Randomized trial of combined triple therapy comprising two types of peginterferon with simeprevir in patients with hepatitis C virus genotype 1b

Tamori, Akihiro; Yoshida, Kanako; Katoh, Osamu; Kioka, Kiyohide; Hoang, Hai; Kozuka, Ritsuzo; Motoyama, Hideki; Kawamura, Etsushi; Hagihara, Atsushi; Uchida‐Kobayashi, Sawako; Morikawa, Hiroyasu; Enomoto, Masaru; Murakami, Yoshiki; Kawada, Norifumi

doi:10.1111/hepr.12689

Cited by 8 publications

(5 citation statements)

References 37 publications

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“…From 2014, an interferon‐free therapy using DAAs, achieving a near 100% SVR, was introduced in clinical practice 25 . Several studies have corroborated the clinical utility and safety of DAA therapy, which can eliminate HCV without remarkable adverse drug events 26–29 . Notably, these promising therapies 30 have further decreased deaths due to HCV infection in Japan, and this trend is expected to continue into the future.…”

Section: Discussionmentioning

confidence: 99%

Trends in hepatitis C virus‐associated mortality rates in Japan, 1998–2017

Hagiya

Koyama

Deguchi

et al. 2021

J of Gastro and Hepatol

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Background and Aim The current prevalence of hepatitis C virus infection and hepatitis C virus‐associated mortality in Japan falls short of the World Health Organization goal of viral hepatitis elimination by 2030. We aimed to evaluate the trends in hepatitis C virus‐associated mortality in Japan. Methods This nationwide observational study used the Japanese Vital Statistics from 1998 to 2017 and included all Japanese hepatitis C virus‐associated deaths (84 936) of adults aged ≥ 40 years. We calculated the crude and age‐standardized mortality rates per 100 000 persons by age and sex. Joinpoint regression analysis was used to identify significant changing points in trends and to estimate the annual percentage changes and the average annual percentage changes for the entire study period. Results The crude mortality rate per 100 000 persons (annual death number) increased from 5.5 (3548) in 1998 to 7.0 (4843) in 2005 and decreased to 4.0 (3095) in 2017. By 2017, the crude mortality rates per 100 000 persons among men and women had dropped to 3.6 and 4.3, respectively. The age‐standardized mortality rate was higher in women than in men. The average annual percentage change was −3.8% (95% confidence interval: −5.0 to −2.5). The declining trend was more rapid in men (−4.5%, 95% confidence interval: −5.3 to −3.6) than in women (−2.7%, 95% confidence interval: −3.8 to −1.6). Conclusions Trends in hepatitis C virus‐associated mortality rates have declined in an accelerating manner in Japan, especially among men.

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Section: Discussionmentioning

confidence: 99%

Trends in hepatitis C virus‐associated mortality rates in Japan, 1998–2017

Hagiya

Koyama

Deguchi

et al. 2021

J of Gastro and Hepatol

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“…Since 2011, direct‐acting antiviral (DAA) regimens with pegylated interferon (PEG‐IFN)‐α and ribavirin (RBV) have been approved for anti‐HCV therapy in patients with chronic HCV genotype 1 infection, and these regimens achieve a higher sustained virological response (SVR) rate than conventional interferon (IFN)‐based therapy . However, PEG‐IFN‐α and RBV are associated with adverse effects.…”

Section: Introductionmentioning

confidence: 99%

The presence of multiple NS5A RASs is associated with the outcome of sofosbuvir and ledipasvir therapy in NS5A inhibitor‐naïve patients with chronic HCV genotype 1b infection in a real‐world cohort

Kozuka

Hoang

Motoyama

et al. 2018

Journal of Viral Hepatitis

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It is unclear whether multiple nonstructural (NS) 5A resistance-associated substitutions (RASs) correlate with the outcome of sofosbuvir (SOF) and ledipasvir (LDV) therapy. We investigated the effects of multiple NS5A RASs in NS5A inhibitor-naïve patients with chronic hepatitis C virus genotype 1b infection treated with SOF/LDV. In 313 patients treated with SOF/LDV, we assessed the effects of multiple NS5A RASs on the sustained virological response (SVR). RASs at L28, R30, L31, Q54, P58, Q62, A92, and Y93 in the NS5A region were examined by direct sequencing. The prevalence of RASs was as follows: 2.6% at L28, 8.7% at R30, 6.1% at L31, 48.7% at Q54, 9.9% at P58, 9.9% at Q62, 5.1% at A92, 13.8% at Y93, and 19.2% at L31 or Y93. A total of 133 patients had no RASs. SVR was achieved in 98.7% of the patients. SVR rates significantly differed between patients with and without the L31 or Y93 RAS (93.0% [53/57] vs 100% [250/250], P = .0011). In addition, among patients with the L31 or Y93 RAS, 29.8%, 45.6% and 24.6% had one, two and three or more NS5A RASs, respectively. The SVR rate was significantly lower in patients with the L31 or Y93 RAS with more than three NS5A RASs compared to those with fewer than three NS5A RASs (71.4% [10/14] vs 100% [43/43], P = .0025). Although the prevalence of multiple NS5A RASs at baseline was low in NS5A inhibitor-naïve patients, the presence of multiple NS5A RASs was associated with the effectiveness of SOF/LDV therapy.

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“…In addition, several highly effective, albeit expensive, direct‐acting antiviral (DAA) treatments have been developed to eliminate HCV infection by directly affecting the enzymatic activity of the HCV. Many clinical studies reported effectiveness, safety, and impact on patients’ quality of life (QOL) of DAA . However, concerns have been raised regarding the cost‐effectiveness of expensive medical technologies, and their burden on Japan's health insurance system.…”

Section: Introductionmentioning

confidence: 99%

Cost‐effectiveness analyses of anti‐hepatitis C virus treatments using quality of life scoring among patients with chronic liver disease in Hiroshima prefecture, Japan

Kaishima

Akita

Ohisa

et al. 2018

Hepatology Research

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Randomized trial of combined triple therapy comprising two types of peginterferon with simeprevir in patients with hepatitis C virus genotype 1b

Abstract: Peginterferon α2a or α2b in combination with SMV + ribavirin therapy showed identical antiviral effects in patients with chronic hepatitis C. Also, the incidence of adverse events was identical for both regimens.

Cited by 8 publications

References 37 publications

Trends in hepatitis C virus‐associated mortality rates in Japan, 1998–2017

Trends in hepatitis C virus‐associated mortality rates in Japan, 1998–2017

The presence of multiple NS5A RASs is associated with the outcome of sofosbuvir and ledipasvir therapy in NS5A inhibitor‐naïve patients with chronic HCV genotype 1b infection in a real‐world cohort

Cost‐effectiveness analyses of anti‐hepatitis C virus treatments using quality of life scoring among patients with chronic liver disease in Hiroshima prefecture, Japan

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