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. In 2020, the United States Food and Drug Administration (US FDA) granted tentative approval of pediatric DTG 10 mg scored, dispersible tablets (pDTG) for CLHIV weighing a minimum of 3 kg and at least four weeks of age. In early 2021, national HIV program in low- and middle-income countries (LMICs) began to transition CLHIV to pDTG. pDTG is administered along with optimized backbone antiretrovirals (ARVs) such as abacavir/ lamivudine 120/60 mg scored dispersible tablets (pABC/3TC) per the WHO’s 2021 Consolidated HIV Guidelines. A new dispersible fixed dose combination (FDC) of abacavir, lamivudine and dolutegravir 60/30/5 mg (pALD) will further improve treatment delivery by providing the WHO-recommended first-line antiretroviral regimen in one convenient tablet. Early 2022, the US FDA approved ViiV Healthcare’s FDC of pALD for CLHIV 10 kg to 24.9 kg, and in June 2023, the indication was extended to infants aged at least 3 months and weighing at least 6 kg. However, it is expected that separate pABC/3TC and pDTG tablets will still be used for children in the 3 to 5.9 kg weight band, at least for the time being. Generic formulations of ABC/3TC/DTG dispersible tablet obtained the US tentative approval in August 2023. To ensure better health outcomes for children, country programs need to be prepared for rollout of new and improved pediatric formulations as they become available on the market.
The objective of this webinar is to Increase awareness and support planning processes in country to prepare for the introduction of pALD and sustain the delivery of pDTG for those in need.