Bayesian Estimation of the Probability of Virologic Failure on Cabotegravir and Rilpivirine Long-Acting in Real Life.

IF 1 Q3 MEDICINE, GENERAL & INTERNAL
Cureus Pub Date : 2025-01-02 eCollection Date: 2025-01-01 DOI:10.7759/cureus.76829
Sebastian Noe, Anna Ivanova, Farhad Schabaz, Ariane E von Krosigk, Carmen Wiese, Eva Wolf, Celia Jonson-Oldenbuettel
{"title":"Bayesian Estimation of the Probability of Virologic Failure on Cabotegravir and Rilpivirine Long-Acting in Real Life.","authors":"Sebastian Noe, Anna Ivanova, Farhad Schabaz, Ariane E von Krosigk, Carmen Wiese, Eva Wolf, Celia Jonson-Oldenbuettel","doi":"10.7759/cureus.76829","DOIUrl":null,"url":null,"abstract":"<p><p>Background Virologic failure (VF) is still a major concern in the use of cabotegravir (CAB) and rilpivirine (RPV) long-acting (LA) for many healthcare professionals (HCP). While many results from clinical trials have been published, there is suspicion that they might underestimate the risk under less-controlled real-life conditions. This study aimed to estimate the probability of VF (primary objective) as well as discontinuation for any reason (secondary objective) among people with HIV (PWH) on CAB and RPV LA every two months (Q2M) in real life using Bayesian methodology.  Methods Bayesian estimation of VF based on prior knowledge about VF and discontinuation on CAB and RPV Q2M from randomized controlled trials (ATLAS-2M, SOLAR) and real-world data from CAB and RPV LA from a large single-center cohort. Results Among 175 PWH, two (1.1%) met the criteria of VF through week 48 (W48), resulting in an estimated risk of VF at W48 of 1.2% [0.6%; 1.9%] using Bayesian estimation. In one of the PWH, two-class resistance was observed at the time of VF, most likely being therapy emerging.  The probability of discontinuation for any reason by W48 was 21.4%, leading to a Bayesian risk estimate of 8.9% [7.3%; 10.5%]. The main reasons for discontinuation were injection-site reactions (n=10). Conclusions Risk of VF on CAB and RPV LA under real-life conditions seems to be comparable to results in clinical trials. This finding can be reassuring for both PWH and HCPs considering CAB and RPV LA as an alternative to oral antiretroviral treatment, particularly when considering the risk factors for VF that have been identified from the cases of VF in the clinical trials for patient selection. At the same time, rates of discontinuation may be considerably higher. However, this does not seem to be an indicator of a worse safety profile outside clinical trials, but probably could be the result of making CAB and RPV LA available to a wider population of PWH.</p>","PeriodicalId":93960,"journal":{"name":"Cureus","volume":"17 1","pages":"e76829"},"PeriodicalIF":1.0000,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11695962/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cureus","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.7759/cureus.76829","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0

Abstract

Background Virologic failure (VF) is still a major concern in the use of cabotegravir (CAB) and rilpivirine (RPV) long-acting (LA) for many healthcare professionals (HCP). While many results from clinical trials have been published, there is suspicion that they might underestimate the risk under less-controlled real-life conditions. This study aimed to estimate the probability of VF (primary objective) as well as discontinuation for any reason (secondary objective) among people with HIV (PWH) on CAB and RPV LA every two months (Q2M) in real life using Bayesian methodology.  Methods Bayesian estimation of VF based on prior knowledge about VF and discontinuation on CAB and RPV Q2M from randomized controlled trials (ATLAS-2M, SOLAR) and real-world data from CAB and RPV LA from a large single-center cohort. Results Among 175 PWH, two (1.1%) met the criteria of VF through week 48 (W48), resulting in an estimated risk of VF at W48 of 1.2% [0.6%; 1.9%] using Bayesian estimation. In one of the PWH, two-class resistance was observed at the time of VF, most likely being therapy emerging.  The probability of discontinuation for any reason by W48 was 21.4%, leading to a Bayesian risk estimate of 8.9% [7.3%; 10.5%]. The main reasons for discontinuation were injection-site reactions (n=10). Conclusions Risk of VF on CAB and RPV LA under real-life conditions seems to be comparable to results in clinical trials. This finding can be reassuring for both PWH and HCPs considering CAB and RPV LA as an alternative to oral antiretroviral treatment, particularly when considering the risk factors for VF that have been identified from the cases of VF in the clinical trials for patient selection. At the same time, rates of discontinuation may be considerably higher. However, this does not seem to be an indicator of a worse safety profile outside clinical trials, but probably could be the result of making CAB and RPV LA available to a wider population of PWH.

现实生活中长效卡波特韦和利匹韦林病毒学失败概率的贝叶斯估计。
病毒学失败(VF)仍然是许多医疗保健专业人员(HCP)使用卡波特韦(CAB)和利匹韦林(RPV)长效(LA)的主要问题。虽然许多临床试验的结果已经公布,但人们怀疑他们可能低估了在控制较少的现实条件下的风险。本研究旨在使用贝叶斯方法估计艾滋病毒感染者(PWH)在现实生活中每两个月(Q2M)服用CAB和RPV LA的VF(主要目标)以及因任何原因停药(次要目标)的概率。方法基于随机对照试验(ATLAS-2M, SOLAR)中关于VF和停药CAB和RPV Q2M的先验知识,以及来自大型单中心队列的CAB和RPV LA的真实数据,对VF进行贝叶斯估计。结果175名PWH患者中,2名(1.1%)患者在48周(W48)前符合VF标准,导致W48时VF的估计风险为1.2% [0.6%;1.9%]使用贝叶斯估计。在其中一个PWH中,在VF发生时观察到两级耐药,很可能是治疗出现。W48因任何原因停药的概率为21.4%,贝叶斯风险估计为8.9% [7.3%;10.5%)。停药的主要原因是注射部位反应(n=10)。结论:在现实条件下,VF对CAB和RPV LA的风险似乎与临床试验的结果相当。这一发现对于考虑将CAB和RPV LA作为口服抗逆转录病毒治疗的替代方案的PWH和HCPs来说是令人放心的,特别是考虑到在临床试验中从VF病例中确定的VF危险因素时。与此同时,停药率可能要高得多。然而,这似乎并不表明临床试验之外的安全性更差,而可能是使CAB和RPV LA可用于更广泛的PWH人群的结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信