The U.S. Food and Drug Administration (FDA) approved Bixlenvo (bictegravir/lenacapavir) as a new once-daily, single-tablet treatment for some adults with HIV whose viral load is already suppressed.

Unlike many single-tablet HIV treatments that contain three medicines, Bixlenvo combines two. For some people, this may offer another option if side effects, drug resistance, drug interactions, or other issues make their current treatment harder to use. It may also simplify treatment for people who have been taking several pills or more complicated HIV treatment plans.

What Is Bixlenvo and How Does It Work?

Bixlenvo is approved as a complete treatment regimen for adults with HIV-1 who have an HIV-1 RNA level below 50 copies per milliliter while on a stable antiretroviral regimen.

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The pill combines two medicines that are already used in HIV care:

Bixlenvo is not approved for people with known or suspected resistance to bictegravir or lenacapavir. Bixlenvo also should not be taken with some medicines that can cause serious interactions or make the HIV treatment less effective.

Bixlenvo has a two-day initiation schedule. On day 1 and day 2, a person takes one Bixlenvo tablet along with additional lenacapavir. Starting on day 3, they take one Bixlenvo tablet once daily as their ongoing treatment. The tablet can be taken with or without food.

What Did Clinical Trials Find?

The FDA approval was based on two phase 3 studies.

ARTISTRY-1 included adults whose HIV was suppressed while they were taking complex treatment regimens. At 48 weeks, 96 percent of people who switched to the tablet had an HIV-1 RNA level below 50 copies per milliliter, compared with 94 percent of those who stayed on their existing regimen.

ARTISTRY-2 included adults whose HIV was already suppressed while taking Biktarvy. At 48 weeks, 93 percent of people who switched to Bixlenvo had an HIV-1 RNA level below 50 copies per milliliter, compared with 91 percent of people who continued taking Biktarvy.

Biktarvy contains bictegravir, emtricitabine, and tenofovir alafenamide.

Possible Side Effects

As with all medications, Bixlenvo may cause side effects. The most common side effects reported in the FDA-approved prescribing information are:

• Headache
• Nausea
• Diarrhea

What This Approval Means for People Living With HIV

Bixlenvo gives some people with well-controlled HIV a new two-drug treatment option. This may be helpful for people who have had problems with side effects, drug resistance, drug interactions, or other issues with their current treatment. For people taking several HIV pills, switching to Bixlenvo may also make treatment simpler.

If you’re interested in changing or simplifying your current HIV treatment, consider talking with your healthcare provider about your options. They can review your viral load, treatment history, resistance results, other medications, and whether you have hepatitis B virus (HBV). Because Bixlenvo does not treat hepatitis B, people who have both HIV and HBV may need additional HBV treatment and close monitoring.