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Thai HIV-1-infected women do not require a dose increase of lopinavir/ritonavir during the third trimester of pregnancy

2011; Lippincott Williams & Wilkins; Volume: 25; Issue: 10 Linguagem: Inglês

10.1097/qad.0b013e328347f7e9

1473-5571

Reshmie Ramautarsing, Jasper van der Lugt, Meena Gorowara, Stephen J. Kerr, David M. Burger, Kiat Ruxrungtham, Praphan Phanuphak, Surasith Chaithongwongwatthana, Anchalee Avihingsanon, Nittaya Phanuphak,

HIV/AIDS drug development and treatment

Objectives: To investigate whether Thai HIV-1-infected pregnant women require a dose increase of lopinavir/ritonavir (LPV/r) and to assess the safety and efficacy of the generic tablets during pregnancy. Design: Prospective, single-center pharmacokinetic study. Methods: HIV-infected pregnant, antiretroviral therapy-naive or experienced women started HAART containing generic LPV/r 400/100 mg tablets twice daily. The 12-h pharmacokinetic curves were recorded at gestational age 20 weeks (GA20, optional), 33 weeks (GA33) and 12 weeks postpartum (12PP, optional). Results: Twenty women were included. Median [interquartile range (IQR)] age was 28 (25–33) years and mean (SD) weight at GA33 was 59.9 (4.2) kg. Mean (SD) values for LPV area under the curve0–12 h, Cmax, Cmin, and Thalf were 72.9 (19.2) mg/l h, 9.3 (2.2) mg/l, 3.2 (1.3) mg/l and 4.8 (2.4) h, respectively, on GA33 and 98.0 (24.1) mg/l h, 11.7 (2.2) mg/l, 4.7 (2.2) mg/l and 5.9 (2.7) h, respectively on 12PP. Twelve women recorded both GA33 and 12PP curves; mean LPV AUC0–12 was significantly lower at GA33 [−24.1 (95% confidence interval −44.4 to –3.7) mg/l h]. At GA33, 19 of 20 women had sufficient LPV trough concentrations (>1.0 mg/l) and at 12PP, all had sufficient LPV trough concentrations. None of the women stopped LPV/r before planned discontinuation due to side-effects. At delivery, 19 of 20 women had a viral load below 50 copies/ml. One woman had a viral load of 60 copies/ml, but was undetectable at 12PP. Conclusion: Standard dose generic LPV/r (400/100 mg twice daily) in Thai HIV-1-infected pregnant women leads to adequate plasma concentrations during the third trimester. The generic LPV/r tablet is well tolerated and effective for use during pregnancy.