FDA Approves Bixlenvo, a New Daily Pill to Treat HIV

What Is Bixlenvo and Why Does It Matter?

The FDA has approved Bixlenvo for adults with HIV-1. It is meant for adults whose virus is already under control with their current HIV treatment. This means their blood test shows low levels of the virus, known as virologically suppressed. Bixlenvo is a complete treatment regimen and replaces their current HIV medications.

Bixlenvo combines two active medicines, bictegravir and lenacapavir, into a single tablet. Bictegravir blocks an enzyme that the virus needs to make copies of itself. Lenacapavir works by interfering with the outer shell, or capsid, of the virus. Together, these two drugs attack the virus at different stages to keep it from spreading in the body.

This approval gives adults living with HIV a new daily option to manage their infection. It offers a simplified single-tablet choice, especially for people who may be taking complex regimens or multiple pills every day.

Why Was It Approved?

The approval was based on two phase 3 clinical studies called ARTISTRY-1 and ARTISTRY-2. Together, these trials included over 1,100 adults with HIV whose virus was already suppressed. In ARTISTRY-1, 557 participants either switched to Bixlenvo or stayed on their multipill treatment regimen. In ARTISTRY-2, 574 participants either switched to Bixlenvo or stayed on another single-pill treatment called Biktarvy.

Both studies measured how well the treatments kept the virus suppressed after 48 weeks. In ARTISTRY-1, 94% of people taking Bixlenvo kept their virus suppressed compared to 96% of those staying on their baseline treatment. In ARTISTRY-2, 93% of participants on Bixlenvo kept their virus suppressed compared to 91% of those taking Biktarvy. The results showed that Bixlenvo worked just as well at keeping the virus at low levels as the other treatments.The studies also looked at safety. Side effects were similar across the study groups, and no major new safety issues were found. Switching to Bixlenvo helped keep the virus in check without causing significant unexpected health problems.

What Do I Need to Know?

Bixlenvo is taken by mouth with or without food. When starting treatment, patients take one Bixlenvo tablet along with two tablets of another medicine called Sunlenca once daily for the first two days. On the third day and every day after, patients take just one Bixlenvo tablet once a day.

The most common side effects of Bixlenvo include headache, nausea, and diarrhea. Patients should tell their healthcare provider about all medicines, vitamins, and supplements they take. Certain heart medications, such as dofetilide, and strong liver enzyme inducers should not be taken with Bixlenvo. Antacids or supplements containing aluminum, magnesium, iron, or calcium can also change how Bixlenvo works and may need to be taken at different times.Patients who are pregnant, planning to become pregnant, or breastfeeding should discuss their care with a healthcare provider. Bictegravir levels may be lower during pregnancy, so a healthcare provider will need to check viral levels closely. Both bictegravir and lenacapavir can pass into breast milk. Always speak with a healthcare provider before starting or changing any HIV treatment.