Biktarvy: Comprehensive HIV-1 Management in a Single Tablet
| Product dosage: 30mg | |||
|---|---|---|---|
| Package (num) | Per pill | Price | Buy |
| 10 | $68.80
Best per pill | $688.00 (0%) | 🛒 Add to cart |
Biktarvy represents a significant advancement in antiretroviral therapy, offering a complete, once-daily, single-tablet regimen for the treatment of HIV-1 infection in appropriate adult and pediatric patients. This fixed-dose combination integrates three potent antiretroviral agents—bictegravir, emtricitabine, and tenofovir alafenamide—into a streamlined therapeutic approach. By combining an integrase strand transfer inhibitor with two nucleoside reverse transcriptase inhibitors, Biktarvy provides robust viral suppression with a high barrier to resistance. Its optimized formulation demonstrates excellent efficacy while minimizing the impact on renal and bone parameters compared to previous tenofovir disoproxil fumarate-based regimens, establishing it as a cornerstone therapy in modern HIV management.
Features
- Fixed-dose combination containing bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg
- Once-daily oral administration without food restrictions
- Formulated as film-coated tablets for improved tolerability
- Demonstrated high barrier to resistance development
- Compatible with coadministration of acid-reducing agents
- Suitable for treatment-naïve patients and virologically suppressed patients seeking to replace their current regimen
Benefits
- Achieves rapid and sustained viral suppression with high rates of virological success
- Simplifies treatment adherence through single-tablet, once-daily dosing
- Minimizes renal and bone toxicity concerns associated with earlier tenofovir formulations
- Maintains efficacy across diverse patient populations, including those with baseline resistance
- Reduces pill burden and complexity of antiretroviral regimens
- Supports long-term treatment success with a favorable safety and tolerability profile
Common use
Biktarvy is indicated 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 3 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. It is particularly valuable for patients requiring a simplified regimen, those with concerns about renal or bone health, and individuals who may benefit from a high genetic barrier to resistance. The medication is commonly used as first-line therapy and for treatment simplification in stable patients.
Dosage and direction
The recommended dosage for adults and pediatric patients weighing at least 25 kg is one tablet taken orally once daily, with or without food. Tablets should be swallowed whole and not crushed, chewed, or split. For patients with estimated creatinine clearance below 30 mL/minute, Biktarvy is not recommended. No dosage adjustment is required for patients with mild to moderate hepatic impairment (Child-Pugh Class A or B), but it is not recommended for those with severe hepatic impairment (Child-Pugh Class C). The medication should be taken at approximately the same time each day to maintain consistent drug levels.
Precautions
Patients should be tested for hepatitis B virus (HBV) infection before initiating therapy, as exacerbations of HBV have been reported in patients coinfected with HIV-1 and HBV following discontinuation of emtricitabine or tenofovir products. Renal function should be assessed before initiation and during therapy, particularly in patients with underlying renal impairment or risk factors for renal dysfunction. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with nucleoside analogues. Immune reconstitution syndrome may occur during initial treatment, requiring close monitoring. Patients should be advised about the importance of adherence to prevent development of resistance.
Contraindications
Biktarvy is contraindicated in patients with previously demonstrated hypersensitivity to any of its components. Concomitant use with rifampin is contraindicated due to significant decreases in bictegravir plasma concentrations. The medication is contraindicated with dofetilide due to the potential for increased dofetilide concentrations and serious or life-threatening events. Concomitant administration with other drugs that significantly reduce bictegravir exposure through induction of CYP3A or UGT1A1 is not recommended.
Possible side effects
The most common adverse reactions (incidence ≥5%, all grades) include diarrhea, nausea, and headache. Serious side effects may include immune reconstitution syndrome, new or worsening renal impairment, lactic acidosis, and hepatomegaly with steatosis. Less common but potentially significant adverse effects include hepatic enzyme elevations, weight increase, and sleep disturbances. Most adverse reactions are mild to moderate in severity and typically occur during the initial weeks of treatment. Long-term safety data continue to support its favorable tolerability profile.
Drug interaction
Biktarvy may interact with drugs that induce CYP3A or UGT1A1, potentially decreasing 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 reduce bictegravir absorption. Biktarvy may increase concentrations of drugs that are substrates of OCT2 or MATE1, such as metformin. Concomitant use with other nephrotoxic agents may increase the risk of renal adverse reactions. Consultation with a complete drug interaction profile is recommended before coadministration.
Missed dose
If a dose is missed 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 resume the usual dosing schedule. Patients should not take a double dose to make up for a missed dose. Healthcare providers should reinforce the importance of adherence and discuss strategies for managing occasional missed doses without compromising virological suppression.
Overdose
Limited experience exists with Biktarvy overdose. In clinical trials, doses up to six times the recommended dose have been administered without unexpected adverse effects. Management of overdose should consist of general supportive measures, including monitoring of vital signs and observation of clinical status. Since tenofovir alafenamide is efficiently removed by hemodialysis, this may be considered in cases of significant overdose, particularly in patients with renal impairment. Removal of emtricitabine by hemodialysis has been demonstrated, while bictegravir dialysis clearance is unknown.
Storage
Store Biktarvy tablets at room temperature between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). Keep in the original container to protect from moisture. The bottle contains a desiccant to maintain stability—do not remove the desiccant. Keep out of reach of children and pets. Do not use if the seal is broken or missing. Discard any unused medication properly according to local regulations for pharmaceutical waste disposal.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Treatment decisions should be made in consultation with a qualified healthcare professional familiar with the patient’s complete medical history. The prescribing information should be consulted for complete details regarding indications, dosing, warnings, and precautions. Individual patient responses may vary, and appropriate monitoring is essential throughout treatment.
Reviews
Clinical trials and real-world evidence consistently demonstrate Biktarvy’s high efficacy, with virological suppression rates exceeding 90% in treatment-naïve patients and maintained suppression in virologically suppressed patients switching therapy. Healthcare providers report high patient satisfaction due to the regimen’s simplicity and tolerability. Long-term studies continue to support its durable efficacy and favorable safety profile. Patients appreciate the minimal side effects and convenience of once-daily dosing without food restrictions. The medication has received positive evaluations in treatment guidelines as a recommended first-line option for HIV-1 management.