Efficacy and safety of direct-acting antiviral agents for HCV in mild-to-moderate chronic kidney disease |
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| Affiliation: | 1. Hepatology Section, Department of Medicine, Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno “CEMIC”, Ciudad Autonoma de Buenos Aires, Argentina;2. Hepatology and Liver Transplant Unit, Hospital Universitario Austral, Pilar, Provincia de Buenos Aires, Argentina;3. Latin American Liver Research, Educational and Awareness Network (LALREAN), Pilar, Provincia de Buenos Aires, Argentina;4. Nephrology Department, La Mancha-Centro Hospital, Alcázar de San Juan, Ciudad Real, Spain;5. Gastroenterology and Hepatology Department, La Mancha-Centro Hospital, Alcázar de San Juan, Ciudad Real, Spain;6. Division of Gastroenterology, Hepatology and Parenteral Nutrition, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA;7. Division of Nephrology, Maggiore Hospital and IRCCS Foundation, Milano, Italy |
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| Abstract: | Background and aimsThe 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.MethodsWe 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 <15 IU/mL, 12 weeks after treatment ended) (SVR12). We collected data on on-treatment adverse events (AEs), severe AEs, and laboratory abnormalities.ResultsThe average baseline eGFR (CKD-EPI equation) was 70.06 ± 20.1 mL/min/1.72 m2; 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%).ConclusionsAll-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. |
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| Keywords: | Adverse effects Antiviral agents Hepatitis C Kidney failure Sustained virologic response Efectos adversos Antivíricos Hepatitis C Insuficiencia renal Respuesta virológica sostenida |
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