Wyen Christoph, Sabranski Michael, Jonsson-Oldenbüttel Celia, Bogner Johannes, Knechten Heribert, Esser Stefan, Qurishi Nazifa, Schellberg Sven, Kolobova Irina, Pelz Jann-Patrick, Whiteside Yohance O, Tadese Bekana K, Rockstroh Jürgen K
Praxis am Ebertplatz, Cologne, Germany.
First Department of Internal Medicine, University Hospital of Cologne, Cologne, Germany.
HIV Med. 2025 Aug;26(8):1289-1299. doi: 10.1111/hiv.70061. Epub 2025 Jul 4.
Doravirine (DOR)-based antiretroviral therapy (ART) has been shown in clinical trials to be effective and well tolerated in treating HIV-1. The EffectiVeness of SwItChing to DORavirine-based Antiretroviral Therapy (VICDOR) study characterized the use, effectiveness and impact on body weight and lipids of DOR-based ART in a virologically suppressed switch population using real-world data from Germany.
VICDOR was a multicentre, retrospective chart review study of virologically suppressed adults with HIV in Germany who switched to DOR-based ART between January 2019 and February 2021. Demographic, clinical and laboratory data were collected up to 15 months after the switch.
A total of 193 individuals were included, with a median age of 49 years (range = 21-78), 85.0% were male, 23.8% were obese (BMI ≥30 kg/m) and 80.8% had at least one comorbidity. Overall, 84.5% switched to DOR/3TC/TDF. The most common reason for switching was to improve tolerability regarding weight gain (37.3%). Of the 161 individuals who remained on DOR and had HIV-1 RNA results, 99.4% remained virologically suppressed after 12 months (with one individual having ≥50 to <200 copies/mL at month 12 and following visit). No virological failures occurred. Median LDL-C change was -7.1 mg/dL (IQR = -23.0 to 8.0; n = 89). Individuals switched to DOR/3TC/TDF had a median weight change of -0.9 kg (IQR = -4.0 to 2.0; n = 50) at month 12; for those switched to DOR/3TC/TDF to improve tolerability regarding weight gain, median weight change was -2.0 kg (IQR = -5.0 to -1.0; n = 23) after 12 months.
DOR-based ART is effective in maintaining virological suppression without evidence of ART-related weight increase in a switch population of individuals with a high prevalence of comorbidities.
基于多韦拉韦(DOR)的抗逆转录病毒疗法(ART)在临床试验中已显示出对治疗HIV-1有效且耐受性良好。改用基于多韦拉韦的抗逆转录病毒疗法的有效性(VICDOR)研究利用来自德国的真实世界数据,对病毒学得到抑制的转换人群中基于DOR的ART的使用情况、有效性以及对体重和脂质的影响进行了描述。
VICDOR是一项多中心回顾性图表审查研究,研究对象为德国病毒学得到抑制的HIV成人患者,他们在2019年1月至2021年2月期间改用基于DOR的ART。收集转换后长达15个月的人口统计学、临床和实验室数据。
共纳入193人,中位年龄为49岁(范围=21-78岁),85.0%为男性,23.8%肥胖(BMI≥30kg/m²),80.8%至少有一种合并症。总体而言,84.5%改用DOR/3TC/TDF。转换的最常见原因是改善体重增加方面的耐受性(37.3%)。在161名继续使用DOR且有HIV-1 RNA检测结果的个体中,99.4%在12个月后病毒学仍得到抑制(有1名个体在第12个月及后续随访时病毒载量≥50至<200拷贝/mL)。未发生病毒学失败。低密度脂蛋白胆固醇(LDL-C)的中位变化为-7.1mg/dL(IQR=-23.0至8.0;n=89)。改用DOR/3TC/TDF的个体在第12个月时体重的中位变化为-0.9kg(IQR=-4.0至2.0;n=50);对于那些为改善体重增加方面的耐受性而改用DOR/3TC/TDF的个体,12个月后体重的中位变化为-2.0kg(IQR=-5.0至-1.0;n=23)。
在合并症患病率高的转换人群中,基于DOR的ART可有效维持病毒学抑制,且无ART相关体重增加的证据。