Biktarvy: Comprehensive HIV-1 Management in a Single Tablet
| Product dosage: 30mg | |||
|---|---|---|---|
| Package (num) | Per pill | Price | Buy |
| 10 | $80.32
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Biktarvy represents a significant advancement in the treatment of HIV-1 infection, offering a complete antiretroviral regimen in a single, once-daily tablet. It combines three potent antiretroviral agents—bictegravir, emtricitabine, and tenofovir alafenamide—into a fixed-dose combination designed to achieve and maintain viral suppression with a high barrier to resistance. This streamlined approach simplifies treatment regimens, enhances adherence, and supports long-term therapeutic success, making it a cornerstone therapy for both treatment-naïve and certain treatment-experienced adults. Its development reflects a continued commitment to improving the 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 administration, with or without food
- Formulated with tenofovir alafenamide (TAF), which demonstrates reduced off-target effects compared to tenofovir disoproxil fumarate (TDF)
- High genetic barrier to resistance, supported by the integrase strand transfer inhibitor (INSTI) bictegravir
- Approved for use in adults and pediatric patients weighing at least 25 kg
Benefits
- Achieves rapid and durable viral suppression, helping patients reach undetectable viral loads
- Reduces pill burden to one tablet per day, significantly improving adherence and treatment persistence
- Favorable safety and tolerability profile, with low rates of discontinuation due to adverse events
- Minimizes the risk of developing antiretroviral resistance, supporting long-term treatment options
- Supports overall patient well-being by simplifying HIV management and reducing treatment-related stress
Common use
Biktarvy is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 25 kilograms. It is approved for use in antiretroviral treatment-naïve patients and as a replacement for the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <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.
Dosage and direction
The recommended dosage of Biktarvy is one tablet taken orally once daily, with or without food. It is crucial to adhere to the once-daily dosing schedule to maintain effective drug concentrations and minimize the risk of viral rebound or resistance development. For patients with renal impairment (creatinine clearance below 30 mL/min), Biktarvy is not recommended. No dosage adjustment is required 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 for hepatitis B virus (HBV) coinfection, as posttreatment exacerbation of hepatitis may occur in patients coinfected with HIV-1 and HBV after discontinuation of antiretroviral therapy. Assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein upon initiation and during therapy as clinically appropriate. Monitor for immune reconstitution syndrome, which may necessitate further evaluation and management. Consider the potential for increased weight and associated metabolic effects in some patients. Use with caution in patients with a history of bone pathology or risk factors for bone mineral density loss.
Contraindications
Biktarvy is contraindicated in patients with a known hypersensitivity to any of its components (bictegravir, emtricitabine, tenofovir alafenamide). Concomitant use with dofetilide or rifampin is contraindicated due to the potential for serious or life-threatening adverse reactions. Rifampin significantly decreases bictegravir plasma concentrations, which may lead to loss of virologic response and possible resistance. Dofetilide coadministration may increase dofetilide plasma concentrations and risk of serious and/or life-threatening events.
Possible side effects
The most common adverse reactions (incidence ≥5%, all grades) observed in clinical trials include diarrhea, nausea, and headache. Serious side effects may include exacerbation of hepatitis B in coinfected patients, immune reconstitution syndrome, and lactic acidosis/severe hepatomegaly with steatosis. Renal impairment, including acute renal failure and Fanconi syndrome, has been reported with tenofovir prodrugs; monitor renal function. Decreases in bone mineral density have been observed; consider monitoring in patients with a history of pathologic fracture or other risk factors for bone loss. Other potential adverse effects include fat redistribution and accumulation.
Drug interaction
Biktarvy may interact with drugs that induce or inhibit UGT1A1 or CYP3A enzymes, potentially altering its efficacy or safety profile. Coadministration with other antiretroviral products is not recommended unless components are known and no overlapping toxicities or duplicate agents are present. Avoid concomitant use with nephrotoxic agents (e.g., high-dose or multiple NSAIDs) due to potential additive effects on renal impairment. Biktarvy may increase the concentration of drugs that are substrates of OCT2 or MATE1 (e.g., metformin); consider dose adjustment or monitoring. 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 dosing 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 usual dosing time, the patient should not take the missed dose and simply resume the usual dosing schedule with the next tablet. Do not double the next dose to make up for a missed one, as this may increase the risk of adverse effects.
Overdose
There is limited clinical experience with overdose of Biktarvy. In the event of an overdose, monitor the patient for evidence of toxicity and provide supportive treatment as necessary. Since tenofovir alafenamide is extensively protein-bound, it is unlikely to be significantly removed by dialysis; however, hemodialysis may remove emtricitabine. Management should include assessment of clinical status, electrolyte balance, and renal function. 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 treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The content is based on the approved prescribing information but may not include all safety information; refer to the full prescribing information for complete details.
Reviews
Clinical trials and real-world evidence have consistently demonstrated Biktarvy’s efficacy in achieving and maintaining viral suppression, with high rates of patient satisfaction due to its simplicity and tolerability. In Phase 3 studies, Biktarvy met non-inferiority criteria compared to other dolutegravir-based regimens, with low discontinuation rates and minimal emergent resistance. Healthcare providers frequently note its utility in reducing regimen complexity and supporting adherence, particularly in patients with challenging schedules or polypharmacy. Long-term data continue to support its role as a first-line and switch option in modern HIV management.