支持替诺福韦地索普西富马酸单药治疗多药耐药的慢性HBV感

StephenW

Hepatitis
SUMMARY AND COMMENT |

Support for Tenofovir Disoproxil Fumarate Monotherapy for Multidrug-Resistant Chronic HBV Infection

Atif Zaman, MD, MPH reviewing Lee HW et al. Clin Gastroenterol Hepatol 2018 Oct 26

Long-term efficacy data show that TDF monotherapy is equally as safe and effective as combination therapy.

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SUMMARY AND COMMENT | GASTROENTEROLOGY, INFECTIOUS DISEASES

November 13, 2018

Support for Tenofovir Disoproxil Fumarate Monotherapy for Multidrug-Resistant Chronic HBV Infection

Atif Zaman, MD, MPH reviewing Lee HW et al. Clin Gastroenterol Hepatol 2018 Oct 26

Long-term efficacy data show that TDF monotherapy is equally as safe and effective as combination therapy.

Early monotherapy regimens for chronic hepatitis B virus (HBV) infection, such as lamivudine, led to high rates of multidrug resistance (MDR). More-potent regimens such as tenofovir disoproxil fumarate (TDF) alone or in combination with another agent have been recommended for MDR, but a lack of long-term efficacy data hampers clear, consistent guidelines.

In an industry-funded, prospective, multicenter cohort study, researchers in Korea evaluated the long-term efficacy of TDF alone or in a combination regimen among 423 patients receiving rescue therapy for MDR HBV infection. The primary endpoint was virologic response, defined as serum HBV DNA <20 IU/mL.

Forty-one percent of patients received TDF monotherapy and the rest combination therapy. Those with adefovir resistance were more likely to receive combination therapy, while those without adefovir resistance were more likely to receive TDF alone. During a median follow-up of 180 weeks (16,615 person-years total), the overall virologic response was 70% at 48 weeks, 86% at 96 weeks, 92% at 144 weeks, 95% at 192 weeks, and 96% at 240 weeks. Response rates were similar in monotherapy and combination therapy groups. Low baseline HBV DNA levels and absence of adefovir resistance were associated with virologic response.
Comment

These data from a real-world setting demonstrate that TDF monotherapy is as effective as TDF combination therapy in achieving and maintaining virologic response in HBV patients who develop multidrug resistance. Most guidelines suggest add-on therapy, but switching to TDF monotherapy would reduce cost, improve compliance, and minimize adverse side effects compared with combination therapy. Therefore, clinicians should first consider TDF monotherapy for these patients.

Editor Disclosures at Time of Publication

Disclosures for Atif Zaman, MD, MPH at time of publication

Grant/Research support:
       

Merck

Citation(s):

Lee HW et al. Long-term efficacy of tenofovir disoproxil fumarate monotherapy for multidrug-resistant chronic HBV infection. Clin Gastroenterol Hepatol 2018 Oct 26; [e-pub]. (https://doi.org/10.1016/j.cgh.2018.10.037)

StephenW

肝炎
摘要和评论|

支持替诺福韦地索普西富马酸单药治疗多药耐药的慢性HBV感染

Atif Zaman，MD，MPH审查Lee HW等人。 Clin Gastroenterol Hepatol 2018年10月26日

长期疗效数据显示，TDF单药治疗与联合治疗同样安全有效。

免费的全文章
摘要和评论|胃肠病，传染病

2018年11月13日

支持替诺福韦地索普西富马酸单药治疗多药耐药的慢性HBV感染

Atif Zaman，MD，MPH审查Lee HW等人。 Clin Gastroenterol Hepatol 2018年10月26日

长期疗效数据显示，TDF单药治疗与联合治疗同样安全有效。

慢性乙型肝炎病毒（HBV）感染的早期单药治疗方案，如拉米夫定，导致多药耐药率（MDR）的高发率。更有效的方案如替诺福韦地索普西富马酸盐（TDF）单独或与其他药物联合推荐用于MDR，但缺乏长期疗效数据阻碍了明确，一致的指导方针。

在一项由行业资助的前瞻性多中心队列研究中，韩国研究人员评估了423例接受MDR HBV感染抢救治疗的患者单独或联合治疗的TDF的长期疗效。主要终点是病毒学应答，定义为血清HBV DNA <20 IU / mL。

41％的患者接受了TDF单药治疗和其余的联合治疗。对阿德福韦耐药的患者更有可能接受联合治疗，而没有阿德福韦耐药的患者更有可能单独接受TDF治疗。在180周的中位随访期间（总共16,615人年），总体病毒学应答在48周时为70％，在96周时为86％，在144周时为92％，在192周时为95％，在96周时为96％。 240周。单药治疗组和联合治疗组的反应率相似。低基线HBV DNA水平和缺乏阿德福韦耐药与病毒学应答相关。
评论

来自现实世界环境的这些数据表明，TDF单一疗法在实现和维持发生多药耐药的HBV患者中的病毒学应答方面与TDF联合疗法一样有效。大多数指南建议使用附加疗法，但与联合疗法相比，改用TDF单药治疗可降低成本，改善依从性并最大限度地减少不良副作用。因此，临床医生应首先考虑对这些患者进行TDF单药治疗。

出版时的编辑披露

Atif Zaman，MD，MPH在出版时的披露

拨款/研究支持：


默克

引用（S）：

Lee HW等人。替诺福韦地索普西富马酸单药治疗多药耐药慢性HBV感染的远期疗效。 Clin Gastroenterol Hepatol 2018年10月26日; [E-PUB]。 （https://doi.org/10.1016/j.cgh.2018.10.037）