Single-tablet HIV regimen hits safety, efficacy targets

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Takeaway

  • Once-daily single-tablet regimen of darunavir, cobicistat, emtricitabine, and tenofovir alafenamide effectively suppresses virological rebound in treatment-experienced HIV-1 infected (TE-HIV) adults.
  • Regimen is noninferior to boosted protease inhibitor (BPI) combined emtricitabine/tenofovir disoproxil fumarate treatment.

Why this matters

  • Once-daily single-table HIV-1 regimens may promote treatment adherence.
  • Darunavir component provides a high genetic barrier to resistance, whereas tenofovir alafenamide is comparable to tenofovir disoproxil fumarate at one-tenth of the dose, decreasing risk for renal toxicity and changes in bone density.
  • Findings also demonstrate utility in adults with history of virological failure on nondarunavir regimens.

Study design

  • Randomized, multicenter, active-controlled, noninferiority, phase-3 (EMERALD) study on TE-HIV adults (study group [SG], n=763; control group [CG; BPI], n=378).
  • Funding: Janssen.

Key results

  • At 48 wk, 2.5% patients of SG and 2.1% of CG had virological rebound (difference, 0.4%; Pnoninferiority<.0001).
  • The cumulative virological rebound rate in SG vs CG was 1.9% vs 0.8% (difference, 1.1%; P<.0001).
  • Viral load <50 copies/mL achieved in 724 patients in SG and 354 in CG.
  • No significant difference seen in time to virological rebound between groups (P=.824).
  • Discontinuations related to adverse events (each, 1%) and grade 3-4 adverse events were similar (7% in SG vs 8% in CG).

Limitations

  • Open-label study.

Coauthored with Chitra Ravi, M.Pharm