Hôpitaux Universitaires Paris-Ile de France-Ouest, Hôpital Raymond Poincaré APHP, Garches, Université Versailles-Saint-Quentin, France.
Sorbonne Universités, INSERM, UPMC Université Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique (IPLESP UMRS 1136), Paris, France.
J Antimicrob Chemother. 2018 Mar 1;73(3):738-747. doi: 10.1093/jac/dkx434.
Intermittent treatment could improve the convenience, tolerability and cost of ART, as well as patients' quality of life. We conducted a 48 week multicentre study of a 4-days-a-week antiretroviral regimen in adults with controlled HIV-1-RNA plasma viral load (VL).
Eligible patients were adults with VL < 50 copies/mL for at least 1 year on triple therapy with a ritonavir-boosted PI (PI/r) or an NNRTI. The study protocol consisted of the same regimen taken on four consecutive days per week followed by a 3 day drug interruption. The primary outcome was the proportion of participants remaining in the strategy with VL < 50 copies/mL up to week 48. The study was designed to show an observed success rate of > 90%, with a power of 87% and a 5% type 1 error. The study was registered with ClinicalTrials.gov (NCT02157311) and EudraCT (2014-000146-29).
One hundred patients (82 men), median age 47 years (IQR 40-53), were included. They had been receiving ART for a median of 5.1 (IQR 2.9-9.3) years and had a median CD4 cell count of 665 (IQR 543-829) cells/mm3. The ongoing regimen included PI/r in 29 cases and NNRTI in 71 cases. At 48 weeks, 96% of participants (95% CI 90%-98%) had no failure while remaining on the 4-days-a-week regimen. Virological failure occurred in three participants, who all resumed daily treatment and became resuppressed. One participant stopped the strategy. No severe treatment-related events occurred.
Antiretroviral maintenance therapy 4 days a week was effective for 48 weeks in 96% of patients, leading to potential reduction of long-term toxicities, high adherence to the antiretroviral regimen and drug cost saving.
间歇性治疗可以提高抗逆转录病毒治疗（ART）的便利性、耐受性和成本效益，同时提高患者的生活质量。我们开展了一项为期 48 周的多中心研究，评估了每周 4 天接受抗逆转录病毒治疗方案在 HIV-1 病毒载量（VL）得到控制的成人中的疗效。
符合条件的患者为在接受利托那韦增效的蛋白酶抑制剂（PI/r）或非核苷类逆转录酶抑制剂（NNRTI）三联治疗至少 1 年，VL<50 拷贝/mL 且持续 1 年的成年人。研究方案为每周连续 4 天接受相同的治疗方案，随后停药 3 天。主要终点为在第 48 周时，VL<50 拷贝/mL 的患者继续接受治疗的比例。研究设计的目标是观察成功率>90%，效能为 87%，Ⅰ类错误率为 5%。本研究在 ClinicalTrials.gov（NCT02157311）和 EudraCT（2014-000146-29）注册。
共纳入 100 例患者（82 例男性），中位年龄 47 岁（四分位距 40-53），接受 ART 治疗的中位时间为 5.1 年（四分位距 2.9-9.3），CD4 细胞计数的中位数为 665 个/μL（四分位距 543-829）。正在进行的治疗方案中，29 例患者使用 PI/r，71 例患者使用 NNRTI。48 周时，96%（95%CI 90%-98%）的患者继续接受每周 4 天的治疗方案，无治疗失败。3 例患者发生病毒学失败，均恢复每日治疗并再次抑制病毒。1 例患者停止该治疗策略。无严重与治疗相关的不良事件发生。
每周接受抗逆转录病毒治疗方案 4 天治疗 48 周，96%的患者有效，可能降低长期毒性、提高抗逆转录病毒治疗方案的依从性和节省药物费用。
