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EClinicalMedicine, Available online 30 May 2024 | https://doi.org/10.1016/j.eclinm.2024.102671 Effect of direct-acting antivirals on disease burden of hepatitis C virus infection in South Korea in 2007-2021: a nationwide, multicentre, retrospective cohort study

Won Sohn ^a,af, Soo Young Park ^b,af, Tae Hee Lee ^c, Young Eun Chon ^d, In Hee Kim ^e, Byung-Seok Lee ^f, Ki Tae Yoon ^g, Jae Young Jang^h, Yu Rim Lee ⁱ, Su Jong Yu ^j, Won-Mook Choi ^k, Sang Gyune Kim^l, Dae Won Jun ^m, Joonho Jeong ⁿ, Ji Hoon Kim^o, Eun Sun Jang ^p, Hwi Young Kim ^q, Sung Bum Cho ^r, Byoung Kuk Jang ^s, Jung Gil Park ^t, Jin-Woo Lee ^u, Yeon Seok Seo ^v, Jung Il Lee ^w, Do Seon Song ^x, Moon Young Kim ^y, Hyung Joon Yim ^z, Dong Hyun Sinn ^aa, Sang Hoon Ahn ^ab,ac, Young Seok Kim ^l, Heejoon Jang ^ad, Won Kim ^ad, Seungbong Han ^ae, Seung Up Kim ^ab,ac

^aKangbuk Samsung Hospital, Sungkyunkwan University, Seoul, South Korea

^bKyungpook National University Hospital, Kyungpook National University, Daegu, South Korea

^cKonyang University College of Medicine, Daejeon, South Korea

^dCHA Bundang Medical Centre, CHA University, Seongnam, South Korea

^eChonbuk National University Hospital, Chonbuk National University Medical School, Jeonju, South Korea

^fChungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, South Korea

^gPusan National University Yangsan Hospital, Pusan National University College of Medicine, Yangsan, South Korea

^hInstitute for Digestive Research, Digestive Disease Center, Soonchunhyang University College of Medicine, Seoul, South Korea

ⁱKyungpook National University Chilgok Hospital, Kyungpook National University, Daegu, South Korea

^jLiver Research Institute, Seoul National University College of Medicine, Seoul, South Korea

^kLiver Centre, Asan Medical Centre, University of Ulsan College of Medicine, Seoul, South Korea

^lSoonchunhyang University Hospital Bucheon, Soonchunhyang University College of Medicine, Bucheon, South Korea

^mHanyang University Hospital, Hanyang University College of Medicine, Seoul, South Korea

ⁿUlsan University Hospital, Ulsan University College of Medicine, Ulsan, South Korea

^oGuro Hospital, Korea University College of Medicine, Seoul, South Korea

^pSeoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea

^qCollege of Medicine, Ewha Womans University, Seoul, South Korea

^rChonnam National University Hospital, Chonnam National University, Hwasun, South Korea

^sKeimyung University School of Medicine, Daegu, South Korea

^tYeungnam University College of Medicine, Daegu, South Korea

^uInha University Hospital, Inha University School of Medicine, Incheon, South Korea

^vKorea University Anam Hospital, Korea University College of Medicine, Seoul, South Korea

^wGangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea

^xSt. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, South Korea

^yYonsei University Wonju College of Medicine, Wonju, South Korea

^zKorea University Ansan Hospital, Korea University College of Medicine, Ansan, South Korea

^aaSamsung Medical Centre, Sungkyunkwan University School of Medicine, Seoul, South Korea

^abYonsei University College of Medicine, Seoul, South Korea

^acYonsei Liver Centre, Severance Hospital, Seoul, South Korea

^adSeoul Metropolitan Government Seoul National University Boramae Medical Centre, Seoul National University College of Medicine, Seoul, South Korea

^aeDepartment of Biostatistics, Korea University College of Medicine, Seoul, South Korea

^afThese authors contributed equally as co-first authors.

Corresponding authors: Won Kim, Seungbong Han, Seung Up Kim

Abstract

Background: It is unclear whether direct-acting antivirals (DAAs) treatment improves the disease burden in hepatitis C virus (HCV) infection. This study aimed to investigate the effect of DAA treatment on the reduction of disease burden in patients with HCV infection using individual participant data.

Methods: This nationwide multicentre retrospective cohort study recruited patients with HCV infection from 29 tertiary institutions in South Korea. The data collection was done from medical records in each institution. The study included the untreated patients and the DAAs-treated patients and excluded those with a history of interferon-based treatments. Disease burden was the primary outcome, as represented by disability-adjusted life years (DALYs). Improvement in fibrosis after DAA treatment was assessed using APRI, FIB-4 index, and liver stiffness (LS) as assessed by transient elastography. Clinical outcomes were hepatocellular carcinoma (HCC), decompensation, and mortality.

Findings: Between January 1, 2007, and February 17, 2022, data from 11,725 patients with HCV infection, 8464 (72%) of whom were treated with DAAs, were analysed. DAA treatment significantly improved APRI- (median 0.64 [interquartile range (IQR), 0.35-1.31]-0.33 [0.23-0.52], p < 0.0001), FIB-4- (median 2.42 [IQR, 1.48-4.40]-1.93 [1.31-2.97], p < 0.0001), and liver LS-based fibrosis (median 7.4 [IQR, 5.3-12.3]-6.2 [4.6-10.2] kPa, p < 0.0001). During the median follow-up period of 27.5 months (IQR, 10.6-52.4), 469 patients died (4.0%), 586 (5.0%) developed HCC, and 580 (4.9%) developed decompensation. The APRI-based DALY estimate was significantly lower in the DAA group than in the untreated group (median 4.55 vs. 5.14 years, p < 0.0001), as was the FIB-4-based DALY estimate (median 5.43 [IQR, 3.00-6.44] vs. 5.79 [3.85-8.07] years, p < 0.0001). The differences between the untreated and DAA groups were greatest in patients aged 40-60 years. In multivariable analyses, the DAA group had a significantly reduced risk of HCC, decompensation, and mortality compared with the untreated group (hazard ratios: 0.41 [95% confidence interval (CI), 0.34-0.48], 0.31 [95% CI, 0.30-0.38], and 0.22 [95% CI, 0.17-0.27], respectively; p < 0.0001).

Interpretation: Our findings suggest that DAA treatment is associated with the improvement of liver-related outcomes and a reduction of liver fibrosis-based disease burden in patients with HCV infection. However, further studies using liver biopsy are needed to clarify the effect of DAA treatment on the reduction in the exact fibrosis-based disease burden beyond noninvasive tests.

논문정보

형식Research article
게재일2024년 05월 (BRIC 등록일 2024-06-18)
연구진국내 연구진
분야 의약학 > 감염의학

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