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ART Selection in Women of Childbearing Age and During Pregnancy

Susan Cu-Uvin, MD
Program Director
Jean Rene Anderson, MD
Released: August 6, 2020

ART in Women: Available Data on Select ARVs

ARIA: DTG/ABC/3TC vs ATV + RTV + FTC/TDF in Treatment-Naive Women

The ARIA study was a multinational, randomized, open-label phase IIIB trial that investigated DTG/ABC/3TC vs ATV/RTV plus FTC/TDF in treatment-naive, nonpregnant women.[20] This figure shows the intention-to-treat, exposed Snapshot analysis at Week 48.

The take-home message is that virologic suppression at Week 48 was superior with DTG/ABC/3TC vs ATV/RTV plus FTC/TDF (82% vs 71%, respectively; P = .005), and higher rates of virologic suppression were observed across subgroups stratified by baseline disease characteristics (HIV-1 RNA ≤ 100,000 copies/mL vs > 100,000 copies/mL; CD4+ cell counts ≤ 350 cells/mm3 vs > 350 cells/mm3) and race (white vs black vs other). It should be noted, however, that there appears to be a considerable racial disparity in response to both agents that deserves much more study and consideration. Indeed, although the response rate was numerically higher with DTG/ABC/3TC vs ATV/RTV plus FTC/TDF in black women of African heritage—74% vs 67%—both were substantially lower vs response rates observed for white women (86% and 80%, respectively).

Pooled Efficacy and Safety Analysis of TAF vs TDF in Women: Virologic Outcomes

A study presented at CROI 2019 reported results from a pooled efficacy and safety analysis of TAF vs TDF in women with HIV infection.[21] As shown, investigators found that TAF and TDF were comparable in terms of efficacy in both treatment-naive women initiating treatment (86% vs 85%, respectively) and those who were virologically suppressed and switched treatment regimens (86% vs 85%, respectively).

TAF vs TDF in Women: Safety Outcomes at Week 96

The same study found significantly improved bone and renal parameters in women receiving TAF vs TDF, especially in the switch setting.[21] The most common adverse events, treatment-emergent renal adverse events, and discontinuations for adverse events or death were similar between both agents and also similar when compared with men.

Pooled Analysis of BIC/FTC/TAF in Women and Girls Across 5 Phase II/III Clinical Trials: Week 48 Efficacy

Finally, shown here are the results of a pooled analysis of BIC/FTC/TAF in women and girls across 5 phase II/III clinical trials.[22] Investigators found high rates of virologic suppression at Week 48 for both virologically suppressed women switching regimens (95% to 100%) and treatment-naive women initiating first-line BIC/FTC/TAF (87% to 93%). The efficacy and safety profiles were consistent with overall analyses in both sexes. Of importance, there was no emergence of resistance detected in patients receiving BIC/FTC/TAF.

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