Drug updated on 9/4/2024
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-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.
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Summary
- Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) 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 (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.
- This summary is based on the review of three randomized controlled trial(s). [1-3]
- Virologic Suppression in Participants with Resistance Mutations: Participants with M184V/I mutations switching to E/C/F/TAF maintained a 100% virologic suppression rate (HIV-1 RNA < 50 copies per milliliter) at weeks 12, 24, and 48, with only one participant showing HIV-1 RNA ≥ 50 copies per milliliter at week 12, which was resolved by confirmatory testing.
- Efficacy in Asian Participants: In ART-naive Asian participants, 93% achieved virologic suppression with TAF versus 88% with TDF at week 144. In ART-experienced participants who switched regimens, 95% maintained virologic suppression on TAF versus 86% on TDF at week 96. Additionally, 91% of those with mild-moderate renal impairment maintained virologic suppression at week 144.
- Effect on Bone Mineral Density in Older Participants: Older participants (≥ 60 years) switching from TDF to E/C/F/TAF showed significant improvements in bone mineral density at week 48, with a 2.24% increase in spine bone mineral density and a 1.33% increase in hip bone mineral density, compared to decreases in the TDF group (-0.10% and -0.73%, respectively).
- Drug-related adverse events (AEs) were reported in 15.6% of participants with resistance mutations, with Grade 3-4 AEs or serious AEs occurring in 9.4% and 7.8% of participants, respectively, but were not drug-related.
- In older participants (≥ 60 years), 20% of those in the E/C/F/TAF group reported AEs considered related to treatment, with no treatment-related serious AEs observed. Similar proportions of AEs led to treatment discontinuation in both groups (4% for E/C/F/TAF vs 2% for TDF).
- Population Types and Subgroups: Virologically suppressed adults with M184V/I mutations, Asian participants (ART-naive and ART-experienced), and older participants (≥ 60 years) were the primary subgroups studied, showing high virologic suppression rates across groups, minimal drug-related adverse events, no significant renal adverse events in Asians, and improved bone mineral density in older adults on E/C/F/TAF.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) Prescribing Information. | 2022 | Gilead Sciences, Inc., Foster City, CA |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in adults with HIV and M184V/I mutation. | Data not availableSubjects F: null% M: null% | 2021 | Journal of Acquired Immune Deficiency Syndromes (1999) |
Efficacy and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in Asian participants with human immunodeficiency virus 1 infection: a sub-analysis of phase 3 clinical trials. | Data not availableSubjects F: null% M: null% | 2019 | HIV Research & Clinical Practice |
Bone mineral density in virologically suppressed people aged 60 years or older with HIV-1 switching from a regimen containing tenofovir disoproxil fumarate to an elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide single-tablet regimen: a multicentre, open-label, phase 3b, randomised trial. | Data not availableSubjects F: null% M: null% | 2019 | The Lancet HIV |
Document Title
Sex Distribution:
Year:
2021
Source:Journal of Acquired Immune Deficiency Syndromes (1999)
Sex Distribution:
Year:
2019
Source:HIV Research & Clinical Practice
Sex Distribution:
Year:
2019
Source:The Lancet HIV