Drug updated on 3/28/2024
| Dosage Form | Tablet (oral; 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide) |
| Drug Class | Antivirals |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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
- Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (Genvoya) is indicated 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.
- The document reviewed was a systematic review/meta-analysis that compared nucleoside/nucleotide reverse transcriptase inhibitor (NRTI)-sparing regimens with Genvoya-based combinations in HIV-1-infected adults.
- A total of one document was analyzed which included twenty-three studies on treatment-naïve patients including four studies assessing NRTI-sparing regimens.
- In terms of efficacy after 48 weeks, it was found that the probability of achieving virological suppression with Genvoya was between 40% and 60% higher than with NRTI-sparing strategies.
- For naïve patients with viral load less than 100000 HIV-1 RNA copies/mL, there existed a credible difference favoring Genvoya over NRTI-sparing treatments according to this meta-analysis study results.
- Based on TAF pharmacological properties as well as tolerability results from clinical studies mentioned within this systematic review/meta-analysis document; it suggests that safety profile for Genvoya might be similar to that of NRTI-sparing regimens making it an appropriate option for initiation therapy among treatment-naive HIV-infected individuals.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) Prescribing Information. | 2022 | Gilead Sciences, Inc., Foster City, CA |