dc.contributor | Vall d'Hebron Barcelona Hospital Campus |
dc.contributor.author | Londoño, María-Carlota |
dc.contributor.author | Riveiro Barciela, Maria del Mar |
dc.contributor.author | Ahumada, Adriana |
dc.contributor.author | Muñoz-Gómez, Raquel |
dc.contributor.author | Roget, Mercé |
dc.contributor.author | Devesa-Medina, María J. |
dc.date.accessioned | 2020-08-03T09:34:17Z |
dc.date.available | 2020-08-03T09:34:17Z |
dc.date.issued | 2019-09-24 |
dc.identifier.citation | Londoño MC, Riveiro-Barciela M, Ahumada A, Muñoz-Gómez R, Roget M, Devesa-Medina MJ, et al. 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. PLoS One. 2019 Sep 24;14(9):e0221567. |
dc.identifier.issn | 1932-6203 |
dc.identifier.uri | https://hdl.handle.net/11351/5132 |
dc.description | HIV and Hepatitis C Coinfection; Chronic Renal Failure; Ribavirin |
dc.description.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®, 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. |
dc.language.iso | eng |
dc.publisher | Public Library of Science |
dc.relation.ispartofseries | PLoS One;14(9) |
dc.rights | Attribution 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ |
dc.source | Scientia |
dc.subject | Infeccions per VIH - Tractament |
dc.subject | Hepatitis C - Tractament |
dc.subject.mesh | Coinfection |
dc.subject.mesh | /drug therapy |
dc.subject.mesh | Hepatitis C, Chronic |
dc.subject.mesh | HIV Infections |
dc.title | 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 |
dc.type | info:eu-repo/semantics/article |
dc.identifier.doi | 10.1371/journal.pone.0221567 |
dc.subject.decs | coinfección |
dc.subject.decs | /tratamiento farmacológico |
dc.subject.decs | hepatitis C crónica |
dc.subject.decs | infecciones por VIH |
dc.relation.publishversion | https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0221567 |
dc.type.version | info:eu-repo/semantics/publishedVersion |
dc.audience | Professionals |
dc.contributor.authoraffiliation | [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 |
dc.identifier.pmid | 31550267 |
dc.identifier.wos | 000532307700007 |
dc.rights.accessrights | info:eu-repo/semantics/openAccess |