Biktarvy represents a significant advancement in the treatment of HIV-1 infection, offering a complete antiretroviral regimen in a single, once-daily tablet. This fixed-dose combination integrates bictegravir, an integrase strand transfer inhibitor (INSTI), with emtricitabine and tenofovir alafenamide, two nucleoside reverse transcriptase inhibitors (NRTIs), forming a potent backbone for viral suppression. It is indicated for use in both treatment-naïve adults and pediatric patients weighing at least 25 kg, as well as for virologically suppressed adults seeking to replace their current antiretroviral regimen. With its high barrier to resistance and favorable tolerability profile, Biktarvy simplifies treatment adherence while maximizing therapeutic outcomes, supporting long-term virologic control and improved quality of life for individuals living with HIV.

Features

• Fixed-dose combination tablet containing bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg
• Once-daily oral dosing, independent of food
• Formulated with a high genetic barrier to resistance
• Suitable for treatment-naïve and virologically suppressed patients
• Available in bottle and blister pack configurations for patient convenience
• FDA-approved for use in adults and pediatric patients weighing at least 25 kilograms

Benefits

• Achieves and maintains virologic suppression with a single-tablet regimen
• Minimizes pill burden, enhancing adherence and reducing treatment fatigue
• Demonstrates high efficacy with a low incidence of treatment-emergent resistance
• Generally well-tolerated profile with reduced impact on renal and bone parameters compared to tenofovir disoproxil fumarate-based regimens
• Supports long-term management goals with a simplified dosing schedule
• Provides a complete antiretroviral strategy suitable for diverse patient populations

Common use

Biktarvy is primarily prescribed for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 25 kg. It serves as a complete regimen for antiretroviral-naïve individuals initiating therapy and as a replacement therapy for those who are 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 Biktarvy. Healthcare providers may consider Biktarvy for patients seeking simplified dosing, those with adherence challenges, or individuals requiring a regimen with a favorable renal and bone safety profile.

Dosage and direction

The recommended dosage of Biktarvy is one tablet taken orally once daily, with or without food. For pediatric patients weighing at least 25 kg, the same once-daily dosing applies. Tablets should be swallowed whole and not crushed, chewed, or split. Dosage adjustment is not required for patients with estimated creatinine clearance ≥30 mL/min. For those with severe renal impairment (CrCl <30 mL/min) or end-stage renal disease requiring dialysis, Biktarvy is not recommended due to insufficient data. No dosage adjustment is necessary for patients with mild to moderate hepatic impairment (Child-Pugh Class A or B); however, it is not recommended for those with severe hepatic impairment (Child-Pugh Class C).

Precautions

Prior to initiating Biktarvy, test patients for hepatitis B virus (HBV) infection, as post-treatment exacerbation of hepatitis may occur. Monitor renal function before and during treatment, particularly in patients with pre-existing renal impairment or those taking nephrotoxic agents. Assess bone mineral density in patients with a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with nucleoside analogues; discontinue use if clinical or laboratory findings suggest these conditions. Immune reconstitution syndrome may occur during initial treatment; monitor for inflammatory responses to opportunistic infections. Consider potential weight gain associated with antiretroviral therapy.

Contraindications

Biktarvy is contraindicated in patients with a known hypersensitivity to any component of the formulation. Concomitant administration with rifampin is contraindicated due to significant decreases in bictegravir plasma concentrations, which may lead to loss of virologic response and possible resistance. Do not coadminister with other products containing emtricitabine, tenofovir alafenamide, tenofovir disoproxil fumarate, or lamivudine. Avoid use with drugs that strongly induce UGT1A1 or CYP3A enzymes, as they may decrease bictegravir concentrations and reduce therapeutic effect.

Possible side effects

The most common adverse reactions (incidence ≥5%) in clinical trials were diarrhea, nausea, and headache. Serious side effects may include immune reconstitution syndrome, new or worsening kidney problems (including acute renal failure and Fanconi syndrome), lactic acidosis with hepatic steatosis, and hepatotoxicity. Less common but potentially significant adverse effects include depressive disorders, weight increase, and elevated creatine kinase. Renal impairment events were reported in <1% of patients. Discontinuation due to adverse reactions occurred in 1% of patients receiving Biktarvy in clinical trials.

Drug interaction

Biktarvy may interact with drugs that affect renal function or compete for active tubular secretion, potentially increasing concentrations of concomitant drugs or Biktarvy components. Coadministration with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, or St. John’s wort is not recommended due to decreased bictegravir concentrations. Antacids containing aluminum, magnesium, or calcium should be administered at least 2 hours before or after Biktarvy. Supplements containing polyvalent cations (iron, calcium) may be taken with food simultaneously with Biktarvy but should be taken on an empty stomach at least 2 hours before Biktarvy. Monitor patients taking drugs with a narrow therapeutic index that are renally excreted.

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 more than 18 hours have passed, the patient should skip the missed dose and take the next dose at the regularly scheduled time. Patients should not take a double dose to make up for a missed dose. Consistent adherence is critical to maintaining virologic suppression and preventing the development of resistance.

Overdose

Limited data exist on Biktarvy overdose in humans. In clinical trials, doses up to 6 times the recommended dose have been administered for 10 days without unexpected adverse effects. Management of overdose should include general supportive measures, including monitoring of vital signs and observation of clinical status. Since tenofovir alafenamide is extensively protein bound, it is unlikely to be significantly removed by dialysis; the removal of bictegravir and emtricitabine by hemodialysis or peritoneal dialysis has not been studied. Contact a poison control center for current recommendations 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 tightly closed and do not remove desiccant. Keep out of reach of children and pets. Do not use beyond the expiration date printed on the container.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Biktarvy is available by prescription only and should be used under the supervision of a qualified healthcare provider. Patients should not initiate, modify, or discontinue treatment without consulting their healthcare provider. The full prescribing information should be consulted for complete details regarding use, warnings, and precautions.

Reviews

Clinical trial data demonstrate Biktarvy’s efficacy and tolerability profile. In Phase 3 studies, Biktarvy achieved virologic suppression (HIV-1 RNA <50 copies/mL) in 92-95% of treatment-naïve adults at Week 144. For virologically suppressed adults switching to Biktarvy, 93% maintained suppression at Week 144. Real-world evidence supports these findings, with studies showing high rates of virologic success and patient satisfaction. Healthcare providers report appreciation for the regimen’s simplicity, high barrier to resistance, and generally favorable side effect profile. Patients frequently note improved quality of life due to reduced pill burden and minimal dietary restrictions.