INSERM CIC 1413 Nantes University, and Service des Maladies Infectieuses, Centre hospitalier universitaire de l'Hôtel-Dieu, Nantes, France.
CHU de Nantes, Direction de la Recherche, Nantes, France.
J Antimicrob Chemother. 2020 Jun 1;75(6):1618-1622. doi: 10.1093/jac/dkaa056.
Few long-term data are available in subjects having initiated ART with an NRTI-sparing regimen.
Outcomes of subjects enrolled in the NEAT 001/ANRS 143 randomized clinical trial (comparing ritonavir-boosted darunavir + raltegravir versus ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine) were retrospectively collected, through anonymized electronic case report forms, up to 6 years post-enrolment.
The last NEAT 001 visit (Week 96) was conducted in 745/805 randomized subjects (363/401 ritonavir-boosted darunavir + raltegravir and 382/404 ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine). Of these, 430 were enrolled in NEAT 001/ANRS 143 LONG TERM (NLT) study (201 raltegravir, 229 tenofovir disoproxil fumarate/emtricitabine), with a median follow-up of 44.4 months.
During NLT follow-up, the proportion of AIDS, non-AIDS events, virological rebound and serious adverse events, discontinuation for virological failure and for adverse events did not differ between groups; discontinuations for virological failure since NEAT 001 inclusion were more frequent in subjects with baseline CD4 <200 cells/mm3 (11.9% versus 5.3%; P = 0.077). At last follow-up, a quarter of subjects (22.2% for ritonavir-boosted darunavir + raltegravir and 29.7% for ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine) were still receiving their initial regimen. Integrase inhibitor exposure was not associated with weight gain (P = 0.48), while tenofovir disoproxil fumarate exposure was associated with a trend to higher creatinine increase (P = 0.067).
After a median of 5.6 years, subjects initiating ritonavir-boosted darunavir + raltegravir or ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine experienced few serious clinical adverse events. Most discontinuations were for reasons unrelated to adverse events or virological failure.
在开始使用无核苷类逆转录酶抑制剂（NRTI）方案的患者中，仅有少量长期数据可用。
通过匿名电子病例报告表，回顾性收集参加 NEAT 001/ANRS 143 随机临床试验（比较利托那韦增强的达芦那韦+拉替拉韦与利托那韦增强的达芦那韦+替诺福韦二吡呋酯/恩曲他滨）中入组患者的结局数据，随访时间最长达 6 年。
最后一次 NEAT 001 访视（第 96 周）在 805 名随机受试者中的 745 名（利托那韦增强的达芦那韦+拉替拉韦 363 名，利托那韦增强的达芦那韦+替诺福韦二吡呋酯/恩曲他滨 382 名）中进行。其中，430 名入组 NEAT 001/ANRS 143 长期（NLT）研究（拉替拉韦 201 名，替诺福韦二吡呋酯/恩曲他滨 229 名），中位随访时间为 44.4 个月。
在 NLT 随访期间，两组之间艾滋病、非艾滋病事件、病毒学反弹和严重不良事件的比例、因病毒学失败和因不良事件停药无差异；自 NEAT 001 入组以来，因病毒学失败而停药的患者中，基线 CD4<200 个细胞/mm3 的患者更为常见（11.9%比 5.3%；P=0.077）。最后一次随访时，四分之一的患者（利托那韦增强的达芦那韦+拉替拉韦组为 22.2%，利托那韦增强的达芦那韦+替诺福韦二吡呋酯/恩曲他滨组为 29.7%）仍在使用初始方案。整合酶抑制剂暴露与体重增加无关（P=0.48），而替诺福韦二吡呋酯暴露与肌酐升高趋势相关（P=0.067）。
中位随访 5.6 年后，开始使用利托那韦增强的达芦那韦+拉替拉韦或利托那韦增强的达芦那韦+替诺福韦二吡呋酯/恩曲他滨的患者经历了较少的严重临床不良事件。大多数停药与不良事件或病毒学失败无关。
