EMERALD Trial: Week 48 Results Demonstrate Efficacy in Single-Tablet HIV Therapy
Study investigators did not observe any resistance-associated mutations related to any study drug.
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SAN DIEGO — Single tablet, once-daily darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) therapy is linked to high suppression rates in adults with HIV-1 infection, according to research to be presented at IDWeek 20171 and published in Lancet HIV.2
Joseph Eron Jr, MD, professor of medicine and Director, Clinical Core at University of North Carolina Center for AIDS Research, in Chapel Hill, North Carolina, and colleagues presented week 48 results of the phase 3 EMERALD clinical trial (Study to Evaluate the Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide [D/C/F/TAF] Regimen Versus Boosted Protease Inhibitor [bPI] Along With Emtricitabine/Tenofovir Disoproxil Fumarate [FTC/TDF] Regimen in Virologically Suppressed, HIV-1 Infected Participants; ClinicalTrials.gov Identifier NCT02269917).
Study participants included 1141 adults with virologically suppressed HIV-1 (median age: 46; 18% women; 76% white; viral load: <50 copies/mL for 2 months or longer). Participants were randomly assigned 2:1 to either continue with current treatment (bPI plus FTC/TDF; n=378) or switch to the once-daily, single-tablet D/C/F/TAF 800/150/200/10 mg regimen.
At week 48, virologic rebound was non-inferior in the treatment group vs the control group (2.5% vs 2.1%; Δ0.4%; 95% CI, -1.5%-2.2%; P <.001). Disease in most of those with rebound was resuppressed without a change of therapy (63% vs 50%).
Virologic suppression and virologic failure rates were 94.9% vs 93.7% and 0.8% vs 0.5% in the treatment vs control groups (Δ1.2%; 95% CI, -1.7%-4.1% and Δ0.3; 95% CI, -0.7-1.2%, respectively).
No treatment-related deaths were reported in either group. Both groups experienced similar rates of adverse events, including adverse event-related 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%).
"When people who are diagnosed with HIV don't adhere to their treatment regimen, they can build up drug resistance, which can render their treatment — and even an entire class of treatments — ineffective," said Dr Eron, in an interview with Infectious Disease Advisor. "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 tenofovir alafenamide into a single tablet."
Dr Orkin reports receiving speaker honoraria, travel bursary, and consulting fees from and serving as a scientific advisor and speaker's bureau member for Janssen Pharmaceuticals, MSD, Viiv Healthcare, and Gilead Sciences. Dr Molina reports receiving research grant funding from Merck and Gilead, serving as a science advisor and receiving speaker honorarium for Janssen, Viiv, BMS, and Teva. Dr Gallant is a Janssen Therapeutics investigator. Dr Negredo is a Janssen board member and scientific advisor and reports receiving a speaker honorarium. Drs Gathe and Eron are Janssen consultants and investigators and report receiving research grants, speaker honoraria, and consulting fees. Drs Van Landuyt, Lathouwers, Hufkens, Petrovic, and Opsomer are employees and shareholders at Janssen.
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- Orkin C, Molina J-M, Gallant J, et al. Week 48 results of EMERALD: a phase 3, randomized, non-inferiority study evaluating the efficacy and safety of switching from boosted-protease inhibitors (bPI) plus emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) regimens to the once daily (QD), single-tablet regimen (STR) of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in virologically-suppressed, HIV-1-infected adults. Presented at: IDWeek 2017; October 4-8, 2017; San Diego, CA. Abstract 1689b.
- Orkin C, Molina J-M, Negredo E, et al; on behalf of the EMERALD study group. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disorpoxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alfenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomized, non-inferiority trial [published online October 6, 2017]. Lancet HIV. doi:10.1016/S2352-3018(17)30179-0