HIV-1-infectionPhase 2/3ARTISTRY-1NCT05502341
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
A Phase 2/3 study testing Bictegravir, Lenacapavir and BIC/LEN FDC in people with HIV-1-infection, run by Gilead Sciences at 94 sites in 15 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Bictegravir, Lenacapavir and BIC/LEN FDC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 689 participants
- Where
- 94 sitesin 15 countries
- Study dates
- 16 Aug 2022to Dec 2029
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
94 sites in 15 countries.
94 sites in 15 countries
United States40 sites
Atlanta ID Group
Atlanta, Georgia, 30309
Central Texas Clinical Research
Austin, Texas, 78705
St. Hope Foundation
Bellaire, Texas, 77401
Be Well Medical Center
Berkeley, California, 48072
Pacific Oaks Medical Group
Beverly Hills, California, 90211
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27514
Medical University of South Carolina (MUSC) Research NEXUS
Charleston, South Carolina, 29425
Howard Brown Health Center
Chicago, Illinois, 60613
AIDS Arms, Inc., DBA Prism Health North Texas
Dallas, Texas, 75208
North Texas Infectious Diseases Consultants
Dallas, Texas, 75246
Midland Florida Clinical Research Center, LLC
DeLand, Florida, 32720
Denver Health Medical Center
Denver, Colorado, 80204
New York Presbyterian Hospital
Flushing, New York, 11355
Therafirst Medical Centers
Fort Lauderdale, Florida, 33308
Gary Richmond, MD, PA, Inc.
Fort Lauderdale, Florida, 33316
Texas Centers for Infectious Disease Associates
Fort Worth, Texas, 76104
Midway Immunology & Research Center, LLC
Ft. Pierce, Florida, 34982
East Carolina University
Greenville, North Carolina, 27858
Gordon E. Crofoot MD PA
Houston, Texas, 77098
Kansas City Care Clinic
Kansas City, Missouri, 64111
Diagnostic Clinic of Longview - Center for Clinical Research
Longview, Texas, 75605
Ruane Clinical Research Group, Inc
Los Angeles, California, 90036
Mercer University School of Medicine
Macon, Georgia, 31201
Schiff Center for liver Diseases/University of Miami
Miami, Florida, 33136
Floridian Clinical Research
Miami Lakes, Florida, 33016
Yale University; School of Medicine; AIDS Program
New Haven, Connecticut, 06510
Ricky K. Hsu, MD, PC
New York, New York, 10001
Saint Michael's Medical Center
Newark, New Jersey, 07102
Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care
Oakland, California, 94609
Orlando Immunology Center
Orlando, Florida, 32803
Therapeutic Concepts, PA
Orlando, Florida, 32803
Bios Clinical Research
Palm Springs, California, 92262
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
University of California San Diego (UCSD)
San Diego, California, 92103
AXCES Research Group
Santa Fe, New Mexico, 87505
Peter Shalit, MD
Seattle, Washington, 98104
Southampton Healthcare, Inc.
St Louis, Missouri, 63139
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
Torrance, California, 90502
The Men's Health Foundation
West Hollywood, California, 90046
Triple O Research Institute PA
West Palm Beach, Florida, 33407
Canada6 sites
Chronic Viral Illness Service / McGill University Health Centre (MUHC)
Decarie Montreal, H4A 3J1
Clinique Medicale du Quartier Latin
Montreal, H2L 0B1
The Ottawa Hospital - General Campus
Ottawa, K1H 8L6
ID Clinic
Regina, S4P 0W5
Maple Leaf Research
Toronto, M5G 1K2
Spectrum Health
Vancouver, V6Z 2T1
Germany5 sites
zibp Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH
Berlin, 10439
Universitatsklinikum Bonn
Bonn, 53127
Infektio Research GmbH & Co.KG
Frankfurt, 60596
ICH Study Center GmbH & Co. KG
Hamburg, 20146
MVZ München am Goetheplatz
München
Italy5 sites
IRCCS Ospedale San Raffaele
Milan, 20127
ASST Fatebenefratelli Sacco
Milan, 20157
Azienda Ospedaliero-Universitaria di Modena
Modena, 40124
Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS
Roma, 00149
ASL Città di Torino
Torino, 10149
Spain5 sites
Hospital Clinic Provincial de Barcelona
Barcelona, 08036
Hospital Ramon y Cajal, Madrid
Madrid, 28034
Hospital Clinico San Carlos
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Virgen del Rocio
Seville, 4103
United Kingdom5 sites
Department of HIV & Sexual Medicine
Birmingham, B9 5SS
Brighton and Sussex University Hospitals NHS Trust
Brighton, BN2 3EW
Barts Health NHS Trust
London, E1 1BB.
HIV medicine and infectious diseases
London, SE5 9RS
St.Stephen's AIDS Trust, Clinical Trials Unit, 1st Floor, St.Stephen's Centre
London, SW109NH
Australia4 sites
St.Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
Taylor Square Private Clinic
Darlinghurst, New South Wales, 2011
Alfred Health
Melbourne, Victoria, 3004
Holdsworth House Medical Practice
Sydney, New South Wales, 2010
France4 sites
CHU Nice-Hôpital l'Archet
Nice, 6202
Hospital Saint Louis
Paris, 75010
Groupe Hospitalier Bichat Claude Bernard
Paris, 75018
Höpital de la Pitié Salpêtrière
Paris, 75651
South Korea4 sites
Kyungpook National University Hospital
Daegu, 41944
Chungnam National University Hospital
Daejeon, 35015
Yonsei University Severance Hospital
Seoul, 03722
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 06591
Taiwan4 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 81362
Far Eastern Memorial Hospital
New Taipei City, 22060
Taoyuan General Hospital
Taoyuan City, 33004
Argentina3 sites
Hospital General de Agudos J.M Ramon Mejia
Buenos Aires, 1072
Fundación Huésped
Buenos Aires, 1202
Helios Salud
Buenos Aires, 1425
Japan3 sites
National Hospital Organization Nagoya Medical Center
Nagoya
National Hospital Organization Osaka National Hospital
Osaka, 540-0006
Center Hospital of the National Center for Global Health and Medicine
Tokyo, 162-0052
South Africa3 sites
Desmond Tutu Health Foundation Clinical Trials Unit
Cape Town, 7925
Sefako Makgatho Health Sciences University
Ga-Rankuwa, 208
Ezintsha
Johannesburg, 2193
Puerto Rico2 sites
Hope Clinical Research
San Juan, PR, 00909
Proyecto ACTU
San Juan, PR, 00935
Dominican Republic1 site
Instituto Dominicano de Estudio Virologicos - IDEV
Santo Domingo
About this study
Official title: 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
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).
- Conditions
- HIV-1-infection
- Being tested
- Bictegravir, Lenacapavir, BIC/LEN FDC, Stable Baseline Regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BictegravirDrug
Also called GS-9883
Tablets administered orally without regard to food
LenacapavirDrug
Also called GS-6207
Tablets administered orally without regard to food
BIC/LEN FDCDrug
Also called Bixlenvo™
Tablets administered orally without regard to food
Stable Baseline RegimenDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Phase 2: Treatment Group 1: BIC 75 mg + LEN 25 mg | Experimental | 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) Receives: Drug: Bictegravir; Drug: Lenacapavir |
| Phase 2: Treatment Group 2: BIC 75 mg + LEN 50 mg | Experimental | 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. Receives: Drug: Bictegravir; Drug: Lenacapavir |
| Phase 2: Treatment Group 3: SBR | Active comparator | 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. Receives: Drug: Stable Baseline Regimen |
| Phase 3: Treatment Group 1: BIC/LEN 75 mg/50 mg FDC | Experimental | 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. Receives: Drug: BIC/LEN FDC |
| Phase 3: Treatment Group 2: SBR | Active comparator | 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. Receives: Drug: Stable Baseline Regimen |
| Phase 2/Phase 3:BIC/LEN 75/50 mg FDC | Experimental | 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). Receives: Drug: Lenacapavir; Drug: BIC/LEN FDC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Week 24
Phase 3: Percentages of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
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.
Measured: Week 48
Secondary outcomes (20)
Phase 2: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm
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.
Measured: Week 24
Phase 2: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 24
Measured: Baseline, Week 24
Phase 2: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) Through 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.
Measured: First dose date up to Week 24
Phase 2: PK Parameter: Cmax for Bictegravir (BIC) at Steady State
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.
Measured: At Week 16 or 24
Phase 2: PK Parameter: Cmax for Lenacapavir (LEN) at Steady State
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.
Measured: At Week 16 or Week 24
Phase 2: PK Parameter: AUCtau of BIC at Steady State
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.
Measured: At Week 16 or 24
Phase 2: PK Parameter: AUCtau for LEN at Steady State
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.
Measured: At Week 16 or Week 24
Phase 2: PK Parameter: Ctrough of BIC at Steady State
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.
Measured: At Week 16 or Week 24
Phase 2: PK Parameter: Ctrough of LEN at Steady State
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.
Measured: At Week 16 or Week 24
Phase 3: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
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).
Measured: Week 48
Phase 3: Change From Baseline in CD4 Cell Count at 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.
Measured: Baseline, Week 48
Phase 3: Percentage of Participants Experiencing TEAEs Through 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.
Measured: First dose date up to Week 48
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
Measured: 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
Measured: 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
Measured: 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
Measured: Week 144
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Change From Baseline in CD4 Cell Count at Week 96
Measured: 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
Measured: Baseline, Week 144
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Percentage of Participants Experiencing TEAEs Through Week 96
Measured: Week 96
Phase 3 Treatment Group 1: (BIC/LEN 75 mg/50 mg FDC): Percentage of Participants Experiencing TEAEs Through Week 144
Measured: Week 144
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start16 Aug 2022
- Primary completion29 Sep 2025
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 689 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502341
- Sponsor's protocol ID
- GS-US-621-6289
- Acronym
- ARTISTRY-1
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2022
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ph2 PK data was included as part of the 2024 HIV-G presentation: https://hivglasgow.org/wp-content/uploads/2025/02/P049_Arora.pdf
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.
PubMed 41763229Arora 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.
PubMed 41313173