Pharmacokinetics of Efavirenz 600 mg Once daily during Pregnancy and Postpartum in Ghanaian Women Living with Human Immunodeficiency Virus

Autor: Lartey, Margaret, Kenu, Ernest, Lassey, Anyetei, Ntumy, Michael, Ganu, Vincent, Sam, Miriam, Boamah, Isaac, Gilani, Fizza S., Yang, Hongmei, Burch, Gena M., Norman, Jennifer, Peloquin, Charles A., Kwara, Awewura
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: Clin Ther
Popis: AIM: The update World Health Organization guidelines recommend efavirenz (EFV) 400 mg as the preferred alternate first-line antiretroviral therapy (ART) to dolutegravir, with EFV 600 mg recommended only in special situations. We examined the pharmacokinetics (PK) of EFV 600 mg/day during pregnancy and postpartum to inform EFV dosing decisions in pregnant women. METHODS: Ghanaian pregnant women with HIV infection initiating tenofovir disoproxil fumarate 300mg/lamivudine 300 mg/EFV 600 mg once daily were enrolled. Efavirenz concentrations were measured at 4 weeks of ART initiation during pregnancy and 6 weeks postpartum using validated LC/MS/MS assays. Efavirenz PK parameters were calculated using noncompartmental analysis and within group parameters between the two periods were compared. FINDINGS: Of 25 enrolled women, 19 completed PK sampling during pregnancy and postpartum. The geometric mean EFV peak concentration (C(max)), trough concentration (C(min)), area under the curve (AUC(0-24h)) and apparent clearance (CL/F) during pregnancy were similar to values at 6 weeks postpartum. Geometric mean ratio pregnancy/postpartum (90% confidence interval) for EFV C(max), C(min), AUC(0-24h) and CL/F were 1.10 (0.93 – 1.31), 0.88 (0.67 – 1.17), 0.84 (0.71 – 0.98) and 1.20 (1.02 – 1.40), respectively. Viral load suppression (HIV RNA
Databáze: OpenAIRE