What is the recommended treatment regimen for patients with HIV-1 (Human Immunodeficiency Virus type 1) infection using BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide)?

BIKTARVY Treatment Regimen for HIV-1 Infection

Bictegravir/emtricitabine/tenofovir alafenamide (BIKTARVY) is recommended as a first-line, complete single-tablet regimen for the treatment of HIV-1 infection in adults, taken once daily with or without food. 1, 2

Dosing Recommendations

• Adults and pediatric patients ≥25 kg: One tablet containing 50 mg bictegravir, 200 mg emtricitabine, and 25 mg tenofovir alafenamide once daily with or without food 2
• Pediatric patients 14 kg to <25 kg: One tablet containing 30 mg bictegravir, 120 mg emtricitabine, and 15 mg tenofovir alafenamide once daily with or without food 2

Pre-Treatment Assessment

Before initiating BIKTARVY, the following tests should be performed:

• HIV-1 RNA level
• CD4 cell count
• HIV genotype testing for NRTI, NNRTI, and PI resistance
• Hepatitis B virus (HBV) screening
• Serum creatinine and estimated creatinine clearance
• Urine glucose and protein
• Serum phosphorus (in patients with chronic kidney disease) 1, 2

Treatment Initiation

ART should be initiated as soon as possible after diagnosis, including immediately after diagnosis if the patient is ready to commit to therapy 1. BIKTARVY is particularly suitable for rapid initiation because:

• No HLA-B*5701 testing is required (unlike abacavir-containing regimens) 3
• It has a high barrier to resistance development 3, 4
• It can be taken with or without food 2

Monitoring Recommendations

1. HIV-1 RNA assessment: 1 month after switching to BIKTARVY and at regular intervals thereafter 1
2. Follow-up visits: At intervals of no longer than every 3 months 1
3. Renal function: Assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein at least every 6 months 1, 2
4. Adherence: Regular assessment using validated adherence instruments and pharmacy refill data 1

Efficacy and Safety Profile

BIKTARVY has demonstrated high efficacy in clinical trials:

• 98.6% of patients maintained HIV-1 RNA <50 copies/mL through 5 years of treatment 4
• No treatment-emergent resistance has been detected in long-term studies 4, 5, 6

Common side effects include:

• Diarrhea (15-18%)
• Nausea (11-18%)
• Headache (13-16%) 5, 6

The BICSTaR study showed that approximately 94% of treatment-naïve patients and 97% of treatment-experienced patients achieved viral suppression after 1 year of BIKTARVY treatment 7.

Special Populations

Hepatitis B Co-infection

• BIKTARVY contains tenofovir alafenamide and emtricitabine, both active against HBV
• Severe acute exacerbations of hepatitis B can occur upon discontinuation
• Close monitoring of hepatic function is required if BIKTARVY is discontinued 2

Renal Impairment

• Not recommended in patients with estimated creatinine clearance 15 to <30 mL/min
• Not recommended in patients with creatinine clearance <15 mL/min who are not receiving chronic hemodialysis 2

Pregnancy

• For virologically-suppressed pregnant individuals: One tablet containing 50 mg bictegravir, 200 mg emtricitabine, and 25 mg tenofovir alafenamide once daily 2

Switching to BIKTARVY

BIKTARVY can be used to replace the current antiretroviral regimen in virologically suppressed patients (HIV-1 RNA <50 copies/mL) with:

• No history of treatment failure
• No known or suspected resistance to bictegravir, emtricitabine, or tenofovir 2

Even in patients with archived M184V/I mutations (which confer resistance to emtricitabine), BIKTARVY may be effective 1.

Common Pitfalls and Caveats

1. Drug Interactions: BIKTARVY is contraindicated with:

   • Dofetilide
   • Rifampin 2

2. Hepatitis B Management: Do not discontinue BIKTARVY in patients with HBV co-infection without appropriate alternative HBV therapy 1, 2

3. Renal Function: Although tenofovir alafenamide has less renal toxicity than tenofovir disoproxil fumarate, regular monitoring of renal function is still required 2

4. Immune Reconstitution Syndrome: May necessitate further evaluation and treatment 2

5. Lactic Acidosis/Hepatomegaly: Discontinue treatment if symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop 2

BIKTARVY's high efficacy, high barrier to resistance, favorable safety profile, and convenient once-daily single-tablet dosing make it an excellent choice for both treatment-naïve and virologically suppressed patients with HIV-1 infection.