What information should I obtain from a patient with HIV-1 infection before prescribing Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide)?

Pre-Prescribing Assessment for Biktarvy

Before prescribing Biktarvy, you must obtain hepatitis B testing, renal function assessment, resistance testing history, and a complete medication review to identify contraindications and drug interactions. 1

Mandatory Laboratory Testing

Hepatitis B Virus Status

• Test for hepatitis B virus (HBV) infection prior to or when initiating Biktarvy 1
• This is critical because severe acute exacerbations of hepatitis B can occur if Biktarvy is discontinued in HBV/HIV co-infected patients 1
• If HBV-positive, plan for close hepatic function monitoring and potential anti-hepatitis B therapy if Biktarvy is ever discontinued 1

Renal Function Assessment

• Assess serum creatinine, estimated creatinine clearance (eCrCl), urine glucose, and urine protein prior to or when initiating Biktarvy 1
• In patients with chronic kidney disease, also assess serum phosphorus 1
• Biktarvy is not recommended if eCrCl is 15 to <30 mL/min, or <15 mL/min in patients not receiving chronic hemodialysis, or <15 mL/min in treatment-naive patients 1

HIV-Specific Testing

• Confirm HIV-1 RNA viral load and CD4+ cell count 2
• Review all prior resistance testing results (genotypic and phenotypic if available) to ensure no known substitutions associated with resistance to bictegravir or tenofovir 1, 2
• If switching from another regimen, confirm virologic suppression (HIV-1 RNA <50 copies/mL) 1

Comprehensive HIV Treatment History

Antiretroviral Exposure History

• Document all prior antiretroviral regimens, including specific drugs, duration of therapy, reasons for changes, and adherence patterns 2
• Ask specifically about pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) use 2
• For patients with long-acting injectable PrEP exposure in the past 12 months, obtain HIV nucleic acid test (NAT) in addition to standard testing 2
• Obtain lowest CD4+ count and highest viral load ever recorded 2
• Review all available prior drug resistance test results 2

HIV-Related Medical History

• Document history of opportunistic infections, HIV-related malignancies, and AIDS-defining conditions 2
• Ask about prior HIV-associated complications including thrombocytopenia, neuropathy, and neurocognitive impairment 2

Complete Medication Review for Drug Interactions

Absolute Contraindications

• Biktarvy is contraindicated with dofetilide 1
• Biktarvy is contraindicated with rifampin 1

Comprehensive Medication Assessment

• Review all prescription medications, over-the-counter drugs, methadone, and dietary/herbal supplements 2
• Many supplements interact with antiretrovirals 2
• Consult drug interaction resources prior to prescribing 1
• Because Biktarvy is a complete regimen, coadministration with other antiretroviral medications is not recommended 1

Additional Medical History

Comorbidities Assessment

• Assess for cardiovascular disease risk factors, dyslipidemia, diabetes mellitus, and osteoporosis 2
• Document history of psychiatric conditions including depression, anxiety, and suicidal ideation 2

Hepatic Function

• Biktarvy is not recommended in patients with severe hepatic impairment (Child-Pugh C) 1

Allergy History

• Document hypersensitivity reactions to prior antiretrovirals, including sulfonamides, NNRTIs, and abacavir 2

Sexually Transmitted Infections

• Screen for gonorrhea, chlamydia, syphilis, herpes simplex virus, and HPV 2
• Obtain serologic tests for hepatitis B and C (if hepatitis B negative, vaccinate) 2

Pregnancy Status

• For pregnant individuals who are virologically-suppressed with no known resistance, Biktarvy can be used 1
• Assess pregnancy intentions in individuals of childbearing potential 2

Common Pitfalls to Avoid

• Never prescribe Biktarvy without confirming HBV status—discontinuation in co-infected patients can cause life-threatening hepatitis flares 1
• Never prescribe if eCrCl is below the recommended threshold—this increases risk of renal toxicity 1
• Never combine with other antiretrovirals—Biktarvy is a complete regimen 1
• Never prescribe with dofetilide or rifampin—these are absolute contraindications 1
• Never assume no resistance without reviewing complete testing history—archived resistance can compromise efficacy 2