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.

PHARMACOLOGY

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

CLINICAL STUDIES

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

References:

  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

Follow MIMS on Twitter


MIMS Clinics

Prescribing news and resources for key therapeutic areas, collated by the MIMS editors.

Register or Subscribe to MIMS

GPs can get MIMS print & online and GPonline for free when they register online – take 2 minutes, and make sure you get your free MIMS access! If you're not a GP, you can subscribe to MIMS for full access.

Register or subscribe

MIMS bulletins

News and updates straight to your inbox.

Prescribing Update: Fortnightly news bulletin
Alert:
Urgent prescribing updates
Spotlight: Disease-themed monthly round-up

Sign me up

MIMS Dermatology

Read the latest issue online exclusively on MIMS Learning.

Read MIMS Dermatology

Mobile apps

MIMS: access the full drug database and quick-reference tables on the go

MIMS Diagnosis and Management: concise information on signs and symptoms, investigations and diseases

Promo Image

Clinical calculators

Handy calculators and conversions for primary care.