Brief Report: Suboptimal Lopinavir Exposure in Infants on Rifampicin Treatment Receiving Double-dosed or Semisuperboosted Lopinavir/Ritonavir: Time for a Change

Autor: Tom G. Jacobs, Vivian Mumbiro, Moses Chitsamatanga, Natasha Namuziya, Alfeu Passanduca, Sara Domínguez-Rodríguez, Alfredo Tagarro, Kusum J. Nathoo, Bwendo Nduna, Alvaro Ballesteros, Lola Madrid, Hilda A. Mujuru, Chishala Chabala, W. Chris Buck, Pablo Rojo, David M. Burger, Cinta Moraleda, Angela Colbers
Rok vydání: 2023
Předmět:
Zdroj: JAIDS : Journal of Acquired Immune Deficiency Syndromes, 93, 1, pp. 42-46
JAIDS : Journal of Acquired Immune Deficiency Syndromes, 93, 42-46
ISSN: 1525-4135
Popis: Contains fulltext : 291766.pdf (Publisher’s version ) (Open Access) BACKGROUND: Although super-boosted lopinavir/ritonavir (LPV/r; ratio 4:4 instead of 4:1) is recommended for infants living with HIV and receiving concomitant rifampicin, in clinical practice, many different LPV/r dosing strategies are applied due to poor availability of pediatric separate ritonavir formulations needed to superboost. We evaluated LPV pharmacokinetics in infants with HIV receiving LPV/r dosed according to local guidelines in various sub-Saharan African countries with or without rifampicin-based tuberculosis (TB) treatment. METHODS: This was a 2-arm pharmacokinetic substudy nested within the EMPIRICAL trial (#NCT03915366). Infants aged 1-12 months recruited into the main study were administered LPV/r according to local guidelines and drug availability either with or without rifampicin-based TB treatment; during rifampicin cotreatment, they received double-dosed (ratio 8:2) or semisuperboosted LPV/r (adding a ritonavir 100 mg crushed tablet to the evening LPV/r dose). Six blood samples were taken over 12 hours after intake of LPV/r. RESULTS: In total, 14/16 included infants had evaluable pharmacokinetic curves; 9/14 had rifampicin cotreatment (5 received double-dosed and 4 semisuperboosted LPV/r). The median (IQR) age was 6.4 months (5.4-9.8), weight 6.0 kg (5.2-6.8), and 10/14 were male. Of those receiving rifampicin, 6/9 infants (67%) had LPV Ctrough
Databáze: OpenAIRE