What routine labs should be drawn for an HIV (Human Immunodeficiency Virus) positive patient on Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide)?

Routine Laboratory Monitoring for HIV+ Patients on Biktarvy

For HIV+ patients on Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), routine laboratory monitoring should include CD4 count, HIV viral load, complete blood count, comprehensive metabolic panel, lipid profile, urinalysis, and screening for sexually transmitted infections every 3-6 months. 1

Initial Baseline Testing (Before Starting Biktarvy)

Before initiating Biktarvy, the following tests should be performed:

• HIV confirmation testing (if not previously documented) 2
• CD4+ T cell count 1, 2
• Plasma HIV RNA level (viral load) 1, 2
• Complete blood count with differential 1
• Comprehensive metabolic panel (including liver and kidney function) 1
• Fasting lipid profile 1
• Fasting glucose or HbA1c 1
• Urinalysis and calculated creatinine clearance 1, 2
• Hepatitis B and C serology 1, 2
• Tuberculosis screening (TST or IGRA) 1, 2
• Sexually transmitted infection screening (syphilis, gonorrhea, chlamydia) 1
• HLA-B*5701 testing (not required for Biktarvy but needed if considering abacavir) 1, 3

Routine Monitoring While on Biktarvy

Every 3-6 Months

• HIV viral load (every 3 months until suppressed for 1 year, then every 6 months) 1
• CD4+ T cell count (every 6 months until consistently >250 cells/μL for at least 1 year, then can be discontinued if virologically suppressed) 1
• Complete blood count with differential 1
• Comprehensive metabolic panel (including liver and kidney function) 1, 4
• Urinalysis (especially important with tenofovir-containing regimens) 1, 4

Every 6-12 Months

• Fasting lipid profile (consider testing 1-3 months after starting Biktarvy, then every 6-12 months) 1
• Fasting glucose or HbA1c (every 6-12 months) 1
• Renal function monitoring (creatinine and estimated glomerular filtration rate) 1, 4

Annually

• STI screening (syphilis, gonorrhea, chlamydia) for patients at risk 1
• Tuberculin skin test or IGRA (for patients at risk for TB) 1
• Hepatitis C antibody testing (for patients at risk) 1
• Trichomoniasis testing (for women) 1

Special Considerations for Biktarvy

Biktarvy contains tenofovir alafenamide (TAF), which has a better renal and bone safety profile than tenofovir disoproxil fumarate (TDF), but still requires monitoring:

• Renal function should be assessed regularly as tenofovir can cause nephrotoxicity 1, 4
• Patients with baseline creatinine clearance <30 mL/min should not receive Biktarvy 4, 3
• Monitor for lactic acidosis and hepatotoxicity, which are rare but serious adverse effects of nucleoside analogs like emtricitabine 4

Frequency Adjustments Based on Clinical Status

• For stable patients with viral suppression for >1 year:

  • HIV RNA monitoring can be reduced to every 6 months 1
  • CD4+ cell count monitoring can be discontinued if consistently >250 cells/μL 1
  • Safety laboratory monitoring can be reduced to every 6 months 1

• For patients with >5 years of stability:

  • Viral and safety laboratory monitoring can be reduced to once yearly if preferred by the patient 1

• More frequent monitoring is indicated for:

  • Patients with detectable viral loads
  • Patients with clinical symptoms
  • Patients with comorbidities affecting renal or liver function
  • Patients who have recently started or changed therapy 1

Common Pitfalls to Avoid

• Don't miss renal monitoring: Tenofovir alafenamide (in Biktarvy) has improved renal safety compared to tenofovir disoproxil fumarate but still requires regular monitoring of renal function 4, 3

• Don't overlook metabolic effects: Biktarvy may affect lipid profiles and glucose metabolism, requiring regular monitoring 1, 5

• Don't continue unnecessary CD4 monitoring: Once CD4 counts are consistently >250 cells/μL for at least a year with viral suppression, routine CD4 monitoring can be discontinued 1

• Don't forget STI screening: Regular screening for sexually transmitted infections is essential, with frequency based on risk factors 1

• Don't miss hepatitis coinfection: Patients with hepatitis B coinfection require additional monitoring as components of Biktarvy have activity against HBV 3

By following these monitoring guidelines, clinicians can effectively track treatment response, detect potential adverse effects early, and ensure optimal outcomes for HIV+ patients on Biktarvy.