000098223 001__ 98223 000098223 005__ 20210120124310.0 000098223 0247_ $$2doi$$a10.1371/journal.pone.0225061 000098223 0248_ $$2sideral$$a121871 000098223 037__ $$aART-2019-121871 000098223 041__ $$aeng 000098223 100__ $$aSousa, J.M. 000098223 245__ $$aReal-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 000098223 260__ $$c2019 000098223 5060_ $$aAccess copy available to the general public$$fUnrestricted 000098223 5203_ $$aAim 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. 000098223 540__ $$9info:eu-repo/semantics/openAccess$$aby$$uhttp://creativecommons.org/licenses/by/3.0/es/ 000098223 590__ $$a2.74$$b2019 000098223 591__ $$aMULTIDISCIPLINARY SCIENCES$$b27 / 71 = 0.38$$c2019$$dQ2$$eT2 000098223 592__ $$a1.023$$b2019 000098223 593__ $$aMultidisciplinary$$c2019$$dQ1 000098223 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000098223 700__ $$aVergara, M. 000098223 700__ $$aPulido, F. 000098223 700__ $$aAntolín, G.S. 000098223 700__ $$aHijona, L. 000098223 700__ $$aCarnicer, F. 000098223 700__ $$aRincón, D. 000098223 700__ $$aSalmerón, J. 000098223 700__ $$aMateos-Muñoz, B. 000098223 700__ $$aJou, A. 000098223 700__ $$aPolo-Lorduy, B. 000098223 700__ $$aRubín, Á. 000098223 700__ $$aEscarda, A. 000098223 700__ $$aAguilar, P. 000098223 700__ $$aAldámiz-Echevarría, T. 000098223 700__ $$aGarcía-Buey, L. 000098223 700__ $$aCarrión, J.A. 000098223 700__ $$aHernández-Guerra, M. 000098223 700__ $$aChimeno-Hernández, S. 000098223 700__ $$aEspinosa, N. 000098223 700__ $$aMorillas, R.M. 000098223 700__ $$aAndrade, R.J. 000098223 700__ $$aDelgado, M. 000098223 700__ $$aGallego, A. 000098223 700__ $$aMagaz, M. 000098223 700__ $$aMoreno-Planas, J.M. 000098223 700__ $$aEstébanez, Á. 000098223 700__ $$aRico, M. 000098223 700__ $$aMenéndez, F. 000098223 700__ $$aSampedro, B. 000098223 700__ $$aMorano, L. 000098223 700__ $$aIzquierdo, S. 000098223 700__ $$aZozaya, J.M. 000098223 700__ $$aRodríguez, M. 000098223 700__ $$aMorán-Sánchez, S. 000098223 700__ $$0(orcid)0000-0003-4672-8083$$aLorente, S.$$uUniversidad de Zaragoza 000098223 700__ $$aMartín-Granizo, I. 000098223 700__ $$aVon-Wichmann, M.Á. 000098223 700__ $$aDelgado, M. 000098223 700__ $$aManzanares, A. 000098223 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina 000098223 773__ $$g14, 11 (2019), e0225061 [18 pp]$$pPLoS One$$tPloS one$$x1932-6203 000098223 8564_ $$s588529$$uhttps://zaguan.unizar.es/record/98223/files/texto_completo.pdf$$yVersión publicada 000098223 8564_ $$s3268164$$uhttps://zaguan.unizar.es/record/98223/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000098223 909CO $$ooai:zaguan.unizar.es:98223$$particulos$$pdriver 000098223 951__ $$a2021-01-20-10:41:39 000098223 980__ $$aARTICLE