Tratamientos basados en sofosbuvir en la infección por el VHC en la enfermedad renal crónica en estadio 4 o estadio 5. Una revisión sistemática con metaanálisis

Translated title of the contribution: Sofosbuvir-based regimens for HCV in stage 4–stage 5 chronic kidney disease. A systematic review with meta-analysis

Fabrizio Fabrizi, Roberta Cerutti, Vivek Dixit, Ezequiel Ridruejo

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Hepatitis C is an important agent of liver damage in patients with chronic kidney disease and the advent of DAAs has dramatically changed the management of HCV positive patients, including those with advanced CKD. Sofosbuvir is the backbone of many anti-HCV regimens based on DAAs but it remains unclear whether it is appropriate for HCV-infected patients with stage 4–5 CKD. Study aims and design: We performed a systematic review of the literature with a meta-analysis of clinical studies in order to evaluate the efficacy and safety of SOF-based DAA regimens in patients with stage 4–5 CKD. The primary outcome was sustained viral response (as a measure of efficacy); the secondary outcomes were the frequency of SAEs and drop-outs due to AEs (as measures of tolerability). The random-effects model of DerSimonian and Laird was adopted, with heterogeneity and stratified analyses. Results: Thirty clinical studies (n = 1537 unique patients) were retrieved. The pooled SVR12 and SAEs rate was 0.99 (95% confidence intervals, 0.97; 1.0, I2 = 99.8%) and 0.09 (95% CI, 0.05; 0.13, I2 = 84.3%), respectively. The pooled SVR12 rate in studies with high HCV RNA levels at baseline was lower, 0.87 (95% CI, 0.75; 1.0, I2 = 73.3%) (P < 0.001). The pooled drop-out rate due to AEs was 0.02 (95% CI, −0.01; 0.04, I2 = 16.1%). Common serious adverse events were anemia (n = 26, 38%) and reduced eGFR (n = 14, 19%). SAEs were more common in studies adopting full-dose sofosbuvir (pooled rate of SAEs 0.15, 95% CI, 0.06; 0.25; I2 = 80.1%) and in those based on ribavirin (0.15, 95% CI, 0.07; 0.23, I2 = 95.8%). Six studies (n = 69 patients) reported eGFR levels at baseline/post- antiviral therapy; no consistent changes were found. Conclusions: SOF-based regimens appear safe and effective in patients with stage 4–5 CKD. Serum creatinine should be carefully monitored during therapy with SOF in patients with CKD. Randomized controlled studies in order to expand our knowledge on this point are under way.

Translated title of the contributionSofosbuvir-based regimens for HCV in stage 4–stage 5 chronic kidney disease. A systematic review with meta-analysis
Original languageSpanish
Pages (from-to)578-589
Number of pages12
JournalNefrologia
Volume41
Issue number5
DOIs
Publication statusPublished - Sep 1 2021

Keywords

  • Adverse events
  • Dialysis
  • Direct-acting antivirals
  • Hepatitis C
  • Sofosbuvir
  • Virological response

ASJC Scopus subject areas

  • Nephrology

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