Real‐world efficacy and safety of sofosbuvir + ribavirin for hepatitis C genotype 2: A nationwide multicenter study by the Japanese Red Cross Liver Study Group

Akahane, Takehiro; Kurosaki, Masayuki; Itakura, Jun; Tsuji, Keiji; Joko, Kouji; Kimura, Hiroyuki; Nasu, Akihiro; Ogawa, Chikara; Kojima, Yuji; Hasebe, Chitomi; Wada, Shinpei; Uchida, Yasushi; Sohda, Tetsuro; Suzuki, Hideyuki; Yoshida, Hideo; Kusakabe, Atsunori; Tamada, Takashi; Kobashi, Haruhiko; Mitsuda, Akeri; Kondo, Masahiko; Shigeno, Masaya; Ide, Yasushi; Morita, Atsuhiro; Kitamura, Tadashi; Abe, Takehiko; Izumi, Namiki

doi:10.1111/hepr.13246

Cited by 29 publications

(42 citation statements)

References 39 publications

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“…This nationwide observational multicenter study was undertaken by the Japanese Red Cross Liver Study Group, including 24 centers of Japanese Red Cross Hospitals. Previously, we reported that the overall SVR rate for GT2 patients treated with SOF + RBV was 96.8% in a multicenter cohort . Until March 2019, we accumulated 28 patients who failed prior SOF + RBV regimens and were retreated with GLE/PIB for 12 weeks.…”

Section: Methodsmentioning

confidence: 99%

“…Direct‐acting antiviral therapies have consistently shown high sustained virologic response (SVR) rates, good tolerability, and efficacy with shorter treatment durations. For HCV genotype 2 (GT2), the sofosbuvir (SOF) plus RBV regimen attained a high SVR rate in the real‐world setting . Conversely, rescue therapy for GT2 patients who failed prior SOF + RBV regimens remains unclear.…”

Section: Introductionmentioning

confidence: 99%

“…a high SVR rate in the real-world setting. 3,4 Conversely, rescue therapy for GT2 patients who failed prior SOF + RBV regimens remains unclear.…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and safety of glecaprevir/pibrentasvir as retreatment therapy for patients with genotype 2 chronic hepatitis C who failed prior sofosbuvir plus ribavirin regimen

Kusakabe

Kurosaki

Itakura

et al. 2019

Hepatology Research

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Aim Rescue therapy for patients with genotype 2 (GT2) chronic hepatitis C who failed prior sofosbuvir (SOF) plus ribavirin (RBV) awaits establishment. This study aims to investigate the efficacy and safety of the fixed‐dose combination of glecaprevir (300 mg)/pibrentasvir (120 mg) (GLE/PIB) for patients with GT2 chronic hepatitis C. Methods In this nationwide observational study undertaken by the Japanese Red Cross Liver Study Group, 28 GT2 patients with prior failure of SOF + RBV were retreated with GLE/PIB for 12 weeks. We evaluated the rate of sustained virologic response (SVR) and adverse events. Results After 4 weeks of therapy, serum hepatitis C virus RNA was below the limit of quantification in all patients. The SVR after 4 and 12 weeks of the end of treatment was validated in 100% (28/28) and 100% (28/28), respectively. The adverse events comprised pruritus (eight patients), fatigue (four patients), and appetite loss (four patients), all of which were mild in severity. Conclusions This study establishes the efficacy of GLE/PIB as retreatment in Japanese patients with GT2 chronic hepatitis C not responding to SOF + RBV.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Efficacy and safety of glecaprevir/pibrentasvir as retreatment therapy for patients with genotype 2 chronic hepatitis C who failed prior sofosbuvir plus ribavirin regimen

Kusakabe

Kurosaki

Itakura

et al. 2019

Hepatology Research

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“…Hepatocellular carcinoma (HCC) is the leading cause of death in patients with chronic hepatitis C. In recent years, direct‐acting antiviral (DAA) treatment has enabled many patients to achieve sustained virological responses (SVR) . Thus, it is expected that the development of HCC will be suppressed .…”

Section: Introductionmentioning

confidence: 99%

Risk assessment of hepatocellular carcinoma development by magnetic resonance elastography in chronic hepatitis C patients who achieved sustained virological responses by direct‐acting antivirals

Tamaki

Higuchi

Kurosaki

et al. 2019

Journal of Viral Hepatitis

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Prediction of hepatocellular carcinoma (HCC) development after sustained virological response (SVR) is clinically important, and the usefulness of noninvasive markers for prediction HCC have been reported. The aim of this study was to compare the prediction accuracy for HCC development by noninvasive markers. A total of 346 patients with chronic hepatitis C without history of HCC who achieved SVR through direct‐acting antivirals were included. Magnetic resonance elastography (MRE) and serum fibrosis markers were measured 12 weeks after the end of treatment, and the subsequent HCC development was examined. The mean observation period was 26.4 ± 7.9 months, and 24 patients developed HCC. Area under the receiver operating characteristic curve of liver stiffness by MRE, Wisteria floribunda agglutinin‐positive mac‐2 binding protein and FIB‐4 for predicting HCC within 3 years was 0.743, 0.697 and 0.647, respectively. The 1/2/3‐year rates of HCC development in patients with liver stiffness ≥3.75 KPa were 6.6%, 11.9% and 14.5%, whereas they were 1.4%, 2.5% and 2.5% in patients with liver stiffness <3.75 KPa (P < 0.001). Multivariate analysis revealed that liver stiffness ≥3.75 was an independent predictive factor for HCC development (hazard ratio, 3.51; 95% confidence interval, 1.24‐9.99). In subgroup analysis, there were 132 patients who were <73 years old and had liver stiffness <3.75 KPa, and no HCC development was observed in these patients. Diagnostic accuracy for predicting HCC development was higher in MRE than serum fibrosis markers and measurement of liver stiffness by MRE could identify patients with high and low risk of HCC development after SVR.

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“…Recently, a number of new direct‐acting antivirals (DAAs) have been developed that selectively target HCV proteins. Sofosbuvir (SOF) is an oral nucleotide analog inhibitor of the HCV non‐structural protein 5B polymerase that is effective for treating HCV GT2 when given in combination with RBV . However, the most commonly reported adverse event was RBV‐induced hemolytic anemia, which resulted in dose reduction of RBV …”

Section: Introductionmentioning

confidence: 99%

Predictive factors of anemia during sofosbuvir and ribavirin therapy for genotype 2 chronic hepatitis C patients

Urabe

Sakamori

Tahata

et al. 2019

Hepatology Research

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Aim Sofosbuvir (SOF) and ribavirin (RBV) combination therapy has improved the sustained virologic response (SVR) rate and shortened the treatment duration for patients with chronic hepatitis C virus (HCV) genotype 2 infection. Ribavirin‐induced hemolytic anemia is one of the most troublesome side‐effects of SOF/RBV therapy; however, factors associated with this condition have not been fully elucidated. We aimed to identify a safer way to complete treatment with SOF/RBV therapy by examining factors related to RBV‐induced hemolytic anemia and identifying patients who did not develop anemia. Methods Two hundred and one patients with genotype 2 chronic hepatitis C treated with SOF/RBV therapy were studied. Significant factors associated with the decline in hemoglobin (Hb) levels from the baseline were analyzed. Results The SVR rate was 96.5% (194 out of 201 patients) based on intent‐to‐treat analysis. In multivariate analysis, inosine triphosphatase (ITPA) gene variation (P < 0.0001) and estimated glomerular filtration rate (eGFR) (0.001) were significantly associated with a decrease in Hb levels less than 2 g/dL. All patients were divided into four groups by ITPA and eGFR at baseline, and we identified patients with ITPA CA/AA and eGFR >75 as a group that did not develop anemia. Conclusions The results presented here suggest that patients with ITPA CA/AA and eGFR >75 had no reduction in Hb levels during the treatment with SOF/RBV in HCV genotype 2‐infected patients. Adding RBV to direct‐acting antiviral therapy might not be problematic in certain patients, at least in terms of the occurrence of anemia.

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Real‐world efficacy and safety of sofosbuvir + ribavirin for hepatitis C genotype 2: A nationwide multicenter study by the Japanese Red Cross Liver Study Group

Abstract: Treatment with SOF + RBV was highly effective and safe in Japanese patients with HCV genotype 2 infection.

Cited by 29 publications

References 39 publications

Efficacy and safety of glecaprevir/pibrentasvir as retreatment therapy for patients with genotype 2 chronic hepatitis C who failed prior sofosbuvir plus ribavirin regimen

Efficacy and safety of glecaprevir/pibrentasvir as retreatment therapy for patients with genotype 2 chronic hepatitis C who failed prior sofosbuvir plus ribavirin regimen

Risk assessment of hepatocellular carcinoma development by magnetic resonance elastography in chronic hepatitis C patients who achieved sustained virological responses by direct‐acting antivirals

Predictive factors of anemia during sofosbuvir and ribavirin therapy for genotype 2 chronic hepatitis C patients

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