Evaluation of the Renal Safety of Direct Acting Antivirals in Chronic Hepatitis C Patients

Abstract

Objective: Direct acting antivirals (DAA) is a class of antivirals that has been extensively used in chronic hepatitis C virus (HCV) patients over the past 6 years. Despite the excellent therapeutic benefits of DAA, there is a knowledge gap regarding the safety of this class. Several reports of possible renal toxicity associated with DAA administration can be found in the literature. The aims of this study are: to assess the renal safety of DAA used for the treatment of chronic HCV infection and to quantify the odds of developing renal toxicity in patients with chronic HCV viral infection. Study Design: Disproportionality analysis was used to detect signals of potential side effects. Place and Duration: Amman –Jordan, One year study since September 2017 to march 2018. Methods: The method that was applied in the current study is obtaining the data from United States (US) food and drug administration (FDA) adverse event reporting system (FAERS). Data between July, 2014 and September, 2017 were combined and explored. Disproportionality analysis was conducted to reports from chronic HCV patients to explore possible association between DAA administration and renal side effects. Original Research Article Ashram and Saleh; JAMPS, 23(3): 34-45, 2021; Article no.JAMPS.67568 35 Results: This study showed that a total of 3,837,418 safety reports were available in the period between July, 2014 and September, 2017. Patients with chronic HCV infection represent 22,022 cases. When considering all DAA as drug of interest, the use of DAA alone or in combination with interferon and/or ribavirin did not increase the risk of having renal side effects. Exploring individual DAA demonstrated a significant association between the incidence of renal side effects and the administration of telaprevir and dasabuvir. Considering renal side effects individually showed a significant association between DAA administration and chronic kidney disease. Conclusions: In this study, we reported a significant association between DAA administration and chronic kidney disease and between telaprevir or dasabuvir and renal side effect. These findings are used for hypothesis generation rather than testing.