Recommendations for the selection of nucleoside analogues as antihuman herpesvirus drugs: a real-world analysis of reported cases from the FDA adverse event reporting system

ABSTRACT

Objective

The aim of this study is to provide guidance for refining medication protocols, developing alternative strategies, and enhancing protection against herpesvirus infections in personalized clinical settings.

Methods

Adverse drug events (ADEs) data for anti-herpesvirus from the first quarter of 2004 to the fourth quarter of 2022 were collected from the FDA Adverse Event Reporting System (FAERS). Disproportionality analysis was performed using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN) methods for data mining.

Results

A total of 18,591, 24,206, 6,150, and 419 reports of ADEs associated with acyclovir (ACV), valacyclovir (VACV), ganciclovir (GCV), and famciclovir (FCV) were screened and extracted from the FAERS. In this study, the report summarized the high frequency and strong correlation of ADEs for the four drugs at the Preferred Term (PT) level. Additionally, the analysis also identified the relationship between ADEs and factors such as age, gender, and severity of outcome at the System Organ Class (SOC) level.

Conclusion

The safety reports for the four-nucleoside analogue anti-herpesvirus drugs are diverse and interconnected. Dosing for patients with herpesvirus infections should be tailored to their specific conditions and the potential risk of disease.

KEYWORDS:

• Nucleoside analogues
• FAERS
• human herpesvirus
• adverse drug reactions
• signal detection

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contribution statement

Conception or design of the work: CXG, XMD and XQ; Acquisition，analysis，or interpretation of data: CXG，XMD and ZZ; Management and checking of all data: CXG, XMD, XQ, JZ, LJM and ZZ; Drafting the article: CXG. All authors critically reviewed the manuscript and interpreted the results. The final manuscript was read, checked and approved by all authors.

Data availability statement

The data underlying this article are available in the FDA adverse events reporting system (FAERS). The datasets were derived from sources in the public domain: https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html.

Ethics statement

The Medical Research Ethics Review Committee of the First Affiliated Hospital of Chongqing Medical University decided to waive the original ethic application procedure, based on the reason that the open public database used in this project.

Supplementary materials

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2024.2374919

Additional information

Funding

This paper was funded by the National Natural Science Foundation of China [81903358].