PMID- 31229261
OWN - NLM
STAT- MEDLINE
DCOM- 20210310
LR  - 20220909
IS  - 2013-2514 (Electronic)
IS  - 2013-2514 (Linking)
VI  - 40
IP  - 1
DP  - 2020 Jan-Feb
TI  - Efficacy and safety of direct-acting antiviral agents for HCV in mild-to-moderate 
      chronic kidney disease.
PG  - 46-52
LID - S0211-6995(19)30096-7 [pii]
LID - 10.1016/j.nefro.2019.03.013 [doi]
AB  - BACKGROUND AND AIMS: The advent of direct-acting antiviral agents promises to 
      change the management of hepatitis C virus infection (HCV) in patients with 
      chronic kidney disease (CKD), a patient group in which the treatment of hepatitis 
      C was historically challenging. We investigated the safety and efficacy of 
      all-oral, interferon-free direct-acting antiviral agents for the treatment of 
      hepatitis C in a 'real-world' cohort of patients with CKD. METHODS: We performed 
      an observational single-arm multi-centre study in a large (n=198) cohort of 
      patients with stage 1-3 CKD who underwent antiviral therapy with DAAs for the 
      treatment of HCV. The primary end-point was sustained virologic response (serum 
      HCV RNA <15IU/mL, 12 weeks after treatment ended) (SVR12). We collected data on 
      on-treatment adverse events (AEs), severe AEs, and laboratory abnormalities. 
      RESULTS: The average baseline eGFR (CKD-EPI equation) was 
      70.06+/-20.1mL/min/1.72m(2); the most common genotype was HCV 1b (n=93, 51%). 
      Advanced liver scarring was found in 58 (46%) patients by transient elastography. 
      Five regimens were adopted: elbasvir/grazoprevir (n=5), glecaprevir/pibrentasvir 
      (n=4), ritonavir-boosted paritaprevir/ombitasvir/dasabuvir (PrOD) regimen (n=40), 
      simeprevir+/-daclatasvir (n=2), and sofosbuvir-based combinations (n=147). The 
      SVR12 rate was 95.4% (95% CI, 93.8%; 96.8%). There were nine virological failures 
      - eight being relapsers. Adverse events occurred in 30% (51/168) of patients, and 
      were managed clinically without discontinuation of therapy or hospitalization. 
      One of the most common AEs was anaemia (n=12), which required discontinuation or 
      dose reduction of ribavirin in some cases (n=6); deterioration of kidney function 
      occurred in three (1.7%). CONCLUSIONS: All-oral, interferon-free therapy with 
      DAAs for chronic HCV in mild-to-moderate CKD was effective and well-tolerated in 
      a 'real-world' clinical setting. Studies are in progress to address whether 
      sustained viral response translates into better survival in this population.
CI  - Copyright (c) 2019. Published by Elsevier Espana, S.L.U.
FAU - Ridruejo, Ezequiel
AU  - Ridruejo E
AD  - Hepatology Section, Department of Medicine, Centro de Educacion Medica e 
      Investigaciones Clinicas Norberto Quirno "CEMIC", Ciudad Autonoma de Buenos 
      Aires, Argentina; Hepatology and Liver Transplant Unit, Hospital Universitario 
      Austral, Pilar, Provincia de Buenos Aires, Argentina; Latin American Liver 
      Research, Educational and Awareness Network (LALREAN), Pilar, Provincia de Buenos 
      Aires, Argentina.
FAU - Garcia-Agudo, Rebeca
AU  - Garcia-Agudo R
AD  - Nephrology Department, La Mancha-Centro Hospital, Alcazar de San Juan, Ciudad 
      Real, Spain.
FAU - Mendizabal, Manuel
AU  - Mendizabal M
AD  - Hepatology and Liver Transplant Unit, Hospital Universitario Austral, Pilar, 
      Provincia de Buenos Aires, Argentina; Latin American Liver Research, Educational 
      and Awareness Network (LALREAN), Pilar, Provincia de Buenos Aires, Argentina.
FAU - Aoufi-Rabih, Sami
AU  - Aoufi-Rabih S
AD  - Gastroenterology and Hepatology Department, La Mancha-Centro Hospital, Alcazar de 
      San Juan, Ciudad Real, Spain.
FAU - Dixit, Vivek
AU  - Dixit V
AD  - Division of Gastroenterology, Hepatology and Parenteral Nutrition, Department of 
      Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
FAU - Silva, Marcelo
AU  - Silva M
AD  - Hepatology and Liver Transplant Unit, Hospital Universitario Austral, Pilar, 
      Provincia de Buenos Aires, Argentina; Latin American Liver Research, Educational 
      and Awareness Network (LALREAN), Pilar, Provincia de Buenos Aires, Argentina.
FAU - Fabrizi, Fabrizio
AU  - Fabrizi F
AD  - Division of Nephrology, Maggiore Hospital and IRCCS Foundation, Milano, Italy. 
      Electronic address: fabrizi@policlinico.mi.it.
LA  - eng
LA  - spa
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20190619
PL  - Spain
TA  - Nefrologia (Engl Ed)
JT  - Nefrologia
JID - 101778581
RN  - 0 (Amides)
RN  - 0 (Anilides)
RN  - 0 (Antiviral Agents)
RN  - 0 (Benzimidazoles)
RN  - 0 (Benzofurans)
RN  - 0 (Carbamates)
RN  - 0 (Cyclopropanes)
RN  - 0 (Drug Combinations)
RN  - 0 (Imidazoles)
RN  - 0 (Lactams, Macrocyclic)
RN  - 0 (Pyrrolidines)
RN  - 0 (Quinoxalines)
RN  - 0 (Sulfonamides)
RN  - 0 (glecaprevir and pibrentasvir)
RN  - 2302768XJ8 (ombitasvir)
RN  - 4O2AB118LA (grazoprevir)
RN  - 56HH86ZVCT (Uracil)
RN  - 632L571YDK (elbasvir)
RN  - 9DLQ4CIU6V (Proline)
RN  - 9WS5RD66HZ (Simeprevir)
RN  - CKR7XL41N4 (2-Naphthylamine)
RN  - DE54EQW8T1 (dasabuvir)
RN  - HG18B9YRS7 (Valine)
RN  - LI2427F9CI (daclatasvir)
RN  - O3J8G9O825 (Ritonavir)
RN  - OU2YM37K86 (paritaprevir)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
MH  - 2-Naphthylamine
MH  - Amides/therapeutic use
MH  - Anilides/therapeutic use
MH  - Antiviral Agents/adverse effects/*therapeutic use
MH  - Benzimidazoles/therapeutic use
MH  - Benzofurans/therapeutic use
MH  - Carbamates/therapeutic use
MH  - Cyclopropanes/therapeutic use
MH  - Drug Combinations
MH  - Drug Therapy, Combination
MH  - Female
MH  - Genotype
MH  - Hepacivirus/genetics
MH  - Hepatitis C/complications/*drug therapy
MH  - Humans
MH  - Imidazoles/therapeutic use
MH  - Lactams, Macrocyclic/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Proline/analogs & derivatives/therapeutic use
MH  - Pyrrolidines/therapeutic use
MH  - Quinoxalines/therapeutic use
MH  - Renal Insufficiency, Chronic/*complications
MH  - Ritonavir/therapeutic use
MH  - Simeprevir/therapeutic use
MH  - Sofosbuvir/therapeutic use
MH  - Sulfonamides/therapeutic use
MH  - Sustained Virologic Response
MH  - Uracil/analogs & derivatives/therapeutic use
MH  - Valine/analogs & derivatives/therapeutic use
OTO - NOTNLM
OT  - Adverse effects
OT  - Antiviral agents
OT  - Antiviricos
OT  - Efectos adversos
OT  - Hepatitis C
OT  - Insuficiencia renal
OT  - Kidney failure
OT  - Respuesta virologica sostenida
OT  - Sustained virologic response
EDAT- 2019/06/24 06:00
MHDA- 2021/03/11 06:00
CRDT- 2019/06/24 06:00
PHST- 2018/12/20 00:00 [received]
PHST- 2019/03/23 00:00 [revised]
PHST- 2019/03/26 00:00 [accepted]
PHST- 2019/06/24 06:00 [pubmed]
PHST- 2021/03/11 06:00 [medline]
PHST- 2019/06/24 06:00 [entrez]
AID - S0211-6995(19)30096-7 [pii]
AID - 10.1016/j.nefro.2019.03.013 [doi]
PST - ppublish
SO  - Nefrologia (Engl Ed). 2020 Jan-Feb;40(1):46-52. doi: 10.1016/j.nefro.2019.03.013. 
      Epub 2019 Jun 19.