This information only pertains to pregnant women and cannot be extrapolated to a population of non-pregnant adults. Further information is needed.
Tenofovir Alafenamide versus Cobicistat in Pregnancy
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Study Design
IMPAACT P1026s is an ongoing, nonrandomized, openlabel, multi-center study of antiretroviral PK in HIV-infected pregnant women. Steady-state PK profiles of TAF following once-daily dosing of either TAF/FTC/RPV (25/200/25 mg, Odefsey®) or TAF/FTC/EVG/ COBI (10/200/150/150 mg, Genvoya®) were obtained during the 2nd and 3rd trimesters (2T/3T) and 6 to 12 weeks postpartum (PP). TAF plasma concentrations were measured by a validated LC-MS/MS method. A two-tailed Wilcoxon signed rank test (a = 0.10) was employed for paired within-subject comparison of PK parameters.
Study Results
A total of 42 subjects from the US were enrolled with a median age at delivery of 30.4 years (range 19.1 to 38.8). For the TAF 25 mg arm, TAF exposure was lower and oral clearance was higher in 3T compared to PP (Table 1). For the TAF/COBI arm, no difference were seen between any ante-partum and post-partum PK parameters. HIV RNA at delivery was <50 copies/mL for 10/11 women in the TAF 25 mg arm and 24/27 women in the TAF/COBI arm. Median infant gestational age and weight at birth were 38.9 weeks and 3.24 kg, respectively. Congenital anomalies considered possibly related to study drugs included a ventral septal defect in one infant and congenital pseudoarthrosis of the left clavicle and neonatal compartment syndrome in another infant. Overall 27/41 infants were HIV-negative and 14 were indeterminate/pending.
Study Conclusions
In women taking TAF without COBI, TAF exposure was lower in 3T compared to PP, whereas no differences were seen between pregnancy and PP in women taking TAF with COBI. Before TAF can be recommended for use in pregnancy additional safety and outcome data as well as intracellular PK data are needed
References
Momper JD, Best B, Wang J, Stek A, Cressey TR, Burchett S, Mirochnick M. Tenofovir alafenamide pharmacokinetics with and without cobicistat in pregnancy. International Aids Conference. Amsterdam, Netherlands. 22; July 2018.
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