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Does an increase in serum creatinine always reflect renal injury? The case of Stribild®
Vikram Arya1, Jeffry Florian, Kendall A Marcus
1Division of Clinical Pharmacology 4, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Insights
Single tablet, once-daily HIV treatment regimens, like Stribild®, improve adherence and reduce dosing errors for treatment-naïve adults. This fixed-dose combination offers a convenient option for managing HIV-1 infection.
Area of Science:
- Antiviral Therapy
- Pharmacology
- Infectious Diseases
Background:
- Single-tablet, once-daily HIV treatment regimens enhance patient convenience and adherence.
- Fixed-dose combination (FDC) tablets aim to minimize dosing errors.
- Stribild® is an approved FDC for treatment-naïve adult HIV-1 patients.
Purpose of the Study:
- To provide an overview of Stribild® as a single-tablet, once-daily HIV treatment option.
- To highlight the components and intended use of Stribild® in HIV-1 management.
Main Methods:
- Review of Stribild®'s composition and approval status.
- Description of the drug's active pharmaceutical ingredients and their mechanisms.
Main Results:
- Stribild® is a four-drug FDC tablet.
- It contains elvitegravir, cobicistat, emtricitabine (FTC), and tenofovir disoproxil fumarate (TDF).
- Approved for treatment-naïve adult HIV-1 patients.
Conclusions:
- Stribild® offers a convenient, once-daily dosing regimen for HIV-1 treatment.
- The FDC formulation simplifies treatment and potentially improves patient outcomes.
Abstract:
Single tablet, once-daily HIV treatment regimens offer patient convenience, the potential for increased adherence, and fewer patient-related dosing errors[1] . Stribild® (manufactured and marketed by Gilead Sciences; referred to as "applicant" in this report), a 4-drug fixed-dose combination (FDC) tablet, is approved for the treatment of HIV-1 infection in treatment-naïve adult patients. Stribild® contains elvitegravir (an integrase strand transfer inhibitor), cobicistat (an inhibitor of cytochrome P450 enzymes), and the nucleoside/nucleotide reverse transcriptase inhibitors emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF).
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