Stribild: a combined four-drug once-daily treatment for HIV

Stribild is a combination tablet containing elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil, for the treatment of HIV. It can be used in treatment-naive patients and patients with no resistance mutations to the individual components.

Monitoring of patients receiving Stribild therapy should include creatinine clearance, serum phosphate, urine glucose and urine protein.
Monitoring of patients receiving Stribild therapy should include creatinine clearance, serum phosphate, urine glucose and urine protein.


Elvitegravir is a novel HIV integrase strand transfer inhibitor with potent antiviral activity. It is combined with cobicistat, a cytochrome P450 3A inhibitor that has no anti-HIV activity but acts as a pharmacoenhancer allowing once-daily dosing. The remaining components, emtricitabine and tenofovir disoproxil, are established nucleoside/nucleotide reverse transcriptase inhibitors.1


The safety and efficacy of a single-tablet regimen comprising elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil were assessed in two randomised, active-controlled phase III studies involving 1,408 antiretroviral-naive HIV-infected patients.1-3

Patient criteria

Patients eligible for inclusion had plasma HIV-1 RNA concentrations of ≥5,000 copies per ml, an estimated glomerular filtration rate of ≥70ml/min and were susceptible to emtricitabine, tenofovir and efavirenz/atazanavir by HIV-1 genotype.2,3

The four-drug, single-tablet regimen was compared with a once-daily fixed-dose combination of efavirenz/emtricitabine/tenofovir disoproxil (Atripla®) in study 102 (n=700) and with ritonavir-boosted atazanavir plus a fixed dose combination of emtricitabine/tenofovir disoproxil (Truvada®) in study 103 (n=708).2,3

Efficacy data

The four-drug regimen was found to be non-inferior to the comparator regimen in both studies in terms of virologic response at 48 weeks, the primary outcome measure (defined as <50 HIV-1 RNA copies/ml).1-3

Virologic success was achieved in 88% and 90% of patients receiving the four-drug single-tablet regimen in studies 102 and 103, respectively, compared with 84% of those receiving the efavirenz/emtricitabine/tenofovir disoproxil regimen and 87% of those receiving ritonavir/atazanavir plus emtricitabine/tenofovir disoproxil.1-3

Safety profile

Safety and tolerability of the four-drug single-tablet regimen was similar to that of the two comparator regimens, with nausea and diarrhoea the most commonly reported adverse effects.1-3


  1. Stribild Summary of Product Characteristics, May 2013.
  2. Sax PE et al. Lancet 2012; 379: 2439–48.
  3. DeJesus E et al. Lancet 2012; 379: 2429–38.

View Stribild drug record

Further information: Gilead

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