回复 把握当下 的帖子
(这难道。。。鼓励停药反弹) - 你可能是正确的。阅读这项临床试验:
Stopping TDF Treatment After Long Term Virologic Suppression in HBeAg-negative CHB (FINITE CHB)
This study is currently recruiting participants.
Verified November 2011 by Gilead Sciences
First Received on March 9, 2011. Last Updated on November 18, 2011 History of Changes
Sponsor: | Gilead Sciences | Information provided by (Responsible Party): | Gilead Sciences | ClinicalTrials.gov Identifier: | NCT01320943 | Purpose Withdrawal of antiviral therapy can result in hepatic or alanine aminotransferase (ALT) flares as Hepatitis B Virus (HBV) replication resumes; however, in some patients, a flare exacerbates chronic hepatitis temporarily but can also result in viral clearance. Hepatic flares are common after stopping anti-HBV therapy. Only patients who already are on treatment with tenofovir disoproxil fumarate (TDF) for at least 4 years and who achieved and maintained virologic suppression (< 400 copies/mL) for 3.5 or more years will be included in this study. One treatment arm will stop the TDF therapy while the other treatment arm will continue the TDF therapy. Patients who stop TDF (Arm A) will be monitored very closely with special focus on biochemical flares (especially ALT increases) and virological relapses (Hepatitis B viral load increases). If any subject in the stop therapy arm exceeds one or more predefined limits for such flares or relapses, TDF will be reinstituted. The study will assess Hepatitis B surface antigen (HBsAg) loss (i.e. specific Hepatitis B virus components are no longer detectable) and seroconversion (occurrence of Hepatitis B surface antibody, a specific antibody which usually occurs after HBsAg loss) rates during study duration. The percentage of patients who need to restart TDF therapy in the stop arm will also be evaluated.
经过长期病毒抑制在HBeAg阴性慢性乙型肝炎(慢性乙肝有限)停止TDF的治疗
这项研究目前正在招募参与者。
Gilead Sciences公司已验证的2011年11月
2011年3月9日,第一次收到。最后更新于11月18日,2011年历史的变迁
主办单位:Gilead Sciences公司
(责任方)提供的信息:Gilead Sciences公司
ClinicalTrials.gov标识符:NCT01320943
目的
抗病毒治疗停药后可导致肝丙氨酸转氨酶(ALT)耀斑或B型肝炎病毒(HBV)复制简历;然而,在一些患者中,耀斑加剧慢性肝炎暂时,但也可能导致病毒清除。是常见的抗乙肝病毒治疗停药后肝耀斑。
在这项研究中,只有已经富马酸替诺福韦酯(TDF)治疗至少4年,并实现和保持病毒学抑制(<400拷贝/毫升)3.5或以上的患者将被纳入。一个治疗组,将停止对TDF的治疗,而其他治疗组将继续TDF的治疗。
将监测患者停止华盈(A组)和非常密切,特别注重生flare(尤其是ALT键增加)和病毒学复发(B型肝炎病毒载量的增加)。在停止治疗
组
的任何问题,如果超过一个或多个这样的flare或复发的预定义的限制,将被再提起TDF的。
这项研究将评估乙肝表面抗原(HBsAg)的损失(即特定的B型肝炎病毒组件不再检测)在研究期间,转阴率(发生B型肝炎表面抗体,特异性抗体,这通常发生在HBsAg消失后)。需要重新启动停止
组
TDF的治疗的患者的比例也将进行评估。
条件干预阶段
慢性乙型肝炎
药物:停止TDF的治疗
第四阶段 |