Effectiveness, safety/tolerability of OBV/PTV/r ± DSV in patients with HCV genotype 1 or 4 with/without HIV-1 co-infection, chronic kidney disease (CKD) stage IIIb-V and dialysis in Spanish clinical practice – Vie-KinD study


Autoři: María-Carlota Londoño aff001;  Mar Riveiro-Barciela aff002;  Adriana Ahumada aff004;  Raquel Muñoz-Gómez aff005;  Mercé Roget aff006;  María J. Devesa-Medina aff007;  Miguel Ángel Serra aff008;  Carmen A. Navascués aff009;  Carme Baliellas aff010;  Teresa Aldamiz-Echevarría aff011;  María L. Gutiérrez aff012;  Benjamín Polo-Lorduy aff013;  Isabel Carmona aff014;  Salvador Benlloch aff002;  Lucía Bonet aff016;  Javier García-Samaniego aff002;  Miguel Jiménez-Pérez aff018;  Senador Morán-Sánchez aff019;  Ángeles Castro aff020;  Manuel Delgado aff020;  Francisco Gea-Rodríguez aff002;  Ignacio Martín-Granizo aff022;  María Luisa Montes aff023;  Luís Morano aff024;  Manuel A. Castaño aff018;  Ignacio de los Santos aff025;  Montserrat Laguno aff026;  Juan Emilio Losa aff027;  Marta Montero-Alonso aff028;  Antonio Rivero aff029;  Cristina de Álvaro aff030;  Amanda Manzanares aff030;  Josep Mallolas aff026;  Guillermina Barril aff031;  Emilio González-Parra aff032;  Luisa García-Buey aff033
Působiště autorů: Liver Unit, Hospital Clínic/IDIBAPS, Barcelona, Barcelona, Spain aff001;  Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERhed), Instituto de Salud Carlos III, Madrid, Madrid, Spain aff002;  Liver Unit, Internal Medicine Department, Hospital Vall d'Hebron, Barcelona, Barcelona, Spain aff003;  Department of Gastroenterology, Hospital General Universitario Gregorio Marañón, Madrid, Madrid, Spain aff004;  Department of Gastroenterology, Hospital General Universitario 12 de Octubre, Madrid, Madrid, Spain aff005;  Liver Unit, Consorci Sanitari de Terrassa, Terrassa, Barcelona, Spain aff006;  Department of Gastroenterology, Hospital Universitario Clínico San Carlos, Madrid, Madrid, Spain aff007;  Digestive Medicine Service, Hospital Clínico Universitario de Valencia, Universidad de Valencia, Valencia, Spain aff008;  Department of Gastroenterology, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain aff009;  Liver Unit, Hospital de Bellvitge, Institut d'Investigació Biomèdica de Bellvitge, University of Barcelona, L'Hospitalet de Llobregat, Barcelona, Spain aff010;  Infectious Diseases-HIV Hospital General Universitario Gregorio Marañón (IiSGM), Madrid, Madrid, Spain aff011;  Department of Gastroenterology, Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain aff012;  Digestive Diseases Unit, Hospital Universitario Fundación Jiménez Díaz, Madrid, Madrid, Spain aff013;  Digestive Disease Unit, Hospital Universitario Virgen Macarena, Sevilla, Sevilla, Spain aff014;  Department of Hepatology, Hospital Universitario y Politécnico La Fe, Valencia, Valencia, Spain aff015;  Department of Gastroenterology, Hospital Universitario Son Espases, Palma de Mallorca, Mallorca, Spain aff016;  Liver Unit, Hospital Universitario La Paz/IdiPaz, Madrid, Madrid, Spain aff017;  Hospital Regional Universitario de Málaga, Málaga, Spain aff018;  Hospital General Universitario Santa Lucía, Cartagena, Murcia, Spain aff019;  Complejo Hospitalario Universitario A Coruña, A Coruña, Spain aff020;  Department of Gastroenterology, Hospital Universitario Ramón y Cajal, Madrid, Madrid, Spain aff021;  Department of Gastroenterology, Hospital Universitario Álvaro Cunqueiro, Vigo, Pontevedra, Spain aff022;  HIV Unit, Hospital Universitario La Paz/IdiPaz, Madrid, Madrid, Spain aff023;  Infectious Disease Unit, Internal Medicine Department, Hospital Universitario Álvaro Cunqueiro, Vigo, Pontevedra, Spain aff024;  Department of Internal Medicine, Hospital Universitario La Princesa, Madrid, Madrid, Spain aff025;  HIV Unit, Infectious Diseases Service, Hospital Clínic/IDIBAPS, Barcelona, Barcelona, Spain aff026;  Infectious Diseases Unit, Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain aff027;  Infectious Diseases Unit, Hospital Universitario y Politécnico La Fe, Valencia, Valencia, Spain aff028;  Infectious Diseases Unit, Hospital Universitario Reina Sofía de Córdoba, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Universidad de Córdoba, Córdoba, Spain aff029;  Medical Department & Quality Assurance, ABBVIE, Madrid, Madrid, Spain aff030;  Nephrology Unit, Hospital Universitario La Princesa, Madrid, Madrid, Spain aff031;  Nephrology Unit, Hospital Universitario Fundación Jiménez Díaz, Madrid, Madrid, Spain aff032;  Liver Unit, Hospital Universitario La Princesa, Madrid, Madrid, Spain aff033
Vyšlo v časopise: PLoS ONE 14(9)
Kategorie: Research Article
doi: 10.1371/journal.pone.0221567

Souhrn

Background and aims

Limited data are available on the effectiveness and tolerability of direct-acting antivirals (DAAs) therapies in the real world for HCV-infected patients with comorbidities. This study aimed to describe the effectiveness of OBV/PTV/r ± DSV (3D/2D regimen) with or without ribavirin (RBV) in HCV or HCV/HIV co-infected patients with GT1/GT4 and CKD (IIIb-V stages), including those under hemodialysis and peritoneal dialysis in routine clinical practice in Spain in 2015.

Material and methods

Non-interventional, retrospective, multicenter data collection study in 31 Spanish sites. Socio-demographic, clinical variables, study treatment characteristics, effectiveness and tolerability data were collected from medical records.

Results

Data from 135 patients with a mean age (SD) of 58.3 (11.4) years were analyzed: 92.6% GT1 (81.6% GT1b and 17.6% GT1a) and 7.4% GT4, 14 (10.4%) HIV/HCV co-infected, 19.0% with fibrosis F3 and 28.1% F4 by FibroScan®, 52.6% were previously treated with pegIFN and RBV. 11.1%, 14.8% and 74.1% of patients had CKD stage IIIb, IV and V respectively. 68.9% of patients were on hemodialysis; 8.9% on peritoneal dialysis and 38.5% had history of renal transplant. A total of 125 (96.2%) of 135 patients were treated with 3D, 10 (7.4%) with 2D and 30.4% received RBV. The overall intention-to-treat (ITT) sustained virologic response at week 12 (SVR12) was 92.6% (125/135) and the overall modified-ITT (mITT) SVR12 was 99.2% (125/126). The SVR12 rates (ITT) per sub-groups were: HCV mono-infected (91.7%), HCV/HIV co-infected (100%), GT1 (92.0%), GT4 (100%), CKD stage IIIb (86.7%), stage IV (95%) and stage V (93%). Among the 10 non-SVR there was only 1 virologic failure (0.7%); 4 patients had missing data due lost to follow up (3.0%) and 5 patients discontinued 3D/2D regimen (3.7%): 4 due to severe adverse events (including 3 deaths) and 1 patient´s decision.

Conclusions

These results have shown that 3D/2D regimens are effective and tolerable in patients with advanced CKD including those in dialysis with GT 1 or 4 chronic HCV mono-infection and HIV/HCV coinfection in a real-life cohort. The overall SVR12 rates were 92.6% (ITT) and 99.2% (mITT) without clinically relevant changes in eGFR until 12 weeks post-treatment. These results are consistent with those reported in clinical trials.

Klíčová slova:

Adverse events – Cirrhosis – Co-infections – Glomerular filtration rate – Hepatitis C virus – Chronic kidney disease – Medical dialysis – Renal transplantation


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