Identifier to cite or link to this item: http://hdl.handle.net/20.500.13003/11752
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
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AuthorManuel Sousa, Jose; Vergara, Mercedes; Pulido, Federico; Sanchez Antolin, Gloria; Hijona, Lander; Carnicer, Fernando; Rincon, Diego; Salmeron, Javier; Mateos-Munoz, Beatriz; Jou, Antoni; Polo-Lorduy, Benjamin; Rubin, Angel; Escarda, Ana; Aguilar, Patricia; Aldamiz-Echevarria, Teresa; Garcia-Buey, Luisa; Carrion, Jose A.; Hernandez-Guerra, Manuel; Chimeno-Hernandez, Sonia; Espinosa, Nuria; Morillas, Rosa Ma; Andrade, Raul J.; Delgado, Manuel; Gallego, Adolfo; Magaz, Marta; Maria Moreno-Planas, Jose; Estebanez, Angel; Rico, Mikel; Menendez, Fernando; Sampedro, Blanca; Morano, Luis; Izquierdo, Sonia; Manuel Zozaya, Jose; Rodriguez, Manuel; Moran-Sanchez, Senador; Lorente, Sara; Martin-Granizo, Ignacio; Angel Von-Wichmann, Miguel; Delgado, Marcial; Manzanares, Amanda
Document typeresearch article
CitationManuel Sousa J, Vergara M, Pulido F, Sanchez AG, Hijona L, Carnicer F, et al. 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. PLoS One. 2019 Nov 12;14(11):e0225061.
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.
Drug Therapy, Combination
Sustained Virologic Response
Hepatitis C, Chronic
Respuesta Virológica Sostenida
Resultado del Tratamiento
Hepatitis C Crónica
Infecciones por VIH
Estudios de Seguimiento
Persona de Mediana Edad
This item appears in following Docusalut collectionsHospital Universitario Son Espases - HUSE > Comunicación científica
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