The EMERALD Study is a Phase 3 randomized (2:1), open-label, noninferiority study examining the strategy of switching patients with suppressed HIV RNA on a regimen consisting of a boosted protease inhibitor plus tenofovir disoproxil fumarate (TDF)/emtricitabine to an investigational single-tablet regimen containing darunavir 800 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (D/C/F/TAF).
These studies demonstrate that coformulated BIC/TAF/FTC is noninferior to two gold-standard regimens comprised of DTG with 2-NRTI backbones, and in fact suggest that BIC/TAF/FTC is better tolerated than the coformulation DTG/ABC/3TC. Importantly, rates of virologic suppression were very high with all regimens, and no resistance mutations were seen in the rare cases of virologic failure.
Highlights from Laura W. Cheever, MD, ScM, HRSA HIV/AIDS Bureau Associate Administrator and Conference Co-Chair. "It’s a great balance between state-of-the-art treatment and science and pragmatic things that Ryan White HIV/AIDS Program providers struggle with and need assistance with."
In a Phase 2 study of treatment-naive individuals, rates of virologic suppression were equivalent to those seen with efavirenz (both treatment groups also were given TDF/FTC), with fewer adverse effects, including fewer neuropsychiatric adverse effects.
In recent years, a number of studies have evaluated 2-drug or even 1-drug ARV regimens, either in initial therapy or in switch regimens for patients with virologic suppression on 3-drug therapy. In general, these have not been as successful in achieving or maintaining virologic suppression as standard ARV therapy.
Leading up to this year, some researchers and clinicians had optimistically viewed dolutegravir an invincible ARV, a drug so mighty that it was unlikely to fail, and even more unlikely to be victim to emergent resistance mutations. Two presentations at CROI demonstrated the vulnerability of dolutegravir to failure and to the development of resistance when it is used as monotherapy.