Efficacy and Safety of Sofosbuvir and Ledipasvir for Hepatitis C in Kidney Transplant Recipients: A Single-center Retrospective Observational Study.

Artan A. S., Mirioğlu Ş., İstemihan Z., Aksoy E., Dirim A. B., Çavuş B., ...More

Balkan medical journal, vol.40, no.3, pp.182-187, 2023 (SCI-Expanded) identifier identifier identifier

  • Publication Type: Article / Article
  • Volume: 40 Issue: 3
  • Publication Date: 2023
  • Doi Number: 10.4274/balkanmedj.galenos.2023.2022-10-13
  • Journal Name: Balkan medical journal
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, CAB Abstracts, Central & Eastern European Academic Source (CEEAS), CINAHL, EMBASE, MEDLINE, Veterinary Science Database, Directory of Open Access Journals
  • Page Numbers: pp.182-187
  • Istanbul University Affiliated: Yes


Background: Treatment using direct-acting antivirals provides high rates of sustained virologic response and a favorable safety profile patients with chronic hepatitis C virus infection. However, data on efficacy of direct-acting antivirals in kidney transplant recipients still limited.Aims: To evaluate the safety and efficacy of fixed-dose sofosbuvir/ ledipasvir combination in kidney transplant recipients.Study Design: Retrospective, observational, single-center study. Methods: Data of 29 kidney transplant recipients who received fixed-dose safety and efficacy of fixed-dose sofosbuvir/ledipasvir combination for 12 or 24 weeks with or without ribavirin were analyzed. The primary outcome was SVR12, which was defined as undetectable HCV-RNA levels 12 weeks after the treatment. Secondary outcomes were graft function, proteinuria, and calcineurin inhibitor trough level variability.Results: The predominant hepatitis C virus genotype was 1b (n = 19, 65.6%). All patients achieved SVR12. No graft failures nor deaths were reported during the study period. Throughout and after the treatment, the levels of aspartate aminotransferase [21 (range: 18-29.5) to 16 (range: 14-20) U/l,p < 0.001] and alanine aminotransferase [22 (range: 15-34) to 14 (range: 12-17.5) U/l, p < 0.001] improved significantly, unlike bilirubin, hemoglobin, and platelet levels. Renal function remained stable. Dose adjustments for calcineurin inhibitors were required. Serious adverse events were not observed. Conclusion: Safety and efficacy of fixed-dose sofosbuvir/ledipasvir combination was effective and safe in kidney transplant recipients with hepatitis C virus. However, cautious monitoring of trough levels of calcineurin inhibitorss is needed due to potential drug-drug interactions during the treatment episode.