Lucius Bictegravir/Emtricitabine/Tenofovir Alafenamide™ | Instruction Manual v.2.5

Designation: Fixed-Dose Combination Antiretroviral Therapy (ART)
Model: Lucius BIC/FTC/TAF
Strength: Bictegravir 50mg/Emtricitabine 200mg/Tenofovir Alafenamide 25mg
Indication: HIV-1 Infection Management System

1. SYSTEM OVERVIEW

The Lucius BIC/FTC/TAF unit is a complete, once-daily, single-tablet regimen engineered for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infection in adults and pediatric patients weighing ≥25 kg.

Mechanism of Action:

• Bictegravir (BIC): Integrase Strand Transfer Inhibitor (INSTI) - blocks HIV integration into host DNA

• Emtricitabine (FTC): Nucleoside Reverse Transcriptase Inhibitor (NRTI) - inhibits viral DNA chain termination

• Tenofovir Alafenamide (TAF): Nucleotide Reverse Transcriptase Inhibitor (NRTI) - intracellular delivery of tenofovir diphosphate

2. INITIALIZATION & DOSING

Standard Operating Protocol:

• One tablet orally once daily with or without food

• Do not crush, split, or chew tablet

Special Populations:

• Renal impairment: Not recommended when eGFR <30 mL/min

• Hepatic impairment: No dose adjustment required

• Pediatric use: Approved for patients weighing ≥25 kg

3. MONITORING & FEEDBACK LOOPS

Baseline & Routine Surveillance Required:

• Virologic: HIV-1 RNA viral load (at baseline, 2-4 weeks, then every 3-6 months)

• Immunologic: CD4+ T-cell count (at baseline and every 3-6 months)

• Renal: Serum creatinine, eGFR, urinalysis (at baseline and annually)

• Metabolic: Fasting lipid panel, glucose (annually)

• Hepatitis B: HBsAg, anti-HBc, anti-HBs (at baseline)

Performance Metrics:

• HIV-1 RNA <50 copies/mL expected within 24 weeks in treatment-naïve patients

• Maintained virologic suppression in switch studies

4. ADVERSE EVENT PROTOCOLS

5. DRUG INTERACTION ALGORITHMS

Contraindicated Combinations:

• Dofetilide (risk of serious arrhythmias)

• Rifampin (reduces bictegravir concentrations)

Use With Caution:

• Antacids: Give 2 hours before or 4 hours after BIC/FTC/TAF

• PPIs: No dose separation needed

• Metformin: Monitor glycemic control

• Other ART: Generally not recommended with other antiretrovirals

6. SAFETY PROTOCOLS

• Hepatitis B warning: Severe acute exacerbations of Hepatitis B may occur upon discontinuation

• Lactic acidosis: Rare but serious; monitor for nonspecific symptoms

• Immune reconstitution syndrome: May occur during initial treatment

• Bone effects: Minimal bone mineral density impact with TAF formulation

7. STORAGE & HANDLING

• Store at 20°-25°C (68°-77°F)

• Keep in original container with desiccant

• Protect from moisture

• Dispense only in original container

8. DISCONTINUATION CRITERIA

• Treatment failure (confirmed virologic rebound)

• Intolerable adverse effects

• Pregnancy (consider alternative regimen)

• Significant renal function decline

Disclaimer:
This manual is a summary representation. Always refer to the full Prescribing Information. Treatment requires specialized HIV care provider supervision.

Manufacturer: Lucius Antiviral Therapeutics
Revision Date: 2024-01-15
REMS Program: Not required

Note: This product is part of a comprehensive HIV management strategy that includes adherence counseling, resistance testing when appropriate, and ongoing monitoring for long-term complications of HIV infection and antiretroviral therapy.

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