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- Title
Efficacy and Safety of Sofosbuvir and Ledipasvir for Hepatitis C in Kidney Transplant Recipients: A Single-center Retrospective Observational Study.
- Authors
Artan, Ayşe Serra; Mirioğlu, Şafak; İstemihan, Zulal; Aksoy, Elif; Dirim, Ahmet Burak; Çavuş, Bilger; Oto, Özgür Akın; Çifçibaşı-Örmeci, Aslı; Beşışık, Fatih; Çalışkan, Yaşar; Öztürk, Savaş; Yazıcı, Halil; Kaymakoğlu, Sabahattin; Türkmen, Aydın
- 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.
- Subjects
DRUG efficacy; COMBINATION drug therapy; SCIENTIFIC observation; HEPATITIS C; KIDNEY transplantation; PATIENTS; ANTIVIRAL agents; RETROSPECTIVE studies; DESCRIPTIVE statistics; TRANSPLANTATION of organs, tissues, etc.; PATIENT safety; ASPARTATE aminotransferase; ALANINE aminotransferase
- Publication
Balkan Medical Journal, 2023, Vol 40, Issue 3, p182
- ISSN
2146-3123
- Publication type
Article
- DOI
10.4274/balkanmedj.galenos.2023.2022-10-13