PMID- 33684523 OWN - NLM STAT- MEDLINE DCOM- 20220315 LR - 20220315 IS - 1665-2681 (Print) IS - 1665-2681 (Linking) VI - 25 DP - 2021 Nov-Dec TI - 'Real-life' experience with direct-acting antiviral agents for HCV after kidney transplant. PG - 100337 LID - S1665-2681(21)00036-3 [pii] LID - 10.1016/j.aohep.2021.100337 [doi] AB - INTRODUCTIONS AND OBJECTIVES: The introduction of direct-acting antiviral (DAA) agents promises to change dramatically the management of hepatitis C in kidney transplant recipients, a patient group where the treatment of hepatitis C is historically challenging. The purpose of the current study was to assess (in a 'real-life' setting) the safety and efficacy of all-oral, interferon-free, direct-acting antiviral agents in kidney transplant recipients with HCV. MATERIAL AND METHODS: We performed a single-arm, multi-center study in a cohort (n = 95) of kidney transplant recipients who underwent antiviral therapy with DAAs. The primary end-point was sustained virologic response (SVR) (serum HCV RNA < 15 IU/mL, 12 weeks after treatment ended; SVR12). We recorded data on on-treatment adverse events (AEs), serious AEs, and laboratory abnormalities. RESULTS: Various regimens were adopted at the discretion of the treating physician: elbasvir/grazoprevir (n = 11), paritaprevir/ritonavir/ombitasvir/dasabuvir (PrOD) regimens +/- ribavirin (n = 23), and sofosbuvir-based regimens +/- ribavirin (n = 61). The SVR12 rate was 93.7% (89/95) (95% CI, 88%; 98%), according to intention-to-treat analysis; three patients without viral response (n = 3) were found. Ribavirin was administered in 8 (8.4%) allograft recipients. The frequency of drop-outs was 4.2% (4/95) (95% CI, 0.2%; 8.2%); these were related to arthralgia/myalgia (n = 2), fatigue (n = 1), and lowered estimated glomerular filtration rate (eGFR) (n = 1). There were no differences with regard to serum creatinine and eGFR before and after antiviral therapy and during follow-up in the whole cohort. The patient who interrupted antiviral treatment due to raised serum creatinine was on sofosbuvir/daclatasvir regimen; one of the four drop-outs obtained SVR. CONCLUSIONS: All-oral, interferon-free therapy with DAAs for chronic HCV after kidney transplantation was effective and well-tolerated in a 'real-life' clinical setting. Identical results have been observed in patients with intact kidneys or advanced chronic kidney disease. Careful evaluation of kidney function over follow-up in kidney transplant recipients who received DAAs regimens is recommended. Clinical trials aimed to assess whether sustained viral response translates into improved patient/graft survival are under way. CI - Copyright (c) 2021 AEDV. Published by Elsevier Espana, S.L.U. All rights reserved. FAU - Fabrizi, Fabrizio AU - Fabrizi F AD - Nephrology Division, IRCCS Ca' Granda Foundation and Maggiore Policlinico Hospital, Milano, Italy. Electronic address: fabrizio.fabrizi@policlinico.mi.it. FAU - Alonso, Cristina AU - Alonso C AD - Hepatology and Liver Transplant Unit, Hospital Universitario Austral, Pilar, Provincia de Buenos Aires, Argentina. FAU - Palazzo, Ana AU - Palazzo A AD - Gastroenterology and Hepatology Division, Hospital Padilla, Tucuman, Argentina. FAU - Anders, Margarita AU - Anders M AD - Gastroenterology and Hepatology Division, Hospital Aleman, Ciudad de Buenos Aires, Argentina. FAU - Reggiardo, Maria Virginia AU - Reggiardo MV AD - Gastroenterology and Hepatology Division, Hospital Provincial del Centenario, Rosario, Argentina. FAU - Cheinquer, Hugo AU - Cheinquer H AD - Gastroenterology and Hepatology Division, Universidad de Federal do Rio Grande do Sul, Porto Alegre, Brazil. FAU - Zuain, Maria Grazia Videla AU - Zuain MGV AD - Gastroenterology and Hepatology Division, Hospital Zubizarreta, Ciudad de Buenos Aires, Argentina. FAU - Figueroa, Sebastian AU - Figueroa S AD - Gastroenterology and Hepatology Division, Hospital Arturo Onativia, Salta, Argentina. FAU - Mendizabal, Manuel AU - Mendizabal M AD - Hepatology and Liver Transplant Unit, Hospital Universitario Austral, Pilar, Provincia de Buenos Aires, Argentina. FAU - Silva, Marcelo AU - Silva M AD - Hepatology and Liver Transplant Unit, Hospital Universitario Austral, Pilar, Provincia de Buenos Aires, Argentina. FAU - Ridruejo, Ezequiel AU - Ridruejo E AD - Hepatology and Liver Transplant Unit, Hospital Universitario Austral, Pilar, Provincia de Buenos Aires, Argentina; Hepatology Section, Department of Medicine, Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno "CEMIC", Ciudad Autonoma de Buenos Aires, Argentina. CN - Latin American Liver Research, Educational and Awareness Network (LALREAN) LA - eng PT - Journal Article PT - Multicenter Study DEP - 20210305 PL - Mexico TA - Ann Hepatol JT - Annals of hepatology JID - 101155885 RN - 0 (Anilides) RN - 0 (Antiviral Agents) RN - 0 (Benzofurans) RN - 0 (Cyclopropanes) RN - 0 (Drug Combinations) RN - 0 (Imidazoles) RN - 0 (Lactams, Macrocyclic) RN - 0 (Quinoxalines) RN - 0 (Sulfonamides) RN - 0 (elbasvir-grazoprevir drug combination) RN - 2302768XJ8 (ombitasvir) RN - 49717AWG6K (Ribavirin) RN - 56HH86ZVCT (Uracil) RN - 9DLQ4CIU6V (Proline) RN - AYI8EX34EU (Creatinine) RN - CKR7XL41N4 (2-Naphthylamine) RN - DE54EQW8T1 (dasabuvir) RN - HG18B9YRS7 (Valine) RN - O3J8G9O825 (Ritonavir) RN - OU2YM37K86 (paritaprevir) RN - WJ6CA3ZU8B (Sofosbuvir) SB - IM MH - 2-Naphthylamine/therapeutic use MH - Administration, Oral MH - Adult MH - Aged MH - Anilides/therapeutic use MH - Antiviral Agents/*therapeutic use MH - Benzofurans MH - Cohort Studies MH - Creatinine/blood MH - Cyclopropanes/therapeutic use MH - Drug Combinations MH - Female MH - Glomerular Filtration Rate MH - Hepatitis C/complications/*drug therapy/pathology MH - Humans MH - Imidazoles MH - *Kidney Transplantation MH - Lactams, Macrocyclic/therapeutic use MH - Male MH - Middle Aged MH - Proline/analogs & derivatives/therapeutic use MH - Quinoxalines MH - Ribavirin/therapeutic use MH - Ritonavir/therapeutic use MH - Sofosbuvir/therapeutic use MH - Sulfonamides/therapeutic use MH - *Sustained Virologic Response MH - Uracil/analogs & derivatives/therapeutic use MH - Valine/therapeutic use OTO - NOTNLM OT - Antiviral agents OT - Chronic kidney disease OT - Hepatitis C OT - Kidney transplant OT - Viral response EDAT- 2021/03/09 06:00 MHDA- 2022/03/16 06:00 CRDT- 2021/03/08 20:11 PHST- 2021/01/11 00:00 [received] PHST- 2021/02/17 00:00 [revised] PHST- 2021/02/18 00:00 [accepted] PHST- 2021/03/09 06:00 [pubmed] PHST- 2022/03/16 06:00 [medline] PHST- 2021/03/08 20:11 [entrez] AID - S1665-2681(21)00036-3 [pii] AID - 10.1016/j.aohep.2021.100337 [doi] PST - ppublish SO - Ann Hepatol. 2021 Nov-Dec;25:100337. doi: 10.1016/j.aohep.2021.100337. Epub 2021 Mar 5.