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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BIXLENVO™ Has a Proven Safety and Tolerability Profile1,2

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SAFETY

Proven Safety and Tolerability Profile Through Week 481,2

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

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Adverse Reactions (All Grades) Reported in ≥2% of PWH Receiving BIXLENVO Through Week 483* ARTISTRY‑1† ARTISTRY‑2‡
BIXLENVO n=371 Complex ARV regimen n=186 BIXLENVO n=383 BIKTARVY n=191
Headache 4% 0 1% 0
Nausea 3% 0 3% 4%
Diarrhea 2% 0 2% 2%

*Frequencies of adverse reactions are based on all adverse events attributed to trial drugs by the investigator.

†ARTISTRY-1 was open-label with a stable baseline regimen as a comparator.

‡ARTISTRY-2 was blinded and placebo-controlled with BIKTARVY as the comparator.

Low rates of discontinuation due to adverse events1,2

  • 2% discontinued BIXLENVO due to AEs compared with 1% on a complex ARV regimen and 2% on BIKTARVY

Renal considerations:

  • Renal clearance contributes minimally to the overall elimination of BIXLENVO3
  • No dose adjustment of BIXLENVO is recommended for renal impairment (estimated CrCl ≥15 mL/min)3*
  • In ARTISTRY-1, the overall safety profile was consistent across levels of renal function, with a low rate of renal-related AEs at Week 481,4†

Fasting Lipid Data at Week 48

ARTISTRY-1: Switching to BIXLENVO resulted in an observed decrease in 4 out of 5 lipid parameters from baseline1,4:

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ARTISTRY-1 Change in Fasting Lipids

-40 -50 316 n= 147 316 147 316 147 316 147 176 188 97 105 47 48 130 123 30 20 10 0 -10 -20 -30 -15 Total
Cholesterol LDL
Cholesterol HDL
Cholesterol Triglycerides +2 +2 -15 +4 -1 0 -9 Median (IQR) Change
From Baseline mg/dL Median (IQR) Change
From Baseline, Median at Baseline,
mg/dL = -1 316 147 3.6 3.7 0.5 -0.5 0 1 TC:HDL Cholesterol -0.3 0 Complex ARV regimen BIXLENVO

Safety analyses were summarized using descriptive statistics. The clinical significance of these findings is unknown.

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ARTISTRY-2 Change in Fasting Lipids2

-1 341 162 0.5 -0.5 0 1 TC:HDL Cholesterol -0.1 0 Median (IQR) Change
From Baseline Median (IQR) Change
From Baseline, mg/dL -40 -50 343 n= 162 343 162 341 162 341 162 30 20 10 0 -10 -20 -30 0 Total
Cholesterol LDL
Cholesterol HDL
Cholesterol Triglycerides +1 +3 0 -5 0 0 +1 BIXLENVO BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide) ®

Safety analyses were summarized using descriptive statistics. The clinical significance of these findings is unknown.

ARTISTRY-2: Weight and BMI were observed to remain stable for participants who switched to BIXLENVO1

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361 81.1 361 26.8 173 81.1 173 27.1 Median Weight
at Baseline, kg = Median BMI
at Baseline, kg/m ² = n= n= -1 -2 -1 -2 -3 BIXLENVO BIKTARVY BIXLENVO BIKTARVY ARTISTRY-2: Change in BMI 1,2 ARTISTRY-2: Change in Weight 1,2 BIXLENVO BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide) ® Median (Q1, Q3)
BMI Change, kg/m ² Median (Q1, Q3)
Weight Change, kg 2 1 0 2 3 1 0 -0.2 0 -0.1 0

ARTISTRY-1 median weight change from baseline: BIXLENVO +0.6 kg (IQR -1.1 to 2.6) vs complex ARV regimen 0.0 kg (IQR -2.0 to 2.4)3

Safety analyses were summarized using descriptive statistics. The clinical significance of these findings is unknown.

ARV, antiretroviral; BMI, body mass index; IQR, interquartile range.

References:
  1. Meissner EG, Ramgopal M, Ruane PJ, et al. Phase 3 efficacy and safety of switch from B/F/TAF to single-tablet BIC/LEN in ARTISTRY-2. Presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 22-25, 2026; Denver, CO.
  2. 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
  3. 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.
DRUG–DRUG INTERACTIONS

BIXLENVO Has a Well-Characterized Drug-Interaction Profile3

Please see the full Prescribing Information for full list of contraindications and established or potentially clinically significant drug interactions with recommended prevention or management strategies.

Use with caution and monitoring, dose adjustment, and/or refer to prescribing information for concomitant drugs
Concomitant Drug Class: Drug Name Effect on Concentration*
Antiarrhythmics:digoxin digoxin
Anticoagulants:DOACs: rivaroxaban, dabigatran, edoxaban DOAC
Corticosteroids (systemic):cortisone/hydrocortisone, dexamethasone corticosteroids (systemic) lenacapavir (dexamethasone)
HMG-CoA reductase inhibitors:lovastatin, simvastatin lovastatin simvastatin
Metformin metformin
Narcotic analgesics metabolized by CYP3A:(eg, fentanyl, oxycodone) fentanyl oxycodone
Tramadol tramadol
Narcotic analgesic for treatment of opioid dependence:buprenorphine, methadone buprenorphine: effects unknownmethadone: effects unknown
Oral medications or supplements containing polyvalent cations (eg, Mg, Al, Ca, Fe): calcium or iron supplements,† cation-containing antacids or laxatives,† sucralfate, buffered medications bictegravir
Phosphodiesterase-5 (PDE-5) inhibitors
(use for ED):sildenafil, tadalafil, vardenafil PDE-5 inhibitors
Sedatives/hypnotics:midazolam (oral),† triazolam midazolam (oral) triazolam
Not recommended
Concomitant Drug Class: Drug Name Effect on Concentration*
Anticonvulsants: oxcarbazepine, phenobarbital lenacapavir bictegravir
Antimycobacterials: rifabutin,† rifapentine lenacapavir bictegravir
Ergot derivatives: dihydroergotamine, ergotamine, methylergonovine dihydroergotamine ergotamine methylergonovine
Opioid antagonist: naloxegol naloxegol
Phosphodiesterase-5 (PDE-5)
inhibitors (use for PAH): tadalafil 		PDE-5 inhibitors
Contraindicated BIXLENVO is contraindicated with dofetilide and strong CYP3A inducers
Concomitant Drug Class: Drug Name Effect on Concentration*
Antiarrhythmics: dofetilide dofetilide
Anticonvulsants: carbamazepine, phenytoin lenacapavir bictegravir
Antimycobacterials: rifampin† lenacapavir bictegravir
Herbal products: St. John’s wort‡ (Hypericum perforatum) lenacapavir bictegravir

Because BIXLENVO is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended.

*↑ = increase, ↓ = decrease. †Drug–drug interaction study was conducted for components of BIXLENVO dosed as individual agents (bictegravir or lenacapavir). ‡The induction potency of St. John's wort may vary widely based on preparation.

Al, aluminum; Ca, calcium; CYP3A, cytochrome P450 3A; DOACs, direct oral anticoagulants; ED, erectile dysfunction; Fe, iron; HMG-CoA, 3-hydroxy-3-methylglutaryl coenzyme A; Mg, magnesium; PAH, pulmonary arterial hypertension.

Reference:
  1. BIXLENVO. Prescribing information. Gilead Sciences, Inc.; 2026.
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THE SMALLEST STR,* TAKEN ONCE DAILY, WITH OR WITHOUT FOOD3,5

*After initiation doses.

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Prescribing Overview

Please see full Prescribing Information for BIKTARVY, including BOXED WARNING.

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).3

†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.4

AE, adverse event; ARV, antiretroviral; eGFR, estimated glomerular filtration rate; HDL, high-density lipoprotein; IQR, interquartile range; LDL, low-density lipoprotein; PWH, people with HIV; STR, single-tablet regimen; TC, total cholesterol.

References:
  1. 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.
  2. 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
  3. BIXLENVO. Prescribing information. Gilead Sciences, Inc.; 2026.
  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. Supplement. Lancet. 2026;407(10535):1249-1258.
  5. Data on file. Gilead Sciences, Inc.; 2026.