Drug updated on 9/4/2024
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.
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Summary
- Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) is 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.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- CAB-LA for HIV-1 Prevention: CAB-LA demonstrated superior efficacy in preventing HIV-1 infection with an HIV-1 infection rate of 0.33% compared to 1.46% in the tenofovir disoproxil fumarate-emtricitabine group (RR 0.21, 95% CI 0.07-0.61).
- CAB-LA+RPV-LA for HIV-1 Treatment: Virological suppression rates were 91.43% at 48 and 96 weeks, comparable to 92.2% with daily oral drugs (RR 0.99, 95% CI 0.97-1.02); long-term suppression after 5 years was 80.9%.
- E/C/F/TAF in HIV/HBV-Coinfected Patients: E/C/F/TAF maintained HIV RNA <50 copies/mL in 95.6% at week 24 and 94.2% at week 48, and HBV DNA <20 IU/mL in 92.7% at week 24 and 89.8% at week 48.
- CAB-LA and RPV-LA: Higher incidence of drug-related adverse events compared to placebo (81.6% vs. 6.2%, RR 12.50, 95% CI 3.98-39.23; I²=85%), with common mild or moderate injection site reactions that decreased over time.
- E/C/F/TAF: Significant improvements in renal function and bone mineral density, but an increase in lipid levels was observed. Withdrawal due to adverse effects occurred in 2.6% of patients.
- There is no population types or subgroup information available in the reviewed studies.
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 |