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This information is intended for US healthcare professionals.

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BIXLENVO™ Was Proven to Sustain Virologic Control at Week 48

Including PWH with preexisting NRTI, NNRTI, or PI mutations1-3

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Study Design
STUDY DESIGN

Evaluated in Over 700 Virologically Suppressed PWH Who Switched to BIXLENVO in Two Ongoing Phase 3 Clinical Studies1-3

Designed to simplify complex ARV regimens for PWH unable to take an STR2

ARTISTRY-1 is a Phase 3, Randomized, Open-Label, Active-Controlled Trial1,2,4
ADULTS ON A COMPLEX ARV REGIMEN* ² • On a complex ARV regimen with HIV-1 RNA <50 copies/mL for ≥6 months • No prior exposure to lenacapavir or resistance to bictegravir • † No chronic HBV infection • ‡ eGFR ≥15 mL/min RANDOMIZED PHASE OPEN-LABEL EXTENSION n=371 § BIXLENVO Continued complex ARV regimen § BIXLENVO n=186 2:1 Up to Week 144 Primary endpoint at Week 48 Week 0
ADULTS ON A COMPLEX ARV REGIMEN* ² • On a complex ARV regimen with HIV-1 RNA <50 copies/mL for ≥6 months • No prior exposure to lenacapavir or resistance to bictegravir • † No chronic HBV infection • ‡ eGFR ≥15 mL/min RANDOMIZED PHASE OPEN-LABEL EXTENSION n=371 § BIXLENVO § BIXLENVO Continued complex ARV regimen n=186 2:1 Up to Week 144 Primary endpoint at Week 48 Week 0

Primary Endpoint:

  • HIV-1 RNA ≥50 copies/mL (US FDA Snapshot algorithm; 4% noninferiority margin) at Week 482

Secondary Endpoints:

  • HIV-1 RNA <50 copies/mL using US FDA Snapshot algorithm at Week 482
  • TEAEs through Week 482

Exploratory Endpoint:

  • Treatment preference5

*Due to antiretroviral resistance, intolerance, drug–drug interactions, or contraindication to existing STRs.2

†Determined by the following at the screening visit: either positive HBV surface antigen and negative HBV surface antibody regardless of HBV core antibody status, or positive HBV core antibody and negative HBV surface antibody regardless of HBV surface antigen status.5

‡Not on renal replacement therapy.2

§BIXLENVO 75 mg/50 mg, with oral loading dose of lenacapavir 600 mg on Days 1 and 2 of treatment after switching from complex ARV regimen.2

Complex ARV regimen definition

A complex ARV regimen was defined as a regimen containing1,2:

  • A boosted PI or NNRTI plus ≥1 other third agent from a class other than NRTI, or
  • ≥2 pills/day, or that requires dosing more than once daily, or
  • Parenteral agent(s) (excluding a complete long-acting injectable regimen) as well as oral agents

ARV, antiretroviral; eGFR, estimated glomerular filtration rate; FDA, Food and Drug Administration; HBV, hepatitis B virus; 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; TEAE, treatment-emergent adverse event.

Evaluated in PWH who were virologically suppressed on standard of care3

ARTISTRY-2 is a Phase 3, Randomized, Double-Blind, Active-Controlled Trial1,3
ADULTS ON BIKTARVY® (bictegravir/emtricitabine/tenofovir alafenamide) ³ • HIV-1 RNA <50 copies/mL • No prior exposure to lenacapavir • No resistance to bictegravir or TAF • No chronic HBV infection* • eGFR ≥30 mL/min OPEN-LABEL EXTENSION RANDOMIZED, DOUBLE-BLIND PHASE n=383 BIXLENVO †‡ BIXLENVO † Continued BIKTARVY § n=191 Primary endpoint at Week 48 Week 0 Up to Week 144 2:1
ADULTS ON BIKTARVY® (bictegravir/emtricitabine/tenofovir alafenamide) ³ • HIV-1 RNA <50 copies/mL • No prior exposure to lenacapavir • No resistance to bictegravir or TAF • No chronic HBV infection* • eGFR ≥30 mL/min RANDOMIZED DOUBLE-BLIND
PHASE OPEN-LABEL EXTENSION n=383 †‡ BIXLENVO † BIXLENVO § Continued BIKTARVY n=191 2:1 Up to Week 144 Primary endpoint at Week 48 Week 0

Primary Endpoint3:

  • HIV-1 RNA ≥50 copies/mL (US FDA Snapshot algorithm; 4% noninferiority margin) at Week 48

Secondary Endpoints3:

  • HIV-1 RNA <50 copies/mL (US FDA Snapshot algorithm) at Week 48
  • TEAEs through Week 48

*Determined by the following at the screening visit: either positive HBV surface antigen and negative HBV surface antibody regardless of HBV core antibody status, or positive HBV core antibody and negative HBV surface antibody regardless of HBV surface antigen status.7

†BIXLENVO 75 mg/50 mg; participants received an oral loading dose of lenacapavir 600 mg on Days 1 and 2 of treatment after switching from BIKTARVY.3

‡Placebo-to-match BIKTARVY.3

§Participants received placebo-to-match BIXLENVO, in addition to placebo-to-match lenacapavir on Days 1 and 2 of treatment.3




eGFR, estimated glomerular filtration rate; FDA, Food and Drug Administration; HBV, hepatitis B virus; PWH, people with HIV; RNA, ribonucleic acid; TAF, tenofovir alafenamide; TEAE, treatment-emergent adverse event.

BASELINE CHARACTERISTICS

The oldest population enrolled in a phase 3 registrational trial for HIV treatment2,4

OLDER AND TREATMENT EXPERIENCED2

  • Median age was 60 years
  • Median 28 years of HIV treatment (range: 22-32)
  • 77% were on a PI-containing regimen (n=427/557)

HISTORY OF RESISTANCE6*

  • >80% had preexisting resistance at baseline
  • Resistance mutations to NRTI, NNRTI, and PI were present in 84%, 70%, and 51% of participants, respectively†
  • 70% of participants had an M184V/I mutation at baseline†

MANAGING COMORBIDITIES2

  • 54% had ≥2 comorbidities (n=298/557), with 14% having chronic kidney disease (n=78/557)
  • 61% were on ≥2 concomitant medications (n=339/557)

*Inclusion criteria included no resistance to bictegravir or previous exposure to lenacapavir.
†Baseline data were derived from historical genotypic reports and retrospective proviral DNA analyses and included 542 participants with available data.

ARTISTRY-1 Baseline Characteristics1
BIXLENVOn=371 Complex ARV regimenn=186
Age, years, median (range) 60 (22-84) 60 (24-75)
≥55 years 78% 75%
Sex assigned at birth
Male 83% 81%
Female 17% 19%
Select comorbidities*†
Dyslipidemia 66% 72%
Hypertension 51% 48%
Hyperglycemia or diabetes 25% 23%
Chronic kidney disease 13% 16%
Number of select comorbidities
1 26% 28%
≥2 54% 52%
Select concomitant medications‡
Antidiabetic agents 23% 24%
Antihypertensive agents 55% 54%
Lipid-lowering agents 71% 72%
Antidiabetic and antihypertensive agents 16% 19%
Antidiabetic, antihypertensive, and lipid-lowering agents 13% 17%
Number of select concomitant medications
1 17% 27%
≥2 64% 55%
History of AIDS 12% 13%
Duration of HIV treatment, median (IQR), years 28.3 (21.6-32.3);
n=358		 28.3 (21.4-31.8);
n=183
Reasons for receiving complex regimen*
History of antiretroviral resistance 80% 82%
Intolerance to components of STRs 24% 21%
Contraindication to STRs 6% 5%
Number of antiretroviral pills per day, median (range) 3.0 (2.0-11.0) 3.0 (2.0-9.0)
Number of antiretroviral pills per day
2 41% 40%
3 26% 26%
4 11% 12%
≥5 22% 22%
Number of antiretrovirals in complex regimen, median (range)§ 2.0 (2.0-5.0) 3.0 (2.0-6.0)
Highest dosing frequency
Daily 59% 65%
Twice daily 41% 35%
Creatinine clearance, median (IQR), mL/min 82.9 (66.4-103.2) 82.4 (65.4-100.2)
>15 to ≤30 1% 2%
>30 to <60 15% 14%
≥60 84% 84%
Gender identity
Cisgender 97% 96%
Transgender 1% 1%
Non-binary or third gender <1% 0
Other 1% 1%
Not disclosed 1% 3%
Race||
Asian 4% 5%
Black 17% 18%
White 70% 67%
Other 3% 2%
Ethnicity#
Hispanic or Latine 22% 23%
Not Hispanic or Latine 73% 69%
HIV-1 RNA ≥50 copies per mL** 4% 4%
CD4 count, median (IQR), cells per µL 626 (457-836);
n=366		 579 (450-747);
n=185
CD4 count <200 cells per µL 3% 3%

*Categories are not mutually exclusive.

†Grouped terms on standardized MedDRA query narrow search.

‡Antidiabetic agents included drugs with WHO ATC2 “drugs used in diabetes”; antihypertensive agents included drugs with WHO ATC2 “agents acting on the renin-angiotensin system,” “antihypertensives” (excluding ATC3 “other antihypertensives”), “beta-blocking agents,” “calcium channel blockers,” or “diuretics”; lipid-lowering agents included drugs with WHO ATC2 “lipid-modifying agents.”

§Multiple reported antiretroviral therapies were counted only once per participant for each drug name and each drug class.

||Local regulators did not allow the collection of race information for 36 participants (19 in the BIXLENVO group and 17 in the complex ARV regimen group).

Category includes American Indian or Alaska Native, Native Hawaiian, Pacific Islander, and other.

#Local regulators did not allow the collection of ethnicity information for 37 participants (21 in the BIXLENVO group and 16 in the complex ARV regimen group).

**Participants had screening HIV-1 RNA <50 copies per mL, but baseline HIV-1 RNA ≥50 copies per mL.

ARV, antiretroviral; ATC2, Anatomical Therapeutic Chemical classification level 2; ATC3, Anatomical Therapeutic Chemical classification level 3; CD4, cluster of differentiation 4; IQR, interquartile range; RNA, ribonucleic acid; STR, single-tablet regimen; WHO, World Health Organization.

Reference:

  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.

Participants were on a wide array of complex regimens at baseline1,2

INSTI + NNRTI (±NRTI) 13% PI + NNRTI (±NRTI) 3% INSTI + EI + NNRTI (±NRTI) 4% INSTI + EI (±NRTI) 3% PI + INSTI + EI (±NRTI) 4% Other* 7% PI + INSTI 30% PI + INSTI + NRTI 24% PI + INSTI + NNRTI (±NRTI) 12% N=557
77% (n=427) ON A PI-CONTAINING 
REGIMEN

*"Other" regimens also included other PI-containing regimens (n=17).

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

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.

84% of all participants had preexisting NRTI mutations at baseline1

Summary of Preexisting Reverse Transcriptase RAMs
NUMBER OF PARTICIPANTS IN FAS
RAMs* BIXLENVO
n=371		 Complex regimen
n=186
Participants with data 97.0% 97.8%
Primary NRTI RAMs 83.1% 85.2%
Average number of NRTI RAMs 4.1 4.3
TAMs 67.8% 69.8%
M41L 46.9% 48.9%
K65R/E/N 11.1% 13.7%
D67N 40.6% 45.6%
K70E 3.6% 3.3%
K70R 30.8% 32.4%
L74I/V 20.3% 19.8%
Y115F 5.3% 4.4%
Q151M 3.1% 3.8%
M184I/V 67.8% 75.3%
M184I/V only 6.9% 5.5%
L210W 31.1% 30.8%
T215F/Y 50.3% 54.4%
K219E/N/Q/R 34.4% 35.7%

*Represent composite data from historical data entered by the sites and proviral DNA genotypic data from the screening analysis.

DNA, deoxyribonucleic acid; FAS, full analysis set; NRTI, nucleoside reverse transcriptase inhibitor; RAM, resistance-associated mutation.

Reference:
  1. Data on file. Gilead Sciences, Inc.; 2026.

Evaluated in PWH who were virologically suppressed on standard of care3

REFLECTS THE POPULATION LIVING WITH HIV3,8

  • Included PWH aged 23 to 77 years, with a median age of 49 years
  • Over one-third were ≥55 years of age (n=205/574)

REPRESENTATION 
MATTERS3

  • >50% were Black, Hispanic, or Latine (n=312/574)

MANAGING COMORBIDITIES3

  • 30% had ≥2 comorbidities (n=173/574)

ARTISTRY-2 Baseline Characteristics1
BIXLENVO
n=383 		BIKTARVY
n=191
Age, years, median (range) 47 (23–77) 51 (26–77)
≥55 years 35% 37%
Assigned female at birth 18% 22%
Race
White 52% 58%
Black 30% 23%
Asian 13% 14%
Other* 5% 5%
Hispanic or Latine† 28% 26%
CD4 count, cells/µL, median (Q1, Q3) 711 (547, 914) 663 (522, 873)
Select comorbidities‡§
Dyslipidemia 41% 41%
Hypertension 37% 33%
Hyperglycemia/Diabetes mellitus 18% 16%
Chronic kidney disease 5% 6%
Number of select comorbidities
1 25% 30%
≥2 32% 27%
Historical primary resistance
mutations‡||
NRTI 10% 19%
NNRTI 17% 18%
Protease inhibitor 5% 9%
INSTI 0 0

*Category includes American Indian or Alaska Native, Native Hawaiian or Pacific Islander, and other.

†Local regulators did not allow the collection of ethnicity information for one participant in the BIKTARVY group.

‡Categories are not mutually exclusive.

§Grouped terms on standardized MedDRA query narrow search.

||Investigators were asked to document previous resistance data from available historical HIV-1 genotype and phenotype reports. The numbers of participants with available resistance data were 144 for NNRTI, 144 for NRTI, 144 for protease inhibitor, and 83 for INSTI in the BIXLENVO group versus 80, 80, 79, and 41, respectively, in the BIKTARVY group.

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

Reference:
  1. 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
EFFICACY

Proven to Sustain Virologic Control at Week 481-3

ARTISTRY-1: Virologic Outcomes1,2

Participants, % 100 80 60 40 20 0 HIV-1 RNA
<50 copies/mL 96% 94% HIV-1 RNA
≥50 copies/mL 1% 1% No Virologic Data (n=356) (n=174) (n=3) (n=2) (n=12) (n=10) 3% 5% Complex ARV regimen (n=186) (n=371) BIXLENVO

Treatment Difference (95.002% CI) in HIV-1 RNA ≥50 copies/mL: -0.3% (-2.3% to 1.8%)

In a post hoc analysis, high rates of virologic suppression were observed regardless of baseline resistance-associated mutations at Week 48* ⁶
100 80 60 40 20 0 Participants, % HIV-1 RNA
≥50 copies/mL HIV-1 RNA
<50 copies/mL No Virologic Data 94% 3% 5% 96% 1% 1% (n=3) (n=2) (n=356) (n=174) (n=12) (n=10) (n=371) BIXLENVO Complex ARV regimen (n=186)

Treatment Difference (95.002% CI) in HIV-1 RNA ≥50 copies/mL: -0.3% (-2.3% to 1.8%)

In a post hoc analysis, high rates of virologic suppression were observed regardless of baseline resistance-associated mutations at Week 48* ⁶

*Among participants with available reverse transcriptase and protease genotypic data (n=360), virologic suppression (HIV-1 RNA <50 copies/mL by FDA Snapshot algorithm) was maintained in those with and without NRTI RAMs (96% vs 95%), NNRTI RAMs (96% vs 94%), and PI RAMs (96% vs 95%) at baseline.

ARTISTRY-2: Virologic Outcomes1,3
Participants, % 100 80 60 40 20 0 HIV-1 RNA
<50 copies/mL (n=358) (n=173) 93% 91% HIV-1 RNA
≥50 copies/mL (n=5) (n=2) 1% 1% No Virologic Data (n=20) (n=16) 5% 8% BIXLENVO (n=383) BIKTARVY (n=191)

Treatment Difference (95.002% CI) in HIV-1 RNA ≥50 copies/mL: 0.3% (-1.9% to 2.4%)

ARTISTRY-2 included PWH with preexisting NRTI, NNRTI, or PI resistance mutations*
100 80 60 40 20 0 93% 91% 5% 1% 8% 1% (n=5) (n=2) (n=358) (n=173) (n=20) (n=16) Participants, % HIV-1 RNA
≥50 copies/mL HIV-1 RNA
<50 copies/mL No Virologic Data BIXLENVO (n=383) (n=191) BIKTARVY

Treatment Difference (95.002% CI) in HIV-1 RNA ≥50 copies/mL: 0.3% (-1.9% to 2.4%)

ARTISTRY-2 included PWH with preexisting NRTI, NNRTI, or
PI resistance mutations*

*ARTISTRY-2 included 17%, 13%, and 6% of participants with historical NNRTI, NRTI, and PI resistance mutations at baseline, respectively.3

RESISTANCE

Demonstrated High Barrier to Resistance1-3

No treatment-emergent capsid resistance mutations were detected through Week 481*

No treatment-emergent substitutions conferred phenotypic resistance to bictegravir through Week 481*†

  • Two participants on BIXLENVO met the criteria for resistance analysis through Week 481‡
  • One participant had no treatment-emergent resistance detected1
  • One participant had an HIV-1 RNA of 299 copies/mL, with a transient, low-level (13% mutant) Q148R substitution in integrase detected at Week 24 using deep sequencing testing, which remained phenotypically susceptible to bictegravir (1.2-fold reduction in comparison to wild-type)1,4
    • This mutation was not detected at Week 484
    • Participant had prior exposure to dolutegravir and raltegravir and had NRTI, NNRTI, and PI mutations prior to study entry, with no INSTI mutations observed at baseline4
    • Participant was resuppressed on BIXLENVO at Week 964

*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

‡Criteria were defined as HIV-1 RNA ≥200 copies/mL at confirmed virologic failure or last visit on study drugs.1

No treatment-emergent capsid resistance mutations were detected through Week 481*

No treatment-emergent substitutions conferred phenotypic resistance to bictegravir through Week 481*†

  • Two participants on BIXLENVO met the criteria for resistance analysis through Week 481‡
  • One participant had no treatment-emergent resistance detected1
  • One participant had an HIV-1 RNA of 208 copies/mL, with an isolated R263K substitution in integrase detected at Week 36, which remained phenotypically susceptible to bictegravir (2-fold reduction in comparison to wild-type)1,3
    • Participant had prior exposure to dolutegravir and raltegravir and polymorphic secondary mutations in integrase (M50I and S119P detected in plasma) prior to study entry3
    • Participant was resuppressed after switching to a different regimen at the investigator’s discretion4

*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

‡Criteria were defined as HIV-1 RNA ≥200 copies/mL at confirmed virologic failure or last visit on study drugs.1

PATIENT-REPORTED OUTCOMES

A majority of participants preferred BIXLENVO to their previous complex ARV regimen as measured by the Treatment Preference Questionnaire1,2*

Patient-Reported Treatment Preference Through Week 482
Percentage of Participants Preferred BIXLENVO Preferred prior complex ARV regimen No preference Week 4 Week 48 12 26 316 297 12 43 n= 80% 85% 3% 3% 12% 7% 0 20 40 60 80 100
80% 80 100 60 40 20 0 12% 3% 85% 7% 3% Percentage of Participants Week 4 No preference Preferred prior complex ARV regimen Preferred BIXLENVO Week 48 n= 297 12 43 316 12 26

These results are descriptive in nature and the clinical significance of this data is unknown.

*Patient-reported treatment preference was assessed with the HIV Treatment Preference Questionnaire, which compared BIXLENVO with the baseline complex ARV regimen. Questionnaires were completed at Weeks 4, 12, 24, and 48, and on-treatment data were summarized. Percentages were calculated as the number of patients reported for each preference divided by the number of participants in the full analysis set in each treatment group.1,2

ARV, antiretroviral.

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. Supplement. Lancet. 2026;407(10535):1249-1258.
  2. Data on file. Gilead Sciences, Inc.; 2026.
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proven safety and tolerability profile2,3

See Safety Profile
Two women are laughing together on a front porch.

The smallest STR,* taken once daily, with or without food1,4

*After initiation doses.

View Dosing

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.

ARV, antiretroviral; CI, confidence interval; FDA, Food and Drug Administration; INSTI, integrase strand transfer inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; PI, protease inhibitor; PWH, people with HIV; RAM, resistance-associated mutation; RNA, ribonucleic acid; STR, single-tablet regimen.

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.
  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. 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: AIDS 2026, the 26th International AIDS Conference; July 26-31, 2026; Rio de Janeiro, Brazil.
  7. 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
  8. Centers for Disease Control and Prevention. HIV diagnoses, deaths, and prevalence: 2026 update. Published May 18, 2026. Accessed July 15, 2026. https://www.cdc.gov/hiv-data/nhss/hiv-diagnoses-deaths-and-prevalence-2026.html