aCHIP, University of Copenhagen, Denmark bUniversity College London, UK cInstitute of Tropical Medicine, Antwerp, Belgium dDepartment of Infectious Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden eRoyal Sussex County Hospital, Brighton, UK fHvidovre Hospital, University of Copenhagen, Denmark gGomel State Medical University, Belarus hHospital Ramon y Cajal, Madrid, Spain iSzpital Specjalistyczny, Chorzów, Poland jUniversity Hospital of Infectious Diseases, Zagreb, Croatia kVilnius University, Faculty of Medicine, Vilnius University Hospital Santaros Klinikos lNovgorod Centre for AIDS Prevention and Control, Russia mKaplan Medical Center, Rehovot, Israel nHospital JM Ramos Mejia, Buenos Aires, Argentina oSapienza University of Rome, Rome, Italy pMedizinische Hochschule Hannover, Germany qCentre Hospitalier de Luxembourg, Luxembourg rViiV Healthcare, RTP, North Carolina, USA.
AIDS. 2019 Nov 1;33(13):2013-2024. doi: 10.1097/QAD.0000000000002320.
To assess the use of two-drug antiretroviral regimens (2DR) and virologic and immunologic outcomes compared with three-drug regimens (3DR) in the EuroSIDA cohort.
Multicentre, prospective cohort study.
Logistic regression was used to analyse the uptake and outcomes among HIV-positive individuals who started or switched to a 2DR compared with those on a 3DR. Virologic outcomes were assessed on-treatment as the proportion of individuals with controlled viral load (<400 copies/ml), or with a composite modified FDA snapshot endpoint (mFDA), with mFDA success defined as controlled viral load at 6 months or 12 months for individuals with a known viral load, no regimen changes, AIDS or death. Immunologic response was defined as a 100 cells/μl or a 25% increase in CD4 cell counts from baseline.
Between 1 July 2010 and 31 December 2016, 423 individuals started or switched to a 2DR (eight antiretroviral-naive) and 4347 started a 3DR (566 naive). Individuals on 2DR tended to have suppressed viral load, higher CD4 cell counts and more comorbidities at baseline compared with those on 3DR. There were no differences in the proportions of individuals who obtained on-treatment or mFDA success, and no significant differences in the adjusted odds ratios for mFDA success or immunologic responses between the 2DR and 3DR groups at 6 months or 12 months.
In routine clinical practice, 2DR were largely used for virologically suppressed individuals with higher cumulative exposure to antiretrovirals and comorbidities. Virologic and immunologic outcomes were similar among those on 2DR or 3DR, although confounding by indication cannot be fully excluded due to the observational nature of the study.
评估在 EuroSIDA 队列中，与三药治疗方案（3DR）相比，二药抗逆转录病毒治疗方案（2DR）的使用情况以及病毒学和免疫学结局。
多中心、前瞻性队列研究。
使用逻辑回归分析开始或转换为 2DR 的 HIV 阳性个体与使用 3DR 的个体的采用情况和结局。治疗中评估病毒学结局，即病毒载量得到控制（<400 拷贝/毫升）的个体比例，或采用复合 FDA 快照终点（mFDA），mFDA 成功定义为已知病毒载量、无方案改变、艾滋病或死亡的个体在 6 个月或 12 个月时病毒载量得到控制。免疫反应定义为 CD4 细胞计数基线增加 100 个/μl 或 25%。
在 2010 年 7 月 1 日至 2016 年 12 月 31 日期间，423 名个体开始或转换为 2DR（8 名无抗逆转录病毒治疗史），4347 名个体开始使用 3DR（566 名无抗逆转录病毒治疗史）。与使用 3DR 的个体相比，使用 2DR 的个体在基线时病毒载量得到抑制、CD4 细胞计数较高、合并症更多。在治疗中或 mFDA 成功的个体比例方面，2DR 和 3DR 组之间没有差异，在 6 个月或 12 个月时 mFDA 成功或免疫反应的调整后比值比也没有显著差异。
在常规临床实践中，2DR 主要用于病毒学抑制、累积抗逆转录病毒暴露量较高和合并症较多的个体。虽然由于研究的观察性质，无法完全排除指示性混杂因素，但使用 2DR 或 3DR 的个体的病毒学和免疫学结局相似。
