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

• Published in: PloS one Vol. 14; no. 11; p. e0225061
• Main Authors: Manuel Sousa, José, 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 Mª, Andrade, Raúl J, Delgado, Manuel, Gallego, Adolfo, Magaz, Marta, Moreno-Planas, José María, Estébanez, Ángel, Rico, Mikel, Menéndez, Fernando, Sampedro, Blanca, Morano, Luís, Izquierdo, Sonia, Zozaya, José Manuel, Rodríguez, Manuel, Morán-Sánchez, Senador, Lorente, Sara, Martín-Granizo, Ignacio, Von-Wichmann, Miguel Ángel, Delgado, Marcial, Manzanares, Amanda
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 12.11.2019; Public Library of Science (PLoS)
• Subjects: Anilides - adverse effects; Anilides - therapeutic use; Antiviral agents; Antiviral Agents - adverse effects; Antiviral Agents - therapeutic use; Antiviral drugs; Biological products industry; Biological response modifiers; Biology and life sciences; Carbamates - adverse effects; Carbamates - therapeutic use; Comorbidity; Comparative analysis; Confidence intervals; Dasabuvir; Development and progression; Digestive system; Drug Therapy, Combination; Female; Follow-Up Studies; Gastroenterology; Genotype & phenotype; Genotypes; Hepatitis; Hepatitis C; Hepatitis C virus; Hepatitis C, Chronic - drug therapy; Hepatology; HIV; HIV Infections - drug therapy; HIV patients; HIV-1 - genetics; Hospitals; Human immunodeficiency virus; Humans; Infections; Infectious diseases; Interferon; Liver; Logistic Models; Macrocyclic Compounds - adverse effects; Macrocyclic Compounds - therapeutic use; Male; Medicine; Medicine and health sciences; Middle Aged; Multivariate Analysis; Ombitasvir; Patients; People and places; Pharmaceutical industry; Political activity; Political aspects; Ribavirin; Ribavirin - adverse effects; Ribavirin - therapeutic use; Ritonavir; Spain; Sulfonamides - adverse effects; Sulfonamides - therapeutic use; Sustained Virologic Response; Treatment Outcome; Uracil - adverse effects; Uracil - analogs & derivatives; Uracil - therapeutic use; Viruses; Spain; United States
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0225061

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<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. 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.