2026-08-29T12:40:20Zhttps://repisalud.isciii.es/rest/oai/requestoai:repisalud.isciii.es:20.500.12105/179312025-03-19T14:04:30Zcom_20.500.12105_15322com_20.500.12105_2051col_20.500.12105_16938col_20.500.12105_16927col_20.500.12105_16958col_20.500.12105_16971col_20.500.12105_16978col_20.500.12105_16982col_20.500.12105_16983
Repisalud
author
Manuel Sousa, José
author
Vergara, Mercedes
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Pulido, Federico
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Sánchez Antolín, Gloria
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Hijona, Lander
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Carnicer, Fernando
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Rincón, Diego
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Salmerón, Javier
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Mateos-Muñoz, Beatriz
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Jou, Antoni
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Polo-Lorduy, Benjamín
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Rubín, Ángel
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Escarda, Ana
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Aguilar, Patricia
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Aldámiz-Echevarria, Teresa
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García-Buey, Luisa
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Carrión, José A
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Hernández-Guerra, Manuel
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Chimeno-Hernández, Sonia
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Espinosa, Nuria
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Morillas, Rosa Mª
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Andrade, Raúl J
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Delgado, Manuel
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Gallego, Adolfo
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Magaz, Marta
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Moreno-Planas, José María
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Estébanez, Ángel
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Rico, Mikel
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Menéndez, Fernando
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Sampedro, Blanca
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Morano, Luís
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Izquierdo, Sonia
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Zozaya, José Manuel
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Rodríguez, Manuel
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Morán-Sánchez, Senador
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Lorente, Sara
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Martín-Granizo, Ignacio
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Von-Wichmann, Miguel Ángel
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Delgado, Marcial
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Manzanares, Amanda
2024-02-10T20:02:29Z
2024-02-10T20:02:29Z
2019-11-12
10.1371/journal.pone.0225061
1932-6203
PloS one
http://hdl.handle.net/10668/14675
31714950
http://hdl.handle.net/20.500.12105/17931
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. 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. 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 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.
eng
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.
research article