在慢性乙型肝炎患者服用替诺福韦倒退肝硬化，肝纤维化

StephenW

http://www.healio.com/hepatology/chronic-hepatitis/news/online/%7B675c6eda-beda-426b-a55e-1dc4cfc4ba7f%7D/cirrhosis-fibrosis-regressed-among-patients-with-chronic-hbv-taking-tenofovir-disoproxil-fumarate?registered=1
在慢性乙型肝炎患者服用替诺福韦倒退肝硬化，肝纤维化
Cirrhosis, fibrosis regressed among patients with chronic HBV taking tenofovir disoproxil fumarate
Marcellin P. Lancet. 2012;doi:10.1016/S0140-6736(12)61425-1.

    December 14, 2012

Tenofovir disoproxil fumarate caused long-term viral suppression and fibrosis regression with few adverse events in patients with chronic hepatitis B, according to recent results.

In a 7-year, open-label study, researchers evaluated 585 patients with chronic HBV treated with tenofovir disoproxil fumarate (DF). Liver biopsies were performed before open-label treatment, and again at 240 weeks. All participants had been enrolled in a prior 48-week, randomized double blind trial comparing tenofovir DF with adefovir dipivoxil, and 489 participants in this follow-up study completed all 240 weeks of treatment.

Among 348 patients who received biopsy after completing treatment, 87% experienced histological improvement and 51% indicated fibrosis regression after 240 weeks of therapy (P<.0001). Ninety-one percent of patients with baseline Ishak scores greater than 2 experienced improved fibrosis, and investigators noted that patients with higher liver injury scores benefited the most (P<.0001).

Fibrosis worsened in 5% of cases during treatment. Twenty-eight percent of biopsied patients had cirrhosis at baseline; 74% of these cases were no longer cirrhotic at 5 years, while three participants developed cirrhosis during therapy (P<.0001 for difference). Multivariate analysis indicated an association between BMI and cirrhosis regression (OR=7.4, 95% CI, 1.87-29.41 for BMI less than 25 kg/m2 compared with 25 kg/m2 or greater)

Adverse events occurred in 16% of all participants, including nine serious events considered treatment-related and eight patients who withdrew from the study because of adverse events. No incidence of virologic breakthrough was related to tenofovir DF resistance. Seven deaths occurred as a result of malignant disease.

“Treatment with tenofovir DF for up to 5 years is safe and well tolerated and maintains viral suppression in the majority of … patients with chronic hepatitis B,” the researchers concluded. “The findings of this study draw attention to the liver’s capacity for fibrosis regression, even when cirrhosis has developed, in hepatitis B when long-term viral suppression is attained. Moreover, the low frequency of adverse outcomes noted in this cohort reinforces the potential clinical benefits associated with regression of fibrosis, especially in patients with cirrhosis.”

StephenW

在7年，开放标签研究中，研究人员评估了585例慢性乙型肝炎治疗富马酸替诺福韦酯（DF）。开放标签治疗前进行肝活检，并再次在240周。所有与会者都进入前48周，随机双盲试验比较替诺福韦DF阿德福韦酯，489人在此后续研究，完成了所有240个星期的治疗。

其中348例患者完成治疗后活检，87％经历了组织学的改善，51％的人表示纤维化回归240周的治疗后（P <0.0001）。 91％的患者基线Ishak评分大于2名经验丰富的改善纤维化，调查人员指出，较高的肝脏损伤评分的患者获益最多（P <0.0001）。

在治疗过程中，纤维化程度在5％的情况下。活检的患者有28％的肝硬化患者在基线时，74％的个案不再肝硬化5年，而开发的三个参与者在治疗肝硬化（P <.0001差异）。多变量分析表明之间的关联的BMI和肝硬化回归（OR = 7.4，95％CI，1.87-29.41 BMI小于25 kg/m2的25 kg/m2或更大）

不良事件发生率为16％，所有参与者，包括9个严重的事件被认为与治疗相关的8例因不良事件退出的研究。没有发病的病毒学突破与替诺福韦DF电阻。七人死亡作为恶性疾病的结果发生。

“替诺福韦DF长达5年的治疗是安全的，耐受性良好，并保持病毒的抑制与慢性B型肝炎患者的大多数，研究人员得出结论。” “这项研究的结果提请注意在B型肝炎的肝纤维化回归的能力，即使在肝硬化的发展，达到长期抑制病毒的。此外，低频率的不良后果在此队列中指出，加强了潜在的临床益处与纤维化回归，尤其是肝硬化患者。“

StephenW

请参阅tonychant的发贴: http://www.hbvhbv.info/forum/thread-1211004-1-1.html