EMERALD: Switch to single-tablet HIV regimen containing darunavir safe, effective

SAN DIEGO — Switching to a once-daily, darunavir-based HIV regimen was noninferior to continuing treatment with a boosted protease inhibitor plus emtricitabine and Viread, according to 48-week data from the EMERALD trial.

The once-daily, single-tablet regimen contains 800 mg of darunavir, 150 mg of Tybost (cobicistat, Gilead Sciences), 200 mg of emtricitabine and 10 mg of Vemlidy (tenofovir alafenamide, Gilead Sciences; D/C/F/TAF). Joseph Eron, MD, professor of medicine and director of the Clinical Core at the University of North Carolina Center for AIDS Research, said at IDWeek that D/C/F/TAF was recently approved on Sept. 25 in Europe and is currently undergoing regulatory review for use in adults and children aged 12 years and older in the United States.

Findings from the study were also published in The Lancet HIV.

For the phase 3 trial, Eron and colleagues randomly assigned 1,141 virologically suppressed patients receiving treatment on a boosted protease inhibitor (bPI) plus emtricitabine and Viread (tenofovir disoproxil fumarate, Gilead Sciences; F/TDF) to switch to D/C/F/TAF (n = 763) or continue treatment with bPI plus F/TDF (n = 378). The primary outcome was the proportion of patients with virological rebound at 48 weeks. The FDA established a noninferiority confidence interval of 4%.

“This is a very tight confidence interval, but I think it’s appropriate because people who are on therapy and are suppressed should stay suppressed,” Eron said.

The rate of virologic rebound was similar among patients in both treatment arms, occurring in 2.5% of those who switched to D/C/F/TAF and 2.1% in the control group. Among rebounding patients, 63% who switched therapy and 50% in the control group were re-suppressed without having to change therapy.

Overall, 94.9% of patients taking D/C/F/TAF and 93.7% in the control group were virologically suppressed at week 48, with virologic failure occurring in 0.8% and 0.5% of patients, respectively. There were no significant differences in treatment discontinuations (1.4% vs. 1.3%), grade 3 or 4 adverse events (6.8% vs. 8.2%) and serious adverse events (4.6% vs. 4.8%) among patients in the D/C/F/TAF and control arms. According to the researchers, there were no deaths in the study, and they did not detect resistance to any of the study drugs.

D/C/F/TAF was also assessed in treatment-naive patients enrolled in the phase 3 AMBER trial. Eron said results from this study will be presented at the European AIDS Conference, held from Oct. 25 to 27 in Milan, Italy.

“The findings from the EMERALD study bring us one step closer to being able to offer those who live with HIV and struggle with adherence an option that combines the efficacy and high genetic barrier to resistance of darunavir with the demonstrated safety profile of TAF into a single tablet,” he said in a press release. – by Stephanie Viguers

References:

Orkin C, et al. Abstract 1689b. Presented at: IDWeek; Oct. 4-8, 2017; San Diego.

Orkin C, et al. Lancet HIV. 2017;doi:10.1016/S2352-3018(17)30179-0.

Disclosures: Eron reports being a consultant and grant investigator for Janssen. Please see the study for all other authors’ relevant financial disclosures.