1 Jul 2026
1st of July 2026
Brussels, July 1st, 2026
NEAT ID: WISARD Trial Reports 96-Week Outcomes in Individuals With Historical K103N Mutation Switching to Dolutegravir/Rilpivirine
The NEAT ID Foundation announces that the final 96-week results of the WISARD clinical study have been accepted for publication in the July edition of AIDS. The study evaluated virological, safety and patient-reported outcomes in adults living with HIV-1 who had a documented historical K103N mutation and were virologically suppressed prior to switching to the two-drug regimen dolutegravir/rilpivirine (DTG/RPV).
About the WISARD Study
WISARD is the first randomised study to explore long-term virological and patient-reported outcomes following a switch to DTG/RPV in individuals with historical K103N mutation. The study was conducted at sites across Europe and was designed to generate scientific insights within this specific research population.
Key 96-Week Findings
• At Week 96, 84% of participants (n/N) (80/95 patients) who switched immediately to DTG/RPV remained virologically suppressed.
• Efficacy outcomes were assessed in the modified intention-to-treat (exposed) population or Efficacy outcomes were assessed in participants who received dolutegravir/rilpivirine
• No emergent resistance to dolutegravir or rilpivirine was detected in the single amplifiable virological failure sample and most participants with transient viraemia who remained on DTG/RPV subsequently re-suppressed.
• Patient-reported outcomes—including health-related quality of life, treatment satisfaction, and sleep measures—remained stable throughout the 96-week period.
• Adverse events were infrequent and predominantly mild in intensity.
These findings provide additional data on virological and patient-reported outcomes in a population with historical NNRTI resistance participating in a controlled research setting.
“WISARD has demonstrated the feasibly of conducting trials in subjects with specific resistance histories,” said Dr Graeme Moyle, Chief Investigator. “The study provides scientific data on virological and patient reported outcomes over 96 weeks that arise from regimen simplification to a once daily single tablet.”
Important regulatory context: Dolutegravir/rilpivirine (marketed as Juluca) is licensed in the European Union for virologically suppressed adults without any known or suspected resistance to NNRTIs or integrase inhibitors, and with no history of virologic failure. Individuals with historical NNRTI resistance mutations such as K103N therefore fall outside the approved indication for Juluca. Findings from WISARD do not imply endorsement, recommendation, or clinical applicability beyond the study population.
Publication Details
Manuscript title: Durable efficacy of dolutegravir/rilpivirine switch in subjects with HIV-1 RNA <50 copies/mL and history of K103N mutation Journal: AIDS
Access to article link:
Funding and Sponsorship
The study was sponsored by the NEAT ID Foundation and funded by ViiV Healthcare.
Contributing sites: Saint Louis Hospital (Paris, France), Nantes University Hospital (Nantes, France), King’s College Hospital (London, UK), Royal Free Hospital (London, UK), Hospital Universitari Vall d’Hebron (Barcelona, Spain), Luigi Sacco Hospital (Milan, Italy), St Mary’s Hospital (London, UK), Elton John Centre (Brighton, UK), Brussels University Hospital (Brussels, Belgium), Chelsea & Westminster Hospital (London, UK), General University Hospital of Elche (Elche, Spain), Hospital de Sant Pau (Barcelona, Spain), The Trafalgar Clinic, Queen Elizabeth Hospital (London, UK), St Bartholomew’s – The Royal London Hospital (London, UK), Bordeaux University Hospital (Bordeaux, France), University Hospital Frankfurt (Frankfurt, Germany), University Medical Center Hamburg-Eppendorf (Hamburg, Germany), University Hospital Antwerp (Antwerp, Belgium), Manchester General Hospital (Manchester, UK), Hospital Clínic Barcelona (Barcelona, Spain), Hôpital de la Pitié-Salpêtrière (Paris, France), Hôpital Lariboisière (Paris, France), ASST Spedali Civili / Brescia (Brescia, Italy), University Hospital Bonn (Bonn, Germany), Mortimer Market Centre (London, UK), Homerton University Hospital
(London, UK), Lothian Hospital (Edinburgh, UK), Sheffield Teaching Hospitals (Sheffield, UK), Alicante General University Hospital (Alicante, Spain), San Raffaele Hospital (Milan, Italy), Saint Vincent’s Hospital (Dublin, Ireland), Hospital Universitario La Paz (Madrid, Spain)
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. Dr Graeme Moyle received his medical degree and doctorate in Australia. His interest in infectious diseases brought him to the UK in 1988 to specialise in HIV, much of his career since has been associated with the Kobler Clinic, Chelsea and Westminster Hospital, London.
He is a member of the International AIDS Society core faculty, has served on the British HIV Association Treatment Guidelines Writing Committee and is an advisor to ibase HIV newsletter and TRIO Healthcare’s US HIV cohort. In addition, Dr Moyle has worked on drug development within the pharmaceutical industry and founded several medical education companies and legacy projects.
Media Contact
Polly Parks NEAT ID Foundation Polly.Parks@NEAT-ID.org +44 07850 695261