1. 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
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Senador Morán-Sánchez, Ignacio Santos, María J. Devesa-Medina, Montserrat Laguno, Carme Baliellas, Adriana Ahumada, Mercè Roget, Benjamín Polo-Lorduy, Lucia Bonet, Isabel Carmona, Javier García-Samaniego, Miguel A. Serra, Amanda Manzanares, María Luisa Montes, Francisco Gea-Rodríguez, Teresa Aldámiz-Echevarría, Guillermina Barril, Manuel Delgado, Marta Montero-Alonso, María Laura Gutiérrez, Raquel Muñoz-Gómez, Salvador Benlloch, Carmen A. Navascués, Juan Emilio Losa, Angeles Castro, Cristina de Álvaro, Luisa García-Buey, Antonio Rivero, Josep Mallolas, Mar Riveiro-Barciela, Ignacio Martín-Granizo, Manuel Castaño, Maria Carlota Londoño, Emilio González-Parra, Luis Morano, Miguel Jiménez-Pérez, [Londoño MC] Liver Unit, Hospital Clínic/IDIBAPS, Barcelona, Spain. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERhed), Instituto de Salud Carlos III, Madrid, Spain. [Riveiro-Barciela M] Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERhed), Instituto de Salud Carlos III, Madrid, Spain. Servei de Medicina Interna, Unitat de Malalties Hepàtiques, Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Ahumada A] Department of Gastroenterology, Hospital General Universitario Gregorio Marañón, Madrid, Spain. [Muñoz-Gómez R] Department of Gastroenterology, Hospital General Universitario 12 de Octubre, Madrid, Spain. [Roget M] Liver Unit, Consorci Sanitari de Terrassa, Terrassa, Barcelona, Spain. [Devesa-Medina MJ] Department of Gastroenterology, Hospital Universitario Clínico San Carlos, Madrid, Spain, and Vall d'Hebron Barcelona Hospital Campus
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Male ,medicine.medical_treatment ,HIV Infections ,Hepacivirus ,0302 clinical medicine ,Infections::Virus Diseases::Hepatitis, Viral, Human::Hepatitis C::Hepatitis C, Chronic [DISEASES] ,ribavirina ,2-Naphthylamine ,mediana edad ,virosis::infecciones por virus ARN::infecciones por Retroviridae::infecciones por Lentivirus::infecciones por VIH [ENFERMEDADES] ,anciano ,Sulfonamides ,Coinfection ,farmacoterapia ,Liver Diseases ,virus diseases ,Valine ,Infeccions per VIH - Tractament ,Cirrhosis ,Nephrology ,drug therapy ,Medicine ,030211 gastroenterology & hepatology ,Drug Therapy, Combination ,insuficiencia renal ,medicine.medical_specialty ,virosis::hepatitis viral humana::hepatitis C::hepatitis C crónica [ENFERMEDADES] ,Genotype ,Proline ,Science ,compuestos macrocíclicos ,Surgical and Invasive Medical Procedures ,Gastroenterology and Hepatology ,Antiviral Agents ,Microbiology ,Urinary System Procedures ,Peritoneal dialysis ,03 medical and health sciences ,Drug Therapy ,Humans ,Lost to follow-up ,Renal Insufficiency, Chronic ,Uracil ,Aged ,Retrospective Studies ,Flaviviruses ,anilidas ,Organisms ,Organ Transplantation ,medicine.disease ,digestive system diseases ,Regimen ,chemistry ,HIV-1 ,Malalties del ronyó ,Carbamates ,genotipo ,Cyclopropanes ,RNA viruses ,antivíricos ,Sustained Virologic Response ,Physiology ,humanos ,chemistry.chemical_compound ,Chronic Kidney Disease ,Medicine and Health Sciences ,Renal Transplantation ,Anilides ,Renal Insufficiency ,030212 general & internal medicine ,Pathology and laboratory medicine ,coinfección ,Multidisciplinary ,Kidney diseases ,Hepatitis C virus ,Infections::Infections::Virus Diseases::RNA Virus Infections::Retroviridae Infections::Lentivirus Infections::Infections::Virus Diseases::HIV Infections [DISEASES] ,resultado del tratamiento ,Infections::Coinfection [DISEASES] ,Middle Aged ,Medical microbiology ,Hepatitis C ,Treatment Outcome ,Infectious Diseases ,Tolerability ,Research Design ,carbamatos ,Viruses ,Female ,Hemodialysis ,Pathogens ,VIH-1 ,Research Article ,Glomerular Filtration Rate ,Macrocyclic Compounds ,Clinical Research Design ,Lactams, Macrocyclic ,Research and Analysis Methods ,sulfonamidas ,Renal Dialysis ,Internal medicine ,Ribavirin ,Medical Dialysis ,medicine ,Dialysis ,Transplantation ,Renal Physiology ,tratamiento farmacológico ,Ritonavir ,Biology and life sciences ,business.industry ,estudios retrospectivos ,Viral pathogens ,Hepatitis C, Chronic ,Hepatitis viruses ,Microbial pathogens ,enfermedades parasitarias::coinfección [ENFERMEDADES] ,Spain ,diálisis renal ,Co-Infections ,Physical therapy ,infecciones por VIH ,Adverse Events ,business ,Hepatitis C - Tractament ,uracilo ,Kidney disease - Abstract
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 (R), 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., MCL has served as consultant for AbbVie, MSD, Janssen, BMS and Gilead; MRB has received grant research from Gilead Science, and speaker fees from AbbVie, Gilead and MSD; MR has received speaker fees from AbbVie; MD has received grant support and consultancy fees from AbbVie, Bayer, Bristol-Myers Squibb, Gilead and Merck, Sharp & Dhome; FGR has served as speaker for AbbVie, Gilead and BMS; MLM has served as a speaker for AbbVie, BMS, Gilead, Janssen, MSD and ViiV; as a consultant for AbbVie, BMS and Janssen and has received research funding from FIPSE 36465/03, FIPSE 36680/07.-NEAT IG5 (NEAT is a project funded by the European Union under the 6th Framework programme) contract number LSHP-CT-2006-037570; MAC has served as a consultant for Gilead and and ViiV healthcare, and has received speaker fees from Janssens, Gilead, ViiV Healthcare; MMA reports personal fees from ViiV Healthcare, Gilead Sciences, Merck, Janssen, AbbVie and ABBOTT Laboratories, outside the submitted work; AR has received consultancy and speaker fees from AbbVie, Gilead Sciences and Merck Sharp & Dohme; JM has received honoraria, speaker fees, consultant fees or funds for research from AbbVie, BMS, Boehringer-Ingelheim, Gilead, Janssen, MSD, Roche and ViiV; EGP has received speaker fees from AbbVie and Gilead; LGB has served as consultant for AbbVie and Intercept and has received speaker fees from Gilead and MSD; AA, RMG, CB, TAE, MLG, BPL, IC, SB, LB, JGS, MJP, IMG, LM, IdlS, ML and JEL don't have a financial interest or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this paper; CdA and AM are paid employees of AbbVie and may hold stock or options. The specific roles of these authors are articulated in the 'author contributions' section. The design, study conduct, and financial support for the study were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the manuscript.
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- 2019