Psychiatric Symptoms in Patients Receiving Dolutegravir.
Psychiatric Symptoms in Patients Receiving Dolutegravir.
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DOI：
10.1097/qai.0000000000001269
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发表时间：
2017-04-01
期刊：
影响因子：
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通讯作者：
Curtis L
中科院分区：
文献类型：
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作者：
Fettiplace A;Stainsby C;Winston A;Givens N;Puccini S;Vannappagari V;Hsu R;Fusco J;Quercia R;Aboud M;Curtis L
补充数字内容在文本中可用。据报道，精神症状（PS）经常发生在艾滋病毒感染者中，可能与特定的抗逆转录病毒药物有关。我们分析了度鲁特韦（DTG）和其他常用锚药观察到的PS。分析了5项随机临床试验（3项双盲试验）、观察性药物流行病学研究与分析（OPERA）队列和自发报告给ViiV Healthcare的病例中DTG治疗期间HIV阳性患者发生的选定PS（失眠、焦虑、抑郁和自杀倾向）。在临床试验中，接受DTG或对照药物[阿扎那韦、地瑞那韦、依法韦仑或雷特格韦（RAL）]治疗的患者报告的PS发生率较低且相似。最常报告的是inflammatory。在SINGLE试验中观察到最高的发生率（DTG 17%，依法韦仑12%），其他试验中的发生率始终较低（DTG：3%-8% vs对照药物：3%-7%）。与其他锚药物治疗的患者相比，更多的依法韦仑治疗的患者因PS而退出。在OPERA中，与DTG、RAL或地瑞那韦治疗的患者相比，依法韦仑治疗的患者基线时的PS史最低。尽管存在基线差异，但治疗期间4种锚药物的患病率和发生率相似。DTG组的PS退出率最低（0%-0.6%），RAL组最高（0%-2.5%）。申办者报告的事件与临床试验数据的性质相似。对3个不同数据来源的分析表明，与其他经常处方的治疗HIV感染的锚药物相似，DTG治疗患者也报告了PS。这些事件的报告频率较低，很少需要DTG停药。
Supplemental Digital Content is Available in the Text. Psychiatric symptoms (PSs) are reported to occur frequently in people living with HIV and may be associated with specific antiretrovirals. We analyzed PSs observed with dolutegravir (DTG) and other frequently prescribed anchor drugs. Selected PSs (insomnia, anxiety, depression, and suicidality) occurring in HIV-positive patients during DTG treatment across 5 randomized clinical trials (3 double-blind), in the Observational Pharmaco-Epidemiology Research & Analysis (OPERA) cohort, and among cases spontaneously reported to ViiV Healthcare were analyzed. In clinical trials, PSs were reported at low and similar rates in patients receiving DTG or comparators [atazanavir, darunavir, efavirenz, or raltegravir (RAL)]. Insomnia was most commonly reported. The highest rates were observed in SINGLE (DTG 17%, efavirenz 12%), with consistently lower rates in the other trials (DTG: 3%–8% versus comparator: 3%–7%). More efavirenz-treated patients withdrew because of PSs than patients treated with other anchor drugs. In OPERA, history of PSs at baseline was lowest in efavirenz-treated patients compared with patients treated with DTG, RAL, or darunavir. Despite baseline differences, prevalence and incidence during treatment were similar across the 4 anchor drugs. Withdrawal rates for PSs were lowest for DTG (0%–0.6%) and highest for RAL (0%–2.5%). Spontaneously reported events were similar in nature to clinical trial data. Analysis of 3 different data sources shows that, similar to other frequently prescribed anchor drugs to treat HIV infection, PSs are also reported in DTG-treated patients. These events are reported with low frequency and rarely necessitate DTG discontinuation.