Dolutegravir/Lamivudine for Maintenance of Virological Suppression in Persons with Historical Suspected or Confirmed Resistance to Lamivudine: Week 48 Results of a Single-Arm, Open-Label, Multicentre, Phase IIA Clinical Trial

杜鲁特格拉维尔 拉米夫定 医学 临床试验 打开标签 病毒学 临床研究阶段 内科学 病毒载量 人类免疫缺陷病毒(HIV) 病毒 抗逆转录病毒疗法 乙型肝炎病毒
作者
Rosa de Miguel Buckley,María Lagarde,José Luís Blanco,Adriana Pinto-Martínez,Rocío Montejano,Ángela Gutiérrez,Roser Navarro-Soler,Esperanza Cañas‐Ruano,Alexy Inciarte,Luz Martín‐Carbonero,Arkaitz Imaz,Cristina Hernández Gutiérrez,Antonio Ocampo,Pedro Gil Divasson,Rafaël Delgado,Federico Pulido,José Ramón Arribas
出处
期刊:Clinical Infectious Diseases [Oxford University Press]
标识
DOI:10.1093/cid/ciaf100
摘要

We investigated the efficacy of dolutegravir/lamivudine for maintenance treatment for people with HIV and previous lamivudine resistance. Open-label, single arm, multicentric clinical trial including virologically suppressed PWH with historical lamivudine resistance (confirmed by genotypic testing or suspected based on clinical history), no integrase resistance and CD4+ >200 cells/mm3 whose ART was changed to dolutegravir/lamivudine if the M184V/I mutation was not detected in baseline proviral DNA population sequencing. Proviral DNA next-generation sequencing (NGS) was retrospectively performed in baseline samples. Primary endpoint was proportion of participants with HIV-1 RNA viral load (VL) ≥50 copies/mL at 48 weeks in the intention-to-treat-exposed (ITT-e) population using the Food and Drug Administration snapshot algorithm. 121 participants enrolled, 114 with a prior genotype with M184V/I, mean virological suppression of 9 years. 24 (19·8%) had the M184V/I in baseline proviral DNA NGS (>5% threshold). At 48 weeks, 4 participants had a VL ≥50 copies/mL (3·3%, 95% CI: 0·9%-8·2%, FDA-Snapshot ITT-e): 1 confirmed virologic withdrawal, 1 precautionary virologic withdrawal and 2 discontinued from study treatment for other reasons with last VL ≥ 50 copies/mL; none had M184V/I in baseline proviral DNA NGS and there was no emergent integrase resistance. 90·1% participants (109/121) had a VL<50 copies/mL (95% CI: 83·3%-94·8%) and there were no data for 6·6 % (8/121 participants) at 48 weeks. After excluding lamivudine mutations in proviral DNA by population sequencing, dolutegravir/lamivudine effectively maintained virological suppression in PWH with CD4+ >200 cells/mm3 and history of lamivudine resistance. Notably, no treatment-emergent resistance was observed.
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