This information is intended for US healthcare professionals.

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

This information is intended for US healthcare professionals.

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Clinical Scenarios of Virologically Suppressed PWH Who May Benefit From a Switch

Consider what may be possible for patients with BIXLENVO™

Actor portrayal.

On a Complex ARV Regimen, Frustrated by Growing Pill Burden

Joe, a virologically suppressed man on a complex regimen.

HIV Treatment History

  • Diagnosed in 1998
  • Has been on several different regimens over the years
  • Currently on DTG + DRV/c/FTC/TAF

Current Mindset

  • Frustrated by his overall pill burden and wonders why he can't be on an STR

Additional Clinical Considerations

  • Elevated liver enzymes and triglyceride levels
  • Recently prescribed pitavastatin for high cholesterol and omega-3 fatty acids for high triglycerides
  • Previous resistance testing identified:
    • NRTI RAMs (M184V, K65R)
    • NNRTI RAMs (E138K, K101E)

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

Actor portrayal.

HIV Treatment History

  • Diagnosed in 1998
  • Has been on several different regimens over the years
  • Currently on DTG + DRV/c/FTC/TAF

Current Mindset

  • Frustrated by his overall pill burden and wonders why he can't be on an STR

Additional Clinical Considerations

  • Elevated liver enzymes, elevated triglycerides
  • Recently prescribed a statin for high cholesterol and omega-3-fatty acid for high triglycerides
  • Proviral DNA testing has identified:
    • NRTI RAMs (M184V, K65R)
    • NNRTI RAMs (E138K, K101E)

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

Joe is one of many who may be facing challenges with polypharmacy

  • 80%-92% of PWH aged ≥50 years take ≥5 non-HIV medications, requiring considerations beyond managing HIV1*
  • 5%-7% of PWH in the US still require multiple pills per day as part of their ARV regimen2†

*Based on a retrospective, case-control study including 20,256 people with HIV using medical and pharmacy claims data from the Optum Research Database from January 1, 2013 to January 31, 2019.

†This information is an estimate derived from the use of information under license from the following IQVIA information service: IQVIA LAAD, for the period of January to December 2025. IQVIA expressly reserves all rights, including rights of copying, distribution, and republication.

Have you seen a patient like this in your practice?

On an STR, Managing Cardiometabolic Comorbidities

Maribel, a virologically suppressed woman who is managing cardiometabolic comorbidities.

HIV Treatment History

  • Diagnosed in 2012
  • Began RPV/FTC/TDF following diagnosis, and is currently on ABC/DTG/3TC

Current Mindset

  • Reassessing HIV treatment options with her doctor in light of emerging age-related comorbidities

Additional Clinical Considerations

  • Recently diagnosed with cardiovascular disease
  • BMI 35, has type 2 diabetes, and is taking an SGLT2 inhibitor
  • No resistance history available

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

Actor portrayal.

HIV Treatment History

  • Diagnosed in 2012
  • Began FTC/RPV/TDF following diagnosis, and is currently on ABC/DTG/3TC

Current Mindset

  • Reassessing HIV treatment options with her doctor in light of emerging age-related comorbidities

Additional Clinical Considerations

  • Recently diagnosed with cardiovascular disease
  • BMI 35, has T2 diabetes and is taking SGLT2 inhibitor
  • No resistance history available

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

In older people with HIV, special attention should be paid to the greater potential for ART-associated AEs3

Including those affecting renal, liver, cardiovascular, central nervous system, metabolic, and bone health

Have you seen a patient like this in your practice?

On an Older Regimen, Concerned About Declining Renal Function

Robert, a virologically suppressed man concerned about declining renal function.

HIV Treatment History

  • Diagnosed in 2003
  • On several different regimens following diagnosis before switching to EVG/c/FTC/TDF in 2013
  • Consistently engaged in care and undetectable since 2013

Current Mindset

  • Interested in exploring new treatment options given recently declining renal function

Additional Clinical Considerations

  • BMI 27, with blood pressure 140/90 mmHg, managed on hypertension medication
  • Recently declining renal function, with last eGFR of 48 mL/min
  • Has experienced GI issues for many years
  • A past genotyping test identified K103N mutation, with gaps in resistance history since then

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

Actor portrayal.

HIV Treatment History

  • Diagnosed in 2003
  • On several different regimens following diagnosis before switching to ELV/c/FTC/TDF in 2013
  • Consistently engaged in care and undetectable since 2013

Current Mindset

  • Interested in exploring new treatment options given recently declining renal function

Additional Clinical Considerations

  • BMI 27, with blood pressure 140/90 mmHg, managed on hypertension medication
  • Recently declining renal function, with last eGFR of 48 mL/min
  • Has experienced GI issues for many years
  • A past genotyping test identified K103N mutation, with gaps in resistance history 
since then

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

As PWH like Robert age, the impact of ART may become an important consideration on overall health3

According to the DHHS Guidelines, reducing pill burden, mitigating drug–drug interactions, and decreasing short- or long-term toxicity are reasons to consider regimen optimization in the setting of viral suppression

Have you seen a patient like this in your practice?

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Explore Efficacy Data From ARTISTRY-1 and ARTISTRY-2

See the Data

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.

ABC/DTG/3TC, abacavir/dolutegravir/lamivudine; AE, adverse event; ART, antiretroviral therapy; ARV, antiretroviral; BMI, body mass index; DHHS, Department of Health and Human Services; DRV/c/FTC/TAF, darunavir/cobicistat/emtricitabine/tenofovir alafenamide; DTG, dolutegravir; eGFR, estimated glomerular filtration rate; EVG/c/FTC/TDF, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; 
GI, gastrointestinal; MSM, men who have sex with men; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; PWH, people with HIV; RAM, resistance-associated mutation; RPV/FTC/TDF, rilpivirine/emtricitabine/tenofovir disoproxil fumarate; SGLT2, sodium-glucose cotransporter 2; STR, single-tablet regimen; WSM, women who have sex with men.

References:
  1. Paudel M, Prajapati G, Buysman EK, et al. Comorbidity and comedication burden among people living with HIV in the United States. Curr Med Res Opin. 2022;38(8):1443-1450.
  2. Data on file. Gilead Sciences, Inc.; 2026.
  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