Biktarvy: Comprehensive HIV-1 Management in a Single Tablet
Biktarvy
| Product dosage: 30mg | |||
|---|---|---|---|
| Package (num) | Per pill | Price | Buy |
| 10 | $80.00
Best per pill | $800.00 (0%) | 🛒 Add to cart |
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 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 regimen is indicated for use in both treatment-naïve adults and virologically suppressed adults seeking to replace their current antiretroviral therapy, providing a streamlined approach to long-term HIV management. Its development focuses on efficacy, safety, and tolerability, aiming to support improved adherence and 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 targets lymphoid tissues effectively at lower systemic exposures 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 and maintain an undetectable viral load.
- Reduces pill burden to one tablet per day, simplifying treatment and supporting long-term adherence.
- Demonstrates a favorable safety and tolerability profile, with low rates of discontinuation due to adverse events.
- Low risk of developing resistance, supporting its use as a foundational regimen in antiretroviral therapy.
- May contribute to improved renal and bone safety parameters compared to regimens containing TDF.
Common use
Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg. It is approved for use in antiretroviral treatment-naïve patients and as a replacement therapy for virologically suppressed adults who are stable on a current antiretroviral regimen with no history of treatment failure and no known resistance to any of the three components of Biktarvy.
Dosage and direction
The recommended dosage of Biktarvy is one tablet taken orally once daily, with or without food. It must be swallowed whole and should not be crushed, chewed, or split. 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 (eGFR ≥30 mL/min); however, it is not recommended for use in patients with severe renal impairment (eGFR <30 mL/min) or end-stage renal disease requiring dialysis.
Precautions
Before initiating Biktarvy, test for hepatitis B virus (HBV) coinfection, as posttreatment exacerbation of hepatitis may occur. Assess estimated creatinine clearance, urine glucose, and urine protein before and during therapy. Use with caution in patients with a history of bone fractures or risk factors for osteoporosis or bone loss. Monitor for immune reconstitution syndrome, particularly during the initial phase of treatment. Consider the potential for drug interactions, especially with medications that reduce bictegravir exposure.
Contraindications
Biktarvy is contraindicated in patients with a known hypersensitivity to any component of the product. Concomitant use with dofetilide or rifampin is contraindicated due to the potential for serious or life-threatening adverse reactions. It is also not recommended for use with other antiretroviral medications, as it is a complete regimen.
Possible side effects
The most common adverse reactions (incidence ≥5%, 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, exacerbation of HBV, renal impairment, decreased bone mineral density, and immune reconstitution syndrome. Changes in lipid parameters have been observed but are generally not clinically significant.
Drug interaction
Biktarvy may interact with drugs that induce or inhibit CYP3A or UGT1A1 enzymes. Coadministration with strong inducers of CYP3A (e.g., rifampin, St. John’s wort) is contraindicated. Use with caution with anticonvulsants (e.g., carbamazepine, phenytoin) and antimycobacterials (e.g., rifabutin) that may reduce bictegravir concentrations. Drugs that inhibit P-gp and BCRP may increase tenofovir concentrations. Antacids containing aluminum, magnesium, or calcium should be taken at least 2 hours before or after Biktarvy.
Missed dose
If a dose is missed and it is within 18 hours of the usual time, the patient should take Biktarvy 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.
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. Hemodialysis may remove emtricitabine and tenofovir, but is unlikely to significantly remove bictegravir due to high protein binding.
Storage
Store Biktarvy tablets at room temperature, 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). Keep in the original container to protect from moisture. Keep out of reach of children and pets.
Disclaimer
This information is intended for healthcare professionals and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of a qualified healthcare provider with any questions regarding a medical condition or treatment. Do not disregard professional medical advice or delay in seeking it because of something you have read in this product card.
Reviews
Clinical trials and real-world evidence support the efficacy and tolerability of Biktarvy. In Phase 3 studies, Biktarvy demonstrated high rates of virologic suppression at 48 and 96 weeks in both treatment-naïve and virologically suppressed patients, with a low incidence of adverse events leading to discontinuation. Many clinicians report high patient satisfaction due to its once-daily dosing, small tablet size, and minimal side effects. Long-term data continue to reinforce its role as a preferred regimen in modern HIV management.