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Raltegravir in HIV-1 Infected Pregnant Women:
Pharmacokinetics, Safety and Efficacy
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Clinical Infectious Diseases Advance Access published May 5, 2015
Maren Blonk1, Angela Colbers1, Carmen Hidalgo-Tenorio2, Kabamba Kabeya3, Katharina Weizsäcker4, Annette Haberl5, José Moltó6, David Hawkins7, Marchina van der Ende8, Andrea Gingelmaier9, Graham Taylor10, Jelena Ivanovic11, Carlo Giaquinto12, David Burger1, on behalf of the PANNA network
The use of raltegravir in HIV-infected pregnant women is important in the prevention of mother-to-child HIV transmission (MTCT), especially in circumstances when a rapid decline of HIV RNA viral load is warranted or when preferred antiretroviral agents cannot be used. Physiological changes during pregnancy can reduce antiretroviral drug exposure. We studied the effect of pregnancy on the pharmacokinetics of raltegravir and its safety and efficacy in HIV-infected pregnant women.
Methods. An open-label, multi-centre, phase IV study in HIV-infected pregnant women receiving raltegravir 400 mg twice daily, was performed (PANNA Network). Steady state pharmacokinetic profiles were obtained in the third trimester and postpartum along with cord and maternal delivery concentrations. Safety and virological efficacy were evaluated.
Results. Twenty-two patients were included of which 68% started raltegravir during pregnancy. Approaching delivery 86% of the patients had an undetectable viral load (<50 copies/mL). None of the children were HIV-infected. Exposure to raltegravir was highly variable. Overall AUC and C12h plasma concentrations in third trimester were on average 29% and 36% lower compared to postpartum: Geometric mean ratios (90% confidence interval) were 0.71 (0.53-0.96) for AUC0-12h and 0.64 (0.34-1.22) for C12h. The median (IQR) ratio of raltegravir cord/maternal blood was 1.21 (1.02-2.17; n=9).
Conclusions. Raltegravir was well tolerated during pregnancy. The pharmacokinetics of raltegravir showed extensive variability. The observed mean decrease in exposure to raltegravir during third trimester compared to postpartum is not considered to be of clinical importance. Raltegravir can be used in standard dosages in HIV-infected pregnant women.
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