Infectious Diseases Unit, IRCCS Policlinico di Sant'Orsola, University of Bologna, Bologna, Italy.
Clinic Pharmacy Unit, IRCCS Policlinico di Sant'Orsola, University of Bologna, Bologna, Italy.
Int J STD AIDS. 2023 Dec;34(14):1018-1023. doi: 10.1177/09564624231195084. Epub 2023 Aug 11.
Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) showing high efficacy and tolerability in both naïve and experienced people living with HIV (PLWHIV) in randomized trials, but scarce data are available to date from the real-life experience.
We performed an observational, retrospective study of PLWHIV on suppressive antiretroviral therapy who switched to a daily single-tablet regimen containing doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg.
As a whole, 62 suppressed patients (51 men, median age, 51.7 years; median CD4 T+ lymphocyte count, 577 cells/mm) were enrolled. After 12 months, 58 (93.5%) patients showed HIV RNA <20 copies/mL and reasons for treatment failure were virological failure in one case, missing data in one case, and adverse events in two cases. At month 12, a significant decrease in median serum level of triglycerides (median change -61.2 mg/dL; = .009) and total cholesterol (median change -38.4 mg/dL; = .021) was reported, while a not significant median weight increase was registered (+0.55 kg).
In our study, simplification to a single-tablet regimen of doravirine/lamivudine/tenofovir disoproxil fumarate in virologically suppressed PLWHIV was effective and showed a good tolerability profile, in association with a significant improvement in serum lipid levels.
多伟拉韦是一种非核苷类逆转录酶抑制剂(NNRTI),在随机试验中,无论是初治还是经治的 HIV 感染者(PLWHIV),均显示出高效和良好的耐受性,但迄今为止,实际经验中数据有限。
我们对接受抑制性抗逆转录病毒治疗的 PLWHIV 进行了一项观察性、回顾性研究,这些患者转换为每日单一片剂方案,包含多伟拉韦 100mg、拉米夫定 300mg 和富马酸替诺福韦二吡呋酯 300mg。
共有 62 例抑制性患者(51 名男性,中位年龄 51.7 岁;中位 CD4+T 淋巴细胞计数 577 个细胞/mm)被纳入研究。12 个月后,58 例(93.5%)患者 HIV RNA<20 拷贝/mL,治疗失败的原因是 1 例出现病毒学失败,1 例数据缺失,2 例出现不良事件。在第 12 个月时,报告了血清甘油三酯中位数显著下降(中位数变化-61.2mg/dL; =.009)和总胆固醇中位数显著下降(中位数变化-38.4mg/dL; =.021),而体重中位数略有增加(增加 0.55kg)。
在我们的研究中,多伟拉韦/拉米夫定/富马酸替诺福韦二吡呋酯单一片剂方案在病毒抑制的 PLWHIV 中简化治疗是有效且耐受性良好的,与血清脂质水平的显著改善相关。