This information is intended for US healthcare professionals.

Prescribing Information
BIXLENVO™ logo. Click to go to Home page.
BIXLENVO™ logo. Click to go to Home page.

This information is intended for US healthcare professionals.

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The Smallest STR, Taken Once Daily, With or Without Food1,2*

*After initiation doses.

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Dosing Schedule Designed to Help Establish Therapeutic Levels1,3

Treatment begins with a 2-day initiation regimen

On Days 1 and 2, take 1 tablet of BIXLENVO™ plus 2 tablets of SUNLENCA® (lenacapavir), as this helps establish therapeutic levels of lenacapavir. On Day 3 and beyond, only once-daily BIXLENVO is needed for maintenance. 


Tablets may be taken with or without food.

Initiation: 2-day regimen of BIXLENVO + SUNLENCA1

On Days 1 and 2, take 1 tablet of BIXLENVO™ tablet and two tablets of SUNLENCA.
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BIXLENVO x1 TABLET

(bictegravir 75 mg/lenacapavir 50 mg tablet)

ORAL SUNLENCA x2 TABLETS

(lenacapavir 300 mg tablet)

Maintenance: 1 tablet of BIXLENVO taken orally once daily1

On Day 3 and beyond, only once-daily BIXLENVO™ is needed for maintenance.

BIXLENVO x1 TABLET

(bictegravir 75 mg/lenacapavir 50 mg tablet)

For more information on missed doses, open the tab below.

Missed initiation dose1

During the initiation period, if the Day 1 or Day 2 doses of BIXLENVO or SUNLENCA are missed, patients should take them as soon as possible.


Patients should not take Day 1 and Day 2 doses of SUNLENCA on the same day.

Missed maintenance dose1

If a maintenance dose of BIXLENVO is missed, patients should take it as soon as possible.

If more than 7 days have elapsed since the last maintenance dose, restart the initiation dosage regimen from Day 1, if clinically appropriate to continue BIXLENVO treatment.

Reference:
  1. BIXLENVO. Prescribing information. Gilead Sciences, Inc.; 2026.

Renal considerations:

  • Renal clearance contributes minimally to the overall elimination of BIXLENVO1
  • No dose adjustment of BIXLENVO is recommended for renal impairment (estimated CrCl ≥15 mL/min)1*
  • In ARTISTRY-1, the overall safety profile was consistent across levels of renal function, with a low rate of renal-related AEs at Week 484,5†

BIXLENVO Is the Smallest STR2,6-9*†

This chart is not inclusive of all HIV STR options or formulations

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This chart does not include the complete prescribing and dosing considerations, use in specific populations, or laboratory monitoring requirements for using these medications.

Please refer to the full Prescribing Information for each medication. Comparison of agents does not imply comparable indications, dosing, appropriate patient populations, clinical effectiveness, safety, or tolerability. BIXLENVO and BIKTARVY are trademarks of Gilead Sciences, Inc., DOVATO and TRIUMEQ are trademarks of ViiV Healthcare group of companies, and SYMTUZA is a trademark of Janssen Pharmaceutical Companies.

*Pills are not actual size. Pill sizes are shown according to a set scale.

†After initiation doses.

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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.

*Mild, moderate, or severe renal impairment (estimated creatinine clearance of ≥15 mL/min).

†Renal-related AEs occurred in 0%, 4%, and 5% of participants receiving BIXLENVO with eGFR >15 to ≤30, >30 to <60, and ≥60 mL/min, respectively.

AE, adverse event; eGFR, estimated glomerular filtration rate; STR, single-tablet regimen.

References:
  1. BIXLENVO. Prescribing information. Gilead Sciences, Inc.; 2026.
  2. Data on file. Gilead Sciences, Inc.; 2026.
  3. Arora P, Oh E, Montezuma-Rusca JM, et al. Pharmacokinetic analysis of oral once-daily bictegravir (BIC) plus lenacapavir (LEN) administered separately (BIC 75 mg + LEN 25 mg; BIC 75 mg + LEN 50 mg) and as BIC/LEN 75/50 mg single tablet regimen to support phase 3 dose selection. Poster presented at: HIV Glasgow; November 10-13, 2024; Glasgow, UK. Poster P049.
  4. 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.
  5. 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. Supplement. Lancet. 2026;407(10535):1249-1258.
  6. Electronic medicines compendium. Biktarvy 50 mg/200 mg/25 mg film-coated tablets-summary of product characteristics (SmPC). Accessed May 26,2026. https://www.medicines.org.uk/emc/product/9313/smpc/print
  7. Electronic medicines compendium. Dovato 50 mg/300 mg film-coated tablets-summary of product characteristics (SmPC). Accessed May 26, 2026. https://www.medicines.org.uk/emc/product/10446/smpc/print
  8. Electronic medicines compendium. Symtuza 800 mg/150 mg/200 mg/10 mg film-coated tablets-summary of product characteristics (SmPC). Accessed May 26, 2026. https://www.medicines.org.uk/emc/product/8430/smpc/print
  9. Electronic medicines compendium. Triumeq 50 mg/600 mg/300 mg film-coated tablets-summary of product characteristics (SmPC). Accessed May 26, 2026. https://www.medicines.org.uk/emc/product/3318/smpc/print