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: Artículo (Versión definitiva)

Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)