Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide

(Genvoya®)

Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide

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Drug updated on 5/17/2024

Dosage FormTablet (oral; 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide)
Drug ClassHIV-1 integrase strand transfer inhibitor (INSTI), CYP3A inhibitor and nucleoside analog reverse transcriptase inhibitors (NRTIs)
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 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 per 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 GENVOYA.

Summary
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  • Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (Genvoya) is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed.
  • Three randomized controlled studies provided information on Genvoya's safety and effectiveness compared to other antiretroviral therapies.
  • The first study showed high efficacy with Genvoya maintaining virologic suppression in 100% of participants through 48 weeks. It also demonstrated tolerability with low rates of serious adverse events among adults with specific resistance mutations.
  • In the second analysis involving Asian populations across four studies, Genvoya exhibited high virologic suppression rates while showing an enhanced safety profile concerning renal health when compared to regimens containing tenofovir disoproxil fumarate (TDF).
  • The third analysis focused on older individuals aged 60 years or more. It was found that bone mineral density improved significantly within this group when treated with Genvoya as opposed to TDF-containing regimens which saw a decline over time.
  • Across all three analyses reviewed, consistent findings indicate that regardless of patient groups including those having resistance mutations or being susceptible towards renal dysfunction due to ethnicity or age-related bone demineralization issues; Genvoya consistently maintains high levels of viral suppression while demonstrating favorable outcomes regarding safety especially related to renal and bone health.

Product Monograph / Prescribing Information

Randomized Controlled Trials