No Difference in Incidence of Hepatocellular Carcinoma in Patients With Chronic Hepatitis B Virus Infection Treated With Entecavir Vs Tenofovir.,Clinical Gastroenterology and Hepatology

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No Difference in Incidence of Hepatocellular Carcinoma in Patients With Chronic Hepatitis B Virus Infection Treated With Entecavir Vs Tenofovir.
Clinical Gastroenterology and Hepatology ( IF 11.6 ) Pub Date : 2020-03-02 , DOI: 10.1016/j.cgh.2020.02.046
Hyunwoo Oh ₁ , Eileen L Yoon ₂ , Dae Won Jun ₁ , Sang Bong Ahn ₃ , Hyo-Young Lee ₃ , Jae Yoon Jeong ₄ , Hyoung Su Kim ₅ , Soung Won Jeong ₆ , Sung Eun Kim ₇ , Jae-Jun Shim ₈ , Joo Hyun Sohn ₉ , Yong Kyun Cho ₁₀ ,

Affiliation

Department of Internal Medicine, Hanyang University Hospital, Hanyang University College of Medicine, Seoul, Republic of Korea.
Department of Internal Medicine, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Republic of Korea.
Department of Internal Medicine, Nowon Eulji Medical Center, Eulji University College of Medicine, Seoul, Republic of Korea.
Department of Gastroenterology and Hepatology, National Medical Center, Seoul, Korea.
Department of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.
Department of Internal Medicine, Soonchunhyang University College of Medicine, Soonchunhyang University Seoul Hospital, Seoul, Republic of Korea.
Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang-si, Republic of Korea.
Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea.
Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri-si, Republic of Korea.
Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

Background & Aims

Studies to evaluate risks of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B virus (HBV) infection treated with the nucelos(t)ide analogues entecavir or tenofovir have produced contradictory results. These differences are likely to be the result of censored data, insufficient observation periods, and different observation periods for patients treated with different drugs. We aimed to compare the incidence of HCC development between patients treated with oral entecavir or tenofovir and followed up for the same time periods.

Methods

We performed a retrospective study, collecting data from 1560 treatment-naive patients with chronic HBV infection who were first treated with entecavir (n = 753) or tenofovir (n = 807) from 2011 through 2015 at 9 academic hospitals in Korea. Clinical outcomes were recorded over a mean time period of 4.7 ± 1.0 years, from 92.4% of patients treated with tenofovir and 92.7% of patients treated with entecavir.

Results

Thirty-four patients in the entecavir group (4.5%) and 45 patients in the tenofovir group (5.6%) developed HCC during the follow-up period. The incidence of HCC did not differ significantly between groups, even in a 516-pair propensity score–matched population.

Conclusions

In a retrospective study of 1560 treatment-naive patients with chronic HBV infection, the incidence of HCC did not differ significantly between patients treated with entecavir vs tenofovir over the same observation period. Clinical trial: KCT0003487.

中文翻译：

恩替卡韦与替诺福韦治疗慢性乙型肝炎病毒感染患者的肝细胞癌发生率没有差异。

背景与目标

对使用核苷（酸）类似物恩替卡韦或替诺福韦治疗的慢性乙型肝炎病毒 (HBV) 感染患者进行肝细胞癌 (HCC) 风险评估的研究产生了相互矛盾的结果。这些差异很可能是截尾数据、观察期不足以及不同药物治疗的患者观察期不同的结果。我们的目的是比较口服恩替卡韦或替诺福韦治疗并在相同时间段进行随访的患者之间发生 HCC 的发生率。

方法

我们进行了一项回顾性研究，收集了 2011 年至 2015 年在韩国 9 家学术医院首次接受恩替卡韦（n = 753）或替诺福韦（n = 807）治疗的 1560 名初治慢性 HBV 感染患者的数据。92.4% 的接受替诺福韦治疗的患者和 92.7% 接受恩替卡韦治疗的患者在 4.7 ± 1.0 年的平均时间段内记录了临床结果。