Department of Dermatology, University of Heidelberg, Heidelberg, Germany.
Eur J Med Res. 2009;14(12):516-9. doi: 10.1186/2047-783x-14-12-516.
There is an unmet medical need for simplified antiretroviral therapy regimens to improve patient's compliance and quality of life. The purpose of this study was to evaluate the efficacy and safety of a once-daily regimen with Tenofovir (TDF), Emtricitabine (FTC) and Nevirapine (NVP) for adult patients with HIV-1 infection.
70 patients were enrolled in a prospective, multicenter, non-randomized, single arm, open-label cohort study. Patients were either naive or had problems with their current ART and needed to be changed to another regimen. Daily drug dosage was 300 mg Tenofovir, 200mg Emtricitabine and 400 mg Nevirapine once daily. Follow-up was performed over 72 weeks.
After 72 weeks, the regimen was still continued by 52 patients (74,3%). Of these, 44 patients (84,6%) had a viral load below detection limit. The median viral load had decreased by 2,5 log and the median CD4 cell count had increased by 44,8%. Most side-effects occurred at an early stage during the study. Resistances were rare (only two resistances were considered as newly developed) and occurred rather late during the study.
A once-daily regimen of Tenofovir, Emtricitabine and Nevirapine is an attractive treatment option since it is safe, effective, and well tolerated.
简化抗逆转录病毒治疗方案以提高患者的依从性和生活质量是未满足的医学需求。本研究的目的是评估每日一次的替诺福韦（TDF）、恩曲他滨（FTC）和奈韦拉平（NVP）方案治疗 HIV-1 感染成年患者的疗效和安全性。
70 例患者入组了一项前瞻性、多中心、非随机、单臂、开放标签的队列研究。患者为初治或当前 ART 存在问题需要更换另一种方案。每日药物剂量为 300mg 替诺福韦、200mg 恩曲他滨和 400mg 奈韦拉平，每日一次。随访时间为 72 周。
72 周后，仍有 52 例患者（74.3%）继续接受该方案治疗。其中，44 例患者（84.6%）病毒载量低于检测下限。病毒载量中位数下降 2.5 对数，CD4 细胞计数中位数增加 44.8%。大多数不良反应发生在研究早期。耐药性罕见（仅发现 2 例耐药性被认为是新出现的），且发生在研究后期。
替诺福韦、恩曲他滨和奈韦拉平每日一次的方案是一种有吸引力的治疗选择，因为它安全、有效且耐受性良好。
