2024-03-29T15:42:47Zhttp://digital.csic.es/dspace-oai/requestoai:digital.csic.es:10261/2126232021-12-28T16:26:49Zcom_10261_11773com_10261_1col_10261_11774
00925njm 22002777a 4500
dc
Sousa, José M.
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-Echevarría, Teresa
author
García-Buey, Luisa
author
Carrión, José A.
author
Hernández-Guerra, Manuel
author
Chimeno-Hernández, Sonia
author
Espinosa, Nuria
author
Morillas, Rosa María
author
Andrade, Raúl J.
author
Delgado, Manuel
author
Gallego, Adolfo
author
Magaz, Marta
author
Moreno-Planas, José M.
author
Estébanez, Ángel
author
Rico, Mikel
author
Menéndez, Fernando
author
Sampedro, Blanca
author
Morano-Amado, Luis E.
author
Izquierdo, Sonia
author
Zozaya, José Manuel
author
Rodríguez, Manuel
author
Morán-Sánchez, Senador
author
Lorente, Sara
author
Martín-Granizo, Ignacio
author
von Wichman, Miguel A.
author
Delgado-Fernández, Marcial
author
Manzanares, Amanda
author
2019-11-12
[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.
PLoS ONE 14(11): e0225061 (2019)
http://hdl.handle.net/10261/212623
10.1371/journal.pone.0225061
1932-6203
http://dx.doi.org/10.13039/100006483
31714950
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