Paediatric Abacavir/Lamivudine/Dolutegravir (pALD) Fixed-Dose Combination. Introduction and Rollout Planning Considerations for National Programmes
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Background 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 paediatric 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 programmes in low- and middle-income countries (LMICs) began to transition CLHIV from treatment regimens containing non-nucleoside reverse transcriptase inhibitor (NNRTI) and lopinavir/ ritonavir to pDTG. As of the last quarter of 2022, at least 73 countries have already placed or received orders for pDTG1 and an estimated 130,000 children have transitioned to pDTG. |