Definition of Virological Endpoints Improving the Design of Human Immunodeficiency Virus (HIV) Cure Strategies Using Analytical Antiretroviral Treatment Interruption
| dc.rights.license | open | en_US |
| dc.contributor.author | ALEXANDRE, Marie | |
| hal.structure.identifier | Statistics In System biology and Translational Medicine [SISTM] | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | PRAGUE, Melanie | |
| hal.structure.identifier | Statistics In System biology and Translational Medicine [SISTM] | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | LHOMME, Edouard | |
| dc.contributor.author | LELIEVRE, Jean-Daniel | |
| hal.structure.identifier | Statistics In System biology and Translational Medicine [SISTM] | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | WITTKOP, Linda | |
| hal.structure.identifier | Statistics In System biology and Translational Medicine [SISTM] | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | RICHERT, Laura | |
| dc.contributor.author | LEVY, Yves | |
| hal.structure.identifier | Statistics In System biology and Translational Medicine [SISTM] | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | THIEBAUT, Rodolphe | |
| dc.date.accessioned | 2024-06-27T13:33:53Z | |
| dc.date.available | 2024-06-27T13:33:53Z | |
| dc.date.issued | 2024-05-31 | |
| dc.identifier.issn | 1058-4838 | en_US |
| dc.identifier.uri | https://oskar-bordeaux.fr/handle/20.500.12278/200675 | |
| dc.description.abstractEn | BACKGROUND: Analytical treatment interruption (ATI) is the gold standard in HIV research for assessing the capability of new therapeutic strategies to control viremia without antiretroviral treatment (ART). The viral setpoint is commonly used as endpoint to evaluate their efficacy. However, in line with recommendations from a consensus meeting, to minimize the risk of increased viremia without ART, trials often implement short ATI phases and stringent virological ART restart criteria. This approach can limit the accurate observation of the setpoint. METHODS: We analyzed viral dynamics in 235 people with HIV from 3 trials, examining virological criteria during ATI phases. Time-related (eg time to rebound, peak, and setpoint) and viral load magnitude-related criteria (peak, setpoint, and time-averaged AUC [nAUC]) were described. Spearman correlations were analyzed to identify (1) surrogate endpoints for setpoint and (2) optimal virological ART restart criteria mitigating the risks of ART interruption and the evaluation of viral control. RESULTS: Comparison of virological criteria between trials showed strong dependencies on ATI design. Similar correlations were found across trials, with nAUC the most strongly correlated with the setpoint, with correlations >0.70. A threshold >100 000 copies/mL for 2 consecutive measures is requested as a virological ART restart criterion. CONCLUSIONS: Our results are in line with recommendations and emphasize the benefits of an ATI phase >12 weeks, with regular monitoring, and a virological ART restart criterion of 10 000 copies/mL to limit the risk for patients while capturing enough information to keep nAUC as an optimal proxy to the setpoint. | |
| dc.description.sponsorship | Initiative for the creation of a Vaccine Research Institute - ANR-10-LABX-0077 | en_US |
| dc.language.iso | EN | en_US |
| dc.subject.en | HIV Cure | |
| dc.subject.en | Analytical Treatment Interruption | |
| dc.subject.en | Antiretroviral Treatment | |
| dc.subject.en | Clinical Trials | |
| dc.subject.en | Virological Endpoint | |
| dc.title.en | Definition of Virological Endpoints Improving the Design of Human Immunodeficiency Virus (HIV) Cure Strategies Using Analytical Antiretroviral Treatment Interruption | |
| dc.title.alternative | Clin Infect Dis | en_US |
| dc.type | Article de revue | en_US |
| dc.identifier.doi | 10.1093/cid/ciae235 | en_US |
| dc.subject.hal | Sciences du Vivant [q-bio]/Santé publique et épidémiologie | en_US |
| dc.identifier.pubmed | 38819800 | en_US |
| dc.description.sponsorshipEurope | European HIV Vaccine Alliance (EHVA): a EU platform for the discovery and evaluation of novel prophylactic and therapeutic vaccine candidates | en_US |
| bordeaux.journal | Clinical Infectious Diseases | en_US |
| bordeaux.page | ciae235 | en_US |
| bordeaux.hal.laboratories | Bordeaux Population Health Research Center (BPH) - UMR 1219 | en_US |
| bordeaux.institution | Université de Bordeaux | en_US |
| bordeaux.institution | INSERM | en_US |
| bordeaux.institution | INRIA | en_US |
| bordeaux.team | SISTM_BPH | en_US |
| bordeaux.peerReviewed | oui | en_US |
| bordeaux.inpress | non | en_US |
| bordeaux.identifier.funderID | Agence Nationale de Recherches sur le Sida et les Hépatites Virales | en_US |
| bordeaux.identifier.funderID | Horizon 2020 | en_US |
| hal.identifier | hal-04627459 | |
| hal.version | 1 | |
| hal.date.transferred | 2024-06-27T13:33:55Z | |
| hal.popular | non | en_US |
| hal.audience | Internationale | en_US |
| hal.export | true | |
| dc.rights.cc | Pas de Licence CC | en_US |
| bordeaux.COinS | ctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Clinical%20Infectious%20Diseases&rft.date=2024-05-31&rft.spage=ciae235&rft.epage=ciae235&rft.eissn=1058-4838&rft.issn=1058-4838&rft.au=ALEXANDRE,%20Marie&PRAGUE,%20Melanie&LHOMME,%20Edouard&LELIEVRE,%20Jean-Daniel&WITTKOP,%20Linda&rft.genre=article |
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