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The incidence of all organ malignancies and overall survival of patient with sustained virological response of HCV-comparable to SMR (standardized mortality ratio) of Japan general population

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Abstract

Objective

This study prospectively observed the incidence of all malignancies and the prognosis of all patients in a population of patients who achieved Sustained Virological Response (SVR) with a 100% capture rate.

Design

A prospective study of 651 SVR cases was conducted from July 2013 to December 2021. The primary endpoint was the occurrence of all malignancies, and the secondary endpoint was overall survival. The cancer incidence during the follow-up period was calculated using the man-year method, and risk factors were analyzed. In addition, sex- and age-matched standardized mortality ratio (SMR) was used to compare the general population with the study population.

Results

The overall median follow-up was 5.44 years. 107 malignancies occurred in 99 patients during the follow-up. The incidence of all malignancies was 3.94/100 person-years. The cumulative incidence was 3.6% at 1 year, 11.1% at 3 years, and 17.9% at 5 years, and continued to increase almost linearly. The incidence of liver cancer and non-liver cancer was 1.94/100 patient-years vs. 1.81%/100 patient-years. The 1-year, 3-year, and 5-year survival rates were 99.3%, 96.5%, and 94.4%, respectively. This life expectancy was compared to the standardized mortality ratio of the Japanese population, which proved non-inferior.

Conclusion

It was found that malignancies of other organs occur as frequently as hepatocellular carcinoma (HCC). Therefore, follow-up of patients who have achieved SVR should focus not only on HCC but also on malignant tumors of other organs, and lifelong follow could contribute prolonged life expectancy for the previously short-lived.

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Data availability

Ministry of Health, Labour and Welfare 2020 Vital Statistics. https://www.mhlw.go.jp/toukei/saikin/hw/**kou/houkoku20/l/03.pdf (accessed date 12 April 2022).

Abbreviations

CAP:

Controlled attenuation parameter

CI:

Confidence interval

CT:

Computed tomography

DAA:

Direct-acting antiviral

HCC:

Hepatocellular carcinoma

HCV:

Hepatitis C virus

MRI:

Magnetic resonance imaging

SMR:

Standardized mortality ratios

SVR:

Sustained virological response

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Funding

The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.

Author information

Authors and Affiliations

  1. Department of Gastroenterology, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan

    Shuntaro Obi, Miho Kanda, Yoshihiko Ooka, Hiroshi Ohyama, Hitoshi Mochizuki & Masao Omata

  2. Department of Internal Medicine, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 2990111, Japan

    Shuntaro Obi

  3. Department of Gastroenterology and Hepatology, Kyoundo Hospital of Sasaki Institute, 1-8 Kanda-Surugadai, Chiyoda-Ku, Tokyo, Japan

    Shuntaro Obi & Miho Kanda

  4. Department of Gastroenterology, Chiba University, 1-8-1 Inohana, Chiba, Chiba, Japan

    Yoshihiko Ooka & Hiroshi Ohyama

  5. Department of Cancer Center, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan

    Ritsuko Yokouchi & Naho Sato

  6. Department of Genome Analysis Center, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan

    Hitoshi Mochizuki

  7. The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

    Masao Omata

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  1. Shuntaro Obi
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Contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by SO, MK, YO, HO, RY, NS, HM, and MO. The first draft of the manuscript was written by SO and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Shuntaro Obi.

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Conflict of interest

Shuntaro Obi, Miho Kanda, Yoshihiko Ooka, Hiroshi Ohyama, Ritsuko Yokouchi, Naho Sato, Hitoshi Mochizuki and Masao Omata have no relevant financial or non-financial interests to disclose.

Ethical considerations

This study was conducted in accordance with the ethical guidelines of the 2013 Declaration of Helsinki and was approved by the Ethics Committee at the institution (Clinical 29–19).

Informed consent

Informed consent was obtained in writing for the 50 cases treated in the clinical trial, [3, 4] and patient consent was obtained for the cases treated in post-marketing DAA clinical practice based on a comprehensive study of in-house electronic data.

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Obi, S., Kanda, M., Ooka, Y. et al. The incidence of all organ malignancies and overall survival of patient with sustained virological response of HCV-comparable to SMR (standardized mortality ratio) of Japan general population. Hepatol Int 17, 562–572 (2023). https://doi.org/10.1007/s12072-023-10495-z

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