Outcome of untreated low-level viremia versus antiviral... : Hepatology (original) (raw)

Original Articles: Viral Hepatitis

Outcome of untreated low-level viremia versus antiviral therapy-induced or spontaneous undetectable HBV-DNA in compensated cirrhosis

Huang, Daniel Q. MBBS1,2; Tamaki, Nobuharu MD, PhD3; Lee, Hyung Woong MD, PhD4; Park, Soo Young MD, PhD5; Lee, Yu Rim MD, PhD5; Lee, Hye Won MD, PhD4; Lim, Seng Gee MBBS1,2; Lim, Tae Seop MD, PhD4; Kurosaki, Masayuki MD, PhD3; Marusawa, Hiroyuki MD, PhD6; Mashiba, Toshie MD, PhD7; Kondo, Masahiko MD, PhD8; Uchida, Yasushi MD, PhD9; Kobashi, Haruhiko MD,PhD10; Furuta, Koichiro MD, PhD11; Izumi, Namiki MD, PhD3; Kim, Beom Kyung MD, PhD4; Sinn, Dong Hyun MD, PhD12

1Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore

2Division of Gastroenterology and Hepatology, National University Hospital, Singapore

3Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan

4Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea

5Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea

6Department of Gastroenterology and Hepatology, Osaka Red Cross Hospital, Osaka, Japan

7Center for Liver-Biliary-Pancreatic Disease, Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan

8Department of Gastroenterology, Japanese Red Cross Otsu Hospital, Otsu, Shiga, Japan

9Department of Gastroenterology, Matsue Red Cross Hospital, Matsue, Shimane, Japan

10Department of Gastroenterology, Japanese Red Cross Okayama Hospital, Okayama, Okayama, Japan

11Department of Gastroenterology, Masuda Red Cross Hospital, Masuda, Shimane, Japan

12Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea

Funding information This study was in part supported by Digital Healthcare Research Grant through the Seokchun Caritas Foundation (SCY2105P). The funder had no role in the study design, data collection, analysis, interpretation, or writing of the report.

Abbreviations: aHR, adjusted HR; ALT, alanine aminotransferase; APASL, Asia-Pacific Association for the Study of the Liver; AST, aspartate aminotransferase; AVT, antiviral therapy; EASL, European Association for the Study of the Liver; eGFR, estimated glomerular filtration rate; LLV, low-level viremia; MVR, maintained virological response; PSM, propensity score matching; PYs, person-years.

Daniel Q. Huang and Nobuharu Tamaki are co-first authors and equally contributed to this work.

Correspondence Beom Kyung Kim, MD, PhD, Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun–gu, Seoul 03722, Republic of Korea. E-mail: [email protected]

Dong Hyun Sinn, MD, PhD, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, Republic of Korea. E-mail: [email protected]

Supplemental Digital Content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's website, www.hepjournal.com.

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Abstract

Background:

Comparative outcomes of HBV-infected compensated cirrhosis with low-level viremia (LLV) versus maintained virological response (MVR) are unclear. We conducted a large, multiethnic, multicenter study to examine the natural history of LLV versus MVR in compensated cirrhosis.

Patients and Methods:

We enrolled patients with HBV-infected compensated cirrhosis (n=2316) from 19 hospitals in South Korea, Singapore, and Japan. We defined the LLV group as untreated patients with ≥1 detectable serum HBV-DNA (20–2000 IU/mL), Spontaneous-MVR group as untreated patients with spontaneously achieved MVR, and antiviral therapy (AVT)-MVR group as patients achieving AVT-induced MVR. Study end points were HCC or hepatic decompensation.

Results:

The annual HCC incidence was 2.7/100 person-years (PYs), 2.6/100 PYs, and 3.3/100 PYs for LLV (n=742), Spontaneous-MVR (n=333), and AVT-MVR (n=1241) groups, respectively (p = 0.81 between LLV vs. Spontaneous-MVR groups and p = 0.37 between LLV vs. AVT-MVR groups). Similarly, the annual decompensation incidence was 1.6/100 PYs, 1.9/100 PYs, and 1.6/100 PYs for LLV, Spontaneous-MVR, and AVT-MVR groups, respectively (p = 0.40 between LLV vs. Spontaneous-MVR groups and p = 0.83 between LLV vs. AVT-MVR groups). Multivariable analyses determined that HCC and decompensation risks in the LLV group were comparable to those with Spontaneous-MVR and AVT-MVR groups (all p >0.05). Propensity score matching also reproduced similar results for HCC and decompensation risks (all _p_>0.05 between LLV vs. Spontaneous-MVR groups and between LLV vs. AVT-MVR groups).

Conclusions:

Untreated LLV in HBV-infected compensated cirrhosis is not associated with increased risk of disease progression compared with Spontaneous-MVR and AVT-MVR. These data have important implications for practice and further research.