Dosing of ritonavir-boosted darunavir for treatment of HIV in pregnancy.

OBJECTIVE

To assess the effectiveness of once- and twice-daily ritonavir-boosted darunavir (DRV/r)-containing regimens for treating HIV in pregnancy to inform the 2025 World Health Organization antiretroviral treatment guidelines update.

DESIGN

Analysis of pooled data from two observational study networks with sites in Romania, Switzerland, and the United Kingdom.

METHODS

Pregnancies resulting in a live birth or stillbirth in women receiving 800/100 mg DRV/r once-daily or 600/100 mg twice-daily during pregnancy were included. The primary outcome was viral suppression (<50 copies/ml) near delivery (from 28 days prior to 7 days after delivery).

RESULTS

Among 162 women on once-daily DRV/r, 95% were virally suppressed near delivery, with no difference between those on DRV/r from conception (95%, 113/119) and those who started on or switched to DRV/r during pregnancy (95%, 41/43). Among 27 women on twice-daily DRV/r, 78% were virally suppressed near delivery. Most women remained on the same DRV/r regimen until delivery, and there were no vertical transmissions. Darunavir drug concentrations for the limited number of pregnancies with data available fell within the expected ranges.

CONCLUSIONS

This analysis provides some reassurance that once-daily DRV/r can be used successfully in pregnancy. However, given the possibility of reduced drug levels in pregnancy with once-daily dosing, viral load monitoring during pregnancy remains essential. Surveillance of pregnancies in women receiving once-daily DRV/r is needed to further support the use of this dosing during pregnancy.