NP-003 Steady-state pharmacokinetics and early safety data in HIV-infected african children weighing ≥25 kg after switching to 50 mg film-coated dolutegravir tablets in the ODYSSEY trial

Background and importanceODYSSEY is an ongoing international randomised trial evaluating dolutegravir (DTG)-based antiretroviral therapy (ART) versus standard-of-care in HIV-infected children starting first- or second-line ART. Pediatric DTG film-coated tablets (FCTs) of 10 mg and 25 mg are unavaila...

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Published in:European journal of hospital pharmacy. Science and practice 2020-03, Vol.27 (Suppl 1), p.A216-A216
Main Authors: Bollen, PDJ, Turkova, A, Kaudha, E, Chidziva, E, Lugemwa, A, Kekitiinwa, A, Parker, A, Shakeshaft, C, Montero, S, Colbers, A, Nanduudu, A, Mujuru, H, Makumbi, S, Amuge, P, Rojo, P, Ford, D, Burger, DM, Gibb, DM
Format: Article
Language:English
Subjects:
Adults
Antiretroviral drugs
Pediatrics
Pharmacokinetics
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Summary:Background and importanceODYSSEY is an ongoing international randomised trial evaluating dolutegravir (DTG)-based antiretroviral therapy (ART) versus standard-of-care in HIV-infected children starting first- or second-line ART. Pediatric DTG film-coated tablets (FCTs) of 10 mg and 25 mg are unavailable in low- and middle income countries (LMIC) were most HIV-infected children live. Adult DTG 50mg FTCs are produced by generic manufacturers at low-cost, are well-tolerated, and already available in many high- and LMICs.Aim and objectivesWithin ODYSSEY pharmacokinetic (PK) substudies were undertaken to assess PK and safety data for a simplified paediatric DTG dosing approach using WHO weight bands (WBs) 25 to
ISSN:2047-9956
2047-9964
DOI:10.1136/ejhpharm-2020-eahpconf.461