Safety and Effectiveness of Xofluza (Baloxavir Marboxil) for Respiratory Viral Illness: A Systematic Review
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Copyright: © 2020 . This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Abstract
Randomized Controlled Trials (RCTs) have provided evidence of the safety and effectiveness of Baloxavir Marboxil (BXM) in antiviral activity of uncomplicated influenza virus. The objective of this article was to perform a narrative review of RCTs of BXM for reduced time to alleviation of symptoms and risk of complications in influenza patients and identify uncertainties and gaps resulting from the design of individual studies. A literature search was conducted for RCTs of BXM of adult and pediatric human trials and Time to Alleviation of Symptoms (TTAS) either as a primary or secondary endpoint. A total of 6 RCTs were identified; target population baseline characteristics, outcome measures, statistical methods, and clinical trial limitations were reported. RCTs of BXM showed consistent overall beneficial effects for TTAS of influenza in comparison to placebo and other antiviral medications like oseltamivir and favipiravir. Only one study included clinical outcome of BXM on SARS-CoV-2; all other RCTs used composite TTAS as the primary endpoint of influenza. An understanding of the deficiencies of individual RCTs of BXM in TTAS of Influenza and SARSCoV- 2 is important in creating a patient specific therapeutic clinical decision and tailoring future research.
