Week 240 Efficacy and Safety of Fostemsavir Plus Optimized Background Therapy in Heavily Treatment-Experienced Adults with HIV-1
dc.contributor.author | Aberg, Judith A. | pt_BR |
dc.contributor.author | Shepherd, Bronagh | pt_BR |
dc.contributor.author | Wang, Marcia | pt_BR |
dc.contributor.author | Madruga, José V. | pt_BR |
dc.contributor.author | Urbina, Fernando Mendo | pt_BR |
dc.contributor.author | Katlama, Christine | pt_BR |
dc.contributor.author | Schrader, Shannon | pt_BR |
dc.contributor.author | Eron, Joseph J. | pt_BR |
dc.contributor.author | Kumar, Princy N. | pt_BR |
dc.contributor.author | Sprinz, Eduardo | pt_BR |
dc.contributor.author | Gartland, Margaret | pt_BR |
dc.contributor.author | Chabria, Shiven | pt_BR |
dc.contributor.author | Clark, Andrew | pt_BR |
dc.contributor.author | Pierce, Amy | pt_BR |
dc.contributor.author | Lataillade, Max | pt_BR |
dc.contributor.author | Tenorio, Allan R. | pt_BR |
dc.date.accessioned | 2024-03-05T04:37:03Z | pt_BR |
dc.date.issued | 2023 | pt_BR |
dc.identifier.issn | 2193-6382 | pt_BR |
dc.identifier.uri | http://hdl.handle.net/10183/272902 | pt_BR |
dc.description.abstract | Introduction: Efficacy and safety of the attachment inhibitor fostemsavir + optimized background therapy (OBT) were evaluated through 48 and 96 weeks in the phase 3 BRIGHTE trial in heavily treatment-experienced (HTE) adults failing their current antiretroviral regimen. Here, we report 240-week efficacy and safety of fostemsavir + OBT in adults with multidrug-resistant human immunodeficiency virus (HIV)-1 in BRIGHTE. Methods: Heavily treatment-experienced adults failing their current regimen entered the randomized cohort (RC; 1-2 fully active antiretrovirals available) or non-randomized cohort (NRC; no fully active antiretrovirals available) and received open-label fostemsavir + OBT (starting Day 8 in RC and Day 1 in NRC). Endpoints included proportion with virologic response (HIV-1 RNA < 40 copies/mL, Snapshot), immunologic efficacy, and safety. Results: At Week 240, 45% and 22% of the RC and NRC, respectively, had virologic response (Snapshot); 7% of the RC and 5% of the NRC had missing data due to coronavirus disease 2019 (COVID-19)-impacted visits. In the observed analysis, 82% of the RC and 66% of the NRC had virologic response. At Week 240, mean change from baseline in CD4+ T-cell count was 296 cells/mm3 (RC) and 240 cells/mm3 (NRC); mean CD4+/CD8+ ratio increased between Weeks 96 and 240 (RC 0.44 to 0.60; NRC 0.23 to 0.32). Between Weeks 96 and 240, four participants discontinued for adverse events, one additional participant experienced a drug-related serious adverse event, and six deaths occurred (median last available CD4+ T-cell count, 3 cells/mm3). COVID-19-related events occurred in 25 out of 371 participants; all resolved without incident. Conclusion: Through ~5 years, fostemsavir + OBT demonstrated durable virologic and immunologic responses with no new safety concerns between Weeks 96 and 240, supporting this regimen as a key therapeutic option for HTE people with multidrug-resistant HIV-1. | en |
dc.format.mimetype | application/pdf | pt_BR |
dc.language.iso | eng | pt_BR |
dc.relation.ispartof | Infectious diseases and therapy. Auckland. Vol. 12, no. 9 (Sept. 2023), p. 2321–2335 | pt_BR |
dc.rights | Open Access | en |
dc.subject | Receptores virais | pt_BR |
dc.subject | Attachment inhibitor | en |
dc.subject | Advanced HIV disease | en |
dc.subject | HIV-1 | pt_BR |
dc.subject | CD4+/CD8+ ratio | en |
dc.subject | Relação CD4-CD8 | pt_BR |
dc.subject | Contagem de linfócito CD4 | pt_BR |
dc.subject | CD4+ T-cell count | en |
dc.subject | Resposta viral sustentada | pt_BR |
dc.subject | Virologic response | en |
dc.title | Week 240 Efficacy and Safety of Fostemsavir Plus Optimized Background Therapy in Heavily Treatment-Experienced Adults with HIV-1 | pt_BR |
dc.type | Artigo de periódico | pt_BR |
dc.identifier.nrb | 001193920 | pt_BR |
dc.type.origin | Estrangeiro | pt_BR |
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