What are the considerations for using Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) in patients with Impaired renal function requiring dialysis?

Biktarvy Use in Patients Requiring Dialysis

Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) is not recommended for patients with severe renal impairment (estimated creatinine clearance 15-30 mL/min) or end-stage renal disease (ESRD) requiring dialysis who are not already on antiretroviral therapy, according to FDA labeling. 1

Renal Considerations for Biktarvy Components

Tenofovir Alafenamide (TAF)

• TAF can be used if creatinine clearance is above 30 mL/min/1.73 m² 2
• Not recommended for patients with creatinine clearance below 15 mL/min 2
• TAF is preferred over tenofovir disoproxil fumarate (TDF) in patients with renal impairment due to less nephrotoxicity 2

Emtricitabine

• Requires dose adjustment for renal impairment 2
• Standard dosing: 200 mg once daily
• For creatinine clearance 30-49 mL/min: 200 mg every 48 hours
• For creatinine clearance 15-29 mL/min: 200 mg every 72 hours
• For creatinine clearance <15 mL/min: 200 mg every 96 hours
• For patients on hemodialysis: 200 mg every 96 hours (after dialysis) 2

Bictegravir

• No specific dose adjustment data available for severe renal impairment

FDA Label Guidance

The FDA label for Biktarvy specifically states:

• Not recommended in patients with:

  • Severe renal impairment (estimated creatinine clearance 15-30 mL/min)
  • ESRD (estimated creatinine clearance <15 mL/min) not receiving chronic hemodialysis
  • Patients with no antiretroviral treatment history and ESRD who are receiving chronic hemodialysis 1

• Monitoring requirements:

  • Prior to initiating Biktarvy, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein
  • During treatment, continue monitoring renal function as clinically appropriate
  • In patients with chronic kidney disease, also assess serum phosphorus 1

Special Considerations for Dialysis Patients

For Treatment-Experienced Patients on Dialysis

• Limited data suggests Biktarvy may be an option for virologically-suppressed adults with ESRD on chronic hemodialysis 3
• A small case series of 6 patients with ESRD on hemodialysis showed successful use of Biktarvy with no significant adverse events 3

For Treatment-Naïve Patients on Dialysis

• Alternative regimens should be considered as first-line therapy
• The fixed-dose combination of glecaprevir and pibrentasvir is the treatment of choice for patients with chronic hepatitis C and stage 4 or 5 CKD (including those on hemodialysis) 2

Monitoring and Safety

• Monitor for signs of renal impairment, including:

  • Changes in serum creatinine
  • Decreased estimated creatinine clearance
  • Glycosuria
  • Proteinuria
  • Phosphaturia 1

• Discontinue Biktarvy if patients develop:

  • Clinically significant decreases in renal function
  • Evidence of Fanconi syndrome 1

Alternative Options for Dialysis Patients

For HIV patients requiring dialysis who cannot use Biktarvy, consider:

1. Dolutegravir-based regimens with appropriate dose adjustments for the NRTI components
2. Raltegravir-based regimens with appropriate dose adjustments for the NRTI components
3. There are data supporting use of elvitegravir/cobicistat/TAF/emtricitabine once daily in patients with end-stage renal disease receiving long-term hemodialysis 2

Conclusion

While Biktarvy offers the convenience of a single-tablet regimen, its use in dialysis patients must be approached with caution. For treatment-naïve patients with ESRD requiring dialysis, alternative regimens with established safety profiles in renal impairment should be considered first-line. For treatment-experienced, virologically-suppressed patients already on dialysis, limited data suggests Biktarvy may be an option, but close monitoring is essential.