Department of Infectious Disease Epidemiology, Robert Koch Institute, Berlin, Germany.
Hannover Medical School, Hannover, Germany.
Front Public Health. 2024 May 30;12:1404255. doi: 10.3389/fpubh.2024.1404255. eCollection 2024.
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.
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.
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).
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.
自 2020 年 12 月以来，在欧洲，卡替拉韦（CAB）和利匹韦林（RPV）联合使用已被批准作为一种双重长效（LA）注射疗法，用于治疗成人人类免疫缺陷病毒 1 型（HIV-1）感染。研究表明，36%至 61%的艾滋病毒感染者（PLWHIV）更喜欢 LA 疗法。然而，在德国或国际上，尚无关于接受 LA 治疗的人数的数据。本研究旨在评估德国目前使用 LA 治疗 HIV-1 的情况和趋势。
基于来自 Insight Health 的药房处方数据，分析和评估了德国 CAB 口服、CAB-LA 和 RPV-LA 整个可用期间的每月处方数量（2021 年 5 月至 2023 年 12 月）。根据 CAB 起始的处方计算了第一针和第二针起始注射以及随后的维持注射次数。
双月方案导致从 2021 年 9 月开始出现两个不断增长的队列，整个期间估计有 14523 例 CAB-LA 处方。因此，2023 年 12 月，约有 1364 名 PLWHIV 接受 LA 治疗，其中 1318 名接受维持治疗。仅进行了双月方案的治疗。考虑到未参加法定健康保险的人数（约 13%），2023 年 12 月，德国约有 1600 名 PLWHIV 接受 LA 治疗。2023 年治疗的平均年度费用为 11940 欧元（含起始维持治疗）和 10950 欧元（不含起始维持治疗）。
据我们所知，这是第一项关于 LA 治疗的真实使用情况和人数的研究。我们研究的一个优势是德国几乎完全覆盖了参加法定健康保险的人群。对 LA 治疗的需求与实际接受 LA 治疗的人数不匹配。尽管接受 LA 治疗的 PLWHIV 人数稳步增加，但在市场推出近 2 年后，他们仅占 2023 年德国估计接受 HIV 治疗总人数的不到 2%。预计不会有显著增加处方；相反，趋势正在趋于平稳，在不久的将来不太可能发生重大变化。因此，德国对这种治疗模式的需求似乎有限。定期进行进一步的后续研究将很有用，并建议进行调查，以了解接受度低的可能原因，为公共卫生专家提供信息，并可能扩大治疗选择。
