BIXLENVO™ HCP Site | Bictegravir (75 mg) + Lenacapavir (50 mg)

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BIXLENVO Combines the Proven Power of Bictegravir With Lenacapavir, the First-in-Class HIV-1 Capsid Inhibitor, All in the Smallest STR^1-3*

A NOVEL COMBINATION^1,4-7

Two complementary components active against the three most common classes associated with resistance (NRTI, NNRTI, PI) in vitro

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PROVEN TO SUSTAIN VIROLOGIC CONTROL AND A HIGH BARRIER TO RESISTANCE AT WEEK 48^1,2†

Studied in PWH with a range of resistance mutations

Explore Efficacy Outcomes

PROVEN SAFETY AND TOLERABILITY PROFILE THROUGH WEEK 48^2,8

ARTISTRY trials included PWH with comorbidities, such as chronic kidney disease

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*After initiation doses.

^†Virologic control is defined as HIV‑1 RNA <50 copies/mL.

See clinical scenarios of virologically suppressed PWH who could benefit from a switch to BIXLENVO

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*Eligible, commercially insured individuals enrolled in Gilead Advancing Access Co-pay Savings Program could pay as little as $0 co-pay. Restrictions apply. Subject to change. See full terms and conditions at www.gileadadvancingaccess.com/hcp/financial-assistance/copay-support

INDICATION AND IMPORTANT SAFETY INFORMATION

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INDICATION

BIXLENVO is indicated as a complete regimen for the treatment of 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.

Please see full Prescribing Information for BIXLENVO.

NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; PI, protease inhibitor; PWH, people with HIV; RNA, ribonucleic acid; STR, single-tablet regimen.

References:

BIXLENVO. Prescribing information. Gilead Sciences, Inc.; 2026.
Orkin C, Ruane PJ, Hedgcock M, et al; ARTISTRY-1 Study Group. Switch to single-tablet bictegravir–lenacapavir from a complex HIV regimen (ARTISTRY-1): a randomised, open-label, phase 3 clinical trial. Lancet. 2026;407(10535):1249-1258.
Data on file. Gilead Sciences, Inc.; 2026.
Link JO, Rhee MS, Tse WC, et al. Clinical targeting of HIV capsid protein with a long-acting small molecule. Nature. 2020;584(7822):614-618.
D’Antoni ML, Chang S, Arora P, Yu H, Margot N, Callebaut C. High in vitro resistance barrier for the bictegravir + lenacapavir combination. Presented at: 20th European AIDS Conference (EACS); October 15-18, 2025; Paris, France.
Tsiang M, Jones GS, Goldsmith J, et al. Antiviral activity of bictegravir (GS-9883), a novel potent HIV-1 integrase strand transfer inhibitor with an improved resistance profile. Antimicrob Agents Chemother. 2016;60(12):7086-7097.
McClung RP, Oster AM, Ocfemia MCB, et al. Transmitted drug resistance among human immunodeficiency virus (HIV)-1 diagnoses in the United States, 2014–2018. Clin Infect Dis. 2022;74(6):1055-1062.
Meissner EG, Ramgopal M, Ruane PJ, et al; ARTISTRY-2 Study Group. Safety and efficacy of switching to bictegravir–lenacapavir versus continuing bictegravir–emtricitabine–tenofovir alafenamide in virologically suppressed people with HIV-1 (ARTISTRY-2): a double-blind, multicentre, randomised, controlled, phase 3, non-inferiority trial. Lancet HIV. Published online May 6, 2026. doi:10.1016/S2352-3018(26)00078-0

Strength & Harmony

BIXLENVO Combines the Proven Power of Bictegravir With Lenacapavir, the First-in-Class HIV-1 Capsid Inhibitor, All in the Smallest STR1-3*

A NOVEL COMBINATION1,4-7

PROVEN TO SUSTAIN VIROLOGIC CONTROL AND A HIGH BARRIER TO RESISTANCE AT WEEK 481,2†

PROVEN SAFETY AND TOLERABILITY PROFILE THROUGH WEEK 482,8