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Half of Patients Treated Long-Term with Tenofovir Lose HBeAg
After more than five years of tenofovir treatment, 50% of patients lose the hepatitis B "e" antigen (HBeAg), 37% seroconvert and develop "e" antibodies, 11% lose the hepatitis B surface antigen (HBsAg), and 8% clear the infection and develop surface antibodies, according to a global study presented at the 23rd Conference of the Asian Pacific Association for the Study of the Liver held in early June.
This and several other studies on tenofovir presented at APASL provided strong proof that tenofovir appears to be highly effective in reducing viral replication with 96% of patients reporting reduced (or no worsening) fibrosis and all achieving undetectable viral load. Even 74% of patients with cirrhosis were no longer cirrhotic after five years of treatment.
Long-term antiviral use has been associated with bone loss and kidney damage, but neither symptom was evident among the patients over the lengthy study period.
In another APASL study, researchers monitored 280 patients who had developed drug resistance to the antiviral lamivudine (Epivir-HBV) to see if they developed resistance when treated with tenofovir (alone or in combination with emtricitabine).
After 96 weeks of treatment, researchers reported that all patients responded well and no drug resistance developed. Tenofovir was successful in stopping viral replication even among virus that had mutated and had been able to "resist" lamivudine.
Source 1: "Six years of treatment with tenofovir..." by Tsai, Buti, Gane et al. APASL Liver Week. Singapore, June 6-10, 2013
www.natap.org/2013/APASL/APASL_30.htm
Source 2: No detectable tenofovir resistance..." by Gane, Corsa, Liu et al. APASL Liver Week. Singapore, June 6-10, 2013
www.natap.org/2013/APASL/APASL_31.htm
Even Patients with High Viral Loads Lose HBeAg with Tenofovir
Half of 10 HBeAg-positive patients with extremely high HBV DNA (exceeding 1 million copies/mL) who were treated with tenofovir over five years (288 weeks) lost HBeAg, 40% developed “e” antibodies, and 72.7% achieved normal ALT levels.
This study is significant because current medical guidelines do not recommend treating patients in the “immune-tolerant” stage of infection—when viral load is high and ALT levels are only slightly elevated.
This study focused on younger Asian adults (average age 32), two-thirds of whom were male. Their results were compared with 172 patients with lower viral loads who were also treated with tenofovir over 288 weeks. The group with lower viral loads achieved undetectable HBV DNA faster (within 60 weeks) while patients with high viral loads took 88 weeks to achieve undetectable HBV DNA.
Tenofovir’s success in spurring HBeAg seroconversion in younger adults—which usually results in a permanent lowering of viral load—may force experts to reconsider whether to change practice guidelines and recommend treating this patient group.
However, the next challenge experts must tackle is how long to treat this younger patient group with antivirals in order to achieve a sustained, permanent HBeAg seroconversion.
Source: “Tenofovir Disoproxil Fumarate (TDF) in Asian…” by Fung, Gordon, Krastev et al. 23rd Conference of the Asian Pacific Association for the Study of the Liver, 6-9 June 2013, Singapore.
www.natap.org/2013/APASL/APASL_28.htm
一半的患者长期治疗泰诺福韦失去大三阳
经过五年多的替诺福韦治疗,50%的患者失去乙肝“e”的抗原(HBeAg),37%的血清转化和发展的“e”抗体,11%失去了乙肝表面抗原(HBsAg),和8%清除感染和发展表面抗体,根据一项全球性研究,提出了在亚太协会第23届会议在六月初召开的肝的研究。
APASL替诺福韦这和其他几个研究提供了有力的证明,替诺福韦似乎是高度有效地减少病毒的复制,96%的患者减少纤维化,全部实现了病毒载量检测不到(或没有恶化)。即使74%的肝硬化患者不再肝硬化的治疗五年后。
已经长期应用抗病毒药物相关的骨质流失,肾脏损害,但在漫长的研究期间患者之间既不症状明显。
在另一个APASL研究中,研究人员监测了280例谁开发耐药抗病毒药拉米夫定(拉米HBV)的,看看他们是否产生抗药性时,替诺福韦治疗(单独或联合恩曲他滨)。
治疗96周后,研究人员报告说所有的患者反应良好,无耐药性开发。泰诺福韦是成功阻止病毒复制,即使在病毒突变,已经能够“抵抗”拉米夫定。
来源:“六十年替诺福韦治疗......”布提,蔡甘恩等。 ,APASL肝周。新加坡,2013年6月6-10日
www.natap.org/2013/APASL/APASL_30.htm
源2:没有检测替诺福韦电阻...“由甘恩,科萨,柳等。APASL肝周,新加坡,2013年6月6-10日
www.natap.org/2013/APASL/APASL_31.htm
即使具有高病毒载量的患者失去大三阳泰诺福韦
10例HBeAg阳性患者HBV-DNA具有极高(超过100万拷贝/ ml)分别用替诺福韦超过五年(288周)的一半失去了大三阳,40%开发的“e”的抗体,并取得72.7%ALT水平正常。
此研究是重要的,因为目前的医疗指引不建议在“免疫耐受”的阶段感染患者治疗时病毒载量和ALT水平仅轻度增高。
这项研究主要集中在年轻的亚洲成年人(平均年龄32岁),其中三分之二为男性。他们的研究结果相比,有172例患者病毒载量较低,谁也替诺福韦治疗288周。病毒载量较低的组更快达到HBV DNA检测不到(后60周),同时具有高病毒载量的患者花了88周达到HBV DNA检测不到。
泰诺福韦的成功,促使HBeAg血清转换在年轻的成年人,这通常会导致一个永久性降低病毒载量,可能会迫使重新考虑是否要改变实践指南和建议治疗这个病人组的专家。
然而,专家们必须解决的下一个挑战是如何看待这个年轻患者使用抗病毒药物,以达到持续的,永久的HBeAg血清转换。
资料来源:“替诺福韦酯富马酸(TDF)在亚洲......”由丰,戈登,克勒斯特夫等。第23届亚太肝脏研究协会,2013年6月6日至9日,新加坡会议。
www.natap.org/2013/APASL/APASL_28.htm
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