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


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
doi: 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:

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


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