Surveillance of ARV safety in pregnancy and breastfeeding: towards a new framework.

ABSTRACT:

Introduction

As new antiretrovirals (ARVs), including long-acting ARVs for treatment and prevention, are approved and introduced, surveillance during pregnancy must become the safety net for evaluating birth outcomes, especially those that are rare and require large numbers of observations. Historically, drug pharmacovigilance in pregnancy has been limited and fragmented between different data sources, resulting in inadequate data to assess risk. The International Maternal Pediatric Adolescent AIDS Clinical Trials Network and World Health Organization convened a Workshop which reviewed strengths and weaknesses of existing programs and discussed an improved framework to integrate existing safety data sources and promote harmonization and digitalization.

Discussion

This paper

SUBMITTER: Renaud F 

PROVIDER: S-EPMC9294858 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature