paediatrics

Authors: Bevers LAH., Kamphuis AEM., van der Wekken-Pas LC, Leisegang R, Lewis L, Burger DM, Colbers A

Presented at: International Workshop on Clinical Pharmacology of HIV, Hepatitis, and Other Antiviral Drugs 2023

FOSTER CITY, Calif.–(BUSINESS WIRE)– Gilead Sciences, Inc. (Nasdaq: GILD) is pleased to announce two public-private partnerships. The first will accelerate the development of an investigational dispersible pediatric formulation containing emtricitabine and tenofovir alafenamide (F/TAF). The second aims to develop investigational pediatric formulations of TAF and sofosbuvir (SOF) designed to eliminate bitterness.

For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment,

Findings from the Strategy for Maintenance of HIV suppression with integrase inhibitor + darunavir/ritonavir in children (PENTA-17) trial, simply known as SMILE, were published in eClinicalMedicine on 2 June 2023. SMILE is the first randomised trial to determine whether children living with HIV on ART with suppressed viral load could maintain the suppression on a once-daily regimen compared to the standard of care (SOC) which involves three ART drugs. 

The inaugural Clinical Trial Management training program took place online on Wednesday, 14 June 2023, after 428 participants registered. The session was well attended by up to 168 clinical trial staff representing 30 countries. The training course is being implemented by UNIVERSAL’s Work package 8 and focuses on improving the capacity of research staff and young investigators to design, implement, and manage regulatory clinical trials, especially paediatric clinical trials.

This was the first module, 

The EPIICAL General Assembly was held online and in person in Venice on 2-4 November 2022. It brought together 80 participants from 29 organisations from the EPIICAL consortium. Attendees came together to discuss, among other topics, highlights of the project as a clinical and experimental platform to evaluate therapeutic strategies for HIV remission and/or cure in children, updates in the treatment and management of paediatric HIV and the vision for EPIICAL in 2024 and beyond.