■在欧洲,自2020年12月起,cabotegravir(CAB)联合利匹韦林(RPV)被批准为治疗成人人类免疫缺陷病毒1型(HIV-1)感染的双重注射长效(LA)疗法.研究表明,36%至61%的HIV感染者(PLWHIV)更喜欢LA治疗。然而,没有关于接受LA治疗的人数的真实数据,在德国或国际。这项研究的目的是评估德国使用LA治疗HIV-1的现状和趋势。
■基于来自InsightHealth的药房处方数据,口服CAB的每月处方数量,CAB-LA,和RPV-LA在德国的整个可用性期间进行了分析和评估(2021年5月至2023年12月)。根据口服CAB起始的处方计算第一次和第二次起始注射和随后的维持注射的次数。
■从2021年9月开始,每两个月的时间表导致两个队列不断增长,整个期间估计有14,523CAB-LA处方。因此,2023年12月,大约有1,364例PLWHIV接受LA治疗,其中1318人正在接受维持治疗。仅进行每两个月一次的治疗。占法定健康保险未涵盖的人群(约13%),2023年12月,共有约1,600名PLWHIV在德国接受LA治疗。2023年平均四舍五入的年度治疗费用为11,940欧元(初始维持治疗)和10,950欧元(未初始维持治疗)。
■据我们所知,这是对接受LA治疗的实际使用情况和人数的第一项研究.我们研究的一个优势是几乎完全覆盖了德国法定健康保险的人。LA治疗的预测需求与接受LA治疗的实际人数不匹配。尽管接受LA治疗的PLWHIV数量稳步增长,在2023年,在德国接受艾滋病毒治疗的估计总人数中,他们占不到2%,在市场启动后将近2年。预计处方不会大幅增加;相反,这种趋势正在趋于平稳,在不久的将来不太可能发生巨大变化。因此,德国对这种治疗模式的需求似乎有限。定期对进一步的课程进行后续研究将是有用的,并被建议,以及对缓慢摄取的可能原因进行调查,以告知公共卫生专家,并可能扩大治疗方案。
UNASSIGNED: In Europe, the combination of cabotegravir (CAB) with rilpivirine (RPV) has been approved as a dual injection long-acting (LA) therapy for the treatment of human immunodeficiency virus type 1 (HIV-1) infections in adults since December 2020. Studies have shown that between 36 and 61% of people living with HIV (PLWHIV) prefer LA therapy. However, there are no real-world data on the number of people receiving LA therapy, in Germany or internationally. The aim of this study was to assess the current situation and trends in usage of LA therapy for the treatment of HIV-1 in Germany.
UNASSIGNED: Based on pharmacy prescription data derived from Insight Health, the monthly number of prescriptions for oral CAB, CAB-LA, and RPV-LA over the entire period of availability in Germany was analyzed and evaluated (May 2021 to December 2023). The number of 1st and 2nd initiation injections and subsequent maintenance injections was calculated on the basis of the prescriptions for oral CAB initiation.
UNASSIGNED: The bimonthly schedule resulted in two growing cohorts from September 2021 with an estimated 14,523 CAB-LA prescriptions over the entire period. Accordingly, in December 2023, there were approximately 1,364 PLWHIV receiving LA therapy, of whom 1,318 were receiving maintenance therapy. Only treatments with bimonthly regimens were carried out. Accounting for people not covered by statutory health insurance (~13%), a total of ~1,600 PLWHIV were receiving LA therapy in Germany in December 2023. The average rounded annual cost of therapy in 2023 was €11,940 (maintenance therapy with initiation) and €10,950 (maintenance therapy without initiation).
UNASSIGNED: To our knowledge, this is the first study of real-world use and number of people receiving LA therapy. A strength of our study is the nearly complete coverage of people with statutory health insurance in Germany. The predicted demand for LA therapy does not match the actual number of people receiving LA therapy. Although the number of PLWHIV receiving LA therapy increased steadily, they accounted for just under 2% of the estimated total number of people receiving HIV therapy in Germany in 2023, almost 2 years after the market launch. No significant increase in prescriptions is expected; on the contrary, the trend is leveling off and is unlikely to change drastically in the near future. Hence, the need for this mode of therapy in Germany appears to be limited. Follow-up studies at regular intervals on the further course would be useful and are recommended, as well as investigations into the possible reasons for the slow uptake to inform public health experts and possibly broaden treatment options.