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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. 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).
A study presented at CROI 2019 reported results from a pooled efficacy and safety analysis of TAF vs TDF in women with HIV infection. 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).
The same study found significantly improved bone and renal parameters in women receiving TAF vs TDF, especially in the switch setting. 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.
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. 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.