AASLD2014:功效和替比夫定与替诺福韦治疗的基础上，路线图概

StephenW

1878Efficacy and safety of telbivudine versus tenofovir treatment based on the Roadmap concept: Results from a randomized, controlled trial in HBeAg-negative chronic hepatitis B patientsZahary Krastev1, Iskren A. Kotzev2, Mustafa K. Celen3, David Mc Neeley4, Kamal A. Hamed4;1University Multiprofile Hospital for Active Treatment “Sv. Ivan Rilski”, Sofia, Bulgaria; 2University Hospital St Marina, Varna, Bulgaria; 3Dicle University School of Medicine, Diyarbakir, Turkey; 4Novartis Pharmaceuticals Corporation, East Hanover, NJBackground: This study evaluated the efficacy and safety of tel-bivudine (LdT) versus tenofovir disoproxil fumarate (TDF) treatment in patients with HBeAg-negative chronic hepatitis B (CHB) following the Roadmap concept of response-guided therapy. Methods: In this prospective, open-label, non-inferiority study, patients were randomized (1:1) to either LdT 600 mg q.d. or TDF 300 mg q.d. Patients received monotherapy (LdT or TDF) for 24 weeks, after which those with HBV DNA ≥300 copies/ mL at Week 24 received an add-on therapy (LdT/TDF) until Week 104, while patients with HBV DNA <300 copies/mL continued the monotherapy. The modified intent-to-treat (mITT) population consisted of all patients who did not discontinue before Week 24 and did not receive an add-on therapy at Week 24. Results: In total, 241 patients were randomized (LdT=121; TDF=120). Of those, 115 LdT and 117 TDF patients were included in the mITT population. Baseline characteristics were well matched between the treatment groups. The primary efficacy endpoint for non-inferiority was met, with 92.1% LdT and 95% TDF patients achieving HBV DNA level <300 copies/ mL at Week 52 (Table). There were no deaths. Serious adverse events (SAEs), reported in 17 patients (8 in LdT and 9 in TDF), were not related to the treatment according to investigator's opinion. Twice as many patients from the LdT monotherapy arm with an abnormal estimated glomerular filtration rate (eGFR) at baseline reverted to normal eGFR compared to the TDF mono-therapy arm. Conclusions: LdT is effective and non-inferior to TDF for the treatment of HBeAg-negative CHB. LdT was associated with an improvement in renal function (eGFR) when compared to TDF.
Table. Efficacy and safety outcomes

Disclosures:
Zahary Krastev - Grant/Research Support: Gilead Sciences INC, Gilead Sciences INC, Gilead Sciences INC, Gilead Sciences INC, novartis
David Mc Neeley - Employment: Novartis Pharmaceutical Corporation; Stock Shareholder: Novartis Pharmaceutical Corporation
Kamal A. Hamed - Employment: Novartis; Stock Shareholder: Novartis
The following people have nothing to disclose: Iskren A. Kotzev, Mustafa K. Celen

StephenW

1878
功效和替比夫定与替诺福韦治疗的基础上，路线图概念的安全性：结果来自一项随机，对照试验中HBeAg阴性慢性乙肝患者
Zahary Krastev1，Iskren答Kotzev2，穆斯塔法·K。Celen3，大卫·麦当劳Neeley4，卡迈勒答Hamed4;
1University Multiprofile医院积极治疗“SV。伊万Rilski“，索非亚，保加利亚; 2University医院街码头，保加利亚瓦尔纳; 3Dicle大学医学院，迪亚巴克尔，土耳其; 4Novartis制药公司，东汉诺威，新泽西州

背景：本研究评估的有效性和电话，bivudine（LDT）安全与富马酸替诺福韦酯（TDF）治疗HBeAg阴性慢性乙型肝炎（CHB）以下的应答指导治疗的路线图概念的待遇。方法：采用前瞻性，开放性，非劣效性研究中，患者被随机分配（1:1）要么LDT600毫克，连用或TDF300毫克q.d.患者接受单药治疗（LDT或TDF）24周，之后，那些与HBV-DNA≥300拷贝/ ml，在第24周获得了附加治疗（LDT/ TDF），直到第104周，而乙肝病毒DNA的患者<300拷贝/毫升继续单药治疗。修改后的意向性治疗（MITT）人群包括谁第24周之前没有停止，也没有收到附加在治疗第24周结果所有患者：共有241例患者被随机（LDT=121; TDF =120）。其中，115 LDT和117 TDF患者被纳入米特人。基线特征在治疗组之间的良好匹配。非劣效性的主要疗效终点是满足，以92.1％的LDT和95％TDF患者达到HBV DNA水平<300拷贝/ ml，在第52周（见表）。目前还没有死亡病例。严重不良事件（SAE）报告17例（8 LDT和9 TDF），并没有涉及到根据研究者的意见处理。两倍多的患者从LDT单药治疗组与不正常的估计肾小球滤过率（eGFR）在基线恢复到正常的表皮生长因子受体相比，TDF单一治疗的胳膊。结论：LDT是有效的，不劣于华盈为HBeAg阴性慢性乙型肝炎的治疗。 LDT时相比TDF与肾功能（EGFR）的改善是相关联的。

表。疗效和安全性结果
图片

披露：

Zahary Krastev - 格兰特/研究支持：吉利德科学公司，吉利德科学公司，吉利德科学公司，吉利德科学公司，诺华公司

大卫麦当劳尼利 - 就业：诺华制药公司;股股东：诺华制药公司

卡迈勒答哈米德 - 就业：诺华公司;股股东：诺华

下面的人都没有透露：Iskren答Kotzev，穆斯塔法·K。Celen

重韧

这想说明，这二个是可以联用?

StephenW

回复 重韧 的帖子

不是.
东欧研究, HBeAg阴性患者, 替比夫定和替诺福韦治疗相同的疗效，安全性.
替比夫定肝肾功能比较好.

研究弱点 - 患者随访期短，因此没有耐药性比较.

重韧

谢谢。哈。还以为是联合用更好。

肝肠欲断

哦，那用替比夫定更便宜！