Aged | * |
dc.subject.mesh | Ribavirin | * |
dc.subject.mesh | Logistic Models | * |
dc.subject.mesh | Sulfonamides | * |
dc.subject.mesh | Follow-Up Studies | * |
dc.subject.mesh | Carbamates | * |
dc.subject.mesh | Hepatitis C | * |
dc.subject.mesh | Humans | * |
dc.subject.mesh | Treatment Outcome | * |
dc.subject.mesh | Uracil | * |
dc.subject.mesh | Anilides | * |
dc.subject.mesh | Macrocyclic Compounds | * |
dc.subject.mesh | Antiviral Agents | * |
dc.subject.mesh | HIV Infections | * |
dc.title | 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 | en |
dc.type | Artigo | es |
dc.identifier.doi | PONE-D-19-20903 [pii] | |
dc.identifier.pmid | 31714950 | |
dc.identifier.sophos | 32257 | |
dc.issue.number | 11 | es |
dc.journal.title | PLoS One | es |
dc.organization | Servizo Galego de Saúde::Estrutura de Xestión Integrada (EOXI)::EOXI de A Coruña - Complexo Hospitalario Universitario de A Coruña::Cirurxía Xeral e dixestiva | es |
dc.organization | Servizo Galego de Saúde::Estrutura de Xestión Integrada (EOXI)::EOXI de Vigo - Complexo Hospitalario Universitario de Vigo::Dixestivo | es |
dc.organization | Servizo Galego de Saúde::Estrutura de Xestión Integrada (EOXI)::EOXI de Vigo - Complexo Hospitalario Universitario de Vigo::Medicina Interna | es |
dc.rights.accessRights | openAccess | es |
dc.subject.decs | resultado del tratamiento | * |
dc.subject.decs | análisis multifactorial | * |
dc.subject.decs | ribavirina | * |
dc.subject.decs | antivíricos | * |
dc.subject.decs | compuestos macrocíclicos | * |
dc.subject.decs | anilidas | * |
dc.subject.decs | estudios de seguimiento | * |
dc.subject.decs | farmacoterapia | * |
dc.subject.decs | mediana edad | * |
dc.subject.decs | infecciones por VIH | * |
dc.subject.decs | modelos logísticos | * |
dc.subject.decs | sulfonamidas | * |
dc.subject.decs | carbamatos | * |
dc.subject.decs | hepatitis C | * |
dc.subject.decs | humanos | * |
dc.subject.decs | uracilo | * |
dc.subject.keyword | CHUAC | es |
dc.subject.keyword | CHUVI | es |
dc.typefides | Artículo Original | es |
dc.typesophos | Artículo Original | es |
dc.volume.number | 14 | es |
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