Drug updated on 12/11/2024
| Dosage Form | Tablet (oral; 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide) |
| Drug Class | HIV 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.
Latest News
Summary
- 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.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) Prescribing Information. | 2022 | Gilead Sciences, Inc., Foster City, CA |