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Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection

医学 队列 病毒载量 安慰剂 内科学 临床终点 队列研究 外科 免疫学 人类免疫缺陷病毒(HIV) 临床试验 病理 替代医学
作者
Sorana Segal‐Maurer,Edwin DeJesus,Hans‐Jürgen Stellbrink,Antonella Castagna,Gary Richmond,Gary I. Sinclair,Krittaecho Siripassorn,Peter Ruane,Mezgebe Berhe,Hui Wang,Nicolas Margot,Hadas Dvory‐Sobol,Robert H. Hyland,Diana M. Brainard,Martin Rhee,Jared M. Baeten,Jean‐Michel Molina
出处
期刊:The New England Journal of Medicine [Massachusetts Medical Society]
卷期号:386 (19): 1793-1803 被引量:107
标识
DOI:10.1056/nejmoa2115542
摘要

Patients with multidrug-resistant human immunodeficiency virus type 1 (HIV-1) infection have limited treatment options. Lenacapavir is a first-in-class capsid inhibitor that showed substantial antiviral activity in a phase 1b study.In this phase 3 trial, we enrolled patients with multidrug-resistant HIV-1 infection in two cohorts, according to the change in the plasma HIV-1 RNA level between the screening and cohort-selection visits. In cohort 1, patients were first randomly assigned in a 2:1 ratio to receive oral lenacapavir or placebo in addition to their failing therapy for 14 days; during the maintenance period, starting on day 15, patients in the lenacapavir group received subcutaneous lenacapavir once every 6 months, and those in the placebo group received oral lenacapavir, followed by subcutaneous lenacapavir; both groups also received optimized background therapy. In cohort 2, all the patients received open-label oral lenacapavir with optimized background therapy on days 1 through 14; subcutaneous lenacapavir was then administered once every 6 months starting on day 15. The primary end point was the percentage of patients in cohort 1 who had a decrease of at least 0.5 log10 copies per milliliter in the viral load by day 15; a key secondary end point was a viral load of less than 50 copies per milliliter at week 26.A total of 72 patients were enrolled, with 36 in each cohort. In cohort 1, a decrease of at least 0.5 log10 copies per milliliter in the viral load by day 15 was observed in 21 of 24 patients (88%) in the lenacapavir group and in 2 of 12 patients (17%) in the placebo group (absolute difference, 71 percentage points; 95% confidence interval, 35 to 90). At week 26, a viral load of less than 50 copies per milliliter was reported in 81% of the patients in cohort 1 and in 83% in cohort 2, with a least-squares mean increase in the CD4+ count of 75 and 104 cells per cubic millimeter, respectively. No serious adverse events related to lenacapavir were identified. In both cohorts, lenacapavir-related capsid substitutions that were associated with decreased susceptibility developed in 8 patients during the maintenance period (6 with M66I substitutions).In patients with multidrug-resistant HIV-1 infection, those who received lenacapavir had a greater reduction from baseline in viral load than those who received placebo. (Funded by Gilead Sciences; CAPELLA ClinicalTrials.gov number, NCT04150068.).
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