Stribild, a Single Tablet Regimen for the Treatment of HIV Disease

Abstract

Introduction: In August 2012, the US Food and Drug Administration (FDA) approved a new single tablet once-a-day therapy for treatment-naive HIV patients. The new tablet contains emtricitabine and tenofovir disoproxil fumarate as well as elvitegravir and cobicistat, a pharmacokinetic enhancer which prolongs the effect of elvitegravir. The new tablet (EVG/COBI/FTC/TDF), known as Stribild (Gilead Sciences, Foster City, CA, USA), is now the only FDA-approved single-tablet, once-daily, HIV medication that is composed of an integrase-inhibitor-based regimen. Methods: Stribild has been tested in two randomized double-blind phase 3 clinical trials with 1,408 patients who had not been previously treated for HIV. In one trial, Stribild was compared to the single-tablet regimen gold standard medication known as Atripla (Gilead Sciences, Foster City, CA, USA) that contains efavirenz, emtricitabine and tenofovir disoproxil fumarate (EFV/FTC/TDF). In the second clinical trial, Stribild was compared to another preferred treatment regimen of ritonavir-boosted atazanavir (ATV/RTV) with coformulated emtricitabine and tenofovir disoproxil fumarate (FTC/TDF, marketed as Truvada; Gilead Sciences, Foster City, CA, USA). Results: The outcomes of the two recently published trials at 48 weeks indicated that Stribild was noninferior to both of the standard treatment regimens in controlling viral load. In the Stribild versus Atripla trial, 305 of 348 patients (87.6%) on Stribild versus 296 of 352 patients (84.1%) on Atripla had an HIV ribonucleic acid (RNA) concentration of <50 copies/mL at week 48. In the Stribild versus ATV/RTV with Truvada trial, 316 of 353 patients (89.5%) on Stribild versus 308 of 355 patients (86.8%) on Atripla had an HIV RNA concentration of <50 copies/mL at 48 weeks. Conclusion: Stribild had a favorable safety profile in the two recently published randomized, double-blind, phase 3 clinical trials. With the approval of Stribild, clinicians now have more flexibility in prescribing single-tablet regimens for patients. © 2013 The Author(s).