Biktarvy 50/200/25mg Tb(blister Pk)

• Dofetilide (risk of increased dofetilide concentrations and life-threatening arrhythmias)
• Rifampin (significant decrease in bictegravir concentrations, leading to loss of virologic response)
• Carbamazepine, Oxcarbazepine, Phenobarbital, Phenytoin (strong CYP3A/UGT1A1 inducers, significant decrease in bictegravir concentrations)
• St. John's Wort (strong CYP3A/UGT1A1 inducer, significant decrease in bictegravir concentrations)

• Polyvalent cation-containing antacids or laxatives (e.g., aluminum, magnesium, calcium, iron supplements): Administer Biktarvy at least 2 hours before or 6 hours after these agents.
• Metformin (increased metformin concentrations, monitor for lactic acidosis)
• Rifabutin, Rifapentine (moderate CYP3A/UGT1A1 inducers, may decrease bictegravir concentrations, coadministration not recommended)
• Dronedarone (increased dronedarone concentrations)
• Ledipasvir/Sofosbuvir, Sofosbuvir/Velpatasvir, Sofosbuvir/Velpatasvir/Voxilaprevir (increased tenofovir concentrations, monitor renal function)
• Aminoglycosides, NSAIDs, high-dose or multiple concomitant nephrotoxic agents (increased risk of renal toxicity with tenofovir)

• Oral contraceptives (may alter concentrations of ethinyl estradiol and norgestimate, but no dose adjustment needed)
• Statins (e.g., atorvastatin, rosuvastatin, simvastatin - potential for increased statin concentrations, monitor)
• Immunosuppressants (e.g., cyclosporine, tacrolimus, sirolimus - potential for increased concentrations, monitor)
• Other drugs metabolized by CYP3A4 or UGT1A1 (monitor for altered concentrations)

• Not specifically listed as minor, but general caution with any new medication.

• Signs of renal dysfunction (e.g., decreased urine output, swelling in legs/feet, fatigue)
• Signs of liver dysfunction (e.g., jaundice, dark urine, pale stools, abdominal pain, nausea, vomiting)
• Signs of lactic acidosis (e.g., unexplained muscle pain, weakness, difficulty breathing, abdominal pain, nausea, vomiting, dizziness, cold/blue extremities)
• Signs of immune reconstitution inflammatory syndrome (IRIS) (e.g., worsening of pre-existing opportunistic infections or inflammatory conditions)
• New or worsening bone pain, fractures (rare, but associated with tenofovir disoproxil fumarate, less so with TAF)
• New or worsening psychiatric symptoms (e.g., depression, anxiety, insomnia, though less common with bictegravir than some other INSTIs)

Biktarvy is generally considered an option for use during pregnancy, particularly for women who are already virologically suppressed on the regimen. Data from the Antiretroviral Pregnancy Registry (APR) and clinical studies indicate no increased risk of major birth defects compared to background rates. Bictegravir, emtricitabine, and tenofovir alafenamide are recommended or alternative agents in various guidelines for use in pregnancy.

Breastfeeding is generally not recommended for women with HIV in developed countries due to the risk of HIV transmission to the infant. While emtricitabine and tenofovir are excreted in breast milk, and bictegravir is also likely present, the primary concern is HIV transmission. Consult with healthcare providers regarding individual circumstances and local guidelines.

Approved for pediatric patients weighing at least 14 kg. Dosing varies by weight. For children weighing 14 kg to less than 25 kg, a lower strength tablet (30/120/15 mg) is used. For children weighing at least 25 kg, the adult strength (50/200/25 mg) is used. Safety and efficacy in children weighing less than 14 kg have not been established.

No specific dose adjustment is required for elderly patients. However, geriatric patients are more likely to have decreased renal function and comorbidities, so renal function should be monitored closely. No overall differences in safety or effectiveness were observed between elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

• Biktarvy is a complete regimen, meaning it contains all necessary components for HIV-1 treatment in one pill, simplifying adherence.
• It can be taken with or without food, but taking it with food may improve absorption of tenofovir alafenamide.
• Avoid co-administration with polyvalent cation-containing antacids, laxatives, or supplements (e.g., aluminum, magnesium, calcium, iron). If necessary, take Biktarvy at least 2 hours before or 6 hours after these agents.
• Patients co-infected with HIV and HBV must not discontinue Biktarvy without close medical supervision due to the risk of severe acute exacerbation of hepatitis B.
• Bictegravir has a high barrier to resistance, making it a robust option for initial therapy.
• Tenofovir alafenamide (TAF) is associated with less impact on renal and bone parameters compared to tenofovir disoproxil fumarate (TDF), making it a preferred option for patients with pre-existing renal or bone concerns.

• Other INSTI-based regimens (e.g., Isentress + Truvada/Descovy, Tivicay + Truvada/Descovy)
• NNRTI-based regimens (e.g., Sustiva + Truvada/Descovy, Edurant + Truvada/Descovy)
• Protease Inhibitor (PI)-based regimens (e.g., Prezista/Norvir + Truvada/Descovy)
• Multi-class regimens tailored to individual patient needs and resistance profiles.