Will Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) make Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) levels not detectable?

From the Guidelines

Yes, Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) can make HIV RNA levels undetectable in most people who take it as prescribed, with a high efficacy rate of 97% in achieving viral suppression to HIV RNA levels below 50 copies/mL at week 24, as shown in a recent study 1. Biktarvy is a complete, single-tablet regimen taken once daily with or without food, containing 50mg bictegravir, 200mg emtricitabine, and 25mg tenofovir alafenamide. Most patients taking Biktarvy consistently achieve an undetectable viral load (typically defined as less than 20-50 copies/mL) within 3-6 months of starting treatment. Biktarvy works by combining three antiretroviral medications that prevent HIV from replicating:

• bictegravir (an integrase strand transfer inhibitor that blocks HIV DNA integration)
• emtricitabine and tenofovir alafenamide (nucleoside/nucleotide reverse transcriptase inhibitors that block viral DNA synthesis). For Biktarvy to be effective, it must be taken every day as prescribed. Missing doses can allow the virus to replicate and potentially develop resistance. Regular viral load testing (typically every 3-6 months) is necessary to confirm that HIV RNA remains undetectable. When HIV is undetectable, it cannot be transmitted sexually, a concept known as Undetectable = Untransmittable (U=U), and this is supported by the latest recommendations from the international antiviral society-usa panel 1. Key points to consider when prescribing Biktarvy include:
• Efficacy in achieving viral suppression
• Safety profile
• Potential drug interactions
• Patient adherence to the treatment regimen. It is also worth noting that Biktarvy has been shown to be effective in patients with latent tuberculosis infection and those receiving rifampin-containing tuberculosis treatment regimens, as demonstrated in recent studies 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. In Trial 1844, treatment outcomes between treatment groups were similar across subgroups by age, sex, race, and region. The mean change from baseline in CD4+ count at Week 48 was -31 cells per mm3 in subjects who switched to BIKTARVY and 4 cells per mm3 in subjects who stayed on ABC/DTG/3TC. At Week 48 the proportion of subjects with HIV-1 RNA ≥50 copies/mL was 0.4% (1/284) in the BIKTARVY group and 1.1% (3/281) in the DTG+F/TAF group (difference -0.7% [95%CI: -2.8%, 1. 0%]). After switching to BIKTARVY, 98% (49/50) of subjects in cohort 1 remained suppressed (HIV-1 RNA < 50 copies/mL) at Week 48 After switching to BIKTARVY (containing 50 mg of BIC, 200 mg of FTC, and 25 mg of TAF), 100% (50/50) of subjects in cohort 2 remained suppressed (HIV-1 RNA < 50 copies/mL) at Week 24

Biktarvy can make HIV RNA levels not detectable.

• In clinical trials, a high percentage of subjects who switched to Biktarvy remained virologically suppressed (HIV-1 RNA < 50 copies/mL) at Week 48.
• The proportion of subjects with HIV-1 RNA ≥50 copies/mL was low in the Biktarvy group.
• Biktarvy is indicated for the treatment of HIV-1 infection in adults and pediatric patients who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen 2, 2.

From the Research

Efficacy of Biktarvy in Reducing HIV RNA Levels

• Biktarvy, a fixed-dose combination of bictegravir, emtricitabine, and tenofovir alafenamide, has been shown to be effective in reducing HIV RNA levels to less than 50 copies per mL in treatment-naive individuals 3, 4, 5, 6, 7.
• In a phase 3 trial, 88% of participants receiving Biktarvy achieved HIV RNA levels less than 50 copies per mL at week 96, compared to 90% of participants receiving a dolutegravir-based regimen 3.
• Another study found that 96.9% of participants receiving Biktarvy had HIV RNA levels less than 50 copies per mL at week 24, compared to 93.9% of participants receiving a dolutegravir-based regimen 4.
• Long-term data from two phase 3 trials showed that Biktarvy was non-inferior to dolutegravir-based regimens in maintaining HIV RNA levels less than 50 copies per mL at week 144, with 82% of participants in the Biktarvy group achieving this outcome 5.
• A real-world study in Japan found that 92% of treatment-naive and 95% of treatment-experienced participants receiving Biktarvy had HIV RNA levels less than 50 copies per mL at 12 months 7.

Safety and Tolerability of Biktarvy

• Biktarvy has been shown to be well-tolerated, with low rates of adverse events leading to discontinuation 3, 4, 5, 7.
• The most common adverse events reported in clinical trials included nausea, diarrhea, and headache 3, 4, 5.
• A study in Japan found that 13% of participants reported drug-related adverse events, with the most common being diarrhea, weight gain, and headache 7.
• Biktarvy has also been shown to have a high barrier to resistance, with no treatment-emergent resistance reported in clinical trials 3, 5.