Usual Adult Dose for HIV Infection

Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg orally once a day

Use: As a complete regimen for the treatment of HIV-1 infection in patients with no antiretroviral treatment history or to replace the current antiretroviral regimen in patients virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of this drug

Usual Pediatric Dose for HIV Infection

At least 14 to less than 25 kg: Bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg orally once a day
At least 25 kg: Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg orally once a day

Comments:

• For children at least 14 to less than 25 kg who are unable to swallow a whole tablet, the tablet can be split and each part can be taken separately as long as all parts are ingested within about 10 minutes.

Use: As a complete regimen for the treatment of HIV-1 infection in patients with no antiretroviral treatment history or to replace the current antiretroviral regimen in patients virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of this drug

Renal Dose Adjustments

Severe renal dysfunction (estimated CrCl 15 to less than 30 mL/min) or ESRD (estimated CrCl less than 15 mL/min) not receiving chronic hemodialysis: Not recommended.

Liver Dose Adjustments

Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Not recommended.

Precautions

US BOXED WARNING:

• POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B: Severe acute exacerbations of hepatitis B reported in patients coinfected with HIV-1 and HBV after stopping products containing emtricitabine and/or tenofovir disoproxil fumarate, and may occur when this drug is stopped. Hepatic function of HIV-1/HBV-coinfected patients should be closely monitored with clinical and laboratory follow-up for at least several months after stopping this drug. If appropriate, antihepatitis B therapy may be necessary.

CONTRAINDICATIONS:
Coadministration with dofetilide or rifampin

Safety and efficacy have not been established in pediatric patients weighing less than 14 kg.

Consult WARNINGS section for additional precautions.

Dialysis

ESRD (estimated CrCl less than 15 mL/min) receiving chronic hemodialysis:

• Patients with no antiretroviral treatment history: Not recommended.
• Virologically-suppressed adult patients: No adjustment recommended.
• On hemodialysis days, the dose should be administered after completion of hemodialysis.

Other Comments

Administration advice:

• Test patients for HBV infection before/when starting this drug.
• In all patients, assess serum creatinine, estimated CrCl, urine glucose, and urine protein before/when starting this drug, and during therapy as clinically appropriate; in patients with chronic kidney disease, also assess serum phosphorus.
• Administer with or without food.
• Administer this drug at least 2 hours before or 6 hours after antacids containing aluminum/magnesium; do not routinely administer this drug together with, or 2 hours after, antacids containing aluminum/magnesium.
• Administer this drug and supplements or antacids containing calcium or iron together with food; do not routinely administer this drug under fasting conditions together with, or 2 hours after, supplements or antacids containing calcium or iron.

Storage requirements:

• Blister pack: Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86F).
• Bottle: Store below 30C (86F); keep tightly closed.
• Dispense only in original containers.

Monitoring:

• Hepatic: Hepatic function of HIV-1/HBV-coinfected patients with clinical and laboratory follow-up (for at least several months after stopping therapy)
• Infections/Infestations: For chronic HBV infection in all patients (before/when starting therapy)
• Metabolic: Serum phosphorus in patients with chronic kidney disease (before/when starting therapy and during therapy)
• Renal: Serum creatinine, estimated CrCl, urine glucose, and urine protein in all patients (before/when starting therapy and during therapy)

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).
• Do not stop this drug without first notifying healthcare provider.
• Notify healthcare provider at once of any symptoms of infection.
• Avoid taking this drug with concurrent/recent use of nephrotoxic agents.
• Stop this drug if clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity develop.
• Take this drug on a regular dosing schedule to avoid missing doses as it can lead to development of resistance.
• Caregivers: For children unable to swallow a whole tablet, you can split the tablet and give each part separately as long as all parts are ingested within about 10 minutes.

Frequently asked questions

• What if I miss a dose of Biktarvy?
• How fast or how long does it take Biktarvy to work?
• Can I drink alcohol while taking Biktarvy?
• Is Biktarvy covered by insurance?
• Can you crush Biktarvy tablets?
• Does Biktarvy cause hair loss?
• What is the generic name for Biktarvy?
• What is the difference between Biktarvy and Descovy?
• Does Biktarvy increase cholesterol?
• Does Biktarvy cause acne?
• Is Biktarvy a protease inhibitor?