Summary

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• This summary is based on the review of two randomized controlled trial(s). ^[1-2]
• In adults with primary human immunodeficiency virus type 1 (HIV-1) infection, both dolutegravir/tenofovir/emtricitabine and darunavir/cobicistat/tenofovir/emtricitabine regimens led to reductions in HIV-1 DNA levels in peripheral blood mononuclear cells (PBMCs) by Week 48, with no significant difference between groups (median decrease: -1.48 vs. -1.39 log10 copies/million PBMCs; P = 0.52).
• Dolutegravir-based regimens achieved faster viral suppression in HIV-1 RNA levels, with a higher proportion of patients reaching <50 copies/mL at Weeks 4, 8, and 12 compared to darunavir/cobicistat. By Week 48, suppression rates were comparable between the dolutegravir and darunavir/cobicistat groups (94% vs. 90%).
• No notable differences in effectiveness were observed among different population types or subgroups, with consistent outcomes across the study sample.
• During pregnancy, darunavir and cobicistat exposure levels are significantly reduced, with darunavir AUC0-24 decreased by 53% in the second trimester and 56% in the third trimester, and cobicistat AUC0-24 decreased by 50% and 56% in the second and third trimesters, respectively, compared to postpartum levels. This reduction in drug exposure may increase risks of virologic failure and perinatal transmission, indicating a potential need for dose adjustments.
• Limited placental transfer of darunavir and cobicistat was observed, which may influence maternal and fetal drug levels and necessitates careful monitoring in pregnant patients to maintain efficacy.
• The reviewed studies highlight the relevance of rapid viral suppression in adults with primary HIV-1 infection, predominantly male and with a median age of 36 years, noting the critical need for early viral control to reduce transmission risk. For pregnant women with HIV, reduced drug exposure to darunavir and cobicistat during the second and third trimesters suggests a need for potential dose adjustments to mitigate risks of virologic failure and perinatal transmission.