학술논문
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.
Document Type
article
Author
José Manuel Sousa; Mercedes Vergara; Federico Pulido; Gloria Sánchez Antolín; Lander Hijona; Fernando Carnicer; Diego Rincón; Javier Salmerón; Beatriz Mateos-Muñoz; Antoni Jou; Benjamín Polo-Lorduy; Ángel Rubín; Ana Escarda; Patricia Aguilar; Teresa Aldámiz-Echevarría; Luisa García-Buey; José A Carrión; Manuel Hernández-Guerra; Sonia Chimeno-Hernández; Nuria Espinosa; Rosa Mª Morillas; Raúl J Andrade; Manuel Delgado; Adolfo Gallego; Marta Magaz; José María Moreno-Planas; Ángel Estébanez; Mikel Rico; Fernando Menéndez; Blanca Sampedro; Luís Morano; Sonia Izquierdo; José Manuel Zozaya; Manuel Rodríguez; Senador Morán-Sánchez; Sara Lorente; Ignacio Martín-Granizo; Miguel Ángel Von-Wichmann; Marcial Delgado; Amanda Manzanares
Source
PLoS ONE, Vol 14, Iss 11, p e0225061 (2019)
Subject
Language
English
ISSN
1932-6203
Abstract
AimWe 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 methodsData 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.ResultsOverall, 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 (pConclusionsOur 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.