Drug updated on 5/17/2024
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.
Latest News
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Summary
- 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
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:
![No Data](/img/Nodata_Icon.png)
Year:
2021
Source:Journal of Acquired Immune Deficiency Syndromes (1999)
Sex Distribution:
![No Data](/img/Nodata_Icon.png)
Year:
2019
Source:HIV Research & Clinical Practice
Sex Distribution:
![No Data](/img/Nodata_Icon.png)
Year:
2019
Source:The Lancet HIV