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
Sousa, J.M. ; Vergara, M. ; Pulido, F. ; Antolín, G.S. ; Hijona, L. ; Carnicer, F. ; Rincón, D. ; Salmerón, J. ; Mateos-Muñoz, B. ; Jou, A. ; Polo-Lorduy, B. ; Rubín, Á. ; Escarda, A. ; Aguilar, P. ; Aldámiz-Echevarría, T. ; García-Buey, L. ; Carrión, J.A. ; Hernández-Guerra, M. ; Chimeno-Hernández, S. ; Espinosa, N. ; Morillas, R.M. ; Andrade, R.J. ; Delgado, M. ; Gallego, A. ; Magaz, M. ; Moreno-Planas, J.M. ; Estébanez, Á. ; Rico, M. ; Menéndez, F. ; Sampedro, B. ; Morano, L. ; Izquierdo, S. ; Zozaya, J.M. ; Rodríguez, M. ; Morán-Sánchez, S. ; Lorente, S. (Universidad de Zaragoza) ; Martín-Granizo, I. ; Von-Wichmann, M.Á. ; Delgado, M. ; Manzanares, A.
Resumen: 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.
Idioma: Inglés
DOI: 10.1371/journal.pone.0225061
Año: 2019
Publicado en: PloS one 14, 11 (2019), e0225061 [18 pp]
ISSN: 1932-6203
Factor impacto JCR: 2.74 (2019)
Categ. JCR: MULTIDISCIPLINARY SCIENCES rank: 27 / 71 = 0.38 (2019) - Q2 - T2
Factor impacto SCIMAGO: 1.023 - Multidisciplinary (Q1)
Tipo y forma: Article (Published version)
Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)
You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
Exportado de SIDERAL (2021-01-20-10:41:39)
Visitas y descargas
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.
Idioma: Inglés
DOI: 10.1371/journal.pone.0225061
Año: 2019
Publicado en: PloS one 14, 11 (2019), e0225061 [18 pp]
ISSN: 1932-6203
Factor impacto JCR: 2.74 (2019)
Categ. JCR: MULTIDISCIPLINARY SCIENCES rank: 27 / 71 = 0.38 (2019) - Q2 - T2
Factor impacto SCIMAGO: 1.023 - Multidisciplinary (Q1)
Tipo y forma: Article (Published version)
Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)
You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use. Exportado de SIDERAL (2021-01-20-10:41:39)
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Record created 2021-01-20, last modified 2021-01-20