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Title

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

AuthorsSousa, José M.; Vergara, Mercedes; Pulido, Federico; Sánchez-Antolín, Gloria; Hijona, Lander; Carnicer, Fernando; Rincón, Diego; Salmerón, Javier; Mateos-Muñoz, Beatriz; Jou, Antoni; Polo-Lorduy, Benjamín; Rubín, Ángel; Escarda, Ana; Aguilar, Patricia; Aldámiz-Echevarría, Teresa; García-Buey, Luisa; Carrión, José A.; Hernández-Guerra, Manuel; Chimeno-Hernández, Sonia; Espinosa, Nuria; Morillas, Rosa María; Andrade, Raúl J.; Delgado, Manuel; Gallego, Adolfo; Magaz, Marta; Moreno-Planas, José M.; Estébanez, Ángel; Rico, Mikel; Menéndez, Fernando; Sampedro, Blanca; Morano-Amado, Luis E.; Izquierdo, Sonia; Zozaya, José Manuel; Rodríguez, Manuel; Morán-Sánchez, Senador; Lorente, Sara; Martín-Granizo, Ignacio; von Wichman, Miguel A.; Delgado-Fernández, Marcial; Manzanares, Amanda
Issue Date12-Nov-2019
PublisherPublic Library of Science
CitationPLoS ONE 14(11): e0225061 (2019)
Abstract[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.
Publisher version (URL)https://doi.org/10.1371/journal.pone.0225061
URIhttp://hdl.handle.net/10261/212623
DOIhttp://dx.doi.org/10.1371/journal.pone.0225061
E-ISSN1932-6203
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