14 Apr 2025
8th March 2025
Brussels, March 8th, 2025
European clinical scientists from the NEAT ID Network present LAte Presenter Treatment OPtimisation (LAPTOP) Study results for the first time at the Conference on Retroviruses and Opportunistic Infections (CROI) 2025 in San Francisco. The LAPTOP Study is the first fully powered head-to-head trial in this particularly vulnerable patient group.
Despite ongoing efforts to improve testing, many people worldwide are still diagnosed with advanced HIV. Early diagnosis and timely treatment are crucial for improving health outcomes and preventing HIV transmission. However, an estimated 40–60% of individuals across Europe still seek HIV care late, often after their immune systems are already severely weakened. This delay increases their health risks and adds to public health challenges.
Since these persons with advance HIV disease respond less well to antiretroviral treatment and are usually underrepresented in major clinical trials, it was unclear which antiretroviral drugs work best for them.
To address this, scientists from the NEAT ID Network conducted a large, randomized study in people with untreated HIV and severe immune system damage or AIDS. They compared two single-tablet treatment regimens Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) and Symtuza®® (darunavir 800mg/cobicistat 150mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) over 48 weeks.
The study results were presented as a Late Breaking Abstract at the Conference on Retroviruses and Opportunistic Infections (CROI) 2025 in San Francisco for the first time. (Behrens GMN et al. Integrase Inhibitor versus Protease Inhibitor-based Therapy for People with Advanced HIV-Disease. CROI 2025, Poster 658)
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 bictegravir therapy was safe and non-inferior to the boosted darunavir treatment.
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 event 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).
Prof. Georg Behrens from Hannover Medical School and chief investigator of the trial stated: “The LAPTOP Study is the first fully powered head-to-head trial in this particularly vulnerable patient group.”
He further highlighted that “These are clinically highly relevant findings, which fill a long-term data gap and provide solid evidence to inform HIV treatment guidelines. We are very grateful to the participants in the study, the LAPTOP Study Team, NEAT ID and funding sources for the continuous engagement in this study.”
Summarising the importance of the study Prof George Behrens said:“For a rapid initiation of therapy in persons with advanced HIV disease and when no resistance data are available, guidelines recommend darunavir-based regimens, whilst in general integrase inhibitor (INSTI) therapies are preferred. LAPTOP provides evidence to suggest that second generation INSTI may be best for late presenters in the current context of low transmitted rates of INSTI resistance.”
Professor Anton Pozniak, a senior author, highlighted the role of the NEAT ID Network in engaging individuals who might benefit from the study, especially during the COVID-19 pandemic, and stressed the importance of this study and its relevance for late presenters.
Dr Esteban Martinez, President of NEAT ID, the research organization which sponsored and led the study, said: “These results provide evidence for their consideration in treatment guidelines and for their application in clinical practice. Until now the guidelines have suggested either a second-generation integrase inhibitor-based or a darunavir-based regimen as the rapid start guidance for persons with advanced HIV disease. I think we can say that all persons with HIV starting antiretrovirals should have integrase inhibitors preferred “.
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 andmobilityofscientists at all levels and foster lasting research collaborations Internationally. Pleasevisit our website for more details:https://www.NEAT-ID.org
2. Professor Georg Behrensis Professor for TCell Immunology in the Department for Rheumatology and Immunologyat Hannover Medical School, Hannover Germany. Hiswork was published in journals including Nat Med, Nat Immunol, Lancet, Lancet ID, J Clin Invest, Clin Infect Dis, AIDS, and others. Georg Behrens was Chairof the EACSTreatment 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. Professor Anton Pozniakis a consultant physician in HIV Medicine at the Chelsea and Westminster Hospital, Professor in the Department of Clinical Research at theLondon Schoolof Hygiene & Tropical Medicine, Past President oftheInternational AIDSSocietyand NEAT ID. Anton has been an advisor on HIV and AIDS to the UK GovernmentHealth Select Committee and a member of the expert advisory group on AIDS for the UKDepartment of Health. He has published more than 400 peer-reviewed papers, mainlyon clinicalaspects of HIV treatment and care and HIV-associated tuberculosis.
4. Dr Esteban Martinezis Senior Consultant inInfectious Diseases at HospitalClínicBarcelona andAssociate Professor of Medicine at University of Barcelona. He is aPastPresident of the European AIDS Clinical Society.
Media contact: Polly.Parks@NEAT-ID.org +44 07850 695261