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 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 integrase strand transfer inhibitor (INSTI)-based 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 disease management. Its development reflects a continued commitment to reducing pill burden and optimizing tolerability without compromising efficacy.
Features
- Fixed-dose combination tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF)
- Once-daily oral administration, with or without food
- Formulated as a film-coated, yellow, oval-shaped tablet debossed with “GSI” on one side and “9883” on the other
- High genetic barrier to resistance, reducing the likelihood of virologic failure
- Compatible with a wide range of concomitant medications, though notable interactions exist (see Drug Interactions)
- Available in 30-count bottles with a child-resistant closure
Benefits
- Achieves rapid and durable viral suppression, with high rates of virologic success in clinical trials
- Simplifies treatment adherence by consolidating three active agents into a single daily tablet
- Demonstrates a favorable renal and bone safety profile compared to regimens containing tenofovir disoproxil fumarate (TDF)
- Minimizes the risk of resistance development due to the potency of bictegravir and the complementary action of FTC/TAF
- Supports long-term metabolic health with a low incidence of lipid abnormalities and weight gain
- Provides a well-tolerated option with a low discontinuation rate due to adverse events
Common use
Biktarvy is primarily prescribed for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral treatment history or 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. 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 should be swallowed whole and not chewed, crushed, or split. For patients with mild to moderate renal impairment (CrCl 30–69 mL/min), regular monitoring of renal function is advised, though no dosage adjustment is required. In pediatric patients weighing at least 25 kg, the same once-daily dosing applies. Adherence to the prescribed dosing schedule is critical to maintain virologic suppression and prevent the development of resistance.
Precautions
- Renal Monitoring: Assess estimated creatinine clearance (CrCl), urine glucose, and urine protein before initiating and during therapy; more frequent monitoring is recommended in patients with preexisting renal impairment or risk factors for renal dysfunction.
- Lactic Acidosis/Severe Hepatomegaly: Although rare, lactic acidosis and severe hepatomegaly with steatosis have been reported with nucleoside analogues, including tenofovir alafenamide and emtricitabine; discontinue use if clinical or laboratory findings suggest these conditions.
- Exacerbation of Hepatitis B: In patients coinfected with HBV, discontinuation of Biktarvy may result in acute exacerbation of hepatitis; monitor hepatic function closely for several months after stopping treatment.
- Immune Reconstitution Syndrome: May occur shortly after initiation of antiretroviral therapy; autoimmune disorders may also manifest in the setting of immune reconstitution.
- Bone Mineral Density: Decreases in bone mineral density have been observed; consider monitoring in patients with a history of pathologic fracture or other risk factors for osteoporosis or bone loss.
Contraindications
Biktarvy is contraindicated in patients with a previous hypersensitivity reaction to any of its components. Coadministration 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 rifapentine, carbamazepine, phenytoin, and St. John’s wort.
Possible side effects
The most common adverse reactions (incidence ≥5%, all grades) in clinical trials include diarrhea, nausea, and headache. Serious side effects, though less common, may include:
- Lactic acidosis and severe hepatomegaly with steatosis
- Exacerbations of hepatitis B in coinfected patients
- Renal impairment, including acute renal failure and Fanconi syndrome
- Immune reconstitution syndrome
- Decreases in bone mineral density
Less frequently reported adverse events include fatigue, dizziness, abnormal dreams, and rash. Most adverse reactions are mild to moderate in severity.
Drug interaction
Biktarvy has significant drug interaction potential, primarily due to bictegravir’s metabolism by UGT1A1 and CYP3A and its role as a mild inducer of CYP3A and CYP2C9. Key interactions include:
- Antacids containing aluminum, magnesium, or calcium: Administer Biktarvy 2 hours before or 6 hours after these products.
- Polyvalent cation-containing supplements (e.g., iron, calcium): Similar dosing separation advised.
- Strong inducers of UGT1A1/CYP3A (e.g., rifampin, carbamazepine): Contraindicated due to reduced bictegravir exposure.
- Metformin: Coadministration may increase metformin concentrations; monitor and adjust metformin dose if necessary.
- Dabigatran: Use with caution and monitor for dabigatran-related adverse effects.
Consult full prescribing information or clinical resources for a comprehensive list and management recommendations.
Missed dose
If a dose is missed and it is within 18 hours of the usual dosing 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. The patient should not take a double dose to make up for a missed dose. Consistent adherence is vital to maintain antiviral efficacy.
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. Bictegravir, emtricitabine, and tenofovir alafenamide are not significantly removed by hemodialysis; the extent to which peritoneal dialysis may remove these agents is unknown. Contact a poison control center for the most current guidance.
Storage
Store Biktarvy tablets at room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Keep in the original container with the cap tightly closed to protect from moisture. Keep out of reach of children and pets. Do not use if the seal 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 a qualified healthcare provider with any questions 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 real-world evidence consistently demonstrate Biktarvy’s high efficacy and tolerability. In Phase 3 studies, Biktarvy achieved virologic suppression (HIV-1 RNA <50 copies/mL) in over 90% of treatment-naïve patients at 48 weeks, with similar results in switch studies. Patients and providers frequently report high satisfaction due to the regimen’s simplicity, minimal side effects, and durability. Long-term data continue to support its use as a first-line and switch option, with sustained viral suppression and a favorable safety profile through 144 weeks of follow-up.