Biktarvy is a complete, once-daily, single-tablet regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg. It combines three powerful antiretroviral agents into one pill, designed to suppress viral load to undetectable levels and maintain immunologic response. This fixed-dose combination represents a significant advancement in HIV therapy, offering high efficacy with a generally favorable tolerability profile. It is indicated for use in both treatment-naïve patients and as a replacement for a current antiretroviral regimen in those who are virologically suppressed.

Features

• Fixed-dose combination tablet containing bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg.
• Once-daily oral administration, with or without food.
• Approved for adults and pediatric patients weighing at least 25 kilograms.
• Formulated with tenofovir alafenamide (TAF), which has demonstrated improved renal and bone safety parameters compared to tenofovir disoproxil fumarate (TDF).
• High barrier to resistance, reducing the risk of virologic failure and development of resistance mutations.

Benefits

• Achieves and maintains viral suppression, leading to undetectable viral loads, which improves long-term health outcomes and prevents HIV transmission.
• Simplifies treatment adherence through a single-tablet, once-daily regimen, reducing pill burden and complexity.
• Generally well-tolerated with a low discontinuation rate due to adverse events, supporting long-term treatment sustainability.
• Offers a favorable safety profile for bones and kidneys compared to regimens containing TDF.
• Provides a potent and durable treatment option suitable for a broad range of patients, including those with pre-existing resistance concerns.

Common use

Biktarvy is commonly used as a complete regimen for the treatment of HIV-1 infection. It is prescribed for adult and pediatric patients (weighing at least 25 kg) who are either new to antiretroviral therapy (treatment-naïve) or who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least three months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. It is not recommended for use in patients with severe renal impairment (CrCl <30 mL/min) or severe hepatic impairment.

Dosage and direction

The recommended dosage of Biktarvy is one tablet taken orally once daily, with or without food. It must be swallowed whole; do not crush, split, or chew the tablet. For pediatric patients weighing at least 25 kg, the same once-daily dosing applies. Dosage adjustment is not required in patients with mild to moderate renal impairment (CrCl ≥30 mL/min) or mild to moderate hepatic impairment (Child-Pugh Class A or B). Adherence to the prescribed dosing schedule is critical to maintain virologic suppression and minimize the risk of developing viral resistance.

Precautions

Before initiating Biktarvy, test for hepatitis B virus (HBV) coinfection, as posttreatment exacerbation of hepatitis may occur. Assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein at baseline and during therapy as clinically appropriate. Monitor for immune reconstitution syndrome, which may necessitate further evaluation and management. Use with caution in patients with a history of bone pathology or risk factors for renal impairment. Due to the presence of tenofovir alafenamide, which is primarily eliminated by the kidneys, renal function should be monitored regularly.

Contraindications

Biktarvy is contraindicated in patients with a previous hypersensitivity reaction to any of its components. Concomitant use with rifampin is contraindicated due to significant decreases in bictegravir plasma concentrations, which may lead to loss of virologic response and possible resistance. It is also contraindicated with other strong inducers of UGT1A1 or CYP3A, such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifapentine, and St. John’s wort.

Possible side effect

The most common adverse reactions (all grades) observed in clinical trials include diarrhea, nausea, and headache. Less common but serious side effects may include lactic acidosis/severe hepatomegaly with steatosis, exacerbations of hepatitis B in coinfected patients, and renal impairment, including acute renal failure and Fanconi syndrome. Immune reconstitution syndrome and changes in bone mineral density have also been reported. Patients should be advised to report any persistent or severe symptoms promptly.

Drug interaction

Biktarvy has several important drug interactions. Coadministration with drugs that reduce bictegravir or tenofovir alafenamide exposure, such as strong inducers of UGT1A1 or CYP3A (e.g., rifampin, carbamazepine), is contraindicated. Use with caution with drugs that affect renal function or compete for active tubular secretion (e.g., acyclovir, cidofovir, ganciclovir, valacyclovir), as this may increase concentrations of tenofovir and the coadministered drug. Antacids containing aluminum, calcium, or magnesium should be taken at least 2 hours before or after Biktarvy. Consult full prescribing information for a comprehensive list of interactions.

Missed dose

If a dose of Biktarvy is missed and it is within 18 hours of the usual time, the patient should take the missed dose as soon as possible and then resume the normal dosing schedule. If it has been more than 18 hours since the missed dose, the patient should not take the missed dose and simply resume the usual dosing schedule with the next scheduled dose. Doubling the dose to make up for a missed dose is not recommended. Consistent adherence is vital to maintain virologic suppression.

Overdose

There is limited experience with overdose of Biktarvy. In the event of overdose, monitor the patient for evidence of toxicity, and provide supportive treatment, including monitoring of vital signs and ECG. Since tenofovir alafenamide is efficiently removed by hemodialysis (with an extraction coefficient of approximately 54%), hemodialysis may be considered in the event of significant overdose, but removal of bictegravir and emtricitabine by dialysis has not been studied. Contact a Poison Control Center for up-to-date guidance on management.

Storage

Store Biktarvy tablets at room temperature, between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Keep in the original container to protect from moisture. Keep out of reach of children and pets. Do not use if the seal over the bottle opening is broken or missing.

Disclaimer

This information is intended for educational purposes and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Do not disregard professional medical advice or delay in seeking it because of something you have read here.

Reviews

Clinical trials and post-marketing surveillance have demonstrated Biktarvy to be highly effective and well-tolerated. In Phase 3 studies, it achieved high rates of virologic suppression with a low incidence of adverse events leading to discontinuation. Many healthcare providers report high patient satisfaction due to its simplicity and tolerability. However, individual experiences may vary, and patients are encouraged to discuss their treatment response and any side effects with their healthcare provider.