Seven-year efficacy and safety of treatment with tenofovir disoproxil fumarate for chronic hepatitis B virus infection.
Seven-year efficacy and safety of treatment with tenofovir disoproxil fumarate for chronic hepatitis B virus infection.
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用替诺福韦毒素毒素治疗的七年疗效和对慢性乙型肝炎病毒感染的治疗的安全性。
DOI：
10.1007/s10620-014-3486-7
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发表时间：
2015-05
影响因子：
3.1
通讯作者：
Marcellin, Patrick
中科院分区：
文献类型：
--
作者：
Buti, Maria;Tsai, Naoky;Petersen, Joerg;Flisiak, Robert;Gurel, Selim;Krastev, Zahary;Schall, Raul Aguilar;Flaherty, John F.;Martins, Eduardo B.;Charuworn, Prista;Kitrinos, Kathryn M.;Subramanian, G. Mani;Gane, Edward;Marcellin, Patrick
长期富马酸替诺福韦酯（TDF）治疗慢性B型肝炎（CH B）与持续的病毒抑制和消退纤维化和肝硬化在第5年（240周），并没有TDF耐药6年（288周）。我们评估了TDF在HBeAg阳性和HBeAg阴性CHB患者中长达7年（336周）的疗效、安全性和耐药性。完成1年（48周）TDF或阿德福韦酯随机治疗的患者有资格接受开放标签TDF，总持续时间为8年（384周）。在最初随机分配的641例患者中，585例（91.3%）进入开放标签期; 437/585例（74.7%）在第7年仍在研究中。对于第7年接受治疗的患者，99.3%的患者保持病毒抑制（HBV DNA < 69 IU/mL），80.0%的患者实现血清丙氨酸氨基转移酶正常化，在HBeAg阳性患者中，84/154（54.5%）和25/154（11.8%）分别实现HBeAg和HBsAg丢失。1/375（0.3%）例HBeAg阴性患者达到HBsAg丢失。7年内未检测到对TDF的耐药性。在开放期，3/4级药物相关不良事件不常见（1.0%）; 10例（1.7%）患者的血清肌酐升高≥0.5 mg/dL，高于基线。从第4年至第7年（第192周至第336周），未观察到骨矿物质密度的显著变化。长期TDF治疗与持续的病毒学、生化学和血清学应答相关，无耐药性。TDF治疗耐受性良好，肾脏和骨骼事件发生率低。这些数据证实了长期TDF治疗CHB的安全性和有效性。本文的在线版本（doi：10.1007/s10620-014-3486-7）包含补充材料，可供授权用户使用。
Long-term tenofovir disoproxil fumarate (TDF) treatment for chronic hepatitis B (CHB) is associated with sustained viral suppression and regression of fibrosis and cirrhosis at year 5 (240 weeks) and no TDF resistance through 6 years (288 weeks). We assessed the efficacy, safety, and resistance of TDF for up to 7 years (336 weeks) in HBeAg-positive and HBeAg-negative CHB patients. Patients who completed 1 year (48 weeks) of randomized treatment with TDF or adefovir dipivoxil were eligible to receive open-label TDF for a total duration of 8 years (384 weeks). Of 641 patients initially randomized, 585 (91.3 %) entered the open-label phase; 437/585 (74.7 %) remained on study at year 7. For patients on treatment at year 7, 99.3 % maintained viral suppression (HBV DNA < 69 IU/mL), 80.0 % achieved serum alanine aminotransferase normalization, and in HBeAg-positive patients, 84/154 (54.5 %) and 25/154 (11.8 %) achieved HBeAg and HBsAg loss, respectively. One/375 (0.3 %) HBeAg-negative patients achieved HBsAg loss. No resistance to TDF was detected through 7 years. During the open-label phase, grade 3/4 drug-related adverse events were uncommon (1.0 %); ten (1.7 %) patients had elevation of serum creatinine ≥0.5 mg/dL above baseline. No significant change in bone mineral density was observed from year 4 to year 7 (week 192 to week 336). Long-term TDF treatment was associated with sustained virologic, biochemical, and serologic responses, without resistance. TDF treatment was well tolerated, with a low incidence of renal and bone events. These data confirm the safety and efficacy of long-term TDF for CHB. The online version of this article (doi:10.1007/s10620-014-3486-7) contains supplementary material, which is available to authorized users.
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影响因子：
120.7
作者：
Chen, CJ;Yang, HI;Iloeje, UH
通讯作者：
Iloeje, UH
影响因子：
29.4
作者：
Iloeje, UH;Yang, HI;Chen, CJ
通讯作者：
Chen, CJ
影响因子：
2.5
作者：
Park, J. W.;Kim, H. S.;Park, C. K.
通讯作者：
Park, C. K.
DOI：
10.3390/v2061279
发表时间：
2010-06
期刊：
Viruses
影响因子：
--
作者：
De Clercq E;Férir G;Kaptein S;Neyts J
通讯作者：
Neyts J
影响因子：
29.4
作者：
Fung, Scott;Kwan, Peter;Gane, Edward
通讯作者：
Gane, Edward