RT Journal Article
T1 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.
A1 Manuel Sousa, José
A1 Vergara, Mercedes
A1 Pulido, Federico
A1 Sánchez Antolín, Gloria
A1 Hijona, Lander
A1 Carnicer, Fernando
A1 Rincón, Diego
A1 Salmerón, Javier
A1 Mateos-Muñoz, Beatriz
A1 Jou, Antoni
A1 Polo-Lorduy, Benjamín
A1 Rubín, Ángel
A1 Escarda, Ana
A1 Aguilar, Patricia
A1 Aldámiz-Echevarría, Teresa
A1 García-Buey, Luisa
A1 Carrión, José A
A1 Hernández-Guerra, Manuel
A1 Chimeno-Hernández, Sonia
A1 Espinosa, Nuria
A1 Morillas, Rosa Mª
A1 Andrade, Raúl J
A1 Delgado, Manuel
A1 Gallego, Adolfo
A1 Magaz, Marta
A1 Moreno-Planas, José María
A1 Estébanez, Ángel
A1 Rico, Mikel
A1 Menéndez, Fernando
A1 Sampedro, Blanca
A1 Morano, Luís
A1 Izquierdo, Sonia
A1 Zozaya, José Manuel
A1 Rodríguez, Manuel
A1 Morán-Sánchez, Senador
A1 Lorente, Sara
A1 Martín-Granizo, Ignacio
A1 Von-Wichmann, Miguel Ángel
A1 Delgado, Marcial
A1 Manzanares, Amanda
AB 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. 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.
YR 2019
FD 2019-11-12
LK http://hdl.handle.net/10668/14675
UL http://hdl.handle.net/10668/14675
LA en
DS RISalud
RD Apr 7, 2025