Todd Sej, Rafferty P, Walker E, Hunter M, Dinsmore W W, Donnelly C M, McCarty E J, Quah S P, Emerson C R
Royal Victoria Hospital, Belfast, UK.
Int J STD AIDS. 2017 Oct;28(11):1074-1081. doi: 10.1177/0956462416688127. Epub 2017 Jan 24.
Dolutegravir (DTG) is the third HIV integrase inhibitor (INI) available for prescription in Belfast since July 2014. It has shown high virological efficacy in both treatment-naïve and -experienced patients. We carried out a retrospective case chart analysis of HIV-1-positive adults commenced on DTG between July 2014 and September 2015. Patients were identified from records as either treatment-naïve or antiretroviral therapy (ART) experienced. Outcomes included: (1) virological response (HIV-1 RNA viral load at 0, 4, 8 and 12 weeks), (2) immunological response (CD4+ cell count at 0, 4, 8 and 12 weeks) and (3) tolerability (side effects and discontinuation). The main exclusion criteria were patients transferring care already established on DTG from other treatment centres or inadequate follow-up information (defined as attendance at <50% of clinical and serological follow-up visits). One hundred and fifty-seven commenced DTG out of 823 patients on ART; 106 (68%) were switched to DTG from another regimen, and 51 (32%) were ART-naïve. One naïve and 14 treatment-experienced patients were excluded from the analysis due to failure to attend clinical follow-up. Analysis of HIV-1 RNA viral load (HIV-1 VL) was divided into three groups: 50 new starters, 68 suppressed at switch and 24 not suppressed at switch. New starters: Baseline median HIV-1 RNA VL 71,259 copies/mL (19,536-196,413); 73% were virally undetectable (HIV-1 RNA VL <70 copies/mL) by week 4. Switching patients: Of those with an HIV-1 RNA undetectable viral load prior to switching, two were detectable with a mean viral load of 443,730 copies/mL after four weeks. Of the 24 patients detectable at switch (median HIV-1 VL 2212 [311-43,467]), 10 were detectable after four weeks. For those with a recordable viraemia, the median HIV-1 VL reduced to 376 (220-1181). At week 12, four patients were detectable with a median VL of 12,390 (567-52,285). Overall, 56 (35%) reported side effects; 40 (25%) reported either difficulty with low mood, anxiety or sleep disturbance. Sixteen (10%) discontinued DTG, with 13 (8%) due to intolerable side effects. DTG is a useful drug in naïve or switch patients. It has the potential to effectively suppress the viral load within the first four weeks of treatment and thus reduces infectiousness. Within the cohort, DTG was generally well tolerated but side effects such as low mood, anxiety and sleep disturbance were high, with 8% of patients discontinuing treatment.
多替拉韦（DTG）是自2014年7月以来在贝尔法斯特可供处方的第三种HIV整合酶抑制剂（INI）。它在初治和经治患者中均显示出高病毒学疗效。我们对2014年7月至2015年9月开始使用DTG的HIV-1阳性成人进行了回顾性病例图表分析。从记录中确定患者为初治或接受过抗逆转录病毒治疗（ART）。结果包括：（1）病毒学反应（0、4、8和12周时的HIV-1 RNA病毒载量），（2）免疫学反应（0、4、8和12周时的CD4 +细胞计数）和（3）耐受性（副作用和停药情况）。主要排除标准是已从其他治疗中心转来且已确立DTG治疗的患者或随访信息不足（定义为临床和血清学随访就诊率<50%）。在823例接受ART治疗的患者中，有157例开始使用DTG；106例（68%）是从另一种治疗方案转换为DTG，51例（32%）是初治患者。由于未参加临床随访，1例初治患者和14例经治患者被排除在分析之外。对HIV-1 RNA病毒载量（HIV-1 VL）的分析分为三组：50例新开始治疗者，68例转换治疗时病毒被抑制者，24例转换治疗时病毒未被抑制者。新开始治疗者：基线HIV-1 RNA VL中位数为71,259拷贝/mL（19,536 - 196,413）；到第4周时，73%的患者病毒载量不可检测（HIV-1 RNA VL <70拷贝/mL）。转换治疗的患者：在转换治疗前病毒载量不可检测的患者中，有2例在4周后病毒载量可检测，平均病毒载量为443,730拷贝/mL。在转换治疗时病毒载量可检测的24例患者（HIV-1 VL中位数为2212 [311 - 43,467]）中，10例在4周后病毒载量仍可检测。对于有可记录病毒血症的患者，HIV-1 VL中位数降至376（220 - 1181）。在第12周时，有4例患者病毒载量可检测，中位数VL为12,390（567 - 52,285）。总体而言，56例（35%）报告有副作用；40例（25%）报告有情绪低落、焦虑或睡眠障碍方面的问题。16例（10%）停用DTG，其中13例（8%）是由于无法耐受的副作用。DTG对初治或转换治疗的患者是一种有用的药物。它有可能在治疗的前四周内有效抑制病毒载量，从而降低传染性。在该队列中，DTG总体耐受性良好，但情绪低落、焦虑和睡眠障碍等副作用发生率较高，有8%的患者停止治疗。
