Drug updated on 11/1/2024
Dosage Form | Tablet (oral; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate: 150mg/150 mg/200 mg/300 mg) |
Drug Class | HIV integrase strand transfer inhibitors (HIV-1 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 12 years of age and older weighing at least 35 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/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 STRIBILD.
Latest News
Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- In a 96-week phase 3b trial involving virologically suppressed people living with HIV (human immunodeficiency viruses) aged ≥65 years, Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (Stribild) demonstrated virologic suppression rates of 94.2% at week 72 and 74.4% at week 96, with no participants having HIV-1 RNA ≥50 copies/ml and no treatment-emergent resistance observed.
- The population studied specifically included older individuals (≥65 years), and findings indicated stable CD4 counts throughout the study, with a median self-reported adherence rate of 100%.
- Safety outcomes revealed no study drug-related serious adverse events; however, three participants experienced drug-related treatment-emergent adverse events leading to premature discontinuation, and there were no clinically relevant changes in fasting lipid parameters or body weight by week 96.
- For Glecaprevir/Pibrentasvir, elevations in alanine transaminase were observed when combined with atazanavir/ritonavir; however, no clinically significant changes in the exposure of any antiretroviral agents were noted when coadministered.
- The evidence indicates that in virologically suppressed adults aged ≥65 years, high virologic suppression rates of 94.2% at week 72 and 74.4% at week 96 were observed with Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (Stribild), alongside stable CD4 counts and no drug-related serious adverse events; median self-reported adherence was 100%, while co-infected patients showed significant drug-drug interaction concerns with HCV (hepatitis C virus) direct-acting antiviral agents.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) Prescribing Information. | 2021 | Gilead Sciences, Inc., Foster City, CA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Bictegravir/emtricitabine/tenofovir alafenamide in older individuals with HIV: Results of a 96-week, phase 3b, open-label, switch trial in virologically suppressed people >/=65 years of age | 2023 | HIV Medicine |
Drug-Drug Interactions of Glecaprevir and Pibrentasvir Coadministered With Human Immunodeficiency Virus Antiretrovirals | 2020 | The Journal of Infectious Diseases |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Clinical considerations in the selection of preexposure prophylaxis for HIV prevention in Canada | 2022 | The Canadian Journal for Infectious Diseases & Medical Microbiology |
Major revision version 11.0 of the European AIDS clinical society guidelines 2021 | 2021 | HIV Medicine |