Biktarvy: Comprehensive HIV-1 Management in a Single Tablet
| Product dosage: 30mg | |||
|---|---|---|---|
| Package (num) | Per pill | Price | Buy |
| 10 | $80.72
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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 into a fixed-dose combination, designed to achieve and maintain viral suppression with a high barrier to resistance. This integrase strand transfer inhibitor-based regimen is indicated for treatment-naïve adults and as a replacement for current antiretroviral therapy in those who are virologically suppressed. Its development focuses on simplifying treatment while maximizing efficacy and tolerability, addressing key challenges in long-term HIV management.
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 as a film-coated tablet for ease of swallowing
- High genetic barrier to resistance development
- Demonstrated efficacy in diverse patient populations, including those with high baseline viral loads
Benefits
- Achieves rapid and sustained viral suppression, supporting long-term immunological recovery
- Simplifies treatment adherence through a single-tablet regimen, reducing pill burden
- Exhibits a favorable safety and tolerability profile with low discontinuation rates
- Minimizes impact on bone mineral density and renal parameters compared to tenofovir disoproxil fumarate-based regimens
- Provides reliable efficacy across broad patient demographics, including those with pre-existing resistance mutations
- Supports long-term treatment success with a high barrier to the development of resistance
Common use
Biktarvy is 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 replacing their current antiretroviral regimen and are virologically suppressed (HIV-1 RNA <50 copies/mL). It is particularly valuable for patients requiring a simplified regimen to support adherence, those with concerns about bone or renal health, and individuals transitioning from more complex multi-tablet regimens. Healthcare providers may consider Biktarvy for patients with specific comorbidities where its favorable drug interaction profile and safety characteristics are advantageous.
Dosage and direction
The recommended dosage of Biktarvy 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 tablet should be taken at approximately the same time each day to maintain consistent drug levels.
Precautions
Before initiating Biktarvy, healthcare providers should assess creatinine clearance, urine glucose, and urine protein. Patients with a history of hepatitis B virus (HBV) coinfection should be closely monitored, as discontinuation of Biktarvy may result in HBV reactivation. 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 evaluation and management of autoimmune disorders. Regular monitoring of renal function and bone mineral density is recommended during treatment.
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. It should not be coadministered with other products containing emtricitabine, tenofovir alafenamide, tenofovir disoproxil fumarate, or lamivudine. Additionally, Biktarvy is contraindicated with drugs that are strong inducers of UGT1A1 or CYP3A, as they may decrease bictegravir concentrations and lead to loss of virologic response.
Possible side effects
The most common adverse reactions (incidence ≥5%) in clinical trials included diarrhea, nausea, and headache. Serious side effects may include exacerbation of hepatitis B in coinfected patients, immune reconstitution syndrome, and rare cases of lactic acidosis. Less common but potentially significant adverse effects include renal impairment, decreases in bone mineral density, and fat redistribution. Most adverse reactions were mild to moderate in severity and generally did not lead to treatment discontinuation. Patients should report any persistent or worsening symptoms to their healthcare provider.
Drug interaction
Biktarvy may interact with drugs that affect renal function or compete for active tubular secretion, potentially increasing concentrations of emtricitabine and tenofovir. Coadministration with strong inducers of UGT1A1 or CYP3A (e.g., rifampin, carbamazepine) is contraindicated. Antacids containing aluminum, calcium, or magnesium should be administered at least 2 hours before or after Biktarvy. Supplements containing iron or calcium may also affect absorption and should be spaced appropriately. Biktarvy may increase concentrations of drugs that are substrates of OCT2 or MATE1, requiring monitoring or dosage adjustment.
Missed dose
If a dose is missed within 18 hours of the usual time, patients should take Biktarvy as soon as possible and then resume the normal dosing schedule. If more than 18 hours have passed, the missed dose should be skipped and the next dose taken at the regularly scheduled time. Patients should not take a double dose to make up for a missed dose. Consistent adherence is crucial for maintaining virologic suppression, so patients should be counseled on strategies to avoid missed doses and the importance of maintaining therapeutic drug levels.
Overdose
Limited experience exists with Biktarvy overdose. The highest dose studied in clinical trials was single doses up to three times the recommended dosage, which were generally well-tolerated. In case of suspected overdose, general supportive measures should be employed, including monitoring of vital signs and observation of clinical status. Since tenofovir alafenamide is efficiently removed by hemodialysis, this may be considered for significant overdoses. Removal of emtricitabine by hemodialysis has also been demonstrated. There is no specific antidote for Biktarvy overdose.
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 and light. The bottle contains a desiccant to maintain stability—do not remove it. Keep out of reach of children and pets. Do not use if the packaging is damaged or if tablets show signs of deterioration. Proper storage ensures maintenance of potency and safety throughout the product’s shelf life.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Treatment decisions should be made by qualified healthcare professionals based on individual patient characteristics and current treatment guidelines. The prescribing information should be consulted for complete details regarding indications, contraindications, warnings, and precautions. Patients should not initiate or discontinue Biktarvy without medical supervision. Information about adverse events may not be comprehensive, and new safety information may emerge post-marketing.
Reviews
Clinical trial data demonstrate Biktarvy’s consistent efficacy across multiple studies, with virologic suppression rates exceeding 90% in treatment-naïve patients through 144 weeks. Real-world evidence supports these findings, showing high rates of virologic success and patient satisfaction. Healthcare providers report appreciation for its simplicity, tolerability, and robust resistance profile. Patients frequently note improved quality of life due to reduced pill burden and minimal side effects. Long-term extension studies continue to show maintained efficacy and safety, supporting Biktarvy’s position as a preferred antiretroviral regimen in current treatment guidelines.