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國內(nèi)首個兒童抗乙肝病毒藥物獲批

出處：媽媽育兒網(wǎng)日期：2017-08-22 14:44:57編輯：chen
（2017年8月16日，中國北京）百時美施貴寶公司今天宣布，基于國外已經(jīng)完成的兒童適應(yīng)癥臨床試驗數(shù)據(jù)和中國進(jìn)行的成人適應(yīng)癥長期臨床觀察數(shù)據(jù)，口服抗乙肝病毒藥物博路定®（恩替卡韋片）于近日獲得國家食品藥品監(jiān)督管理總局（CFDA）批準(zhǔn)[1]，用于治療2歲至小于18歲慢性乙肝病毒（HBV）感染代償性肝病的核苷初治患者。這是中國首個被批準(zhǔn)用于小齡兒童（<12歲）乙肝患者的核苷類藥物，有望給更多被乙肝病毒“肝擾”的患兒“信心的力量”，使他們可以與其他同齡人一樣輕松地生活。

近二十多年來，隨著乙肝疫苗接種預(yù)防策略的持續(xù)普及和落實，中國新生兒的乙肝防控取得了顯著成效，5歲以下兒童慢乙肝病毒感染率已降至1%以下[2]。“然而，目前我國育齡期婦女乙肝表面抗原攜帶率約有6%。盡管通過注射乙肝疫苗和乙肝免疫球蛋白，90%-95%的表面抗原陽性母親所生的孩子都可以免于乙肝病毒感染，可仍有少數(shù)高病毒載量乙肝孕婦所生的嬰兒會受到乙肝病毒的感染。” 北京解放軍302醫(yī)院青少年肝病診療與研究中心張鴻飛教授指出：“兒童乙肝感染者處于免疫耐受期時，可以不考慮抗病毒治療。但若進(jìn)入免疫活動期和再活動期，則需要及時進(jìn)行抗病毒治療，否則就會錯過最佳治療時機(jī)，對孩子的成長和以后的生活造成嚴(yán)重影響。”

數(shù)據(jù)顯示，與成人相比，兒童乙肝患者慢性化發(fā)生率更高。其中，圍產(chǎn)期和幼兒期感染HBV的慢性化發(fā)生率分別為90%和30%左右，約有3%-5%的患兒在成年前就可能發(fā)展為肝硬化，0.01%-0.03%甚至可能發(fā)展為肝癌[3]。張鴻飛教授補充道：“對于血清轉(zhuǎn)氨酶（ALT）正常的慢乙肝患兒而言，除了需要定期監(jiān)測肝功能和肝膽脾B超等，必要時還須進(jìn)行肝臟組織學(xué)檢查，以明確肝臟病變。早期精準(zhǔn)、安全、有效的抗病毒治療，可以大大降低成人期肝硬化和肝癌發(fā)生的風(fēng)險。”

據(jù)最新版中國《乙型肝炎防治指南》，無論是成人還是兒童慢乙肝患者，其治療目標(biāo)都是最大限度地抑制乙型肝炎病毒DNA復(fù)制，減少肝臟炎癥壞死，大幅度降低進(jìn)展至肝硬化、肝癌的風(fēng)險[4]。“雖然治療目標(biāo)明確，但我國低齡兒童抗病毒治療長期以來卻始終面臨少藥可用的困境。” 張鴻飛教授指出，“博路定®（恩替卡韋片）是目前有乙肝兒童治療適應(yīng)癥的最有效的口服核苷類抗病毒藥物，能夠抑制乙肝病毒在肝臟中的復(fù)制，減少肝臟炎癥壞死，逆轉(zhuǎn)肝臟纖維化，從而降低肝病進(jìn)展至肝硬化及肝癌的風(fēng)險。其兒童口服片劑適應(yīng)癥的獲批，開啟了中國兒童抗病毒治療的全新篇章，為改善慢乙肝患兒的生活質(zhì)量注入了信心，同時也對臨床規(guī)范化治療起到了積極的推動作用。”

2005年，博路定®（恩替卡韋片）在中國被批準(zhǔn)用于治療病毒復(fù)制活躍、ALT持續(xù)升高或有肝臟組織學(xué)顯示活動性病變的成人慢性乙肝患者。近年來，其在兒童抗病毒治療中的有效性和安全性也不斷得到證實。2014年，博路定®（恩替卡韋片）被美國食品藥品監(jiān)督管理局（FDA）批準(zhǔn)，在充分知情同意的基礎(chǔ)上，用于2歲及以上乙肝患兒的治療。2016年《Hepatology》雜志發(fā)表了一項隨機(jī)、雙盲、多中心的III期臨床試驗研究，結(jié)果顯示：經(jīng)博路定®（恩替卡韋片）治療2歲至<18歲的核苷初治的乙肝病毒e抗原（HBeAg）陽性的患兒，48周和96周HBV DNA降至50IU/ml以下的比例為49%和64%，HBeAg血清學(xué)轉(zhuǎn)換分別達(dá)24%、37%。96周耐藥率1.3%。同時安全性良好，對兒童的生長發(fā)育無影響[5]。

“為滿足中國乙肝患者迫切的治療需求，百時美施貴寶于十多年前加速在中國上市‘強效低耐藥’的博路定®（恩替卡韋片），重振乙肝抗病毒治療的信心，至今已惠及超過100萬中國慢乙肝患者。”百時美施貴寶中國病毒學(xué)事業(yè)部負(fù)責(zé)人黃迪仁表示：“今天，百時美施貴寶仍堅持兌現(xiàn)對中國肝炎防控的承諾。在科學(xué)、高效、嚴(yán)謹(jǐn)?shù)乃幤穼徳u審批體系下，豁免在中國進(jìn)行臨床試驗使博路定®（恩替卡韋片）兒童口服片劑適應(yīng)癥得以在中國加速獲批上市，有望幫助更多中國慢乙肝患兒‘乙路輕松成長’。”

關(guān)于百時美施貴寶

百時美施貴寶是一家以“研發(fā)并提供創(chuàng)新藥物，幫助患者戰(zhàn)勝嚴(yán)重疾病”為使命的全球性生物制藥公司。百時美施貴寶于1982年進(jìn)入中國，于同年成立的中美上海施貴寶制藥有限公司是在中國成立的第一家中美合資制藥企業(yè)。公司在肝炎、腫瘤和免疫腫瘤等疾病領(lǐng)域處于行業(yè)領(lǐng)先地位。如需了解更多信息，請瀏覽公司全球官方網(wǎng)站BMS.com，或通過LinkedIn、Twitter、YouTube以及Facebook獲取最新信息。

[1] 2016年國家食品藥品監(jiān)督管理局發(fā)布“食品藥品監(jiān)管總局關(guān)于解決藥品注冊申請積壓實行優(yōu)先審評審批的意見（食藥監(jiān)藥化管[2016]19號）”，兒童用藥可豁免在中國開展臨床研究。

[2] 中華醫(yī)學(xué)會肝病學(xué)分會.中華醫(yī)學(xué)會感染病學(xué)分會.慢性乙型肝炎防治指南（2015更新版）.《中華肝臟病雜志》.2015, 23(12). 888-905

[3] 張鴻飛.兒童慢性乙型肝炎的抗病毒治療[J].中華肝臟病雜志,2010,18(7):495-497

[4] 中華醫(yī)學(xué)會肝病學(xué)分會.中華醫(yī)學(xué)會感染病學(xué)分會.慢性乙型肝炎防治指南（2015更新版）.《中華肝臟病雜志》.2015, 23(12). 888-905

[5] Jonas, et al, Randomized, Controlled Trial of Entecavir Versus Placebo in Children With Hepatitis B Envelope Antigen–Positive Chronic Hepatitis B, Hepatology, 2016, 63(2):377-387

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