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논문 기본 정보

자료유형
학술저널
저자정보
Kim Hyung Joon (Department of Internal Medicine Chung-Ang University College of Medicine Seoul Korea.) Kim Ju Hyun (Department of Internal Medicine Division of Gastroenterology Gil Medical Center Gachon University C) Yeon Jong Eun (Department of Internal Medicine Korea University College of Medicine Seoul Korea.) Seo Yeon Seok (Department of Internal Medicine Korea University College of Medicine Seoul Korea.) Jang Jeong Won (Department of Internal Medicine Catholic University of Korea College of Medicine Seoul Korea.) Cho Yong Kyun (Division of Gastroenterology and Hepatology Department of Internal Medicine Kangbuk Samsung Hospita) Jang Byoung Kuk (Department of Internal Medicine Keimyung University School of Medicine Daegu Korea.) Han Byung Hoon (Department of Internal Medicine Kosin University Gospel Hospital Kosin University College of Medici) Lee Changhyeong (Department of Internal Medicine Daegu Catholic University School of Medicine Daegu Korea.) Lee Joon Hyeok (Department of Medicine Samsung Medical Center Sungkyunkwan University School of Medicine Seoul Kore) Yoon Jung-Hwan (Department of Internal Medicine and Liver Research Institute Seoul National University College of M) Kim Kang Mo (Department of Gastroenterology Asan Medical Center University of Ulsan College of Medicine Seoul Ko) Kim Moon Young (Department of Internal Medicine Yonsei University Wonju College of Medicine Wonju Korea.) Kim Do Young (Department of Internal Medicine Yonsei University College of Medicine Seoul Korea.) Park Neung Hwa (Department of Internal Medicine Ulsan University Hospital University of Ulsan College of Medicine U) Cho Eun Young (Department of Internal Medicine Wonkwang University School of Medicine Iksan Korea.) Lee June Sung (Department of Internal Medicine Ilsan Paik Hospital Inje University College of Medicine Ilsan Korea) Lee Jin-Woo (Department of Internal Medicine Inha University Hospital Inha University School of Medicine Incheon) Kim In Hee (Department of Gastroenterology Jeonbuk National University Hospital Jeonju Korea.) Song Byung-Cheol (Department of Internal Medicine Jeju National University School of Medicine Jeju Korea.) Lee Byung-Seok (Department of Internal Medicine School of Medicine Chungnam National University Daejeon Korea.) Kwon Oh Sang (Department of Internal Medicine Division of Gastroenterology Gil Medical Center Gachon University C)
저널정보
대한의학회 Journal of Korean Medical Science Journal of Korean Medical Science Vol.37 No.11
발행연도
2022.3
수록면
1 - 14 (14page)
DOI
10.3346/jkms.2022.37.e92

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초록· 키워드

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Background: Tenofovir disoproxil fumarate (TDF, Viread®) had been used as a standard treatment option of chronic hepatitis B (CHB). This clinical trial was conducted to evaluate the efficacy and safety of DA-2802 (tenofovir disoproxil orotate) compared to TDF. Methods: The present study was a double blind randomized controlled trial. Patients with CHB were recruited from 25 hospitals in Korea and given DA-2802 at a dose of 319 mg once daily or Viread® at a dose of 300 mg once daily for 48 weeks from March 2017 to January 2019. Change in hepatitis B virus (HBV) DNA level at week 48 after dosing compared to baseline was the primary efficacy endpoint. Secondary efficacy endpoints were proportions of subjects with undetectable HBV DNA, those with normal alanine aminotransferase (ALT) levels, and those with loss of hepatitis B envelop antigen (HBeAg), those with loss of hepatitis B surface antigen (HBsAg). Adverse events (AEs) were also investigated. Results: A total of 122 patients (DA-2802 group: n = 61, Viread® group: n = 61) were used as full analysis set for efficacy analysis. Mean age, proportion of males, laboratory results and virologic characteristics were not different between the two groups. The change in HBV DNA level at week 48 from baseline was ?5.13 ± 1.40 in the DA-2802 group and ?4.97 ± 1.40 log10 copies/mL in the Viread® group. The analysis of primary endpoint using the nonparametric analysis of covariance showed statistically significant results (P < 0.001), which confirmed non-inferiority of DA-2802 to Viread® by a prespecified noninferiority margin of 1. The proportion of undetectable HBV DNA was 78.7% in the DA-2802 group and 75.4% in the Viread® group (P = 0.698). The proportion of subjects who had normal ALT levels was 75.4% in the DA-2802 group and 73.3% in the Viread® group (P = 0.795). The proportion of those with HBeAg loss was 8.1% in the DA-2802 group and 10.8% in the Viread® group (P = 1.000). No subject showed HBsAg loss. The frequency of AEs during treatment was similar between the two groups. Most AEs were mild to moderate in severity. Conclusion: DA-2802 is considered an effective and safe treatment for patients with CHB.
#Tenofovir #Hepatitis B #Chronic #Hepatitis B Virus #Efficacy #Safety

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