Effect of sofosbuvir and ribavirin therapy on hearing

Abstract

Introduction An estimated 185 million people worldwide are currently infected with chronic hepatitis C virus and ∼3–4 million new infections occur each year. Sofosbuvir (SOF) administered in combination with ribavirin (RBV) resulted in high sustained virological response rates across genotype (GT) 1–6 patients. It is also the first available regimen for patients who are unsuitable for interferon. A combination of SOF and RBV was safe and well tolerated with no death or discontinuation of treatment due to adverse events. The most frequent adverse events were headache, anemia, fatigue, and nausea. Objective This study was designed to detect the effect of dual treatment with SOF/RBV on hearing and on cochlear hair cells in 50 patients with chronic hepatitis C. Subjects and methods Fifty adult male patients with chronic HCV infection and fulfilling the indications to start the medical treatment with Sovaldi, they were subjected to pre and post treatment hearing assessment by Pure Tone Audiometry (PTA) and Oto Acoustic Emission (OAEs). Results According to pure-tone audiometry, no statistically significant difference was detected in hearing threshold among patients at different frequencies, pretreatment and post-treatment. According to distortion-product otoacoustic emission (S/N), there was a highly statistically significant difference in distortion-product otoacoustic emission (S/N), at the most of frequencies in pretreatment and post-treatment. This differences confirmed (outer hair cell) damage as an ototoxic effect for SOF/RBV therapy. Recommendation Long-term follow-up to determine this effect on the outer hair cell either temporary or permanent.