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
| Autor: | Sousa, J. M., Vergara, Mercedes, Pulido, F., Antolín, G. S., Hijona, L., Carnicer, F., Rincón, D., Salmerón, J., Mateos-Muñoz, B., Jou, A., Polo-Lorduy, B., Rubín, Á., Escarda, A., Aguilar, P., Aldámiz-Echevarría, T., García-Buey, L., Carrión, José A., Hernández-Guerra, M., Chimeno-Hernández, S., Espinosa, N., Morillas Cunill, Rosa Ma., Andrade, R. J., Delgado, M., Gallego, Adolfo, Magaz, M., Moreno-Planas, J. M., Estébanez, Á., Rico, M., Menéndez, F., Sampedro, B., Morano Amado, Luis Enrique, Izquierdo, S., Zozaya, J. M., Rodríguez, M., Morán-Sánchez, Senador, Lorente, S., Martín-Granizo, I., Von-Wichmann, M. Á., Manzanares, A., Universitat Autònoma de Barcelona |
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| Přispěvatelé: | AbbVie Pharmaceuticals |
| Rok vydání: | 2019 |
| Předmět: |
Male
European People modelos logísticos Spanish People HIV Infections Hepacivirus Gastroenterology Geographical locations 0302 clinical medicine Immunodeficiency Viruses ribavirina 2-Naphthylamine Ethnicities mediana edad education.field_of_study Sulfonamides farmacoterapia Liver Diseases virus diseases Valine Cirrhosis Coinfection Medicine 030211 gastroenterology & hepatology Drug Therapy Combination medicine.medical_specialty Proline Science compuestos macrocíclicos Gastroenterology and Hepatology Tractament antiretroviral de gran activitat Antiviral Agents Microbiology 03 medical and health sciences Drug Therapy VIH (Virus) -- Tractament Humans education Uracil Medicine and health sciences Flaviviruses anilidas Organisms medicine.disease digestive system diseases Logistic Models chemistry Paritaprevir HIV-1 Population Groupings Carbamates People and places Developmental Biology Cyclopropanes RNA viruses antivíricos Sustained Virologic Response viruses humanos estudios de seguimiento chemistry.chemical_compound Anilides 030212 general & internal medicine Medicaments antivírics Hispanic People Pathology and laboratory medicine Multidisciplinary Dasabuvir Hepatitis C virus resultado del tratamiento Hepatitis C Middle Aged Medical microbiology Europe Treatment Outcome Infectious Diseases carbamatos Viruses Female Pathogens VIH-1 medicine.drug Research Article Macrocyclic Compounds Lactams Macrocyclic Population Viral diseases sulfonamidas Internal medicine Ribavirin Retroviruses medicine análisis multifactorial European Union Biology and life sciences business.industry Lentivirus Viral pathogens HIV Hepatitis C Chronic Fibrosis Ombitasvir Hepatitis viruses Microbial pathogens Spain Co-Infections Multivariate Analysis Ritonavir infecciones por VIH business uracilo Follow-Up Studies |
| Zdroj: | PLoS ONE r-IGTP. Repositorio Institucional de Producción Científica del Instituto de Investigación Germans Trias i Pujol instname Plos One r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe Dipòsit Digital de Documents de la UAB Universitat Autònoma de Barcelona Digital.CSIC. Repositorio Institucional del CSIC Zaguán. Repositorio Digital de la Universidad de Zaragoza PLoS One r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante Zaguán: Repositorio Digital de la Universidad de Zaragoza Universidad de Zaragoza r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau PLoS ONE, Vol 14, Iss 11, p e0225061 (2019) |
| ISSN: | 1932-6203 |
| Popis: | [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 [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. The design, study conduct, and financial support for the study were provided by AbbVie (https://www.abbvie.com/). |
| Databáze: | OpenAIRE |
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