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

English version

Autoři: José Manuel Sousa ^aff001; Mercedes Vergara ^aff002; Federico Pulido ^aff003; Gloria Sánchez Antolín ^aff004; Lander Hijona ^aff005; Fernando Carnicer ^aff006; Diego Rincón ^aff007; Javier Salmerón ^aff008; Beatriz Mateos-Muñoz ^aff009; Antoni Jou ^aff010; Benjamín Polo-Lorduy ^aff011; Ángel Rubín ^aff012; Ana Escarda ^aff013; Patricia Aguilar ^aff014; Teresa Aldamiz-Echevarría ^aff015; Luisa García-Buey ^aff016; José A. Carrión ^aff017; Manuel Hernández-Guerra ^aff018; Sonia Chimeno-Hernández ^aff019; Nuria Espinosa ^aff020; Rosa Mª Morillas ^aff021; Raúl J. Andrade ^aff022; Manuel Delgado ^aff023; Adolfo Gallego ^aff024; Marta Magaz ^aff025; José María Moreno-Planas ^aff026; Ángel Estébanez ^aff027; Mikel Rico ^aff028; Fernando Menéndez ^aff029; Blanca Sampedro ^aff030; Luís Morano ^aff031; Sonia Izquierdo ^aff032; José Manuel Zozaya ^aff033; Manuel Rodríguez ^aff034; Senador Morán-Sánchez ^aff035; Sara Lorente ^aff036; Ignacio Martín-Granizo ^aff037; Miguel Ángel Von-Wichmann ^aff038; Marcial Delgado ^aff039; Amanda Manzanares ^aff040
Působiště autorů: Hepatology Department, Hospital Universitario Virgen del Rocío, Sevilla, Sevilla, Spain ^aff001; Hepatology Unit, Digestive Disease Department, Parc Taulí Sabadell Hospital Universitari, Sabadell, Barcelona, Spain, CIBERehd, Instituto Carlos III, Madrid, Spain ^aff002; HIV Unit, Hospital Universitario 12 de Octubre, imas12, Universidad Complutense de Madrid (UCM), Madrid, Spain ^aff003; Hepatology Department, Hospital Universitario Río Hortega, Valladolid, Valladolid, Spain ^aff004; Hepatology Department, Hospital Universitario Araba, Vitoria-Gasteiz, Álava, Spain ^aff005; Hepatology Department, Hospital General Universitario de Alicante, Alicante, Alicante, Spain ^aff006; Hepatology Department, Hospital General Universitario Gregorio Marañón, CIBERehd and (UCM), Madrid, Spain ^aff007; Hepatology Department, Complejo Hospitalario Universitario de Granada, Granada, Granada, Spain ^aff008; Hepatology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain ^aff009; HIV Clinical Unit, Internal Medicine Department and Fundació de la Lluita contra la SIDA, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Barcelona, Spain ^aff010; Hepatology Department, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain ^aff011; Hepatology Department, Hospital Universitario y Politécnico de La Fe, Valencia, Valencia, Spain ^aff012; Hepatology Department, Hospital Universitario Son Espases, Palma de Mallorca, Spain ^aff013; Digestive System Clinical Unit, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Hospital Universitario Reina Sofía/Córdoba University, Córdoba, Spain ^aff014; Infectious Diseases-HIV, Hospital General Universitario Gregorio Marañón (IiSGM), Madrid, Madrid, Spain ^aff015; Hepatology Department, Hospital Universitario de La Princesa, Madrid, Spain ^aff016; Liver Section, Gastroenterology Department, Hospital del Mar, IMIM (Hospital del Mar Medical Research Institute), UAB (Universitat Autonoma de Barcelona) Barcelona, Spain ^aff017; Hepatology Department, Hospital Universitario de Canarias, La Laguna, Santa Cruz de Tenerife, Spain ^aff018; Hepatology Department, Hospital Arnau de Vilanova, Valencia, Valencia, Spain ^aff019; Clinical Unit of Infectious Diseases, Microbiology and Preventive Medicine, Infectious Diseases Research Group, Institute of Biomedicine of Seville (IBiS), University of Seville/CSIC,Sevilla, Spain ^aff020; Liver Section, Department of Gastroenterology, Hospital Universitari Germans Trias i Pujol, IGTP, Badalona, Barcelona, Spain, and CIBEREHD ^aff021; Unidad de Gestión Clínica de Aparato Digestivo, Instituto de Investigación Biomédica de Málaga-IBIMA, Hospital Universitario Virgen de la Victoria, Universidad de Málaga, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas CIBE ^aff022; Hepatology Department, Complejo Hospitalario Universitario A Coruña, A Coruña, Spain ^aff023; Hepatology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Barcelona, Spain ^aff024; Hepatology Department, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain ^aff025; Digestive System Department, Complejo Hospitalario Universitario de Albacete, Albacete, Spain ^aff026; Hepatology Department, Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain ^aff027; Infectious Diseases Unit, Hospital Universitario La Paz, Madrid, Spain ^aff028; Hepatology Department, Hospital Universitario Basurto, Bilbao, Vizcaya, Spain ^aff029; Hepatology Department, Hospital Galdakao, Galdakao, Vizcaya, Spain ^aff030; Infectious Diseases Unit, Hospital Universitario Álvaro Cunqueiro, Vigo, Pontevedra, Spain ^aff031; Hepatology Department, Hospital Clínico San Carlos, Madrid, Spain ^aff032; Hepatology Department, Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain ^aff033; Liver Unit, Division of Gastroenterology & Hepatology. Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain ^aff034; Hepatology Department, Hospital General Universitario Santa Lucía, Cartagena, Murcia, Spain ^aff035; Hepatology Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Zaragoza, Spain ^aff036; Department of Gastroenterology, Hospital Universitario Álvaro Cunqueiro, Vigo, Pontevedra, Spain ^aff037; Infectious Diseases Unit, Hospital Universitario Donostia, Donostia, Gipuzkoa, Spain ^aff038; Infectious Diseases Unit, Hospital Regional Universitario de Málaga, Málaga, Spain ^aff039; AbbVie Spain, S.L.U., Madrid, Spain ^aff040
Vyšlo v časopise: PLoS ONE 14(11)
Kategorie: Research Article
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pone.0225061

Souhrn

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<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.

Klíčová slova:

Hepatitis C virus – Cirrhosis – HIV infections – Fibrosis – Co-infections – Spain – Spanish people

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