添加到标签中的慢性乙型肝炎患者的长期安全性数据

StephenW

Da Hee Han, PharmD
July 05, 2018
Long-Term Safety Data for Vemlidy in Chronic Hepatitis B Added to Labeling

Revised labeling includes long-term safety data for tenofovir alafenamide
Revised labeling includes long-term safety data for tenofovir alafenamide

The Food and Drug Administration (FDA) has approved updated labeling for Vemlidy (tenofovir alafenamide; Gilead) to include long-term safety data and new drug interaction data between Vemlidy and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) when tenofovir alafenamide is given as part of the fixed-dose combination Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide).

Vemlidy, a nucleoside analogue (reverse transcriptase inhibitor), is currently approved to treat chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.

The Adverse Reactions section now includes pooled safety data from Study GS-US-320-0108 and Study GS-US-320-0110 in adults with chronic hepatitis B and compensated liver disease who continued to receive their original blinded treatment through Week 120, as well as from adult patients who received open-label Vemlidy from Weeks 96 through 120. The Week 96 analysis showed the most common adverse reaction reported was headache (occurring in ≥10% of patients). The proportion of patients who discontinued Vemlidy or tenofovir disoproxil fumarate (TDF) therapy due to adverse reactions of any severity was 1.5% and 0.9%, respectively.

At Week 120, the safety profile of Vemlidy appeared similar in patients who continued to receive blinded treatment as seen in Week 96. Moreover, the safety profile in patients who remained on Vemlidy during the open-label phase was similar to that in patients who switched from TDF to Vemlidy at Week 96.

Additional safety data regarding renal laboratory changes and bone mineral density (BMD) effects were also included in the updated labeling. In a pooled analysis, median change from baseline to Week 96 in eGFR was -1.2mL per minute in the Vemlidy group vs -4.8mL per minute in those receiving TDF. The mean percentage change in BMD from baseline to Week 96 as assessed by dual-energy X-ray absorptiometry (DXA) was -0.7% with Vemlidy vs -2.6% with TDF at the lumbar spine and -0.3% vs -2.5% at the total hip. The revised labeling also includes the frequency of laboratory abnormalities (ALT, LDL-C, glycosuria, AST, creatine kinase, serum amlyase) in Studies 108 and 110 for both Vemlidy and TDF.

In addition, the Drug Interactions section was updated to add that sofosbuvir/velpatasvir (Epclusa) and sofosbuvir/velpatasvir/voxilaprevir (Vosevi) do not have clinically significant interactions with Vemlidy.

For more information call or visit Vemlidy.com.

StephenW

Da Hee Han，PharmD
2018年7月5日
添加到标签中的慢性乙型肝炎患者的长期安全性数据

修订标签包括替诺福韦艾拉酚胺的长期安全性数据
修订标签包括替诺福韦艾拉酚胺的长期安全性数据

美国食品和药物管理局（FDA）已批准更新Vemlidy（替诺福韦艾拉那酰胺;吉利德）的标签，包括当使用替诺福韦艾拉酚胺时，Vemlidy和Vosevi（sofosbuvir / velpatasvir / voxilaprevir）之间的长期安全性数据和新的药物相互作用数据固定剂量组合Odefsey（恩曲他滨/ rilpivirine / tenofovir alafenamide）。

Vemlidy是一种核苷类似物（逆转录酶抑制剂），目前被批准用于治疗患有代偿性肝病的成人的慢性乙型肝炎病毒（HBV）感染。

不良反应部分现在包括来自研究GS-US-320-0108和研究GS-US-320-0110的成人慢性乙型肝炎和代偿性肝病的合并安全性数据，他们在第120周继续接受原始的盲法治疗，如以及从第96周到第120周接受开放标签的Vemlidy的成年患者。第96周分析显示报告的最常见的不良反应是头痛（发生在≥10％的患者中）。由于任何严重程度的不良反应，停用Vemlidy或替诺福韦地索普西富马酸盐（TDF）治疗的患者比例分别为1.5％和0.9％。

在第120周，Vemlidy的安全性特征似乎与第96周所见的继续接受盲法治疗的患者相似。此外，在开放标签阶段留在Vemlidy的患者的安全性特征与切换患者的相似。从第12周的TDF到Vemlidy。

关于肾实验室变化和骨矿物质密度（BMD）影响的其他安全性数据也包括在更新的标签中。在汇总分析中，在Veminidy组中，eGFR中从基线到第96周的中值变化为每分钟-1.2mL，而接受TDF的那些为每分钟-4.8mL。通过双能X射线吸收测定法（DXA）评估的BMD从基线到第96周的平均百分比变化为-0.7％，Vemlidy与腰椎TDF为-2.6％，-0.3％对比-2.5％。全臀。修订后的标签还包括Velenidy和TDF的研究108和110中实验室异常（ALT，LDL-C，糖尿，AST，肌酸激酶，血清淀粉酶）的频率。

此外，更新了药物相互作用部分，补充说sofosbuvir / velpatasvir（Epclusa）和sofosbuvir / velpatasvir / voxilaprevir（Vosevi）与Vemlidy没有临床上显着的相互作用。

欲了解更多信息，请致电或访问Vemlidy.com。