Lopinavir/ritonavir dosing during pregnancy in Brazil and maternal/infant laboratory abnormalities

Abstract

We declare no conflict of interest. ABSTRACT Objectives:To describe laboratory abnormalities among HIV-infected women and their infants with standard and increased lopinavir/ritonavir (LPV/r) dosing during the third trimester of pregnancy. Methods: We evaluated data on pregnant women from NISDI cohorts (2002)(2003)(2004)(2005)(2006)(2007)(2008)(2009)) enrolled in Brazil, who received at least 28 days of LPV/r during the third pregnancy trimester and gave birth to singleton infants. Results: 164 women received LPV/r standard dosing [(798/198 . Mean plasma viral load was higher in Group 2. There were statistically significant, but not clinically meaningful, differences between groups in mean AST, ALT, cholesterol, and triglycerides. The proportion of women with Grade 3 or 4 adverse events was very low, with no statistically significant differences between groups in severe adverse events related to ALT, AST, total bilirubin, cholesterol, or triglycerides. There were statistically significant, but not clinically meaningful, differences between infant groups in ALT and creatinine. The proportion of infants with Grade 3 or 4 adverse events was very low, and there were no statistically significant differences in severe adverse events related to ALT, AST, BUN, or creatinine. Conclusion: The proportions of women and infants with severe laboratory adverse events were very low. Increased LPV/r dosing during the third trimester of pregnancy appears to be safe for HIV-infected women and their infants.

No Need for Lopinavir Dose Adjustment during Pregnancy: a Population Pharmacokinetic and Exposure-Response Analysis in Pregnant and Nonpregnant HIV-Infected Subjects

“…Several clinical studies have demonstrated LPV/r efficacy in achieving virologic suppression in mothers during pregnancy and preventing HIV transmission to their children (9)(10)(11)(12)(13)(14)(15)(16). Reports of higher LPV clearance during pregnancy have prompted some investigators to propose the use of a higher dose during the third trimester, while others advocated no adjustment to the standard 400/100-mg twice-daily (BID) regimen (17)(18)(19)(20).…”