Department of Internal Medicine, OLVG Hospital, Amsterdam, the Netherlands; and.
Department of Clinical Pharmacology, OLVG Hospital, Amsterdam, the Netherlands.
J Acquir Immune Defic Syndr. 2024 Feb 1;95(2):190-196. doi: 10.1097/QAI.0000000000003337.
Doravirine is a non-nucleoside reverse transcriptase inhibitor with demonstrated efficacy as a third agent in treatment-naive and treatment-experienced people living with HIV (PLWH) in registration studies. However, limited real-world data are available.
By searching electronic health care records, PLWH using doravirine-based regimens were selected with at least 1 year of follow-up after their first prescription. All stable PLWH who were switched to a doravirine-based regimen were included in the analysis. The primary outcome was the durability of a doravirine-based regimen 1 year after prescription. Reasons for stopping were also collected. Secondary outcomes for PLWH continuing a doravirine-based regimen after 1 year were routine laboratory assessment, body mass index, and differences in medication costs compared with their previous cART.
A total of 687 patients (92% men) were included from September 2019 to August 2022: 97.7% switched to doravirine/tenofovir/lamivudine (DOR/TDF/3TC). After 1 year, 94/687 (13.6%) PLWH stopped this therapy. The main reason for discontinuation was patient-reported adverse events in 70/687 (10.2%). Medical reasons for discontinuation included increased alanine tranaminase levels in 6/687 (0.9%), decreased estimated glomerular filtration rate in 3/687 (0.4%), and precautions after diagnosis of osteoporosis in 2/687 (0.3%) patients. Virologic failure occurred in 4/687 cases (0.6%), and 1 case demonstrated resistance mutations. The secondary outcomes demonstrated a statistically significant increase in alanine tranaminase levels and decrease in LDL-c levels. The switch to a doravirine-based regimen in the Netherlands reduced medication costs by 27%.
This study demonstrated that switching to a doravirine-based regimen, mostly DOR/TDF/3TC, was highly effective and generally well tolerated, with substantial cost savings.
多伟拉韦是一种非核苷类逆转录酶抑制剂，已在注册研究中证明其在初治和经治 HIV 感染者（PLWH）中作为第三种药物的疗效。然而，可用的真实世界数据有限。
通过搜索电子医疗记录，选择至少在首次处方后有 1 年随访的使用多伟拉韦方案的 PLWH。所有稳定的 PLWH 转换为多伟拉韦方案的均纳入分析。主要结局是处方后 1 年多伟拉韦方案的持久性。还收集了停药原因。对 1 年后继续使用多伟拉韦方案的 PLWH 的次要结局是常规实验室评估、体重指数和与之前 cART 相比的药物费用差异。
共纳入 2019 年 9 月至 2022 年 8 月的 687 例患者（92%为男性）：97.7%转换为多伟拉韦/替诺福韦/拉米夫定（DOR/TDF/3TC）。1 年后，687 例患者中有 94 例（13.6%）停止了该治疗。停药的主要原因是 70/687（10.2%）例患者报告的不良反应。停药的医疗原因包括 6/687（0.9%）例丙氨酸转氨酶升高、3/687（0.4%）例估算肾小球滤过率降低和 2/687（0.3%）例骨质疏松症诊断后采取预防措施。687 例中有 4 例（0.6%）发生病毒学失败，1 例出现耐药突变。次要结局显示丙氨酸转氨酶水平升高和 LDL-c 水平降低具有统计学意义。在荷兰，改用多伟拉韦方案可降低 27%的药物费用。
本研究表明，改用多伟拉韦方案，主要是 DOR/TDF/3TC，非常有效且通常耐受性良好，同时节省了大量药物费用。
