Paediatric Abacavir/Lamivudine/ Dolutegravir (pALD) Fixed-Dose Combination

Overview

Paediatric ALD (ABACAVIR/LAMIVUDINE/DOLUTEGRAVIR) FDC Introduction and rollout planning considerations for national programmes

Dolutegravir (DTG)-based HIV treatment regimens are recommended by the World Health Organization (WHO) for children living with HIV (CLHIV) who weigh at least 3 kg. Paediatric DTG 10 mg scored, dispersible tablets (pDTG) for CLHIV weighing a minimum of 3 kg and at least four weeks of age (pDTG) are currently administered along with optimised backbone antiretrovirals such as abacavir/ lamivudine 120/60 mg scored dispersible tablets (pABC/3TC) per the WHO’s 2021 Consolidated HIV Guidelines.

This brief aims to inform the transition from pDTG + pABC/3TC to the new fixed-dose combination (FDC) dispersible tablet of paediatric ABC/3TC/DTG 60/30/5 mg (pALD) which will provide the regimen in one convenient tablet.

In 2022, the US FDA approved ViiV Healthcare’s FDC of pALD for CLHIV 6 kg to 24.9 kg. The generic versions, with the same weight band dosing, are expected second half of 2023 (US FDA tentative approval).

Country programmes should begin to plan for generic pALD introduction, ensuring that they are not overstocked with pDTG and pABC/3TC. The GAP-f pDTG Task Team has put forth some considerations for national HIV programmes, implementing partners, and service providers. The document is available in English, with French, Kiswahili, Portuguese and Spanish translations. Please share with colleagues working with national HIV programmes.

About the Global Accelerator For Paediatric Formulations (Gap-f )

GAP-f is a WHO Network hosted within the Research for Health Department in the Science Division and was created to respond to the paediatric treatment gap. Following the resolution at the 69th World Health Assembly on promoting innovation and access to quality, safe, efficacious, and affordable medicines for children, GAP-f was conceived to build on and formalize the model developed within the HIV community to provide a sustainable mechanism that ensures that safer, more effective, and more durable paediatric formulations are developed and made available to children against an accelerated timeline. More information is available at https://www.who.int/initiatives/gap-f.

Signatory: This brief was developed by the GAP-f pDTG Task Team
Website: https://www.who.int/initiatives/gap-f |Email: gap-f@who.int