Inverse Propensity Score-Weighted Analysis of Entecavir and Tenofovir Disoproxil Fumarate in Patients with Chronic Hepatitis B: A Large-Scale Multicenter Study

Author:

Kim Jihye1ORCID,Hur Moon Haeng2,Kim Seung Up3ORCID,Kim Jin-Wook1,Sinn Dong Hyun4,Lee Hyun Woong5ORCID,Kim Moon Young6ORCID,Cheong Jae Youn7ORCID,Jung Yong Jin8,Lee Han Ah9ORCID,Jin Young-Joo10,Yoon Jun Sik11ORCID,Park Sung-Jae11,Lee Chang Hun12ORCID,Kim In Hee12,Lee June Sung13ORCID,Cho Young Youn14,Kim Hyung Joon14,Park Soo Young15ORCID,Seo Yeon Seok16,Oh Hyunwoo17ORCID,Jun Dae Won18ORCID,Kim Mi Na19,Chang Young20,Jang Jae Young20,Hwang Sang Youn21,Kim Yoon Jun2ORCID

Affiliation:

1. Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam 13620, Republic of Korea

2. Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul 03080, Republic of Korea

3. Department of Internal Medicine and Yonsei Liver Center, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Republic of Korea

4. Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Republic of Korea

5. Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Republic of Korea

6. Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju 26426, Republic of Korea

7. Department of Gastroenterology, Ajou University School of Medicine, Suwon 16499, Republic of Korea

8. Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul 07061, Republic of Korea

9. Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul 07985, Republic of Korea

10. Department of Internal Medicine, Inha University Hospital, Inha University School of Medicine, Incheon 22332, Republic of Korea

11. Department of Gastroenterology and Hepatology, Inje University Busan Paik Hospital, Busan 47392, Republic of Korea

12. Department of Internal Medicine, Jeonbuk National University Hospital, Jeonju 54907, Republic of Korea

13. Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang 10380, Republic of Korea

14. Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul 06973, Republic of Korea

15. Department of Internal Medicine, School of Medicine, Kyungpook National University Hospital, Kyungpook National University, Daegu 41944, Republic of Korea

16. Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul 02841, Republic of Korea

17. Department of Internal Medicine, Uijeongbu Eulji Medical Center, Eulji University School of Medicine, Uijeongbu 11759, Republic of Korea

18. Department of Internal Medicine, Hanyang University Hospital, Hanyang University College of Medicine, Seoul 04763, Republic of Korea

19. Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam 13496, Republic of Korea

20. Department of Internal Medicine, Soonchunhyang University College of Medicine Seoul Hospital, Seoul 04401, Republic of Korea

21. Department of Internal Medicine and Gastrointestinal Cancer Center, Dongnam Institute of Radiological & Medical Sciences, Busan 46033, Republic of Korea

Abstract

Tenofovir disoproxil fumarate (TDF) is reportedly superior or at least comparable to entecavir (ETV) in preventing hepatocellular carcinoma (HCC) among chronic hepatitis B (CHB) patients; however, it remains controversial. This study aimed to conduct comprehensive comparisons between the two antivirals. CHB patients initially treated with ETV or TDF between 2012 and 2015 at 20 referral centers in Korea were included. The primary outcome was the cumulative incidence of HCC. The secondary outcomes included death or liver transplantation, liver-related outcome, extrahepatic malignancy, development of cirrhosis, decompensation events, complete virologic response (CVR), seroconversion rate, and safety. Baseline characteristics were balanced using the inverse probability of treatment weighting (IPTW). Overall, 4210 patients were enrolled: 1019 received ETV and 3191 received TDF. During the median follow-ups of 5.6 and 5.5 years, 86 and 232 cases of HCC were confirmed in the ETV and TDF groups, respectively. There was no difference in HCC incidence between the groups both before (p = 0.36) and after IPTW was applied (p = 0.81). Although the incidence of extrahepatic malignancy was significantly higher in the ETV group than in the TDF group before weighting (p = 0.02), no difference was confirmed after IPTW (p = 0.29). The cumulative incidence rates of death or liver transplantation, liver-related outcome, new cirrhosis development, and decompensation events were also comparable in the crude population (p = 0.24–0.91) and in the IPTW-adjusted population (p = 0.39–0.80). Both groups exhibited similar rates of CVR (ETV vs. TDF: 95.1% vs. 95.8%, p = 0.38), and negative conversion of hepatitis B e antigen (41.6% vs. 37.2%, p = 0.09) or surface antigen (2.8% vs. 1.9%, p = 0.10). Compared to the ETV group, more patients in the TDF group changed initial antivirals due to side effects, including decreased kidney function (n = 17), hypophosphatemia (n = 20), and osteoporosis (n = 18). In this large-scale multicenter study, ETV and TDF demonstrated comparable effectiveness across a broad range of outcomes in patients with treatment-naïve CHB during similar follow-up periods.

Funder

Samjin Pharmaceutical Co., Ltd. Korea

Publisher

MDPI AG

Subject

Cancer Research,Oncology

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