What are the dosing recommendations for Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) in a patient with Impaired renal function undergoing hemodialysis?

Biktarvy Dosing in Hemodialysis Patients

Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) can be used at standard dosing (50/200/25 mg once daily) in virologically-suppressed patients with end-stage renal disease on chronic hemodialysis, administered after dialysis sessions on dialysis days. 1

FDA-Approved Dosing for Hemodialysis

• The FDA label explicitly approves Biktarvy 50/200/25 mg once daily for virologically-suppressed adults with estimated creatinine clearance below 15 mL/min receiving chronic hemodialysis 1
• This represents a major advancement as it allows once-daily, single-tablet dosing without dose adjustment in this population 1

Critical Restrictions and Contraindications

Biktarvy is NOT recommended in the following scenarios:

• Patients with CrCl 15 to <30 mL/min (not yet on dialysis) 1
• Patients with CrCl <15 mL/min who are NOT receiving chronic hemodialysis 1
• Patients with CrCl <15 mL/min who have no prior antiretroviral treatment history (treatment-naive) 1

The FDA approval specifically requires virological suppression (HIV-1 RNA <50 copies/mL) for use in hemodialysis patients 1

Timing of Administration

• Administer Biktarvy after hemodialysis sessions on dialysis days 2, 3, 4
• Post-dialysis dosing prevents premature drug removal during dialysis and facilitates directly observed therapy 2, 3
• On non-dialysis days, maintain once-daily dosing at a consistent time 1

Supporting Clinical Evidence

The strongest recent evidence comes from a 2025 phase 3b open-label extension study demonstrating:

• All 10 participants maintained virological suppression (HIV-1 RNA <50 copies/mL) over 48 weeks of Biktarvy treatment 5
• No treatment discontinuations occurred due to adverse events 5
• Bictegravir trough concentrations remained 4-7 fold higher than the established protein-adjusted 95% effective concentration against wild-type HIV-1, despite being lower than in patients with normal renal function 5

Additional real-world data from 2023 case series:

• Six patients with ESRD on hemodialysis successfully used Biktarvy with maintained viral suppression 6
• The regimen allowed once-daily dosing, eliminated serious drug interactions, and simplified antiretroviral therapy 6

Pharmacokinetic Considerations

Tenofovir alafenamide (TAF) accumulation:

• TAF exposures are 79-92% higher in severe renal impairment compared to normal renal function 7
• However, TFV exposures from TAF 25 mg in severe renal impairment remain 10-40% lower than historical TDF exposures in patients with normal renal function 7
• This favorable profile makes TAF-based regimens safer than older TDF-based regimens in renal impairment 7

Emtricitabine considerations:

• Older guidelines from 2014 recommended emtricitabine 200 mg every 96 hours in hemodialysis patients 2
• However, the current FDA-approved Biktarvy formulation uses standard daily dosing of all components, which has been validated in clinical trials 1, 5

Critical Pitfalls to Avoid

1. Do not use Biktarvy in treatment-naive hemodialysis patients - FDA approval is only for virologically-suppressed individuals 1

2. Do not use Biktarvy in patients with CrCl 15-29 mL/min who are not yet on dialysis - this population lacks safety and efficacy data 1

3. Do not administer before dialysis sessions - this leads to premature drug removal and subtherapeutic levels 2, 3

4. Avoid use in peritoneal dialysis without extreme caution - limited data exists, with one 2024 case report showing 15-fold higher TFV plasma concentrations and 2-fold higher intracellular TFV-DP, suggesting potential for nephrotoxicity and need for dose adjustment 8, 9

5. Monitor baseline and ongoing renal parameters - assess serum creatinine, estimated creatinine clearance, urine glucose, urine protein, and serum phosphorus as clinically appropriate 1

Advantages Over Alternative Regimens

• Single-tablet, once-daily regimen eliminates complex dose adjustments required with older antiretrovirals 6, 5
• No pharmacokinetic boosting required (unlike older regimens with cobicistat), reducing drug-drug interaction potential 6, 5
• Reduced pill burden particularly important for patients on multiple medications for comorbidities 5
• Suitable for transplant candidates due to minimal drug interactions 5