替诺福韦地索普西富马酸盐批准用于年轻的HBV患者

StephenW

Da Hee Han, PharmD
December 17, 2018
Tenofovir Disoproxil Fumarate Approved for Use in Younger Patients With HBV
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Pharmacokinetic data from the GS-US-174-0144 trial has been added to the labeling. Pharmacokinetic data from the GS-US-174-0144 trial has been added to the labeling.

The labeling for Viread (tenofovir disoproxil fumarate; Gilead Sciences) has been updated to include use in chronic hepatitis B patients aged 2 to <12 years old based on safety, efficacy, and pharmacokinetic data from the GS-US-174-0144 trial.

The Indication section has been revised to state that Viread is intended for use in the treatment of chronic hepatitis B in adults and pediatric patients 2 years of age and older weighing at least 10kg. The Dosage and Administration section was also updated to distinguish Viread tablets from Viread oral powder for ease of use by the provider; the revision also highlights that the dosing is the same for both HIV and HBV indications.

In Trial 144 (N=89), HBeAg positive patients aged 2 to <12 years were assigned to Viread 8mg/kg (max 300mg dose) or placebo once daily for 48 weeks. At week 48, 77% of Viread-treated patients had HBV DNA <400 copies/mL vs 7% of placebo-treated patients. The safety and efficacy of Viread in patients <2 years and weighing <10kg have not been established. ALT normalization was seen in 66% vs 15% of patients in the Viread and placebo groups, respectively. HBeAg seroconversion was seen in 25% and 24% of patients treated with Viread and placebo, respectively.



Safety data from Trial 144 showed the mean percentage bone mineral density (BMD) gains from baseline to week 48 in lumbar spine and total body BMD in Viread-treated patients were less than the mean percentage BMD gains seen in placebo-treated patients. Also at week 48, the cumulative percentage of patients with ≥4% decreases in spine or whole body BMD was numerically higher in the Viread group vs the placebo group. Height was not affected for the duration of the clinical trial.

Viread, a nucleotide analogue (HIV-1 and HBV reverse transcriptase inhibitor), is also approved to treat HIV-1 infection in combination with other antiretrovirals in children and adults.

Viread is available as 150mg, 200mg, 250mg, and 300mg strength tablets in 30-count bottles. It is also supplied as a 40mg/g oral powder in 60g bottles.

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For more information call (800) 445-3235 or visit FDA.gov.

StephenW

Da Hee Han，PharmD
2018年12月17日
替诺福韦地索普西富马酸盐批准用于年轻的HBV患者


来自GS-US-174-0144试验的药代动力学数据已被添加到标记中。来自GS-US-174-0144试验的药代动力学数据已被添加到标记中。

根据GS-US-174-0144试验的安全性，有效性和药代动力学数据，Viread（替诺福韦地索普西富马酸盐; Gilead Sciences）的标签已经更新，包括用于2至<12岁的慢性乙型肝炎患者。

指示部分已经修订，声称Viread用于治疗成人和2岁及以上体重至少10kg的儿科患者的慢性乙型肝炎。剂量和用法部分也进行了更新，以便将Viread药片与Viread口服粉末区分开来，以方便提供者使用;该修订还强调了HIV和HBV适应症的剂量是相同的。

在试验144（N = 89）中，将2至<12岁的HBeAg阳性患者分配至Viread 8mg / kg（最大300mg剂量）或安慰剂，每日一次，持续48周。在第48周，77％的Viread治疗患者的HBV DNA <400拷贝/ mL，而7％的安慰剂治疗患者。 Viread在<2年且体重<10kg的患者中的安全性和有效性尚未确定。在Viread组和安慰剂组中，ALT正常化分别为66％和15％的患者。用Viread和安慰剂治疗的患者分别有25％和24％的患者出现HBeAg血清学转换。



来自试验144的安全性数据显示，腰椎的基线至第48周的骨矿物质密度（BMD）增加的平均百分比和Viread治疗的患者的总体BMD低于安慰剂治疗患者的BMD增加的平均百分比。同样在第48周，Viread组与安慰剂组相比，脊柱或全身BMD降低≥4％的患者的累积百分比在数值上更高。在临床试验期间，身高没有受到影响。

Viread是一种核苷酸类似物（HIV-1和HBV逆转录酶抑制剂），也被批准用于治疗儿童和成人中的其他抗逆转录病毒药物的HIV-1感染。

Viread有30毫克瓶装150毫克，200毫克，250毫克和300毫克强度的片剂。它还以60g瓶装40mg / g口服粉末的形式提供。

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欲了解更多信息，请致电(800)445-3235或访问FDA.gov