针对有临床需求的艾滋病毒感染者非常规使用注射用长效卡博特韦和利匹韦林抗HIV-1：52周真实世界数据

Unconventional use of injectable long-acting cabotegravir and rilpivirine against HIV-1 in PWH in clinical need: 52 weeks real-world data.

作者信息

Iannone Valentina, Rossotti Roberto, Bana Nicholas Brian, Cavazza Gabriele, D'Amico Federico, Lombardi Francesca, Salvo Pierluigi Francesco, Baldin Gianmaria, Di Giambenedetto Simona, Bernacchia Dario, Pagani Gabriele, Borghetti Alberto, Rusconi Stefano

机构信息

Department of Healtcare Surveillance and Bioetichs, Section of Infectious Diseases, Catholic University of Sacred Heart, Rome, Italy.

Department of Infectious Diseases, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.

出版信息

BMC Infect Dis. 2025 Jan 22;25(1):105. doi: 10.1186/s12879-025-10499-0.

DOI:10.1186/s12879-025-10499-0

PMID:39844075

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11756072/

Abstract

BACKGROUND

Long-acting Cabotegravir and Rilpivirine (LA CAB + RPV) shows potential advantages in heavily comorbid and even in viremic people with HIV (PWH). We assessed LA CAB + RPV durability in a cohort of PWH with a high comorbidity burden and adherence issues.

METHODS

Retrospective observational study in two Italian outpatient settings enrolling PWH who switched to LA CAB + RPV from February 2021 to January 2024 in presence of exclusion criteria enlisted in registrational trials or with other worrisome clinical risks. Kaplan-Meier (KM) was used to assess the probability of CAB/RPV discontinuation. Cox regression analysis was used to evaluate potential predictors of discontinuation.

RESULTS

We enrolled 74 PWH, with a median of 7 injections (IQR 5-9), a median age of 53 years (IQR 45-61), median time of exposure to antiretrovirals of 11 years (IQR 8-18) and median time from HIV diagnosis of 11.8 years (IQR 6.6-18.2). Eleven (14.9%) discontinued LA CAB + RPV mainly for injection-site pain. Of 53 PWH who were undetectable before switch, 37 maintained viral suppression at week 52. We registered only one virological failure at week 12. Twenty-one started injections with unsuppressed viral loads (median 66 cps/ml, IQR 40-215) and 10 (47.6%) achieved viral suppression. Overall probability of discontinuation was 14.9% at week 52. Younger age was protective against discontinuation (HR 0.93, 95%CI 0.88-0.99, p = 0.048).

CONCLUSIONS

Our results support the potential advantages in using LA CAB + RPV in PWH with adherence issues and comorbidities.

摘要

背景

长效卡博特韦和rilpivirine（LA CAB + RPV）在合并症严重甚至病毒血症的艾滋病毒感染者（PWH）中显示出潜在优势。我们评估了LA CAB + RPV在合并症负担高且存在依从性问题的PWH队列中的持久性。

方法

在意大利的两个门诊机构进行回顾性观察研究，纳入在2021年2月至2024年1月期间因注册试验中列出的排除标准或其他令人担忧的临床风险而改用LA CAB + RPV的PWH。采用Kaplan-Meier（KM）法评估停用CAB/RPV的概率。采用Cox回归分析评估停用的潜在预测因素。

结果

我们纳入了74例PWH，中位注射次数为7次（四分位间距5 - 9次），中位年龄为53岁（四分位间距45 - 61岁），抗逆转录病毒药物暴露中位时间为11年（四分位间距8 - 18年），自艾滋病毒诊断以来的中位时间为11.8年（四分位间距6.6 - 18.2年）。11例（14.9%）停用LA CAB + RPV，主要原因是注射部位疼痛。在转换前病毒载量不可测的53例PWH中，37例在第52周维持病毒抑制。我们仅在第12周记录到1例病毒学失败。21例开始注射时病毒载量未被抑制（中位值66拷贝数/毫升，四分位间距40 - 215），10例（47.6%）实现病毒抑制。第52周停用的总体概率为14.9%。年龄较小可防止停用（风险比0.93，95%置信区间0.88 - 0.99，p = 0.048）。