%0 Journal Article
%A Manuel Sousa, José
%A Vergara, Mercedes
%A Pulido, Federico
%A Sánchez Antolín, Gloria
%A Hijona, Lander
%A Carnicer, Fernando
%A Rincón, Diego
%A Salmerón, Javier
%A Mateos-Muñoz, Beatriz
%A Jou, Antoni
%A Polo-Lorduy, Benjamín
%A Rubín, Ángel
%A Escarda, Ana
%A Aguilar, Patricia
%A Aldámiz-Echevarría, Teresa
%A García-Buey, Luisa
%A Carrión, José A
%A Hernández-Guerra, Manuel
%A Chimeno-Hernández, Sonia
%A Espinosa, Nuria
%A Morillas, Rosa Mª
%A Andrade, Raúl J
%A Delgado, Manuel
%A Gallego, Adolfo
%A Magaz, Marta
%A Moreno-Planas, José María
%A Estébanez, Ángel
%A Rico, Mikel
%A Menéndez, Fernando
%A Sampedro, Blanca
%A Morano, Luís
%A Izquierdo, Sonia
%A Zozaya, José Manuel
%A Rodríguez, Manuel
%A Morán-Sánchez, Senador
%A Lorente, Sara
%A Martín-Granizo, Ignacio
%A Von-Wichmann, Miguel Ángel
%A Delgado, Marcial
%A Manzanares, Amanda
%T 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.
%D 2019
%U http://hdl.handle.net/10668/14675
%X 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.
%~