ISSN : 2146-3123
E-ISSN : 2146-3131

Efficacy and Safety of Sofosbuvir and Ledipasvir for Hepatitis C in Kidney Transplant Recipients: A Single-center Retrospective Observational Study
Ayşe Serra Artan1, Şafak Mirioğlu1,2, Zulal İstemihan3, Elif Aksoy1, Ahmet Burak Dirim1, Bilger Çavuş3, Özgür Akın Oto1, Aslı Çifçibaşı-Örmeci3, Fatih Beşışık3, Yaşar Çalışkan1,4, Savaş Öztürk1, Halil Yazıcı1, Sabahattin Kaymakoğlu3, Aydın Türkmen1
1Division of Nephrology, Department of Internal Medicine, İstanbul University, İstanbul Faculty of Medicine, İstanbul, Turkey
2Division of Nephrology, Department of Internal Medicine, Bezmialem Vakıf University Faculty of Medicine, İstanbul, Turkey
3Division of Gastroenterohepatology, Department of Internal Medicine, İstanbul University, İstanbul Faculty of Medicine, İstanbul, Turkey
4Center for Abdominal Transplantation, Saint Louis University Faculty of Medicine, Saint Louis, MO, USA
DOI : 10.4274/balkanmedj.galenos.2023.2022-10-13
Pages : 182-187

Abstract

Background: Treatment using direct-acting antivirals provides high rates of sustained virologic response and a favorable safety profile for patients with chronic hepatitis C virus infection. However, data on the efficacy of direct-acting antivirals  in kidney transplant recipients are 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 a 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.

Viewed : 2626
Downloaded : 1288