An analysis of FDA Adverse Event Reporting System data suggests baloxavir marboxil has lower hepatic toxicity than oseltamivir and may be a safer option for patients with liver diseases.
Results showed metabolic dysfunction was an independent predictor of liver-related events and hepatocellular carcinoma in patients with chronic HCV who achieved SVR.
Study results highlight the role of HCV and alcohol use in the growing global disease burden posed by cirrhosis, which is projected to increase over the next 20 years.
The CRL for the sBLA cites a lack of sufficient data to support the full evaluation of the effectiveness and safety of a 4-dose regimen in this patient population.