U.S. FDA Approves Gilead’s Bixlenvo™, a New Once-Daily Single Tablet Option for Virologically Suppressed Adults With HIV, Including Those on Complex Regimens

U.S. FDA Approves Gilead’s Bixlenvo^™, a New Once-Daily Single Tablet Option for Virologically Suppressed Adults With HIV, Including Those on Complex Regimens

– Novel Daily Oral Tablet Combines Bictegravir, a Guideline-Recommended INSTI with a High Barrier to Resistance, with Lenacapavir, a First-in-Class Capsid Inhibitor with No Cross-Resistance to Other Existing Antiretrovirals –

– BixlenvoNow the Smallest STR; First and Only STR for Most People on Complex HIV Treatment Regimens –

FOSTER CITY, Calif.–(BUSINESS WIRE)–
Gilead Sciences, Inc. (Nasdaq: GILD) today 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.

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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.

“Bixlenvo offers a new once-daily STR designed for the evolving needs of people with HIV,” said Chloe Orkin, MD, lead primary investigator for ARTISTRY-1 and Clinical Professor of Infection and Inequities at Queen Mary University of London. “The approval is a significant advancement in HIV treatment, especially for individuals unable to benefit from guideline-recommended STRs due to challenges like pre-existing resistance or tolerability. It expands tailored, simplified dosing to people whose needs were not fully met by existing single tablet therapies.”

The FDA approval is based on results from the Phase 3 ARTISTRY-1 (NCT05502341) and ARTISTRY-2 (NCT06333808) trials, with data presented during late-breaker sessions at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026). 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.

“Bixlenvo continues Gilead’s long-term commitment to innovation in HIV. Bringing together bictegravir with our first-in-class capsid inhibitor, lenacapavir, Bixlenvo offers a novel choice to people with HIV looking to switch or simplify their treatment regimen,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences. “Our goal at Gilead is to provide multiple options for HIV treatment and prevention and with a pipeline of potential daily, weekly and longer acting options, today’s approval could be the first of many in the years ahead.”

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.

Please see below for the U.S. Indication and Important Safety Information for Bixlenvo.

About Bixlenvo

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.

For more information, visit www.BIXLENVO.com.

U.S. Indication for Bixlenvo

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.

IMPORTANT SAFETY INFORMATION

Contraindications

Coadministration: 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

Prescribing Information: 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

Dosage: 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.

About Gilead HIV

For almost 40 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV prevention medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people.

Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic worldwide. Gilead has been repeatedly recognized as the top two leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS.

Discover more about Gilead’s unique collaborations worldwide and the work to help end the HIV epidemic.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving bictegravir and lenacapavir (such as ARTISTRY-1 and ARTISTRY-2); uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for programs and/or indications currently under evaluation, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; the risk that physicians and patients may not see the advantages of Bixlenvo for the treatment of HIV in adults who are virologically suppressed; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

Bixlenvo^™, Sunlenca^®, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.

U.S. Prescribing Information for Bixlenvo is available at www.gilead.com.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X (@Gilead Sciences) and LinkedIn, or contact Gilead Public Affairs.