---
title: "Once-weekly islatravir‑lenacapavir single‑tablet switch is non‑inferior to daily ART at 48 weeks i"
id: "pubmed-42586113"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42586113"
content_type: "clinical_feed_article"
specialty: "Infectious Disease"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42586113/"
doi: "10.1016/S0140-6736(26)01442-X"
published_at: "2026-08-29T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Once-weekly islatravir‑lenacapavir single‑tablet switch is non‑inferior to daily ART at 48 weeks i
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42586113
- **Specialty:** [Infectious Disease](https://medichelpline.com/clinical-feed/infectious-disease.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42586113/)
- **DOI:** [10.1016/S0140-6736(26)01442-X](https://doi.org/10.1016%2FS0140-6736(26)01442-X)
- **Published At:** 2026-08-29T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- The phase 3 ISLEND-2 trial evaluated switching virologically suppressed adults with **HIV‑1** from daily oral standard‑of‑care antiretroviral therapy to a once‑weekly single‑tablet regimen of **islatravir‑lenacapavir** (islatravir 2 mg + lenacapavir 300 mg). - The study was randomised, open‑label, active‑controlled, non‑inferiority, conducted at 100 sites across 14 countries and territories. - Eligibility required adults (≥18 years) with HIV‑1, virologically suppressed on daily oral therapy for ≥6 months and no prior virological failure. - Participants were randomised 1:1 (stratified by region, antiretroviral class, and CD4+ count) to switch to once‑weekly islatravir‑lenacapavir or continue daily standard of care for at least 96 weeks; the primary analysis reported week 48 results. - Primary endpoint: proportion with HIV‑1 RNA ≥50 copies/mL at week 48 using the FDA Snapshot algorithm; non‑inferiority margin 4%, analyzed in all randomised participants who received any dose. - Enrollment and analysis numbers: 727 screened; 647 eligible; 634 randomised; 626 received treatment (314 islatravir‑lenacapavir, 312 standard‑of‑care). - Baseline demographics: 34% female, 31% Black, 19% Asian, 20% Hispanic/Latine, 14% aged ≥65 years; 88% were on a single‑tablet regimen and 76% on INSTI‑containing regimens at baseline. - Week 48 efficacy: 0.3% (1/314) in the islatravir‑lenacapavir arm and 1.3% (4/312) in the standard‑of‑care arm had HIV‑1 RNA ≥50 copies/mL; difference −1.0% (95.002% CI −3.0 to 1.1), meeting non‑inferiority. - Safety: treatment‑related adverse events reported in 18% of islatravir‑lenacapavir recipients versus <1% of standard‑of‑care recipients. Grade ≥3 adverse events occurred in 8% and 9% of participants respectively; serious adverse events in 7% and 9% respectively. Discontinuations for adverse events were 1% and <1%. Three deaths occurred (1 in islatravir‑lenacapavir, 2 in standard‑of‑care), none considered treatment‑related. - Interpretation: Once‑weekly **islatravir‑lenacapavir** demonstrated non‑inferior virological efficacy at week 48 and was generally well tolerated; longer‑term safety follow‑up is needed. - Trial registration: ClinicalTrials.gov NCT06630299. Funding from Gilead Sciences and Merck Sharp & Dohme.
## Clinical Analysis & Structured Key Points
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Epub 2026 Aug 12. # Switch to once-weekly, single-tablet islatravir-lenacapavir from daily standard of care for HIV-1 (ISLEND-2): a multicentre, randomised, open-label, active-controlled, phase 3 non-inferiority trial [Amy E Colson](https://pubmed.ncbi.nlm.nih.gov/?term=Colson+AE&cauthor_id=42586113)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-1 "Zinberg Clinic, Cambridge Health Alliance, Cambridge, MA, USA; Community Resource Initiative, Boston, MA, USA. Electronic address: acolson@challiance.org."), [Princy N Kumar](https://pubmed.ncbi.nlm.nih.gov/?term=Kumar+PN&cauthor_id=42586113)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-2 "Division of Infectious Diseases and Tropical Medicine, Georgetown University Hospital, Washington, DC, USA."), [Peter J Ruane](https://pubmed.ncbi.nlm.nih.gov/?term=Ruane+PJ&cauthor_id=42586113)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-3 "Ruane Clinical Research Group, Los Angeles, CA, USA."), [Ploenchan Chetchotisakd](https://pubmed.ncbi.nlm.nih.gov/?term=Chetchotisakd+P&cauthor_id=42586113)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-4 "Department of Medicine, Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand."), [Winai Ratanasuwan](https://pubmed.ncbi.nlm.nih.gov/?term=Ratanasuwan+W&cauthor_id=42586113)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-5 "Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand."), [Afaaf Liberty](https://pubmed.ncbi.nlm.nih.gov/?term=Liberty+A&cauthor_id=42586113)[ 6 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-6 "Perinatal HIV Research Unit-Soweto, Chris Hani Baragwanath Hospital, Johannesburg, South Africa."), [Ronald G Nahass](https://pubmed.ncbi.nlm.nih.gov/?term=Nahass+RG&cauthor_id=42586113)[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-7 "ID Care, Hillsborough, NJ, USA."), [Alejandro Arenas-Pinto](https://pubmed.ncbi.nlm.nih.gov/?term=Arenas-Pinto+A&cauthor_id=42586113)[ 8 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-8 "Institute for Global Health, University College London, London, UK."), [Frank A Post](https://pubmed.ncbi.nlm.nih.gov/?term=Post+FA&cauthor_id=42586113)[ 9 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-9 "Department of Sexual Health and HIV, King's College Hospital, NHS Foundation Trust, London, UK."), [David A Baker](https://pubmed.ncbi.nlm.nih.gov/?term=Baker+DA&cauthor_id=42586113)[ 10 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-10 "East Sydney Doctors, Darlinghurst, NSW, Australia."), [Pedro Cahn](https://pubmed.ncbi.nlm.nih.gov/?term=Cahn+P&cauthor_id=42586113)[ 11 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-11 "Fundación Huésped, Buenos Aires, Argentina."), [Eveline Hofmann](https://pubmed.ncbi.nlm.nih.gov/?term=Hofmann+E&cauthor_id=42586113)[ 12 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-12 "Department of Infectious Diseases, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland."), [Dai Watanabe](https://pubmed.ncbi.nlm.nih.gov/?term=Watanabe+D&cauthor_id=42586113)[ 13 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-13 "AIDS Medical Center, NHO Osaka National Hospital, Osaka, Japan."), [Po-Liang Lu](https://pubmed.ncbi.nlm.nih.gov/?term=Lu+PL&cauthor_id=42586113)[ 14 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-14 "Chung-Ho Memorial Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan."), [Anna H E Roukens](https://pubmed.ncbi.nlm.nih.gov/?term=Roukens+AHE&cauthor_id=42586113)[ 15 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-15 "Leiden University Center for Infectious Diseases, Leiden University Medical Center, Leiden, Netherlands."), [Miłosz Parczewski](https://pubmed.ncbi.nlm.nih.gov/?term=Parczewski+M&cauthor_id=42586113)[ 16 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-16 "Department of Infectious, Tropical Diseases and Acquired Immune Deficiency, Pomeranian Medical University, Szczecin, Poland."), [Hongyuan Wang](https://pubmed.ncbi.nlm.nih.gov/?term=Wang+H&cauthor_id=42586113)[ 17 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-17 "Gilead Sciences, Foster City, CA, USA."), [Ke Chen](https://pubmed.ncbi.nlm.nih.gov/?term=Chen+K&cauthor_id=42586113)[ 18 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-18 "Merck & Co, Rahway, NJ, USA."), [Fadi Shihadeh](https://pubmed.ncbi.nlm.nih.gov/?term=Shihadeh+F&cauthor_id=42586113)[ 17 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-17 "Gilead Sciences, Foster City, CA, USA."), [Melissa Shaughnessy](https://pubmed.ncbi.nlm.nih.gov/?term=Shaughnessy+M&cauthor_id=42586113)[ 18 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-18 "Merck & Co, Rahway, NJ, USA."), [Hadas Dvory-Sobol](https://pubmed.ncbi.nlm.nih.gov/?term=Dvory-Sobol+H&cauthor_id=42586113)[ 17 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-17 "Gilead Sciences, Foster City, CA, USA."), [Devi SenGupta](https://pubmed.ncbi.nlm.nih.gov/?term=SenGupta+D&cauthor_id=42586113)[ 17 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-17 "Gilead Sciences, Foster City, CA, USA."), [Cyril Llamoso](https://pubmed.ncbi.nlm.nih.gov/?term=Llamoso+C&cauthor_id=42586113)[ 18 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-18 "Merck & Co, Rahway, NJ, USA."), [Martin Rhee](https://pubmed.ncbi.nlm.nih.gov/?term=Rhee+M&cauthor_id=42586113)[ 17 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-17 "Gilead Sciences, Foster City, CA, USA."), [Onyema Ogbuagu](https://pubmed.ncbi.nlm.nih.gov/?term=Ogbuagu+O&cauthor_id=42586113)[ 19 ](https://pubmed.ncbi.nlm.nih.gov/42586113/#full-view-affiliation-19 "Yale School of Medicine, Yale University, New Haven, CT, USA."); [ISLEND-2 Study Team](https://pubmed.ncbi.nlm.nih.gov/?term=ISLEND-2+Study+Team%5BCorporate+Author%5D) Collaborators, Affiliations Expand * PMID: **42586113** * DOI: [ 10.1016/S0140-6736(26)01442-X ](https://doi.org/10.1016/s0140-6736\(26\)01442-x) Item in Clipboard Clinical Trial # Switch to once-weekly, single-tablet islatravir-lenacapavir from daily standard of care for HIV-1 (ISLEND-2): a multicentre, randomised, open-label, active-controlled, phase 3 non-inferiority trial Amy E Colson et al. Lancet. 2026. Show details Display options Display options Format Abstract PubMed PMID Lancet Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Lancet%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Lancet%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42586113/) . 2026 Aug 29;408(10557):821-832. doi: 10.1016/S0140-6736(26)01442-X. Epub 2026 Aug 12. * PMID: **42586113** * DOI: [ 10.1016/S0140-6736(26)01442-X ](https://doi.org/10.1016/s0140-6736\(26\)01442-x) Item in Clipboard Full text links Cite Display options Display options Format Abstract PubMed PMID ## Abstract **Background:** Antiretroviral therapies with long dosing intervals have the potential to improve virological outcomes and treatment satisfaction for people with HIV-1. We report the primary endpoint results from week 48 of ISLEND-2, a phase 3 trial evaluating the efficacy and safety of switching to once-weekly oral islatravir-lenacapavir from daily oral standard of care in virologically suppressed adults with HIV-1. **Methods:** This randomised, open-label, active-controlled, phase 3 non-inferiority trial was conducted at 100 sites in 14 countries and territories. Eligible participants were adults (aged ≥18 years) with HIV-1 who had been virologically suppressed on daily oral standard-of-care treatment for at least 6 months and had no previous virological failure. Participants were randomly assigned (1:1), using interactive response technology and stratified by geographical region, antiretroviral class, and CD4+ T-cell count, to switch to the once-weekly, single-tablet oral regimen of islatravir (2 mg)-lenacapavir (300 mg) or to continue daily oral standard of care for at least 96 weeks. The primary endpoint was the proportion of participants with an HIV-1 RNA viral load of 50 copies per mL or higher at week 48 (as per the US Food and Drug Administration-defined Snapshot algorithm), with a non-inferiority margin of 4%, assessed in all randomly assigned participants who received any dose of the assigned treatment. This trial is registered with ClinicalTrials.gov, [NCT06630299](http://clinicaltrials.gov/show/NCT06630299 "See in ClinicalTrials.gov"), and is active but closed to new participants. **Findings:** From Oct 8, 2024, to April 30, 2025, 727 participants were screened, of whom 647 were eligible for the study, 634 were randomly assigned, and 626 received treatment: 314 with islatravir-lenacapavir and 312 with standard of care. Of 626 participants, 211 (34%) were female, 193 (31%) were Black, 119 (19%) were Asian, 123 (20%) were Hispanic or Latine, and 89 (14%) were aged 65 years or older. At baseline, 552 (88%) were on a single-tablet antiretroviral regimen and 478 (76%) were receiving regimens containing integrase strand transfer inhibitors. At week 48, one (0·3%) of 314 participants in the islatravir-lenacapavir group and four (1·3%) of 312 participants in the standard-of-care group had an HIV-1 RNA viral load of 50 copies per mL or higher (difference -1·0% [95·002% CI -3·0 to 1·1]), meeting the non-inferiority criteria. Treatment-related adverse events occurred in 58 (18%) of 314 participants in the islatravir-lenacapavir group and one (<1%) of 312 participants in the standard-of-care group. Two (1%) of 314 participants in the islatravir-lenacapavir group and one (<1%) of 312 participants in the standard-of-care group discontinued the study owing to adverse events, with adverse events of grade 3 or higher occurring in 24 (8%) and 28 (9%) participants and serious adverse events in 22 (7%) and 27 (9%) participants in the islatravir-lenacapavir group and standard-of-care group, respectively. There were three deaths: one in the islatravir-lenacapavir group and two in the standard-of-care group, none of which were considered treatment-related. **Interpretation:** Once-weekly islatravir-lenacapavir showed non-inferior efficacy to the standard of care and was generally well tolerated. Longer-term safety data will provide further valuable insights beyond the week 48 data presented here. Islatravir-lenacapavir has potential to be the first once-weekly complete oral single-tablet regimen for HIV-1 treatment. **Funding:** Gilead Sciences and Merck Sharp & Dohme. Copyright © 2026 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Conflict of interest statement Declaration of interests AEC received honoraria for speakers bureaus and support for attending meetings and/or travel from Gilead Sciences, and payments (paid to their institution) for industry-sponsored clinical trials from Gilead Sciences and Merck. PNK participated on data safety monitoring boards or advisory boards for Gilead Sciences, Merck, and ViiV Healthcare; received grants or contracts (paid to their institution) from Gilead Sciences, Merck, Theratechnologies, and ViiV Healthcare; received payments (paid to their institution) for industry-sponsored clinical trials from Merck; and holds stock or stock options in Gilead Sciences, Johnson & Johnson, Merck, Moderna, Pfizer, Theratechnologies, and ViiV Healthcare. PJR received honoraria for speakers bureaus from Gilead Sciences and ViiV Healthcare. AL received payments (paid to their institution) for industry-sponsored clinical trials from GSK and MSD. RGN received payments (paid to their institution) for industry-sponsored clinical trials from GSK, Merck, and ViiV Healthcare; and is President of the Infectious Diseases Society of America. AA-P received payment for advisory board participation from ViiV Healthcare. FAP received support for attending meetings and/or travel from Gilead Sciences and MSD; and payments (paid to their institution) for industry-sponsored clinical trials from Gilead Sciences, Immunocore, Merck, and ViiV Healthcare. DAB received payment (paid to their institution) for industry-sponsored clinical trials and honoraria for presentations from ViiV Healthcare. PCa received research grants (paid to their institution) from ViiV Healthcare; consulting fees from Gilead Sciences, Merck, and ViiV Healthcare; and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from ViiV Healthcare. EH received payments (paid to their institution) for attending meetings and/or travel from AstraZeneca and Gilead Sciences. DW received grants for clinical trials (paid to their institution) from AbbVie, CMIC, Gilead Sciences, GSK, MSD, and ViiV Healthcare; and honora
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