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Bixlenvo (bictegravir/lenacapavir) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat human immunodeficiency virus type 1 (HIV-1) in certain adults whose virus is already suppressed and who are switching from their current treatment.
Bixlenvo contains two HIV medicines: bictegravir and lenacapavir. Bictegravir blocks an HIV enzyme called integrase. This helps stop HIV from inserting its genetic material into human cells.
Lenacapavir blocks the HIV capsid, a protein shell that is important at several stages of the virus’s life cycle. Together, these medicines help stop HIV-1 from making more copies of itself.
Doctors prescribe Bixlenvo when adults taking a stable HIV treatment have an HIV-1 RNA level below 50 copies per milliliter and no known or suspected drug resistance to bictegravir or lenacapavir.
HIV-1 is the virus that causes acquired immune deficiency syndrome (AIDS).
Bixlenvo is taken by mouth. At the start of treatment, it is taken with additional lenacapavir (Sunlenca) tablets. Bixlenvo and Sunlenca may be taken with or without food.
If you take an antacid that contains aluminum or magnesium, take Bixlenvo at least two hours before or six hours after the antacid. If you take a supplement or antacid that contains calcium or iron, take it with Bixlenvo and with food.
The typical dosing schedule is:
This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.
In clinical studies of adults with HIV-1 who switched to Bixlenvo, the most common side effects occurred in about 2 percent to 4 percent of people. These included:
Bixlenvo can cause serious side effects that may require immediate medical attention. These include:
Get medical help right away if you think you are having a serious reaction.
Gilead Sciences, the manufacturer of Bixlenvo, offers the Gilead Advancing Access Program. Eligible people with commercial insurance may pay as little as $0 for their copay. People with government insurance or no insurance can also get help identifying potential sources of financial support.
To learn more, visit the Gilead Advancing Access website, call 800-226-2056, or enroll online for 24/7 support.
Do not take Bixlenvo if you have ever had an allergic reaction to a medicine that contains bictegravir or lenacapavir.
Tell your healthcare provider about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements such as St. John’s wort. Some medicines can interact with Bixlenvo.
Before taking Bixlenvo, tell your healthcare provider if you have hepatitis B.
Do not take Bixlenvo if you take dofetilide or strong CYP3A inducers.
If you miss a dose of Bixlenvo or Sunlenca on day 1 or day 2, take it as soon as possible. Do not take the day 1 and day 2 doses of Sunlenca on the same day.
If you miss a dose of Bixlenvo on day 3 or later, take it as soon as possible. If more than seven days have passed since your last dose, contact your healthcare provider. They will decide how you should continue your HIV-1 treatment.
If you are pregnant or plan to become pregnant, tell your healthcare provider. Bixlenvo contains bictegravir, and levels of bictegravir may be lower during pregnancy. Your healthcare provider should closely monitor the amount of HIV-1 in your blood.
The Antiretroviral Pregnancy Registry tracks pregnancy outcomes in people exposed to Bixlenvo. Healthcare providers can register pregnancies with the registry or by calling 800-258-4263.
If you are breastfeeding or plan to breastfeed, tell your healthcare provider. Bixlenvo can pass into breast milk. Talk with your healthcare provider about breastfeeding while taking Bixlenvo.
Possible risks include:
These answers are fact-checked by our editorial staff.
How effective is Bixlenvo for HIV?
In two studies of adults with HIV-1 who already had viral suppression, 96 percent of people taking Bixlenvo in one study and 93 percent in the other had HIV-1 RNA below 50 copies per milliliter at week 48. In both studies, 1 percent of people taking Bixlenvo had HIV-1 RNA of 50 copies per milliliter or higher at week 48. Results were similar across groups based on age, sex, race, ethnicity, and region.
How long does Bixlenvo take to work for HIV?
Bixlenvo is used to replace a current HIV treatment in adults whose HIV-1 is already suppressed. This means their HIV-1 RNA is below 50 copies per milliliter while taking a stable treatment. The studies reported results through week 48, but they do not say exactly how long Bixlenvo takes to start working after the switch.
Does Bixlenvo interact with other medicines?
Yes. Bixlenvo can interact with some prescription medicines, over-the-counter medicines, and herbal products. Some interactions can lower Bixlenvo levels and make treatment less effective, while others can increase the risk of side effects.
Do not take Bixlenvo with dofetilide or strong CYP3A inducers, because these combinations are contraindicated. St. John’s wort is also contraindicated.
Bixlenvo can also interact with medicines such as certain seizure medicines, antibiotics used for tuberculosis, pain medicines, statins, metformin, antacids, and mineral supplements. Tell your healthcare provider about everything you take so they can check for possible interactions.
What tests or monitoring are needed with Bixlenvo for HIV?
If you have both HIV-1 and hepatitis B, your healthcare provider may need to monitor you closely, especially if you switch from a treatment that also worked against hepatitis B. You may also need a separate medicine to treat hepatitis B.
Studies of Bixlenvo reported changes in blood tests, including serum creatinine and liver enzymes called ALT and AST. The specific schedule for these tests is not provided.
On myHIVteam, people share their experiences with HIV, get advice, and find support from others who understand.
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