If you are living with HIV, your health care provider may talk to you about switching to a medicine called Bixlenvo (bictegravir/lenacapavir). It is a complete HIV treatment that combines two medicines in a single, once-daily tablet.
Bixlenvo is used to control the virus that causes HIV. It is a treatment option for certain adults who are already doing well on their current HIV medicines and want to switch to something different, such as a smaller pill.
Continue reading to learn more about Bixlenvo for HIV, how it works, how it's taken, and what clinical studies have shown.
Is Bixlenvo Right for Me?
Bixlenvo is FDA-approved as a complete regimen to treat HIV in adults. "Complete regimen" means it is designed to be your only HIV medicine. You take it on its own rather than adding it to other HIV medicines.
Bixlenvo is meant for people who are switching from another HIV treatment, not for people who are just starting HIV treatment for the first time. To be a good candidate for Bixlenvo, you generally need to meet all of the following:
- You are an adult with HIV.
- Your current HIV medicines are working well, and your virus is under control. This is called being "virologically suppressed," and it means your viral load (the amount of HIV in your blood) is less than 50 copies per milliliter (mL).
- You have been on a stable HIV treatment regimen for a while.
- Your HIV is not known or suspected to be resistant to either of the two medicines in Bixlenvo (bictegravir and lenacapavir).
There are a few situations where Bixlenvo is not the right choice. You should not take Bixlenvo if you take certain medicines. Combining them can cause serious problems or keep Bixlenvo from working. Tell your health care provider about all the medicines and supplements you take, including over-the-counter products and herbal products. For more information about this, see our article about Bixlenvo's drug interactions and side effects.
If you have HIV as well as hepatitis B, tell your health care provider before you switch to Bixlenvo. People with long-term (chronic) hepatitis B were not included in the Bixlenvo studies. Bixlenvo does not treat hepatitis B, but some other HIV medicines do. If your current HIV regimen also treats hepatitis B, stopping it could allow hepatitis B to flare. So, your health care provider may need to add a separate medicine for hepatitis B when you switch to Bixlenvo.
Your health care provider can review your treatment history, lab results, and overall health to help decide whether Bixlenvo is a good option for you.
How Does Bixlenvo Work for HIV?
Bixlenvo contains two different HIV medicines that work in different ways to control the virus. Neither one cures HIV, but together they help lower the amount of virus in your body and keep it under control.
- Bictegravir is a type of medicine called an integrase strand transfer inhibitor (often shortened to "INSTI"). It blocks an HIV enzyme called integrase. HIV needs integrase to insert its genetic material into your cells. By blocking this step, bictegravir helps stop the virus from making copies of itself.
- Lenacapavir is a type of medicine called a capsid inhibitor. The capsid is the protein shell that protects the virus and helps it reproduce. Lenacapavir attaches to the capsid and interferes with several steps the virus needs to complete its life cycle.
Keeping the virus under control helps protect your immune system, which is the part of your body that fights infection.
How Do I Take Bixlenvo?
Bixlenvo is a tablet that you take by mouth once a day. You can take it with or without food.
Treatment starts with a two-day "initiation" period. During these first two days, you take Bixlenvo together with a second medicine called Sunlenca (lenacapavir tablets). Taking both medicines during this start-up period is an important part of how Bixlenvo works. The extra lenacapavir helps quickly raise the levels of lenacapavir, one of the active ingredients in Bixlenvo,
so there is enough medicine in your body for it to begin working. Contact your
health care provider if you have questions about taking Bixlenvo.
Your schedule will likely look like this:
- Day 1: Take one Bixlenvo tablet plus two Sunlenca tablets (600 mg total).
- Day 2: Take one Bixlenvo tablet plus two Sunlenca tablets (600 mg total).
- Day 3 and every day after: Take one Bixlenvo tablet once daily.
If you miss a dose, take it as soon as you can. If more than seven days have passed since your last dose, contact your health care provider, who will need to decide how you should restart treatment.
It is important not to run out of Bixlenvo or stop taking it without talking to your provider. If you stop your medicine even for a short time, the amount of virus in your blood can go up, and the virus may become resistant to the medicine and harder to treat. When your supply starts to run low, contact your pharmacy or health care provider for a refill.
How Was Bixlenvo Studied for HIV?
Bixlenvo was studied in two main clinical trials, called ARTISTRY-1 and ARTISTRY-2. Both trials enrolled adults whose HIV was already under control and who switched from their current treatment to Bixlenvo.
ARTISTRY-1
It was an open-label study (meaning participants and researchers knew who was taking which medicine) and included 557 adults. The participants were on more complex regimens, for example, taking several pills a day, dosing more than once a day, or using an injectable HIV medicine along with pills. They were randomly assigned to either switch to Bixlenvo or stay on their current regimen. Below are some details about the participants at the beginning of the study:
- The average age was 59 years, ranging from 22 to 84.
- About 82% were men and 18% were women.
- About 69% were White, 17% were Black, 4% were Asian, and 3% were another race; 22% identified as Hispanic or Latino.
ARTISTRY-2
It was a double-blind study (meaning neither participants nor researchers knew who was taking which medicine) that included 574 adults who were already taking a single-tablet HIV medicine called Biktarvy. They were randomly assigned to either switch to Bixlenvo or stay on Biktarvy. Some details about the participants:
- The average age was 49 years, ranging from 23 to 77.
- About 81% were men, and 19% were women.
- About 54% were White, 27% were Black, 13% were Asian, and 5% were another race; 27% identified as Hispanic or Latino.
In both studies, the main goal was to see whether people kept their virus under control (a viral load of less than 50 copies/mL) after 48 weeks of treatment.
What Are the Benefits of Bixlenvo Based on Studies?
Both studies showed that switching to Bixlenvo kept HIV under control about as well as the treatments it was compared with. After 48 weeks, most people who switched to Bixlenvo still had their virus suppressed. Only a very small number (about 1%) had a viral load that was no longer controlled after switching to Bixlenvo.
The table below shows the percentage of people whose viral load stayed under control (less than 50 copies/mL) at week 48.
| Study | Treatment | Viral Load Under Control at Week 48 |
|---|---|---|
| ARTISTRY-1 | Switched to Bixlenvo | 96% |
| Stayed on previous regimen | 94% | |
| ARTISTRY-2 | Switched to Bixlenvo | 93% |
| Stayed on Biktarvy | 91% |
Researchers also looked at changes in CD4 cell count, a measure of immune system health. They found that results were generally similar whether people switched to Bixlenvo or stayed on their previous treatment.
Your results may be different from what was seen in the studies. Your health care provider will check your viral load and overall health during treatment and let you know how well Bixlenvo is working for you.
Is There Any Cost Assistance Available?
Yes. The drugmaker of Bixlenvo offers a support program. This program may be able to help you with cost, regardless of your insurance plan. To find out more and see if you qualify for assistance, you can go to their website or call them directly at 800-226-2056.
