What is the recommended dosage adjustment for Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) in patients with Chronic Kidney Disease (CKD)?

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Last updated: March 24, 2025View editorial policy

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From the Research

Biktarvy dosage adjustment is not required for patients with mild to moderate chronic kidney disease (CKD), but for those with severe renal impairment, a cautious increase of tenofovir alafenamide dosage intervals to 2 or 3 days may be considered. For patients with estimated creatinine clearance (CrCl) ≥30 mL/min, the standard dose of one tablet daily containing bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg can be used 1. However, Biktarvy is not recommended for patients with severe renal impairment (CrCl <30 mL/min) or end-stage renal disease requiring hemodialysis, as emtricitabine requires dose adjustment in this population, which cannot be achieved with the fixed-dose combination tablet. The pharmacokinetic properties of tenofovir alafenamide result in lower plasma tenofovir concentrations compared to tenofovir disoproxil fumarate, reducing the potential for renal toxicity 2, 3. Regular monitoring of renal function is still recommended for all patients on Biktarvy, especially those with risk factors for kidney disease. Key factors to consider in dosage adjustment include the patient's glomerular filtration rate (GFR) and the potential for drug interactions or accumulation in patients with renal dysfunction 4, 5. In clinical practice, careful consideration of the patient's individual needs and renal function is necessary to minimize the risk of adverse effects and ensure effective treatment. Some studies suggest that tenofovir alafenamide may be safe and effective in patients with varying levels of CKD severity, but more research is needed to confirm these findings 2. Overall, the decision to adjust the dosage of Biktarvy in patients with CKD should be based on the individual patient's needs and renal function, as well as the potential risks and benefits of treatment. The most recent and highest quality study suggests that kidney function markedly affects circulating tenofovir exposure after tenofovir alafenamide administration in patients with HIV, and a cautious increase of tenofovir alafenamide dosage intervals may be considered in patients with moderate or severe CKD 1. In summary, Biktarvy dosage adjustment is not required for patients with mild to moderate CKD, but careful monitoring and consideration of the patient's individual needs and renal function are necessary to minimize the risk of adverse effects and ensure effective treatment.

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This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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