Announcement • Aug 28

Gilead Sciences Announces FDA Approval Of Bixlenvo For Virologically Suppressed Adults With HIV

Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg), the smallest once-daily single tablet regimen (STR) for the treatment of HIV in adults who are virologically suppressed. Bixlenvo is now the first and only STR option for virologically suppressed people with HIV who are on complex regimens and unable to take currently available STRs. This novel HIV treatment pairs bictegravir, a global guideline-recommended integrase strand transfer inhibitor (INSTI) with a high barrier to resistance, with lenacapavir, a first-in-class capsid inhibitor that has a novel mechanism of action with no cross-resistance to other antiretrovirals. The FDA approval is based on results from the Phase 3 ARTISTRY-1 (NCT05502341) and ARTISTRY-2 (NCT06333808) trials. The trials evaluated Bixlenvo in adults with HIV who are virologically suppressed, including those who switched from complex multi-tablet regimens or from Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg). In both trials, Bixlenvo demonstrated comparable efficacy in maintaining virologic suppression at Week 48 and was generally well tolerated, with no significant or new safety concerns identified. Most common adverse reactions reported in at least 2% of participants across the ARTISTRY program were headache, nausea, and diarrhea. Detailed ARTISTRY-1 results were published in The Lancet, and ARTISTRY-2 results were published in Lancet HIV. ARTISTRY-1 enrolled the oldest study population in a Phase 3 registrational trial for HIV-1 treatment to date, with a median participant age of 60 years. Participants were taking between two and 11 pills per day at baseline, with approximately 40% taking antiretroviral therapy more than once daily. Additionally, the trial participants had extensive HIV treatment experience, with a median treatment duration of 28 years, a high level of historical antiretroviral resistance (67% with NRTI resistance) and a high proportion of participants on a complex regimen because of antiretroviral resistance (81%). The Phase 3 results demonstrated that switching from complex multi-tablet regimens to Bixlenvo was associated with improvements in certain fasting lipid parameters and participant-reported treatment satisfaction. ARTISTRY-2 showed that switching to Bixlenvo had no significant impact on weight. Bixlenvo requires a two-day initiation dose with Sunlenca (lenacapavir), thereafter only Bixlenvo is taken orally once a day. Bictegravir and lenacapavir in combination are not approved by any regulatory authority outside of the United States. There is currently no cure for HIV or AIDS. Bixlenvo is a once-daily, single tablet regimen that combines bictegravir, a global guideline-recommended integrase strand transfer inhibitor (INSTI) with a high barrier to resistance, and lenacapavir, a first-in-class capsid inhibitor with a multi-stage mechanism of action. Together, bictegravir and lenacapavir target multiple stages of the HIV life cycle. Developed for adults with HIV who are virologically suppressed, including those on complex regimens, Bixlenvo expands treatment choice with a simple daily oral option supported by results from the Phase 3 ARTISTRY clinical program. Bixlenvo is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected resistance to the individual components of Bixlenvo. Contraindications: Concomitant administration of Bixlenvo is contraindicated with dofetilide and strong CYP3A inducers. Warnings and precautions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during Bixlenvo therapy and monitor for adverse reactions. Adverse reactions: Most common adverse reactions (incidence >2%; all grades) reported in clinical trials were headache (4%), nausea (3%), and diarrhea (2%). Drug interactions: Consult the full Prescribing Information for Bixlenvo for more information on contraindications, warnings, and potentially significant drug interactions, including clinical comments. Enzymes/transporters: Drugs that are both a strong inducer of CYP3A and induce UGT1A1 can substantially decrease the concentration of components of Bixlenvo. Drugs that are strong or moderate inducers of CYP3A may significantly decrease the concentrations of components of Bixlenvo. Drugs that are both a strong CYP3A inhibitor and a UGT1A1 inhibitor, or combined P-gp, UGT1A1, and strong CYP3A inhibitors can significantly increase concentrations of components of Bixlenvo. Dosage and administration: Two-day initiation regimen of Bixlenvo 1 tablet plus Sunlenca 2 tablets taken orally daily, followed by a maintenance regimen of Bixlenvo 1 tablet orally once daily. Tablets may be taken with or without food. Day 1: Bixlenvo 1 tablet of 75 mg/50 mg orally and Sunlenca 2 tablets of 300 mg orally (600 mg dose). Day 2: Bixlenvo 1 tablet of 75 mg/50 mg orally and Sunlenca 2 tablets of 300 mg orally (600 mg dose). Day 3 and once daily thereafter: Bixlenvo 1 tablet of 75 mg/50 mg orally once daily. Missed dose: If the initiation doses of Bixlenvo or Sunlenca are missed, patients should take them as soon as possible. Patients should not take both Day 1 and Day 2 doses of Sunlenca on the same day. Patients should take missed maintenance doses as soon as possible. If more than 7 days have elapsed since the last maintenance dose, restart initiation dosage regimen from Day 1, if clinically appropriate to continue treatment. Pregnancy and lactation: Pregnancy: Lower exposures of bictegravir were observed in clinical studies with a bictegravir-containing regimen; therefore, viral load should be monitored closely in pregnant individuals. An Antiretroviral Pregnancy Registry (APR) has been established. Lactation: Individuals with HIV-1 should be informed of the potential risks of breastfeeding.

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