This information is intended for US healthcare professionals.

Prescribing Information
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This information is intended for US healthcare professionals.

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BIXLENVO™ FAQs

Find answers to common questions

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Study Design

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 <50 copies/mL) on a stable antiretroviral regimen, with no known or suspected resistance to the individual components of BIXLENVO.1

Explore study design

RNA, ribonucleic acid.

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

Comparing BIXLENVO with BIKTARVY, a DHHS guideline–recommended standard of care regimen, helped to further evaluate the efficacy and safety of BIXLENVO and generate evidence to support regulatory review.1-3

See the data

DHHS, Department of Health and Human Services.

References:
  1. BIKTARVY. Prescribing information. Gilead Sciences, Inc.; 2025.
  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. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV. US Department of Health and Human Services. Updated May 27, 2026. Accessed July 13, 2026. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/guidelines-adult-adolescent-arv.pdf

MOA

BIXLENVO combines bictegravir, a second-generation INSTI, with lenacapavir, a first-in-class capsid inhibitor—two complementary components active against the three most common classes associated with resistance (NRTI, NNRTI, PI) in vitro.1-6

Learn about this novel combination

INSTI, integrase strand transfer inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.

References:
  1. BIXLENVO. Prescribing information. Gilead Sciences, Inc.; 2026.
  2. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV. US Department of Health and Human Services. Updated May 27, 2026. Accessed July 13, 2026. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/guidelines-adult-adolescent-arv.pdf
  3. 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.
  4. 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.
  5. 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.
  6. 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.

BIXLENVO combines bictegravir and lenacapavir to disrupt multiple stages of the HIV-1 life cycle.1

Bictegravir inhibits activity of HIV-1 integrase to prevent integration of viral DNA and halt HIV replication, while lenacapavir interferes with three essential stages of the HIV life cycle: nuclear transport, virus assembly and release, and capsid core formation.

See mechanism of action

DNA, deoxyribonucleic acid.

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

Efficacy

BIXLENVO sustained virologic control (HIV-1 RNA <50 copies/mL) at Week 48 in participants switching from both complex ARV regimens (ARTISTRY-1) and a standard of care regimen (ARTISTRY-2).1-3

ARTISTRY-1 was a phase 3, randomized, open-label, noninferiority trial that evaluated the efficacy and safety of switching from a complex stable baseline ARV regimen to BIXLENVO. Participants were randomized in a 2:1 ratio to either switch to BIXLENVO or stay on their stable baseline regimen.1,2

ARTISTRY-1 included the oldest population enrolled in a phase 3 registrational trial for HIV treatment. Key baseline characteristics included a median age of 60 years and a median of 28 years of HIV treatment; >80% of patients had a history of resistance, 54% of patients had ≥2 comorbidities—including 14% with chronic kidney disease, and 61% on ≥2 concomitant medications.2,4

ARTISTRY-2 was a phase 3, randomized, double-blind, active-controlled, noninferiority trial that evaluated the efficacy and safety of switching from BIKTARVY® (bictegravir/emtricitabine/tenofovir alafenamide) to BIXLENVO. Participants were randomized in a 2:1 ratio to either switch to BIXLENVO or stay on BIKTARVY.1,3

ARTISTRY-2 evaluated in PWH who were virologically suppressed on standard of care. Key baseline characteristics included a median age of 49 years; 30% of patients had ≥2 comorbidities and >50% were Black, Hispanic, or Latine.1,3

See efficacy data

ARV, antiretroviral; PWH, people with HIV; RNA, ribonucleic acid.

References:
  1. BIXLENVO. Prescribing information. Gilead Sciences, Inc.; 2026.
  2. 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.
  3. 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
  4. Data on file. Gilead Sciences, Inc.; 2026.

BIXLENVO demonstrated a high barrier of resistance across the ARTISTRY trials.1-3 No treatment-emergent capsid resistance mutations were detected,* and no treatment-emergent substitutions conferred phenotypic resistance to bictegravir through Week 48.1*†

One participant in ARTISTRY-1 had a transient, low-level Q148R substitution in integrase at Week 24 that remained phenotypically susceptible to bictegravir (1.2-fold reduction in comparison to wild-type) and was not detected at Week 48.1,4 One participant in ARTISTRY-2 had an isolated R263K substitution in integrase that also remained phenotypically susceptible to bictegravir (2-fold reduction in comparison to wild-type).1,3

*Based on the final resistance analysis population.4

†Biological cutoff for phenotypic resistance for bictegravir is defined as >10-fold reduction in comparison to wild-type.4

Explore resistance data
References:
  1. BIXLENVO. Prescribing information. Gilead Sciences, Inc.; 2026.
  2. 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.
  3. 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. Supplement. Lancet HIV. Published online May 6, 2026. doi:10.1016/S2352-3018(26)00078-0
  4. Data on file. Gilead Sciences, Inc.; 2026.

Participants with prior resistance histories were represented in both phase 3 studies of BIXLENVO.1,2 In ARTISTRY-1, >80% of participants had preexisting resistance at baseline: 84% with NRTI resistance, 70% with NNRTI resistance, and 51% with PI resistance.3* In ARTISTRY-2, 17% of participants had historical NNRTI resistance, 13% had NRTI resistance, and 6% had PI resistance.2 BIXLENVO is not indicated for people with resistance to its components.4

Does not constitute medical advice and should not substitute for clinical decision-making.

*From historical genotypic reports and retrospective proviral DNA analysis, n with data = 542/557 (97%).

See clinical scenarios to identify potential PWH in your care

DNA, deoxyribonucleic acid; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; PI, protease inhibitor; PWH, people with HIV.

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. Margot N, Pennetzdorfer N, Naik V, et al. Baseline and week 48 resistance analyses in the phase 3 ARTISTRY-1 study evaluating the bictegravir/lenacapavir single-tablet regimen. Presented at: The 26th International AIDS Conference; July 26-31, 2026; Rio de Janeiro, Brazil.
  4. BIXLENVO. Prescribing information. Gilead Sciences, Inc.; 2026.

Commercial testing is not yet widely available.

Safety

BIXLENVO demonstrated a proven safety and tolerability profile in two phase 3 clinical trials through Week 48, with low discontinuation rates due to adverse events (~2%).1,2 Most common adverse reactions (≥2%) for PWH receiving BIXLENVO included headache, nausea, and diarrhea.3

Review safety data

PWH, people with HIV.

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.

Renal clearance is a minor contributor to the overall elimination of bictegravir and lenacapavir, with 35% and <1% of dose excreted in urine for bictegravir and lenacapavir, respectively.1

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

ARTISTRY-1 included individuals with severe renal impairment (eGFR ≥15 mL/min, and not on renal replacement therapy); ARTISTRY-2 included individuals with eGFR ≥30 mL/min.1,2 No dose adjustment is required for patients with mild, moderate, or severe renal impairment (CrCl ≥15 mL/min), nor in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.3

BIXLENVO was not studied in patients with severe hepatic impairment (Child-Pugh Class C), and was not studied in patients with ESRD estimated CrCl <15 mL/min.3

See more safety information

CrCl, creatinine clearance; eGFR, estimated glomerular filtration rate; ESRD, end-stage renal disease.

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.

In ARTISTRY-1, participants who switched to BIXLENVO from a complex ARV regimen had an observed decrease in 4 out of 5 fasting lipid parameters.1,2 In ARTISTRY-2, lipid parameters were observed to remain stable for participants who switched to BIXLENVO.3

In ARTISTRY-1, there was no observed impact on bodyweight for participants who switched to BIXLENVO.1 In ARTISTRY-2, there was no observed impact on bodyweight or BMI for participants who switched to BIXLENVO.3,4

ARV, antiretroviral; BMI, body mass index.

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. 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.
  3. 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.
  4. 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

BIXLENVO itself has not been studied in pregnancy because pregnancy was an exclusion criterion during ARTISTRY enrollment.1-3

References:
  1. BIXLENVO. Prescribing information. Gilead Sciences, Inc.; 2026.
  2. 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.
  3. 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

The efficacy and safety of BIXLENVO have not been established in PWH less than 18 years of age.1

PWH, people with HIV.

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

Dosing

Treatment begins with a 2-day initiation regimen of BIXLENVO plus 2 tablets of SUNLENCA® (lenacapavir) taken orally each day to help establish therapeutic levels of lenacapavir.1,2 Beginning on Day 3, only once-daily BIXLENVO taken orally is needed.1

BIXLENVO may be taken with or without food.1

View dosing schedule
References:
  1. BIXLENVO. Prescribing information. Gilead Sciences, Inc.; 2026.
  2. 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 2024; November 10-13, 2024; Glasgow, UK. Poster P049.

During the initiation period, if the Day 1 or Day 2 doses of BIXLENVO or SUNLENCA® (lenacapavir) 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.1

Missed doses should be taken as soon as possible. If more than 7 days have elapsed since the last maintenance dose, restart the Day 1 and Day 2 initiation dosages if clinically appropriate to continue BIXLENVO treatment. Do not take these on the same day.1

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

Yes. The 2-day initiation regimen requires separate prescriptions for BIXLENVO and SUNLENCA® (lenacapavir). Maintenance therapy requires only one prescription for BIXLENVO.1

See guidance for prescribing BIXLENVO
Reference:
  1. BIXLENVO. Prescribing information. Gilead Sciences, Inc.; 2026.

Access

Each insurance company is different and will review benefit policies and coverage determinations at different times. During this initial review period, typical payer requirements for BIXLENVO may include prior authorization, medical exception, or administrative review. Advancing Access® can help your patient stay informed.

The timeline to approval and access can vary and depends on the payer and the benefit pathway. It is also informed by the completeness of the documentation submitted.

  • For example, some prior authorizations can be reviewed and approved within 48-72 hours, while medical benefit approvals can take several weeks
  • Network specialty pharmacies can help with information and gathering the required forms, including for prior authorization or medical necessity. For more information about access and coverage, visit Advancing Access®

The Advancing Access® program provides support, including co-pay assistance (eligible commercially insured patients may pay as little as $0), insurance support, and patient assistance for uninsured individuals.

Explore support

Yes. A co-pay savings program is available for eligible, commercially insured patients on BIXLENVO. Advancing Access® can help your patients, who may pay as little as $0 in co-pays per year with no monthly limit for BIXLENVO.*

Explore support

*Eligible, commercially insured individuals enrolled in the Gilead Advancing Access Co-pay Savings Program could pay as little as $0 co-pay. Uninsured individuals can contact Gilead's Advancing Access program for information about support options. Restrictions apply. Subject to change. See full terms and conditions at www.gileadadvancingaccess.com/hcp/financial-assistance/copay-support

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

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SEE CLINICAL SCENARIOS OF VIROLOGICALLY SUPPRESSED PWH WHO COULD BENEFIT FROM A SWITCH TO BIXLENVO

Patient Profiles

Bictegravir and Lenacapavir disrupt 4 critical stages of the HIV life cycle1

See the Science

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.

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