主张长期抗病毒HBV治疗

StephenW

Long-term antiviral HBV treatment advocated      
主张长期抗病毒HBV治疗.
            By Kirsty Oswald, medwireNews Reporter
Study results support the long-term use of tenofovir disoproxil fumarate (DF) for chronic hepatitis B virus (HBV), showing that it can suppress the virus and lead to regression of fibrosis and cirrhosis in patients after 5 years' treatment.
"The histological response and regression of fibrosis seen in this study are probably due to the potent viral suppression achieved with long-term use of tenofovir DF," say Patrick Marcellin (INSERM, Clichy, France) and colleagues.
"In clinical practice, maintenance of viral suppression is feasible given the overall favourable safety profile and the absence of treatment-limiting toxicity."
The study, published in TheLancet, included 348 patients who had been enrolled in phase III studies of tenofovir DF and continued open-label treatment during a planned 7 years.
After 5 years, 330 of 334 patients tested showed HBV viral suppression. Overall, 51% of patients had regression of fibrosis and 87% showed histologic improvement.
Additionally, 96% of patients showed regression of cirrhosis and only 5% of patients who had no cirrhosis at baseline (Ishak score <4) showed a worsening in Ishak score. Notably, 74% of the 96 patients who initially presented with cirrhosis (Ishak score ≥ 5) showed regression of fibrosis and were no longer cirrhotic.
Interestingly, the authors found that body mass index (BMI) was an independent predictor for cirrhosis regression, such that normal weight patients (BMI <25 kg/m2) had 18.9-fold increased odds of regression compared with obese patients (BMI ≥30 kg/m2). They say that this finding needs further investigation.
"This study and many others now support the recommendation that patients with chronic hepatitis B receive long-term treatment with a potent oral antiviral agent with a high barrier to resistance," say Michele Tana and Jay Hoofnagle, from the National Institutes of Health, Bethesda, Maryland, USA, in an accompanying editorial.
However, they add that many challenges and unanswered questions remain in the long-term treatment of HBV, such as how long patients should be treated for and how best safety should be monitored.

Licensed from medwireNews with permission from Springer Healthcare Ltd. ©Springer Healthcare Ltd. All rights reserved. Neither of these parties endorse or recommend any commercial products, services, or equipment.

  

StephenW

长期的抗病毒HBV治疗主张
发布时间2012年12月17日5:15 PM·没有评论
KIRSTY奥斯瓦尔德，medwireNews记者

研究结果支持长期使用富马酸替诺福韦酯（DF）治疗慢性乙型肝炎病毒（HBV），它可以抑制病毒，并导致回归纤维化和肝硬化患者治疗后5年。

“实现强效抑制病毒，长期使用替诺福韦DF和回归纤维化的组织学反应可能是由于本研究中发现，”说：帕特里克，Marcellin（INSERM，克利希，法国）和他的同事。

“在临床实践中，维修抑制病毒是可行，鉴于整体良好的安全性和治疗限制性毒性反应的情况下。”

这项研究发表在TheLancet，包括348例已参加第三阶段的研究，替诺福韦DF和计划7年期间继续开放标签治疗。

5年后，330 334例测试表明HBV病毒抑制。总体而言，51％的患者有肝纤维化的回归和87％，表现出组织学的改善。

此外，96％的患者表现为肝硬化的回归，并呈日益恶化的Ishak评分只有5％的患者在基线时有没有肝硬化（Ishak评分<4）。值得一提的是，74％的96例患者最初表现为肝硬化（Ishak评分≥5）表明回归肝纤维化，，并且不再肝硬化。

有趣的是，研究人员发现，身体质量指数（BMI）是一个独立的预测肝硬化回归，正常体重的患者（BMI <25 kg/m2）中增加了18.9倍的赔率回归相比，肥胖患者（BMI≥30公斤/平方米）。他们说，这一发现还需要进一步的调查。

“这项研究和其他许多人现在支持的建议，与慢性B型肝炎患者接受长期治疗的一个有效的口服抗病毒药物具有较高的耐药屏障，”米歇尔塔纳和Jay Hoofnagle说，从美国国立卫生研究院，贝塞斯达美国马里兰州，在随后的社论。

然而，他们补充说，许多挑战和悬而未决的问题仍然长期治疗乙肝，如长的病人应如何处理，以及如何最好的安全性，应监测。

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StephenW

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2961425-1/fulltext
Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up studyProf Patrick Marcellin MD a , Prof Edward Gane MD b, Prof Maria Buti MD c, Prof Nezam Afdhal MD d, Prof William Sievert MD e, Prof Ira M Jacobson MD f, Prof Mary Kay Washington MD g, Prof George Germanidis MD h, John F Flaherty PharmD i, Raul Aguilar Schall PhD i, Jeffrey D Bornstein MD i, Kathryn M Kitrinos PhD i, G Mani Subramanian MD i, John G McHutchison MD i, Prof E Jenny Heathcote MBBS j
SummaryBackgroundWhether long-term suppression of replication of hepatitis B virus (HBV) has any beneficial effect on regression of advanced liver fibrosis associated with chronic HBV infection remains unclear. We aimed to assess the effects on fibrosis and cirrhosis of at least 5 years’ treatment with tenofovir disoproxil fumarate (DF) in chronic HBV infection.

MethodsAfter 48 weeks of randomised double-blind comparison (trials NCT00117676 and NCT00116805) of tenofovir DF with adefovir dipivoxil, participants (positive or negative for HBeAg) were eligible to enter a 7-year study of open-label tenofovir DF treatment, with a pre-specified repeat liver biopsy at week 240. We assessed histological improvement (≥2 point reduction in Knodell necroinflammatory score with no worsening of fibrosis) and regression of fibrosis (≥1 unit decrease by Ishak scoring system).

FindingsOf 641 patients who received randomised treatment, 585 (91%) entered the open-label phase, and 489 (76%) completed 240 weeks. 348 patients (54%) had biopsy results at both baseline and week 240. 304 (87%) of the 348 had histological improvement, and 176 (51%) had regression of fibrosis at week 240 (p<0·0001). Of the 96 (28%) patients with cirrhosis (Ishak score 5 or 6) at baseline, 71 (74%) no longer had cirrhosis (≥1 unit decrease in score), whereas three of 252 patients without cirrhosis at baseline progressed to cirrhosis at year 5 (p<0·0001). Virological breakthrough occurred infrequently and was not due to resistance to tenofovir DF. The safety profile was favourable: 91 (16%) patients had adverse events but only nine patients had serious events related to the study drug.

InterpretationIn patients with chronic HBV infection, up to 5 years of treatment with tenofovir DF was safe and effective. Long-term suppression of HBV can lead to regression of fibrosis and cirrhosis.

FundingGilead Sciences.

MP4

正常体重比较好?

StephenW

回复 MP4 的帖子

是的.
正常体重的患者（BMI <25 kg/m2）有18.9倍的赔率相比，肥胖患者（BMI≥30 kg/m2）消退肝.
normal weight patients (BMI <25 kg/m2) had 18.9-fold increased odds of regression compared with obese patients (BMI ≥30 kg/m2).

咬牙硬挺

感谢分享

dfyy8989

肥胖患者（BMI≥30 kg/m2）消退肝.
?

StephenW

回复 dfyy8989 的帖子

正常体重的患者（BMI <25 kg/m2）比 肥胖患者（BMI≥30 kg/m2）18.9倍更有可能逆转肝纤维化.

BMI (Body Mass Index)身体质量指数

dfyy8989

StephenW 发表于 2012-12-20 13:16
回复 dfyy8989 的帖子

正常体重的患者（BMI

谢谢