Efficacy of tenofovir disoproxil fumarate at 240 weeks in patients with chronic hepatitis B with high baseline viral load.
Efficacy of tenofovir disoproxil fumarate at 240 weeks in patients with chronic hepatitis B with high baseline viral load.
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DOI：
10.1002/hep.26277
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发表时间：
2013-08
期刊：
影响因子：
13.5
通讯作者：
Marcellin, Patrick
中科院分区：
文献类型：
--
作者：
Gordon, Stuart C.;Krastev, Zahary;Horban, Andrzej;Petersen, Joerg;Sperl, Jan;Dinh, Phillip;Martins, Eduardo B.;Yee, Leland J.;Flaherty, John F.;Kitrinos, Kathryn M.;Rustgi, Vinod K.;Marcellin, Patrick
我们评估了基线高病毒载量（HVL）的慢性B型肝炎（CH B）患者接受富马酸替诺福韦酯（TDF）治疗240周后的抗病毒应答，HVL定义为B型肝炎病毒（HBV）DNA ≥9 log 10拷贝/mL。共有641例HBeAg阴性和HBeAg阳性患者（129例HVL患者）接受了48周的TDF 300 mg（HVL n = 82）或阿德福韦酯（ADV）10 mg（HVL n = 47），随后接受了额外192周的开放标签TDF。第72周或之后确认HBV DNA ≥400拷贝/mL的患者可选择添加恩曲他滨（FTC）。到第240周，98.3%的HVL和99.2%的非HVL患者在治疗中达到HBV DNA <400拷贝/mL。两组在基线和第240周之间的组织学消退率相似。HVL患者达到HBV DNA <400 copies/mL的时间通常比非HVL患者长，但到第96周，两组中HBV DNA <400 copies/mL的患者百分比相似。在HVL患者中，与ADV相比，初始接受TDF的患者达到HBV DNA <400拷贝/mL的时间更短。基线HVL患者在240周时没有持续病毒血症或与TDF耐药相关的氨基酸取代。结论：HVL的CHB患者可以通过长期TDF治疗实现HBV DNA阴性，尽管相对于非HVL患者，HBV DNA <400拷贝/mL的时间可能更长。
We evaluated the antiviral response of patients with chronic hepatitis B (CHB) who had baseline high viral load (HVL), defined as having hepatitis B virus (HBV) DNA ≥9 log10 copies/mL, after 240 weeks of tenofovir disoproxil fumarate (TDF) treatment. A total of 641 hepatitis B e antigen (HBeAg)-negative and HBeAg-positive patients (129 with HVL) received 48 weeks of TDF 300 mg (HVL n = 82) or adefovir dipivoxil (ADV) 10 mg (HVL n = 47), followed by open-label TDF for an additional 192 weeks. Patients with confirmed HBV DNA ≥400 copies/mL on or after week 72 had the option of adding emtricitabine (FTC). By week 240, 98.3% of HVL and 99.2% of non-HVL patients on treatment achieved HBV DNA <400 copies/mL. Both groups had similar rates of histologic regression between baseline and week 240. Patients with HVL generally took longer to achieve HBV DNA <400 copies/mL than non-HVL patients, but by week 96, the percentages of patients with HBV DNA <400 copies/mL were similar in both groups. Among HVL patients, time to achieving HBV DNA <400 copies/mL was shorter among those initially receiving TDF, compared to ADV. No patient with baseline HVL had persistent viremia at week 240 or amino acid substitutions associated with TDF resistance. Conclusion: CHB patients with HVL can achieve HBV DNA negativity with long-term TDF treatment, although time to HBV DNA <400 copies/mL may be longer, relative to patients with non-HVL.
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