Why is Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) preferred for treatment-naive patients newly diagnosed with Human Immunodeficiency Virus (HIV)?

From the Guidelines

Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) is the preferred treatment for naive patients newly diagnosed with HIV due to its high efficacy, excellent tolerability, and convenient once-daily single-tablet dosing, as recommended by the 2024 International Antiviral Society-USA panel 1. The standard regimen is one tablet daily, containing 50mg bictegravir, 200mg emtricitabine, and 25mg tenofovir alafenamide, taken with or without food. Key benefits of Biktarvy include:

• High genetic barrier to resistance, meaning the virus is less likely to develop mutations that render the medication ineffective
• Minimal drug interactions compared to other regimens
• Favorable safety profiles with less kidney toxicity and bone mineral density loss than older tenofovir formulations
• Convenient single-tablet formulation that promotes adherence, crucial for successful long-term HIV management Biktarvy works by combining an integrase strand transfer inhibitor (bictegravir) with two nucleoside reverse transcriptase inhibitors (emtricitabine and tenofovir alafenamide), effectively blocking HIV replication at multiple stages. This triple-mechanism approach provides robust viral suppression, making it an ideal choice for treatment-naive patients. It is essential for patients to inform their providers about all medications they take, particularly antacids containing aluminum or magnesium, which should be taken at least 2 hours apart from Biktarvy. Overall, Biktarvy's benefits make it the preferred treatment option for naive patients newly diagnosed with HIV, as supported by the latest guidelines from the International Antiviral Society-USA panel 1.

From the FDA Drug Label

BIKTARVY is a three-drug combination of bictegravir (BIC), a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg: who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir. (1)

Biktarvy is preferred for treatment-naive patients newly diagnosed with HIV because it is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg with no antiretroviral treatment history 2. The key points are:

• Complete regimen: Biktarvy is a three-drug combination that can be used as a complete regimen for HIV-1 treatment.
• Treatment-naive patients: Biktarvy is indicated for patients with no antiretroviral treatment history.
• Pediatric patients: Biktarvy can be used in pediatric patients weighing at least 14 kg. It is essential to note that Biktarvy's efficacy and safety have been established in treatment-naive patients, making it a preferred option for this population 2.

From the Research

Efficacy of Biktarvy

• Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) has been shown to be effective in treating HIV-1 infection in both treatment-naive and treatment-experienced individuals 3, 4, 5, 6, 7.
• The efficacy of Biktarvy in clinical practice is comparable to phase III trials, with high levels of virologic effectiveness and tolerability 3, 4.
• Studies have demonstrated that Biktarvy is non-inferior to other antiretroviral regimens, such as dolutegravir, abacavir, and lamivudine, in terms of virologic suppression and safety 5, 6.

Safety and Tolerability

• Biktarvy has been shown to be well-tolerated, with low rates of adverse events and discontinuations due to side effects 4, 5, 6, 7.
• The most common adverse events associated with Biktarvy are nausea, diarrhea, and headache 6.
• Real-world studies have demonstrated low discontinuation rates and high rates of virologic suppression in individuals treated with Biktarvy, both treatment-naive and treatment-experienced 7.

Preference for Treatment-Naive Patients

• Biktarvy is preferred for treatment-naive patients due to its high efficacy, safety, and tolerability profile 3, 4, 5, 6, 7.
• The fixed-dose combination of bictegravir, emtricitabine, and tenofovir alafenamide provides a convenient and simple treatment regimen for patients, which can improve adherence and outcomes 5, 6.
• The availability of real-world data and long-term follow-up studies supports the use of Biktarvy as a first-line treatment option for HIV-1 infection in treatment-naive patients 3, 4, 7.