Drug updated on 4/15/2024
| Dosage Form | Tablet (oral; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate: 150mg/150 mg/200 mg/300 mg) |
| Drug Class | Antivirals |
| 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.
Summary
- Elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate (Stribild) is recommended as a complete regimen for the management 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.
- Two studies were analyzed, providing information on the effectiveness and safety of Stribild compared to other antiretroviral therapies such as long-acting cabotegravir (CAB-LA) + rilpivirine (RPV-LA) and tenofovir disoproxil fumarate-based therapy.
- The studies revealed that LA-AntiRetroVirals demonstrated comparable safety profiles with common reactions being mild or moderate injection site reaction. CAB-LA showed more satisfactory efficacy than tenofovir disoproxil fumarate-emtricitabine in preventing HIV-1 infection, indicating higher effectiveness compared to daily oral drugs like Stribild.
- In terms of population types and subgroup considerations, LA-AntiRetroVirals were versatile across different patient histories including both treatment-naive and experienced patients.
- Specifically for an Asian population coinfected with HIV/Hepatitis B Virus (HBV), switching to Stribild maintained HBV & HIV viral suppression while improving proteinuria & Bone Mineral Density (BMD). However, it increased lipid levels at week 48, suggesting a generally favorable safety profile but specific consideration needed for this group due to its impact on lipid levels.
- The same study also reported high effectiveness with over 94% of participants maintaining their HIV RNA at <50 copies/mL after week 48 post switch from previous regime to Stribild.
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 |
|---|---|---|
| Safety and efficacy of long-acting injectable agents for HIV-1: systematic review and meta-analysis. | 2023 | JMIR Public Health and Surveillance |
| Efficacy and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide as maintenance treatment in HIV/ HBV-coinfected patients. | 2021 | Journal of AIDS |
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 |