在严格观察下停用TDF安全的

StephenW

Discontinuation of TDF for HBV Safe Under Strict Observation

Berg T, et al. J Hepatol. 2018;doi:10.1053/j.jhep.2017.07.012.
Healio Gastroenterology, November 2018

Results of a randomized control study showed the potential for hepatitis surface antigen loss and sustained virologic response in patients without cirrhosis and negative for HBV e-antigen after stopping long-term tenofovir disoproxil fumarate, according to recently published data.

“Although there is currently no cure for chronic hepatitis B virus (HBV) infection, the virus can be effectively controlled with current antiviral treatment strategies using either interferon (IFN) or nucleos(t)ide analogues (NA),” Thomas Berg, MD, from the University Clinic Leipzig in Germany, and colleagues wrote. “The results of this study support the concept of stopping antiviral therapy in long-term HBV DNA-suppressed patients without cirrhosis, under strict observation.”

The researchers randomly assigned 21 patients to stop TDF therapy and 21 patients to continue therapy. Of those who stopped therapy, 13 remained off-therapy up to 144 weeks of follow-up.

During the study, eight patients qualified to restart TDF due to persistently high levels of viremia or early flares of HBV DNA and alanine aminotransferase levels.

By week 144, four patients who discontinued TDF achieved HBsAg loss and three patients achieved HBsAg seroconversion. No patients who continued therapy achieved HBsAg loss or seroconversion.

HBV DNA and ALT levels fluctuated among patients who discontinued therapy, whereas those who remained on therapy demonstrated constant HBV DNA levels.

At study end, 76% of those who discontinued TDF therapy had HBV DNA of 2,000 IU/mL or less and ALT levels at the upper limit of normal or lower.

“Although there were clear fluctuations in HBV DNA levels and ALT levels in the patients who discontinued TDF therapy, there were no unexpected safety issues in this patient group,” the researchers wrote. “Overall, the results from this study are encouraging. However, this study was experimental in nature and was conducted with a highly controlled cohort that was under strict observation. The study did not aim to make any recommendations regarding stopping TDF therapy in patients with HBV during routine clinical practice.” – by Talitha Bennett

Disclosure: The study was funded by Gilead Sciences. Berg reports grants and personal fees from AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, Bayer, Vertex, Tibotec, Intercept, Merck Sharp & Dohme, and Roche. Please see the full study for all other authors’ relevant financial disclosures.

StephenW

在严格观察下停用HBV安全的TDF

Berg T等人。 J Hepatol。 2018; DOI：10.1053 / j.jhep.2017.07.012。
Healio Gastroenterology，2018年11月

根据最近公布的数据，随机对照研究的结果显示，在停用长期替诺福韦地索普索富马酸盐后，无肝硬化患者肝炎表面抗原丢失和持续病毒学应答的可能性和HBV e抗原阴性。

“虽然目前尚无治疗慢性乙型肝炎病毒（HBV）感染的方法，但目前使用干扰素（IFN）或核苷（酸）类似物（NA）的抗病毒治疗策略可有效控制病毒，”Thomas Berg，MD来自德国莱比锡大学诊所的同事们写道。 “这项研究的结果支持在严格观察的情况下停止长期HBV DNA抑制的无肝硬化患者的抗病毒治疗的概念。”

研究人员随机分配了21名患者停止TDF治疗，21名患者继续治疗。在那些停止治疗的患者中，13名患者在接受144周的随访期间仍未接受治疗。

在研究期间，由于持续高水平的病毒血症或HBV DNA和丙氨酸氨基转移酶水平的早期发作，8名患者有资格重新开始TDF。

到第144周，4名停用TDF的患者达到HBsAg损失，3名患者达到HBsAg血清转换。没有继续治疗的患者达到HBsAg丢失或血清转换。

HBV DNA和ALT水平在停止治疗的患者中波动，而那些继续接受治疗的患者表现出恒定的HBV DNA水平。

在研究结束时，76％停用TDF治疗的患者HBV DNA为2,000 IU / mL或更低，ALT水平在正常或更低的上限。

研究人员写道：“虽然停用TDF治疗的患者HBV DNA水平和ALT水平明显波动，但该患者组没有出现意外的安全问题。” “总的来说，这项研究的结果令人鼓舞。然而，这项研究本质上是实验性的，并且是在严格观察的高度控制的队列中进行的。该研究的目的不是为了在常规临床实践中就HBV患者停止TDF治疗提出任何建议。“ - 作者：Talitha Bennett

披露：该研究由吉利德科学公司资助。 Berg报告了来自AbbVie，Bristol-Myers Squibb，Gilead Sciences，Janssen，Bayer，Vertex，Tibotec，Intercept，Merck Sharp＆Dohme和Roche的补助金和个人费用。有关所有其他作者的相关财务披露，请参阅完整的研究。

Hepbest

停可以，但是需要严密监测。
半年内是关键