Birlie Belay, Braekers Roel, Awoke Tadesse, Kasim Adetayo, Shkedy Ziv
Department of Statistics, Jimma University, Jimma, Ethiopia.
I-BioStat, Hasselt University, Diepenbeek, Belgium.
BMC Infect Dis. 2017 Jun 27;17(1):453. doi: 10.1186/s12879-017-2533-3.
Highly active antiretroviral therapy (HAART) has shown a dramatic change in controlling the burden of HIV/AIDS. However, the new challenge of HAART is to allow long-term sustainability. Toxicities, comorbidity, pregnancy, and treatment failure, among others, would result in frequent initial HAART regimen change. The aim of this study was to evaluate the durability of first line antiretroviral therapy and to assess the causes of initial highly active antiretroviral therapeutic regimen changes among patients on HAART.
A Hospital based retrospective study was conducted from January 2007 to August 2013 at Jimma University Hospital, Southwest Ethiopia. Data on the prescribed ARV along with start date, switching date, and reason for change was collected. The primary outcome was defined as the time-to-treatment change. We adopted a multi-state survival modeling approach assuming each treatment regimen as state. We estimate the transition probability of patients to move from one regimen to another.
A total of 1284 ART naive patients were included in the study. Almost half of the patients (41.2%) changed their treatment during follow up for various reasons; 442 (34.4%) changed once and 86 (6.69%) changed more than once. Toxicity was the most common reason for treatment changes accounting for 48.94% of the changes, followed by comorbidity (New TB) 14.31%. The HAART combinations that were robust to treatment changes were tenofovir (TDF) + lamivudine (3TC)+ efavirenz (EFV), tenofovir + lamivudine (3TC) + nevirapine (NVP) and zidovudine (AZT) + lamivudine (3TC) + nevirapine (NVP) with 3.6%, 4.5% and 11% treatment changes, respectively.
Moving away from drugs with poor safety profiles, such as stavudine(d4T), could reduce modification rates and this would improve regimen tolerability, while preserving future treatment options.
高效抗逆转录病毒疗法（HAART）在控制艾滋病毒/艾滋病负担方面已显示出巨大变化。然而，HAART的新挑战是实现长期可持续性。毒性、合并症、妊娠和治疗失败等因素会导致初始HAART方案频繁变更。本研究的目的是评估一线抗逆转录病毒疗法的持久性，并评估接受HAART治疗的患者初始高效抗逆转录病毒治疗方案变更的原因。
2007年1月至2013年8月在埃塞俄比亚西南部的吉姆马大学医院进行了一项基于医院的回顾性研究。收集了规定的抗逆转录病毒药物数据以及开始日期、换药日期和变更原因。主要结局定义为治疗变更时间。我们采用多状态生存建模方法，将每种治疗方案视为一个状态。我们估计患者从一种方案转换到另一种方案的转移概率。
共有1284名初治抗逆转录病毒治疗患者纳入研究。几乎一半的患者（41.2%）因各种原因在随访期间更换了治疗方案；442名（34.4%）患者更换了一次，86名（6.69%）患者更换了不止一次。毒性是治疗方案变更最常见的原因，占变更的48.94%，其次是合并症（新发结核病），占14.31%。对治疗方案变更耐受性较好的HAART组合为替诺福韦（TDF）+拉米夫定（3TC）+依非韦伦（EFV）、替诺福韦+拉米夫定（3TC）+奈韦拉平（NVP）和齐多夫定（AZT）+拉米夫定（3TC）+奈韦拉平（NVP），治疗方案变更率分别为3.6%、4.5%和11%。
摒弃安全性较差的药物，如司他夫定（d4T），可降低调整率，这将提高方案耐受性，同时保留未来的治疗选择。
