抗HIV药物Sustiva获准用于某些婴儿

圣路易斯(MD Consult)——2013年5月3日，百时美-施贵宝宣布，美国食品药品管理局(FDA)已批准扩大非核苷逆转录酶抑制剂Sustiva(依法韦仑)治疗人类免疫缺陷病毒1型(HIV-1)感染的适用范围。该药最初于1998年获准用于治疗年龄≥3岁、体重≥10 kg的HIV-1感染患者。从现在起，该药也可被用于年龄≥3个月、体重≥3.5 kg的婴儿。根据批准令，对这一人群可选择每日1次给药方案，对无法吞咽胶囊或药片的患者可采用分散型胶囊给药方法。

这项批准令是以3项开放标记研究的结果为依据的。这些研究招募了182例抗逆转录病毒初治和经治的HIV-1患者(年龄为3个月~21岁)，评估了Sustiva联合其他抗逆转录药物中位治疗123周的药代动力学、安全性和抗逆转录病毒活性。结果显示，至研究结束时，在所有年龄段患者中均观察到了病毒学和免疫学应答。

在这3项儿科试验中观察到的不良反应与成人临床试验的观察结果相似，不同的是儿科患者中皮疹更常见(32%)且常常更严重。5例儿科患者因皮疹而退出研究。

不建议对年龄不足3个月或体重不足3.5 kg的患者使用Sustiva，原因是该药对于这类患者的安全性、药代动力学和抗逆转录病毒活性尚不明确，而且假如Sustiva用量不足，可能增加这类患者发生HIV耐药的风险。

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ST LOUIS (MD Consult) - On May 3, 2013, Bristol-Myers Squibb announced that the US Food and Drug Administration (FDA) has granted approval for expanded use of the non-nucleoside reverse transcriptase inhibitor Sustiva (efavirenz) for the treatment of human immunodeficiency virus-1 (HIV-1) infection. The drug was originally approved in 1998 to treat patients infected with HIV-1 aged 3 years and older who weighed at least 10 kg. Now, the product is also approved for use in infants aged 3 months and older who weigh at least 3.5 kg. This approval offers a once-daily option as part of a regimen for this population, and includes a capsule sprinkle administration method for patients who cannot swallow capsules or tablets.

This approval was granted on the basis of results from 3 open-label studies that evaluated the pharmacokinetics, safety, and antiretroviral activity of Sustiva in combination with other antiretroviral agents in 182 antiretroviral-naïve and -experienced patients infected with HIV-1 (aged 3 months to 21 years) for a median of 123 weeks. Virologic and immunologic response was observed across all ages at the end of the studies.

The adverse reactions observed in the 3 pediatric trials were similar to those observed in clinical trials in adults, except that rash was more common in pediatric patients (32%) and more often of higher grade. Five pediatric patients discontinued study participation because of rash.

Use of Sustiva in patients younger than 3 months or who weigh less than 3.5 kg is not recommended because the safety, pharmacokinetics, and antiretroviral activity of the product has not been evaluated in this age group, and such patients may run the risk of HIV resistance if Sustiva is underdosed.

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