Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide

(Genvoya®)

Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide

Drug updated on 12/11/2024

Dosage FormTablet (oral; 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide)
Drug ClassHIV integrase strand transfer inhibitors (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 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.

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Summary
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  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • In virologically suppressed people living with human immunodeficiency virus (HIV) (PLWH) aged ≥65 years, switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) demonstrated continued viral suppression, with no participants experiencing HIV-1 RNA levels ≥50 copies/mL at 72 or 96 weeks; viral suppression rates were 94.2% at week 72 and 74.4% at week 96, with stable CD4 counts and a median self-reported adherence of 100%.
  • In HIV-1 and hepatitis C virus (HCV) co-infected participants treated with ledipasvir/sofosbuvir (LDV/SOF) and either elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or rilpivirine/F/TAF (R/F/TAF) regimens, SVR12 for HCV was achieved in 97% of cases, and HIV suppression was maintained in 96% of participants on E/C/F/TAF and 95% on R/F/TAF by week 24, with comparable efficacy across both regimens.
  • No clinically significant interactions were observed between E/C/F/TAF and glecaprevir/pibrentasvir, confirming that co-administration does not compromise the effectiveness of E/C/F/TAF, although interactions with certain antiretrovirals like atazanavir/ritonavir require careful management.
  • In virologically suppressed PLWH aged ≥65 years, switching to B/F/TAF was associated with a favorable safety profile, with no drug-related serious adverse events reported and only three participants discontinuing due to treatment-emergent adverse events; no clinically relevant changes in fasting lipid parameters or body weight were observed over the 96-week period.
  • In HIV-1/HCV co-infected participants, no cases of renal toxicity were reported with LDV/SOF co-administered with E/C/F/TAF or R/F/TAF, and only one participant on R/F/TAF discontinued treatment due to worsening hypercholesterolemia. Additionally, no clinically significant drug interactions were observed with E/C/F/TAF except when combined with atazanavir/ritonavir, where elevations in alanine transaminase occurred.
  • The reviewed studies highlighted specific population types including virologically suppressed PLWH aged ≥65 years, demonstrating high rates of viral suppression and minimal drug-related adverse events; HIV-1/HCV co-infected participants, including those with compensated cirrhosis, achieving a 97% SVR12 rate while maintaining HIV suppression; and HIV patients on various antiretroviral regimens, where significant drug interactions were noted primarily with atazanavir/ritonavir and boosted protease inhibitors, underscoring the need for tailored therapeutic considerations in these populations.