Castelnuovo Barbara, Mubiru Frank, Kiragga Agnes N, Musomba Rachel, Mbabazi Olive, Gonza Paul, Kambugu Andrew, Ratanshi Rosalind Parks
Infectious Diseases Institute, Makerere University, Kampala, Uganda.
BMJ Open. 2018 Feb 21;8(2):e015490. doi: 10.1136/bmjopen-2016-015490.
Little information is available on patients on antiretroviral treatment (ART) after a long-term period from sub-Saharan Africa, with the longest follow-up and related outcomes being after 10 years on ART. At the Infectious Diseases Institute (IDI) (Kampala, Uganda), we set up a cohort of patients already on ART for 10 years at the time of enrolment, who will be followed up for additional 10 years.
A prospective observational cohort of 1000 adult patients previously on ART for 10 years was enrolled between May 2014 and September 2015. Patients were eligible for enrolment if they were in their consecutive 10th year of ART regardless of the combination of drugs for both first- and second-line ART. Data were collected at enrolment and all annual study visits. Follow-up visits are scheduled once a year for 10 years. Biological samples (packed cells, plasma and serum) are stored at enrolment and follow-up visits.
Out of 1000 patients enrolled, 345 (34.5%) originate from a pre-existing research cohort at IDI, while 655 (65.5%) were enrolled from the routine clinic. Overall, 81% of the patients were on first line at the time of the enrolment in the ART long-term cohort, with the more frequent regimen being zidovudine plus lamivudine plus nevirapine (44% of the cohort), followed by zidovudine plus lamivudine plus efavirenz (22%) and tenofovir plus lamivudine or emtricitabine plus efavirenz (10%). At cohort enrolment, viral suppression was defined as HIV-RNA <400 copies/mL was 95.8%.
Through collaboration with other institutions, we are planning several substudies, including the evaluation of the risk for cardiovascular diseases, the assessment of bone mineral density, screening for liver cirrhosis using fibroscan technology and investigation of drug-drug interactions between ART and common drugs used for non-communicable diseases.
关于撒哈拉以南非洲地区接受抗逆转录病毒治疗（ART）的患者在长期治疗后的情况，可获取的信息较少，目前最长的随访及相关结果是在接受ART治疗10年后。在传染病研究所（IDI，位于乌干达坎帕拉），我们建立了一个队列，其中的患者在入组时已经接受了10年的ART治疗，并将再随访10年。
2014年5月至2015年9月期间，纳入了1000名此前接受ART治疗10年的成年患者组成的前瞻性观察队列。无论一线和二线ART使用何种药物组合，只要患者处于连续接受ART治疗的第10年，就有资格入组。在入组时以及所有年度研究访视时收集数据。计划进行为期10年的每年一次的随访访视。在入组和随访访视时储存生物样本（浓缩细胞、血浆和血清）。
在入组的1000名患者中，345名（34.5%）来自IDI现有的一个研究队列，而655名（65.5%）是从常规诊所入组的。总体而言，在ART长期队列入组时，81%的患者处于一线治疗，最常用的治疗方案是齐多夫定加拉米夫定加奈韦拉平（占队列的44%），其次是齐多夫定加拉米夫定加依非韦伦（22%）以及替诺福韦加拉米夫定或恩曲他滨加依非韦伦（10%）。在队列入组时，病毒抑制定义为HIV-RNA<400拷贝/mL，比例为95.8%。
通过与其他机构合作，我们正在计划开展多项子研究，包括评估心血管疾病风险、评估骨矿物质密度、使用FibroScan技术筛查肝硬化以及研究ART与用于非传染性疾病的常用药物之间的药物相互作用。
