1 Dec 2025
1st of December 2025
Brussels, December 1st, 2025,
FOR IMMEDIATE RELEASE ON December 1st at 11am GMT
The NEAT ID Foundation announces publication in The Lancet Infectious Diseases from the Late Presenter Treatment Optimization (LAPTOP) study - the largest randomized clinical trial to date dedicated to identifying optimal first-line antiretroviral therapy for people with advanced HIV disease.
The landmark NEAT ID Study Identifies Optimal HIV Treatment for People with Advanced Disease. The LAPTOP Trial finds integrase inhibitor-based therapy superior in efficacy and safety for late presenters. The paper is titled “Integrase versus protease inhibitor therapy in advanced HIV disease (LAPTOP): a multicountry, randomised, open-label, non-inferiority trial” and is published in The Lancet Infectious Diseases as of Monday the 1st of December at 11am GMT.
Link to download PDF (Free for 50 days): https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(25)00681-4/fulltext
The study involved 442 participants, (81%) male, (62%) white, and 86% having very low CD4 cell counts (below 100/µL). They were randomly assigned to one of the two treatment arms. The results showed that the treatment with bictegravir (B)/emtricitabine (F)/tenofovir alafenamide (TAF) [B/F/TAF] was safe and non-inferior to therapy with darunavir (D)/cobicistat (C) emtricitabine (F)/tenofovir alafenamide (TAF) [D/c/F/TAF].
Participants in the bictegravir arm were more likely to have an adequate response to the treatment at 12 weeks or an undetectable virus load (<50 copies) at 48 weeks.
In the in intention-to-treat analyses, the primary composite outcome composed of virological and clinical events occurred in 49/220 persons in the bictegravir group versus 70/222 persons in the darunavir group by 48 weeks (adjusted hazard ratio [aHR] 0.70; 95% confidence interval [CI] 0.48-1.00; p=0.05, non-inferiority demonstrated). Per-protocol analyses yielded similar results (aHR 0.69; 95% CI 0.48-1.00).
Insufficient virological response (HIV-1 RNA reduction <1 log 10 copies/mL at week 12, or viral load >50 HIV-1 RNA copies/mL at week 48) was significantly lower in the bictegravir group (HR 0.53; 95% CI 0.32-0.88, p=0.014).
Additionally, people in the bictegravir group had a lower risk of drug-related side effects with grade ≥2 occurring in 7.3% of participants versus 14.4% in the darunavir group (p=0.04).
Globally, around 30% of people newly diagnosed with HIV present with advanced disease (CD4 <200 cells/µL or AIDS-defining illness). These individuals face markedly higher mortality and poorer treatment outcomes. The LAPTOP findings address a critical evidence gap, confirming that modern integrase inhibitor regimens can be safely and effectively used even in individuals with profound immunosuppression.
“Our results demonstrate that integrase inhibitor–based therapies are not only safe but also virologically superior,” says Professor Georg Behrens, Hannover. “With this, we provide the first prospective evidence that can change global HIV treatment guidelines and improve the care of people diagnosed with HIV at a late stage.”
“The LAPTOP study provides long-awaited evidence supporting the use of integrase inhibitor–based regimens in people with advanced HIV disease,” says Dr Esteban Martínez, President of NEAT ID. “These results confirm that we can safely initiate potent, modern therapy even in patients with profound immunosuppression, improving their prognosis from the very start of treatment.”
Contributing sites: INMI Lazzaro Spallanzani (Italy), La Paz (Spain), CHU Saint-Pierre (Belgium), Hôpital Saint-Louis (France), Kings College Hospital (United Kingdom), University Hospital Bonn (Germany), St George’s Hospital (United Kingdom), Hospital de la Santa Creu (Spain), Medical School Hannover (Germany), Hôpital Lariboisiere (France), Vall d’Hebron (Spain), Hospital Clinic Barcelona (Spain), Elche (Spain), San Raffaele, Milan (Italy), University Hospital Frankfurt (Germany), Pitié-Salpêtrière Hospital (France), Hospital Ramon y Cajal (Spain), University Hospital Klinikum rechts der Isar – TUM (Germany), Alicante (Spain), Leeds Teaching Hospital (United Kingdom), Southmead Hospital Bristol (United Kingdom), Institute of Tropical Medicine Antwerp (Belgium), Luigi Sacco Hospital, Milan (Italy), Infection Medical Centre Hamburg (Germany), North Manchester General Hospital (United Kingdom), Chelsea and Westminster Hospital (United Kingdom), Guy’s Hospital (United Kingdom), Universitaire Ziekenhuis Gent (Belgium), University Hospital Köln (Germany), CH de Melun (France), Homerton Hospital (United Kingdom), Hôpital Européen Marseille (France), Hospital Bellvitge (Spain), Mortimer Market Centre (United Kingdom), Universitario Virgen de la Victoria (Spain), Hôpital Gui de Chauliac (France), Hôpital Saint Antoine (France), ASST Santi Paolo (Italy), Mater Misericordiae University Hospital (Ireland), Hospital del Mar (Spain), St Mary’s Hospital (United Kingdom), Giessen (Germany), Barts (United Kingdom), Hospital Germans Trias i Pujol (Spain), Hospital Universitario de la Princesa (Spain), Nantes (France), Queen Elizabeth Hospital (United Kingdom), Hospital Universitario 12 de Octubre (Spain), Royal Bournemouth Hospital (United Kingdom), Royal Free Hospital (United Kingdom), and St Vincent’s University Hospital (Ireland).
The study is sponsored by NEAT ID and funded by Gilead Sciences and Janssen Pharmaceutica.
ENDS
Notes to editors:
1. NEAT ID's mission is to support and develop Clinical Research on Infectious Diseases and spread expertise, resources and funds. NEAT ID provides training and mobility of scientists at all levels and foster lasting research collaborations Internationally. Please visit our website for more details: https://www.NEAT-ID.org
2. Professor Georg Behrens is Professor for T Cell Immunology in the Department for Rheumatology and Immunology at Hannover Medical School, Hannover Germany. His work was published in journals including Nat Med, Nat Immunol, Lancet, Lancet ID, J Clin Invest, Clin Infect Dis, AIDS, and others. Georg Behrens was Chair of the EACS Treatment Guidelines, and he was president of the German AIDS Society for many years. He is principal investigator of national and international studies in HIV medicine and NEAT ID Executive Member.
3. Dr Esteban Martinez is Senior Consultant in Infectious Diseases at Hospital Clínic Barcelona and Associate Professor of Medicine at University of Barcelona. He is a Past President of the European AIDS Clinical Society.
Media contact: Polly.Parks@NEAT-ID.org +44 07850 695261