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Elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate

(Stribild®)

Stribild®

Drug updated on 12/11/2024

Dosage Form Tablet (oral; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate: 150mg/150 mg/200 mg/300 mg)
Drug ClassHIV integrase strand transfer inhibitors (HIV-1 INSTI), CYP3A inhibitors, and HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI)
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older weighing at least 35 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of STRIBILD.

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Summary
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  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • In a 96-week phase 3b trial involving virologically suppressed people living with human immunodeficiency viruses (HIV) aged ≥65 years, Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (Stribild) demonstrated virologic suppression rates of 94.2% at week 72 and 74.4% at week 96, with no participants having HIV-1 RNA ≥50 copies/ml and no treatment-emergent resistance observed.
  • The population studied specifically included older individuals (≥65 years), and findings indicated stable CD4 counts throughout the study, with a median self-reported adherence rate of 100%.
  • Safety outcomes revealed no study drug-related serious adverse events; however, three participants experienced drug-related treatment-emergent adverse events leading to premature discontinuation, and there were no clinically relevant changes in fasting lipid parameters or body weight by week 96.
  • For Glecaprevir/Pibrentasvir, elevations in alanine transaminase were observed when combined with atazanavir/ritonavir; however, no clinically significant changes in the exposure of any antiretroviral agents were noted when coadministered.
  • The evidence indicates that in virologically suppressed adults aged ≥65 years, high virologic suppression rates of 94.2% at week 72 and 74.4% at week 96 were observed with Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (Stribild), alongside stable CD4 counts and no drug-related serious adverse events; median self-reported adherence was 100%, while co-infected patients showed significant drug-drug interaction concerns with hepatitis C virus (HCV) direct-acting antiviral agents.