About BIXLENVO™

BIXLENVO is the smallest complete once-daily pill for HIV treatment taken by mouth, with or without food.^†

*Pill image not actual size.

^†After 2-day starter doses.

It combines the power of bictegravir with first-of-its-kind lenacapavir.

BIXLENVO was evaluated across a diverse range of people in 2 clinical studies.

The ARTISTRY-1 and ARTISTRY-2 studies included more than 1,000 participants combined, including those with more complex HIV treatment histories.^‡

ARTISTRY-1
Studied people on a complex multi-pill regimen^§ who switched to BIXLENVO vs. those who stayed on their current treatment
Typical age of people was 60 years old
Typical amount of time on HIV treatment was 28.3 years
More than half of participants had 2 or more additional health conditions

ARTISTRY-2
Studied people on a single-tablet regimen^‖ who switched to BIXLENVO vs. those who stayed on their current treatment
Typical age of people was 49 years old
Typical amount of time on HIV treatment was 12 years
About 1 in 3 participants had 2 or more additional health conditions

^‡Some people within both clinical trials had a history of resistance.

^§A complex regimen in ARTISTRY-1 involved multiple pills, multiple daily doses, injectable and oral medicines used together, or certain combinations of HIV medicines.

^‖The single-tablet regimen in ARTISTRY-2 was BIKTARVY® (bictegravir, emtricitabine, tenofovir alafenamide).

Both studies included people who were undetectable^¶ for at least 6 months before starting and varied in age, gender, and background.

Some people switched to BIXLENVO (371 people in ARTISTRY-1, 383 people in ARTISTRY-2) and some continued their current treatment (186 people in ARTISTRY-1, 191 people in ARTISTRY-2). A goal of the studies was to see whether people remained undetectable after being on treatment for a year with BIXLENVO compared to those on a complex multi-tablet regimen or a leading single-tablet regimen.

At 1 year, most people who switched from their current treatment to BIXLENVO and took their treatment every day stayed undetectable (96% compared to 94% undetectable on a complex multi-tablet regimen in ARTISTRY-1, 93% compared to 91% undetectable on a leading single-tablet regimen in ARTISTRY-2).

^¶Undetectable means that there is so little virus in the blood that a lab test cannot measure it (less than 50 copies/mL).

Common side effects of BIXLENVO:

In 2 clinical trials, the most common side effects in ≥2% of people taking BIXLENVO at 1 year were headache, nausea, and diarrhea.

In both studies, 2% of people stopped taking BIXLENVO due to side effects compared to 1% of people on multi-pill regimens and 2% of people taking a single-tablet regimen.

Want to know more about taking BIXLENVO?

How to take BIXLENVO

Ask your healthcare provider about BIXLENVO, a new treatment option for HIV.

Learn more

What is BIXLENVO?

BIXLENVO is a prescription medicine that is used to treat HIV-1 in adults to replace their current HIV-1 medicines when their healthcare provider determines that they meet certain requirements.

BIXLENVO does not cure HIV-1 or AIDS. HIV-1 is the virus that causes AIDS.

Important Safety Information

Tap for Important Safety Information for BIXLENVO.

Who should not take BIXLENVO?

Do not take BIXLENVO if you take dofetilide or certain other medications called strong CYP3A inducers. Ask your healthcare provider if you are not sure.

What are the possible side effects of BIXLENVO?

The most common side effects of BIXLENVO in clinical studies were headache (4%), nausea (3%), and diarrhea (2%). These are not all the possible side effects of BIXLENVO. Call your doctor for medical advice about side effects.

What should I tell my healthcare provider before taking BIXLENVO?

All your health problems, including if you have hepatitis B virus (HBV).
If you are pregnant or plan to become pregnant. Tell your healthcare provider if you become pregnant during treatment with BIXLENVO.
If you are breastfeeding (nursing) or plan to breastfeed. BIXLENVO passes to your baby in your breast milk. Talk to your healthcare provider about the risks to your baby from breastfeeding during treatment with BIXLENVO.
All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, including St. John’s Wort. BIXLENVO and other medicines may affect each other. Keep a list of all your medicines and show it to your healthcare provider and pharmacist and ask if it is safe to take BIXLENVO with all of your other medicines. Do not start a new medicine without telling your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

What is BIXLENVO?

BIXLENVO is a prescription medicine that is used to treat HIV-1 in adults to replace their current HIV-1 medicines when their healthcare provider determines that they meet certain requirements.

BIXLENVO does not cure HIV-1 or AIDS. HIV-1 is the virus that causes AIDS.

Please see Important Facts about BIXLENVO.