Manuel Sousa, JoséVergara, MercedesPulido, FedericoSánchez Antolín, GloriaHijona, LanderCarnicer, FernandoRincón, DiegoSalmerón, JavierMateos-Muñoz, BeatrizJou, AntoniPolo-Lorduy, BenjamínRubín, ÁngelEscarda, AnaAguilar, PatriciaAldámiz-Echevarría, TeresaGarcía-Buey, LuisaCarrión, José AHernández-Guerra, ManuelChimeno-Hernández, SoniaEspinosa, NuriaMorillas, Rosa MªAndrade, Raúl JDelgado, ManuelGallego, AdolfoMagaz, MartaMoreno-Planas, José MaríaEstébanez, ÁngelRico, MikelMenéndez, FernandoSampedro, BlancaMorano, LuísIzquierdo, SoniaZozaya, José ManuelRodríguez, ManuelMorán-Sánchez, SenadorLorente, SaraMartín-Granizo, IgnacioVon-Wichmann, Miguel ÁngelDelgado, MarcialManzanares, Amanda2023-02-082023-02-082019-11-12http://hdl.handle.net/10668/14675We 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. 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. 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 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.enAttribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/2-NaphthylamineAnilidesAntiviral AgentsCarbamatesCyclopropanesDrug Therapy, CombinationFemaleFollow-Up StudiesHIV InfectionsHIV-1Hepatitis C, ChronicHumansLactams, MacrocyclicLogistic ModelsMacrocyclic CompoundsMaleMiddle AgedMultivariate AnalysisProlineRibavirinSpainSulfonamidesSustained Virologic ResponseTreatment OutcomeUracilValineresearch article31714950open access10.1371/journal.pone.02250611932-6203PMC6850697https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0225061&type=printablehttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6850697/pdf