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Hepatology:替诺福韦酯或可成为青少年HBV患者的有效疗法

来源:生物谷 2012-12-06 23:02

2012年12月6日 讯 /生物谷BIOON/ --一项临床试验近日研究发现,成年人的抗病毒药物替诺福韦酯(tenofovir DF),对于治疗携带乙型肝炎病毒(HBV)的青少年携带者是安全且有效的,相关研究成果刊登于国际杂志Hepatology上。

慢性乙肝在全球影响着大约3亿5千万人的健康及生活,每年有600,000人死于慢性乙肝。研究者Karen表示,感染HBV的儿童更易发展为严重的肝脏疾病,而且很有可能因为严重的肝脏疾病死亡。替诺福韦酯是一种治疗成年感染者的有效药物,我们的研究发现,替诺福韦酯对于治疗青少年感染者也同样有效。

研究者对12至17岁之间的101名青少年个体进行了双盲试验以及安慰剂治疗试验,参与者中52人随机接受每日300mg的替诺福韦酯,54名参与者接受安慰剂治疗,时间为72周,病毒学应答效应,即抗病毒药物抑制病毒的效力,是临床试验的主要结果表征,试验前,91%的参与者被检出HBV阳性,其中85%的参与者进行了HBV的前治疗。

试验结果显示,替诺福韦酯可以有效抑制HBV的水平,而且可以使得青少年(接受治疗或未治疗的青少年)的丙氨酸转氨酶恢复正常;而且替诺福韦酯对于抑制青少年HBV患者较为有效,研究结果显示,替诺福韦酯对于控制青少年HBV感染者是一个有效的疗法。(生物谷Bioon.com)

Randomized, placebo-controlled trial of tenofovir disoproxil fumarate in adolescents with chronic hepatitis B

Karen F. Murray1,¶,*, Leszek Szenborn2, Jacek Wysocki3, Stephen Rossi4, Amoreena C. Corsa4, Phillip Dinh4, John McHutchison4, Phillip S. Pang4, Luminita M. Luminos5, Malgorzata Pawlowska6, Jacek Mizerski7

Tenofovir disoproxil fumarate (DF) is highly effective for the suppression of hepatitis B virus (HBV) in chronically infected adults. This study evaluated the safety and efficacy of tenofovir DF in adolescents with chronic hepatitis B (CHB). In this double-blind, placebo-controlled trial, adolescents 12 to <18 years of age with CHB were randomized to tenofovir DF 300 mg (n = 52) or placebo (n = 54) once daily for 72 weeks. The primary endpoint was virologic response (HBV DNA <400 copies/mL) at week 72. One hundred six patients were enrolled; 101 patients completed 72 weeks of treatment. At baseline, 91% of patients were hepatitis B e antigen–positive and 85% had prior exposure to HBV therapy. A virologic response was observed in 89% (46/52) of patients who received tenofovir DF and 0% (0/54) of patients who received placebo (P < 0.001). Treatment response was not affected by prior HBV treatment. Furthermore, no resistance to tenofovir DF developed through week 72. Among patients with an alanine aminotransferase (ALT) level greater than the upper limit of normal at baseline, normalization of ALT occurred in 74% of patients receiving tenofovir DF and 31% of patients receiving placebo (P < 0.001). The rate of grade 3/4 adverse events was higher among patients treated with placebo (24%) than patients treated with tenofovir DF (10%). No patients met the safety endpoint of a 6% decrease in spine bone mineral density at week 72. Conclusion: Tenofovir DF therapy in HBV-infected adolescents was well tolerated and highly effective at suppressing HBV DNA and normalizing ALT values in both treatment-naïve adolescents and those with prior exposure to HBV therapy. (HEPATOLOGY 2012;56:2018–2026)

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