Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)

NCT05502341 — Phase 2 / Phase 3, Active not recruiting, 689 participants, Gilead Sciences

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An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens

Registry	NCT05502341, acronym ARTISTRY-1
Status	Active not recruiting
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	689 (Actual)
Sponsor	Gilead Sciences (Industry)
Conditions	HIV-1-infection
Interventions	Bictegravir, Lenacapavir, BIC/LEN FDC, Stable Baseline Regimen (Drug)
Dates	start 2022-08-16, primary completion 2025-09-29, completion 2029-12-01 (estimated), first posted 2022-08-16, last updated 2026-10-21
Locations	94 sites in United States, Argentina, Australia, Canada, Dominican Republic, France, Germany, Italy and 7 more countries

-Summary

The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC) plus lenacapavir (LEN), versus current therapy (Phase 2) and BIC/LEN fixed-dose combination (FDC) versus current therapy (Phase 3) in people living with HIV (PWH).

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+Arms and interventions

Arm	Type	Interventions	Description
Phase 2: Treatment Group 1: BIC 75 mg + LEN 25 mg	Experimental	Drug: Bictegravir; Drug: Lenacapavir	Participants will switch from their Stable Baseline Regimen (SBR) to a regimen of BIC 75 mg + LEN 25 mg, tablets administered orally once daily for up to 24 weeks. Participants will receive a 2-day pharmacokinetic (PK) oral loading dose of LEN 600 mg, on Days 1 and 2, in addition to the daily doses of BIC 75 mg + LEN 25 mg starting on Day 1. Participants who discontinue early or complete the Randomized Phase (RP) will have an option to continue in Extension Period (EP)
Phase 2: Treatment Group 2: BIC 75 mg + LEN 50 mg	Experimental	Drug: Bictegravir; Drug: Lenacapavir	Participants will switch from their SBR to a regimen of BIC 75 mg + LEN 50 mg, tablets administered orally once daily for up to 24 weeks. Participants will receive a 2-day PK oral loading dose of LEN 600 mg, on Days 1 and 2, in addition to the daily doses of BIC 75 mg + LEN 50 mg starting on Day 1. Participants who discontinue early or complete the RP will have an option to continue in EP.
Phase 2: Treatment Group 3: SBR	Active comparator	Drug: Stable Baseline Regimen	Participants will continue with their SBR for up to 24 weeks. Participants who discontinue early or complete the RP will have an option to continue in EP.
Phase 3: Treatment Group 1: BIC/LEN 75 mg/50 mg FDC	Experimental	Drug: BIC/LEN FDC	Participants will switch from their SBR to a regimen of BIC/LEN 75mg/50mg FDC, administered orally once daily for up to 48 weeks. Participants will receive a 2-day PK oral loading dose of LEN 600 mg, on Days 1 and 2, in addition to the daily doses of BIC/LEN 75 mg/50 mg FDC starting on Day 1. Participants who discontinue early or complete the RP will have an option to continue in EP.
Phase 3: Treatment Group 2: SBR	Active comparator	Drug: Stable Baseline Regimen	Participants will continue with their SBR for up to 48 weeks. Participants who will discontinue early or complete the RP had an option to continue in EP.
Phase 2/Phase 3:BIC/LEN 75/50 mg FDC	Experimental	Drug: Lenacapavir; Drug: BIC/LEN FDC	At the end of randomized treatment, participants in Phase 2 and Phase 3 treatment groups who discontinue early or complete the RP will be given an option to enter in EP and will receive BIC/LEN 75/50 mg FDC until the drug is available in market or Gilead elects to withdraw the study. Participants in the SBR groups (Phase 2 Treatment Group 3 and Phase 3 Treatment Group 2 will also receive a 2-day PK oral loading dose of LEN 600 mg, on Days 1 and 2 of EP).

Bictegravir (Drug), also known as GS-9883: Tablets administered orally without regard to food
Lenacapavir (Drug), also known as GS-6207: Tablets administered orally without regard to food
BIC/LEN FDC (Drug), also known as Bixlenvo™: Tablets administered orally without regard to food
Stable Baseline Regimen (Drug): SBR will include a combination of antiretroviral (ARV) regimen. ARV regimen may include the following, except for participants taking a single tablet regimen or taking a complete parenteral regimen (Cabenuva). * Nucleos(t)ide Reverse Transcriptase Inhibitors: * Abacavir * Emtricitabine * Lamivudine * Tenofovir alafenamide * Tenofovir disoproxil fumarate * Zidovudine * Non-Nucleosite Reverse Transcriptase Inhibitors: * Delavirdine * Efavirenz * Nevirapine * Rilpivirine * Doravirine * Integrase Inhibitors: * Bictegravir * Cabotegravir * Dolutegravir * Elvitegravir * Raltegravir * Protease Inhibitors: * Atazanavir * Darunavir * Fosamprenavir * Indinavir * Lopinavir * Nelfinavir * Saquinavir * Tipranavir * Chemokine Co-receptor 5 (CCR5) Antagonist: * Maraviroc * Fusion Inhibitors: * Enfuvirtide * gp120 Attachment Inhibitor: * Fostemsavir * Anti-CD4 Monoclonal Antibodies: * Ibalizumab-uiyk

+Outcome measures

Primary outcomes

Phase 2: Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) ≥ 50 Copies/mL at Week 24 as Determined by the United States Food and Drug Administration (US FDA) Defined Snapshot Algorithm [Week 24]: Participants who had the last available on-treatment HIV-1 RNA≥ 50 copies/mL in the week 24 analysis window, or who did not have on-treatment HIV-1 RNA data in the week 24 analysis window and participants who discontinued study drug prior to or in the week 24 analysis window due to lack of efficacy, or who discontinued study drug prior to or in the week 24 analysis window due to adverse event (AE) or death and have the last available on-treatment HIV-1 RNA≥ 50 copies/mL, or who discontinued study drug prior to or in the week 24 analysis window due to reasons other than AE, death, or lack of efficacy and have the last available on-treatment HIV-1 RNA ≥ 50 copies/mL were included. The Week 24 window for snapshot algorithm was between Days 127 and 210 (inclusively). Percentages were rounded off.
Phase 3: Percentages of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm [Week 48]: Participants who had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL in the Week 48 analysis window, or who did not have on-treatment HIV-1 RNA data in the Week 48 analysis window and who discontinued study drug prior to or in the Week 48 analysis window due to lack of efficacy, or who discontinued study drug prior to or in the Week 48 analysis window due to AE or death and have the last available on-treatment HIV-1 RNA ≥ 50 copies/mL, or who discontinued study drug prior to or in the Week 48 analysis window due to reasons other than AE, death, or lack of efficacy and have the last available on-treatment HIV-1 RNA ≥ 50 copies/mL were included. The Week 48 window for snapshot algorithm was between Days 295 and 378 (inclusively). Percentages were rounded off.

Secondary outcomes

Phase 2: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm [Week 24]: Participants who had the last available on-treatment HIV-1 RNA < 50 copies/mL in the Week 24 analysis window were included. The Week 24 window for snapshot algorithm was between Days 127 and 210 (inclusively). Percentages were rounded off.
Phase 2: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 24 [Baseline, Week 24]
Phase 2: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) Through Week 24 [First dose date up to Week 24]: An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a study drug that did not necessarily had a causal relationship with the treatment. TEAEs were defined as any AE that begins on or after the date of first dose of study drug up to the date of last dose of study drug plus 60 days (for BIC+LEN or BIC/LEN FDC) or 30 days (for SBR) or any AE leading to study drug discontinuation. Percentages were rounded off.
Phase 2: PK Parameter: Cmax for Bictegravir (BIC) at Steady State [At Week 16 or 24]: Cmax is defined as the maximum observed concentration of drug. Participants chose to participate at either Week 16 or Week 24 visit as the steady state visit.
Phase 2: PK Parameter: Cmax for Lenacapavir (LEN) at Steady State [At Week 16 or Week 24]: Cmax is defined as the maximum observed concentration of drug. Participants chose to participate at either Week 16 or Week 24 visit as the steady state visit.
Phase 2: PK Parameter: AUCtau of BIC at Steady State [At Week 16 or 24]: AUCtau is defined as the area under the concentration versus time curve over the dosing interval. Participants chose to participate at either Week 16 or Week 24 visit as the steady state visit.
Phase 2: PK Parameter: AUCtau for LEN at Steady State [At Week 16 or Week 24]: AUCtau is defined as the area under the concentration versus time curve over the dosing interval. Participants chose to participate at either Week 16 or Week 24 visit as the steady state visit.
Phase 2: PK Parameter: Ctrough of BIC at Steady State [At Week 16 or Week 24]: Ctrough is defined as the observed drug concentration at the end of the dosing interval. Participants chose to participate at either Week 16 or Week 24 visit as the steady state visit.
Phase 2: PK Parameter: Ctrough of LEN at Steady State [At Week 16 or Week 24]: Ctrough is defined as the observed drug concentration at the end of the dosing interval. Participants chose to participate at either Week 16 or Week 24 visit as the steady state visit.
Phase 3: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm [Week 48]: Participants who had the last available on-treatment HIV-1 RNA < 50 copies/mL in the Week 48 analysis window were included. The Week 48 window for snapshot algorithm was between Days 295 and 378 (inclusively).
Phase 3: Change From Baseline in CD4 Cell Count at Week 48 [Baseline, Week 48]: An AE was any untoward medical occurrence in a clinical study participant administered a study drug that did not necessarily had a causal relationship with the treatment. TEAEs were defined as any AE that begins on or after the date of first dose of study drug up to the date of last dose of study drug plus 60 days (for BIC+LEN or BIC/LEN FDC) or 30 days (for SBR) or any AE leading to study drug discontinuation. Percentages were rounded off.
Phase 3: Percentage of Participants Experiencing TEAEs Through Week 48 [First dose date up to Week 48]: An AE was any untoward medical occurrence in a clinical study participant administered a study drug that did not necessarily had a causal relationship with the treatment. TEAEs were defined as 1 or both of the following: Any AEs leading to premature discontinuation of study drug, or any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug. Percentages were rounded off.
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm [Week 96]
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 144 as Determined by the US FDA-defined Snapshot Algorithm [Week 144]
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm [Week 96]
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144 as Determined by the US FDA-defined Snapshot Algorithm [Week 144]
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Change From Baseline in CD4 Cell Count at Week 96 [Baseline, Week 96]
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Change From Baseline in CD4 Cell Count at Week 144 [Baseline, Week 144]
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Percentage of Participants Experiencing TEAEs Through Week 96 [Week 96]
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Percentage of Participants Experiencing TEAEs Through Week 144 [Week 144]

+Eligibility

Sex: All, ages: 18 Years to any

Key Inclusion Criteria:

* If plasma HIV-1 RNA measurements in the 6 months prior to screening are available, all levels must be < 50 copies/mL.
* At least one documented plasma HIV-1 RNA level measured between 6 and 12 months (± 2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be < 50 copies/mL
* Plasma HIV-1 RNA levels < 50 copies/mL at screening.
* Currently receiving a complex antiretroviral (ARV) regimen due to previous viral resistance, or intolerance, or contraindication to existing single-tablet regimens (STR), and on this regimen for at least 6 months prior to the screening visit. The criteria to define a complex regimen in this study are as follows:

  * A regimen containing a boosted protease inhibitor or a nonnucleos(t)ide reverse transcriptase inhibitor (NRTI) plus at least 1 other third agent (ie, an agent from a class other than NRTIs) (eg, bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®)(BVY) + darunavir/cobicistat, BVY + etravirine), or
  * A regimen of ≥ 2 pills/day, or a regimen requiring dosing more than once daily, or
  * A regimen containing parenteral agent(s) (excluding a complete long-acting injectable regimen, such as intramuscular cabotegravir plus rilpivirine) as well as oral agents.
* No documented or suspected resistance to bictegravir (BIC).
* Estimated glomerular filtration rate ≥ 15 mL/min according to the Cockcroft-Gault formula for creatinine clearance (CLcr) who are not on renal replacement therapy.

Key Exclusion Criteria:

* Prior use of, or exposure to, lenacapavir (LEN)
* Active tuberculosis infection
* Chronic hepatitis B virus (HBV) infection

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

+Posted results

Participant flow

Milestone	Phase 2: Treatment Group 1: BIC 75 mg + LEN 25 mg	Phase 2: Treatment Group 2: BIC 75 mg + LEN 50 mg	Phase 2: Treatment Group 3: SBR	Phase 3: Treatment Group 1: BIC/LEN 75 mg/50 mg FDC	Phase 3: Treatment Group 2: SBR
Started	51	52	25	373	188
Completed	0	0	0	0	0
Not completed	51	52	25	373	188

Outcome results

Phase 2: Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) ≥ 50 Copies/mL at Week 24 as Determined by the United States Food and Drug Administration (US FDA) Defined Snapshot Algorithm (Primary), Number, percentage of participants: Phase 2: Treatment Group 1: BIC 75 mg + LEN 25 mg 0; Phase 2: Treatment Group 2: BIC 75 mg + LEN 50 mg 1.9; Phase 2: Treatment Group 3: SBR 0 (p 1.000)
Phase 3: Percentages of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm (Primary), Number, percentage of participants: Phase 3:Treatment Group 1:BIC/LEN 75 mg/50 mg FDC 0.8; Phase 3: Treatment Group 2: SBR 1.1
Phase 2: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm (Secondary), Number, percentage of participants: Phase 2: Treatment Group 1: BIC 75 mg + LEN 25 mg 96.1; Phase 2: Treatment Group 2: BIC 75 mg + LEN 50 mg 96.2; Phase 2: Treatment Group 3: SBR 100 (p 1.000)
Phase 2: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 24 (Secondary), Mean, cells/µL: Phase 2: Treatment Group 1: BIC 75 mg + LEN 25 mg 608 +/- 238.9; Phase 2: Treatment Group 2: BIC 75 mg + LEN 50 mg 684 +/- 329.8; Phase 2: Treatment Group 3: SBR 566 +/- 304.5 (p 0.9893)
Phase 2: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) Through Week 24 (Secondary), Number, percentage of participants: Phase 2: Treatment Group 1: BIC 75 mg + LEN 25 mg 76.5; Phase 2: Treatment Group 2: BIC 75 mg + LEN 50 mg 63.5; Phase 2: Treatment Group 3: SBR 68.0
Phase 2: PK Parameter: Cmax for Bictegravir (BIC) at Steady State (Secondary), Mean, ng/mL: Phase 2: Treatment Group 1: BIC 75 mg + LEN 25 mg 9400 +/- 3020; Phase 2: Treatment Group 2: BIC 75 mg + LEN 50 mg 9860 +/- 3480
Phase 2: PK Parameter: Cmax for Lenacapavir (LEN) at Steady State (Secondary), Mean, ng/mL: Phase 2: Treatment Group 1: BIC 75 mg + LEN 25 mg 87.4 +/- 77.6; Phase 2: Treatment Group 2: BIC 75 mg + LEN 50 mg 134 +/- 101
Phase 2: PK Parameter: AUCtau of BIC at Steady State (Secondary), Mean, h*ng/mL: Phase 2: Treatment Group 1: BIC 75 mg + LEN 25 mg 143000 +/- 48300; Phase 2: Treatment Group 2: BIC 75 mg + LEN 50 mg 154000 +/- 67000
Phase 2: PK Parameter: AUCtau for LEN at Steady State (Secondary), Mean, h*ng/mL: Phase 2: Treatment Group 1: BIC 75 mg + LEN 25 mg 1530 +/- 1100; Phase 2: Treatment Group 2: BIC 75 mg + LEN 50 mg 2620 +/- 2100
Phase 2: PK Parameter: Ctrough of BIC at Steady State (Secondary), Mean, h*ng/mL: Phase 2: Treatment Group 1: BIC 75 mg + LEN 25 mg 4270 +/- 1930; Phase 2: Treatment Group 2: BIC 75 mg + LEN 50 mg 4800 +/- 2950
Phase 2: PK Parameter: Ctrough of LEN at Steady State (Secondary), Mean, h*ng/mL: Phase 2: Treatment Group 1: BIC 75 mg + LEN 25 mg 63.4 +/- 43.9; Phase 2: Treatment Group 2: BIC 75 mg + LEN 50 mg 104 +/- 83.7
Phase 3: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm (Secondary), Number, percentage of participants: Phase 3: Treatment Group 1: BIC/LEN 75 mg/50 mg FDC 96.0; Phase 3: Treatment Group 2: SBR 93.5
Phase 3: Change From Baseline in CD4 Cell Count at Week 48 (Secondary), Mean, cells/µL: Phase 3: Treatment Group 1: BIC/LEN 75 mg/50 mg FDC 665 +/- 296.2; Phase 3: Treatment Group 2: SBR 629 +/- 274.7 (p 0.2239)
Phase 3: Percentage of Participants Experiencing TEAEs Through Week 48 (Secondary), Number, percentage of participants: Phase 3: Treatment Group 1: BIC/LEN 75 mg/50 mg FDC 79.5; Phase 3: Treatment Group 2: SBR 81.2
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm (Secondary)
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 144 as Determined by the US FDA-defined Snapshot Algorithm (Secondary)
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm (Secondary)
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144 as Determined by the US FDA-defined Snapshot Algorithm (Secondary)
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Change From Baseline in CD4 Cell Count at Week 96 (Secondary)
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Change From Baseline in CD4 Cell Count at Week 144 (Secondary)
2 more outcome measures not shown.

Adverse events

Time frame: All-Cause Mortality and Adverse Events: Up to 48 weeks

Arm	Deaths	Serious adverse events	Other adverse events
Phase 2: Treatment Group 1: BIC 75 mg + LEN 25 mg	0/51 (0.0%)	3/51 (5.9%)	20/51 (39.2%)
Phase 2: Treatment Group 2: BIC 75 mg + LEN 50 mg	1/52 (1.9%)	2/52 (3.8%)	13/52 (25.0%)
Phase 2: Treatment Group 3: SBR	0/25 (0.0%)	2/25 (8.0%)	5/25 (20.0%)
Phase 3: Treatment Group 1: BIC/ LEN 75 mg/50 mg FDC	5/373 (1.3%)	52/371 (14.0%)	141/371 (38.0%)
Phase 3: Treatment Group 2: SBR	0/188 (0.0%)	22/186 (11.8%)	70/186 (37.6%)

Serious adverse events by term

Term	Organ system	Phase 2: Treatment Group 1: BIC 75 mg + LEN 25 mg	Phase 2: Treatment Group 2: BIC 75 mg + LEN 50 mg	Phase 2: Treatment Group 3: SBR	Phase 3: Treatment Group 1: BIC/ LEN 75 mg/50 mg FDC	Phase 3: Treatment Group 2: SBR
Acute myocardial infarction	Cardiac disorders	0/51	0/52	0/25	0/371	2/186
Angina unstable	Cardiac disorders	0/51	0/52	0/25	2/371	0/186
Atrioventricular block complete	Cardiac disorders	0/51	0/52	0/25	1/371	0/186
Bundle branch block right	Cardiac disorders	0/51	0/52	0/25	1/371	0/186
Cardiac arrest	Cardiac disorders	0/51	0/52	0/25	1/371	0/186
Cardiac failure	Cardiac disorders	0/51	0/52	0/25	0/371	1/186
Cardiac failure acute	Cardiac disorders	0/51	0/52	1/25	0/371	0/186
Cardiomyopathy	Cardiac disorders	0/51	0/52	1/25	0/371	0/186
Coronary artery disease	Cardiac disorders	0/51	1/52	0/25	2/371	1/186
Intracardiac thrombus	Cardiac disorders	0/51	0/52	1/25	0/371	0/186
Pericarditis	Cardiac disorders	0/51	0/52	0/25	0/371	1/186
Sinus node dysfunction	Cardiac disorders	0/51	0/52	0/25	0/371	1/186
Tachyarrhythmia	Cardiac disorders	0/51	0/52	0/25	1/371	0/186
Retinal detachment	Eye disorders	0/51	0/52	0/25	1/371	0/186
Abdominal pain	Gastrointestinal disorders	0/51	0/52	0/25	1/371	1/186
Dysphagia	Gastrointestinal disorders	0/51	0/52	0/25	1/371	0/186
Large intestinal haemorrhage	Gastrointestinal disorders	0/51	0/52	0/25	1/371	0/186
Pancreatitis	Gastrointestinal disorders	0/51	0/52	0/25	1/371	0/186
Pancreatitis acute	Gastrointestinal disorders	0/51	0/52	0/25	1/371	1/186
Small intestinal obstruction	Gastrointestinal disorders	0/51	0/52	0/25	0/371	1/186
Chest pain	General disorders	0/51	0/52	0/25	0/371	1/186
Death, not Otherwise specified	General disorders	0/51	0/52	0/25	2/371	0/186
Oedema peripheral	General disorders	0/51	0/52	0/25	1/371	0/186
Bile duct stone	Hepatobiliary disorders	0/51	0/52	0/25	0/371	1/186
Biliary tract disorder	Hepatobiliary disorders	0/51	0/52	0/25	1/371	0/186
Cholecystitis acute	Hepatobiliary disorders	0/51	0/52	0/25	2/371	0/186
Hypertransaminasaemia	Hepatobiliary disorders	0/51	0/52	0/25	1/371	0/186
Portal hypertension	Hepatobiliary disorders	0/51	0/52	0/25	0/371	1/186
Allergy to arthropod sting	Immune system disorders	0/51	0/52	0/25	1/371	0/186
Breast abscess	Infections and infestations	0/51	0/52	0/25	1/371	0/186
Bronchitis	Infections and infestations	0/51	0/52	0/25	1/371	0/186
Cellulitis	Infections and infestations	0/51	0/52	1/25	1/371	0/186
Clostridium colitis	Infections and infestations	0/51	0/52	0/25	1/371	0/186
Covid-19	Infections and infestations	0/51	0/52	0/25	2/371	0/186
Cystitis	Infections and infestations	0/51	0/52	0/25	1/371	0/186
Diabetic foot infection	Infections and infestations	0/51	1/52	0/25	0/371	0/186
Gastroenteritis	Infections and infestations	1/51	0/52	0/25	0/371	0/186
Hand-foot-and-mouth disease	Infections and infestations	0/51	0/52	0/25	1/371	0/186
Herpes zoster	Infections and infestations	0/51	0/52	0/25	1/371	0/186
Infectious pleural effusion	Infections and infestations	0/51	0/52	0/25	1/371	0/186
Monkeypox	Infections and infestations	0/51	0/52	0/25	0/371	1/186
Oesophageal candidiasis	Infections and infestations	0/51	0/52	0/25	1/371	0/186
Orchitis	Infections and infestations	0/51	0/52	0/25	1/371	0/186
Osteomyelitis	Infections and infestations	0/51	0/52	0/25	0/371	1/186
Pneumonia	Infections and infestations	0/51	0/52	0/25	0/371	2/186
Postoperative wound infection	Infections and infestations	0/51	0/52	0/25	1/371	0/186
Pyelonephritis acute	Infections and infestations	0/51	0/52	0/25	1/371	0/186
Thrombophlebitis septic	Infections and infestations	0/51	0/52	0/25	1/371	0/186
Urinary tract infection	Infections and infestations	0/51	0/52	0/25	2/371	0/186
Anaemia postoperative	Injury, poisoning and procedural complications	0/51	0/52	0/25	0/371	1/186
Femoral neck fracture	Injury, poisoning and procedural complications	0/51	0/52	0/25	0/371	1/186
Femur fracture	Injury, poisoning and procedural complications	0/51	0/52	0/25	1/371	0/186
Hip fracture	Injury, poisoning and procedural complications	0/51	0/52	0/25	1/371	0/186
Pelvic fracture	Injury, poisoning and procedural complications	0/51	0/52	0/25	1/371	0/186
Post procedural haematuria	Injury, poisoning and procedural complications	0/51	0/52	0/25	1/371	0/186
Diabetes mellitus	Metabolism and nutrition disorders	0/51	0/52	0/25	1/371	0/186
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	0/51	0/52	0/25	1/371	0/186
Muscular weakness	Musculoskeletal and connective tissue disorders	1/51	0/52	0/25	0/371	0/186
Osteoarthritis	Musculoskeletal and connective tissue disorders	0/51	0/52	0/25	1/371	0/186
Osteonecrosis	Musculoskeletal and connective tissue disorders	0/51	0/52	0/25	1/371	0/186

36 more terms not shown.

Other adverse events by term

Term	Organ system	Phase 2: Treatment Group 1: BIC 75 mg + LEN 25 mg	Phase 2: Treatment Group 2: BIC 75 mg + LEN 50 mg	Phase 2: Treatment Group 3: SBR	Phase 3: Treatment Group 1: BIC/ LEN 75 mg/50 mg FDC	Phase 3: Treatment Group 2: SBR
Constipation	Gastrointestinal disorders	3/51	2/52	0/25	11/371	5/186
Diarrhoea	Gastrointestinal disorders	5/51	2/52	1/25	22/371	11/186
Covid-19	Infections and infestations	4/51	2/52	2/25	18/371	6/186
Nasopharyngitis	Infections and infestations	4/51	0/52	0/25	26/371	17/186
Upper respiratory tract infection	Infections and infestations	2/51	2/52	1/25	34/371	24/186
Arthralgia	Musculoskeletal and connective tissue disorders	3/51	1/52	0/25	19/371	8/186
Headache	Nervous system disorders	2/51	2/52	0/25	28/371	4/186
Cough	Respiratory, thoracic and mediastinal disorders	3/51	1/52	0/25	18/371	11/186
Hypertension	Vascular disorders	1/51	4/52	1/25	20/371	6/186

+Locations (94)

Facility	City	Country
Be Well Medical Center	Berkeley, California	United States
Pacific Oaks Medical Group	Beverly Hills, California	United States
Ruane Clinical Research Group, Inc	Los Angeles, California	United States
Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care	Oakland, California	United States
Bios Clinical Research	Palm Springs, California	United States
University of California San Diego (UCSD)	San Diego, California	United States
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center	Torrance, California	United States
The Men's Health Foundation	West Hollywood, California	United States
Denver Health Medical Center	Denver, Colorado	United States
Yale University; School of Medicine; AIDS Program	New Haven, Connecticut	United States
Midland Florida Clinical Research Center, LLC	DeLand, Florida	United States
Therafirst Medical Centers	Fort Lauderdale, Florida	United States
Gary Richmond, MD, PA, Inc.	Fort Lauderdale, Florida	United States
Midway Immunology & Research Center, LLC	Ft. Pierce, Florida	United States
Schiff Center for liver Diseases/University of Miami	Miami, Florida	United States
Floridian Clinical Research	Miami Lakes, Florida	United States
Orlando Immunology Center	Orlando, Florida	United States
Therapeutic Concepts, PA	Orlando, Florida	United States
Triple O Research Institute PA	West Palm Beach, Florida	United States
Atlanta ID Group	Atlanta, Georgia	United States
Mercer University School of Medicine	Macon, Georgia	United States
Howard Brown Health Center	Chicago, Illinois	United States
Kansas City Care Clinic	Kansas City, Missouri	United States
Southampton Healthcare, Inc.	St Louis, Missouri	United States
Saint Michael's Medical Center	Newark, New Jersey	United States
AXCES Research Group	Santa Fe, New Mexico	United States
New York Presbyterian Hospital	Flushing, New York	United States
Ricky K. Hsu, MD, PC	New York, New York	United States
University of North Carolina - Chapel Hill	Chapel Hill, North Carolina	United States
East Carolina University	Greenville, North Carolina	United States
Philadelphia FIGHT	Philadelphia, Pennsylvania	United States
Medical University of South Carolina (MUSC) Research NEXUS	Charleston, South Carolina	United States
Central Texas Clinical Research	Austin, Texas	United States
St. Hope Foundation	Bellaire, Texas	United States
AIDS Arms, Inc., DBA Prism Health North Texas	Dallas, Texas	United States
North Texas Infectious Diseases Consultants	Dallas, Texas	United States
Texas Centers for Infectious Disease Associates	Fort Worth, Texas	United States
Gordon E. Crofoot MD PA	Houston, Texas	United States
Diagnostic Clinic of Longview - Center for Clinical Research	Longview, Texas	United States
Peter Shalit, MD	Seattle, Washington	United States
Hospital General de Agudos J.M Ramon Mejia	Buenos Aires	Argentina
Fundación Huésped	Buenos Aires	Argentina
Helios Salud	Buenos Aires	Argentina
St.Vincent's Hospital Sydney	Darlinghurst, New South Wales	Australia
Taylor Square Private Clinic	Darlinghurst, New South Wales	Australia
Holdsworth House Medical Practice	Sydney, New South Wales	Australia
Alfred Health	Melbourne, Victoria	Australia
Chronic Viral Illness Service / McGill University Health Centre (MUHC)	Decarie Montreal	Canada
Clinique Medicale du Quartier Latin	Montreal	Canada
The Ottawa Hospital - General Campus	Ottawa	Canada
ID Clinic	Regina	Canada
Maple Leaf Research	Toronto	Canada
Spectrum Health	Vancouver	Canada
Instituto Dominicano de Estudio Virologicos - IDEV	Santo Domingo	Dominican Republic
CHU Nice-Hôpital l'Archet	Nice	France
Hospital Saint Louis	Paris	France
Groupe Hospitalier Bichat Claude Bernard	Paris	France
Höpital de la Pitié Salpêtrière	Paris	France
zibp Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH	Berlin	Germany
Universitatsklinikum Bonn	Bonn	Germany
Infektio Research GmbH & Co.KG	Frankfurt	Germany
ICH Study Center GmbH & Co. KG	Hamburg	Germany
MVZ München am Goetheplatz	München	Germany
IRCCS Ospedale San Raffaele	Milan	Italy
ASST Fatebenefratelli Sacco	Milan	Italy
Azienda Ospedaliero-Universitaria di Modena	Modena	Italy
Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS	Roma	Italy
ASL Città di Torino	Torino	Italy
National Hospital Organization Nagoya Medical Center	Nagoya	Japan
National Hospital Organization Osaka National Hospital	Osaka	Japan
Center Hospital of the National Center for Global Health and Medicine	Tokyo	Japan
Hope Clinical Research	San Juan, PR	Puerto Rico
Proyecto ACTU	San Juan, PR	Puerto Rico
Desmond Tutu Health Foundation Clinical Trials Unit	Cape Town	South Africa
Sefako Makgatho Health Sciences University	Ga-Rankuwa	South Africa
Ezintsha	Johannesburg	South Africa
Kyungpook National University Hospital	Daegu	South Korea
Chungnam National University Hospital	Daejeon	South Korea
Yonsei University Severance Hospital	Seoul	South Korea
The Catholic University of Korea Seoul St. Mary's Hospital	Seoul	South Korea
Hospital Clinic Provincial de Barcelona	Barcelona	Spain
Hospital Ramon y Cajal, Madrid	Madrid	Spain
Hospital Clinico San Carlos	Madrid	Spain
Hospital Universitario La Paz	Madrid	Spain
Hospital Universitario Virgen del Rocio	Seville	Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung City	Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung City	Taiwan
Far Eastern Memorial Hospital	New Taipei City	Taiwan
Taoyuan General Hospital	Taoyuan City	Taiwan
Department of HIV & Sexual Medicine	Birmingham	United Kingdom
Brighton and Sussex University Hospitals NHS Trust	Brighton	United Kingdom
Barts Health NHS Trust	London	United Kingdom
HIV medicine and infectious diseases	London	United Kingdom
St.Stephen's AIDS Trust, Clinical Trials Unit, 1st Floor, St.Stephen's Centre	London	United Kingdom

+Publications

Results publication: Ph2 PK data was included as part of the 2024 HIV-G presentation: https://hivglasgow.org/wp-content/uploads/2025/02/P049_Arora.pdf
Results publication: Orkin C, Ruane PJ, Hedgcock M, Gaultier C, Losso MH, Trottier B, Lutz T, O'Reilly M, Bloch M, Slim J, Ramgopal M, Sokhela S, Mounzer K, Tsai HC, Santana Bagur J, Zhang X, Aizen K, Price K, Margot N, Montezuma-Rusca JM, Sklar P, Rhee M, Cahn P; 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 Mar 28;407(10535):1249-1258. doi: 10.1016/S0140-6736(26)00307-7. Epub 2026 Feb 25. PMID 41763229
Results publication: Arora P, Hindman JT, West S, Ling J, Palaparthy R, Marathe DD. The effect of antacid and mineral supplements on bictegravir pharmacokinetics: results from a Phase 1, open-label, drug-drug interaction study. Antimicrob Agents Chemother. 2026 Jan 7;70(1):e0078125. doi: 10.1128/aac.00781-25. Epub 2025 Nov 28. PMID 41313173

+Study documents

Study Protocol (PDF, 2026-04-21)
Statistical Analysis Plan: Phase 2 Week 24 Primary Analysis (PDF, 2023-08-16)
Statistical Analysis Plan: Phase 3 Week 48 Primary Analysis (PDF, 2025-10-31)