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00925njm 22002777a 4500 dc Manuel Sousa, José author Vergara, Mercedes author Pulido, Federico author Sánchez Antolín, Gloria author Hijona, Lander author Carnicer, Fernando author Rincón, Diego author Salmerón, Javier author Mateos-Muñoz, Beatriz author Jou, Antoni author Polo-Lorduy, Benjamín author Rubín, Ángel author Escarda, Ana author Aguilar, Patricia author Aldámiz-Echevarria, Teresa author García-Buey, Luisa author Carrión, José A author Hernández-Guerra, Manuel author Chimeno-Hernández, Sonia author Espinosa, Nuria author Morillas, Rosa Mª author Andrade, Raúl J author Delgado, Manuel author Gallego, Adolfo author Magaz, Marta author Moreno-Planas, José María author Estébanez, Ángel author Rico, Mikel author Menéndez, Fernando author Sampedro, Blanca author Morano, Luís author Izquierdo, Sonia author Zozaya, José Manuel author Rodríguez, Manuel author Morán-Sánchez, Senador author Lorente, Sara author Martín-Granizo, Ignacio author Von-Wichmann, Miguel Ángel author Delgado, Marcial author Manzanares, Amanda author 2019-11-12 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. 10.1371/journal.pone.0225061 1932-6203 PloS one http://hdl.handle.net/10668/14675 31714950 http://hdl.handle.net/20.500.12105/17931 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.