Safety and efficacy of glecaprevir and pibrentasvir in Japanese hemodialysis patients with genotype 2 hepatitis C virus infection

Suda, Goki; Hasebe, Chitomi; Abe, Masami; Kurosaki, Masayuki; Itakura, Jun; Izumi, Namiki; Uchida, Yuzo; Mochida, Satoshi; Haga, Hiroaki; Ueno, Yoshiyuki; Abe, Kazumichi; Takahashi, Atsushi; Ohira, Hiromasa; Tsukuda, Yoko; Furuya, Ken; Baba, Masaru; Yamamoto, Yoshiya; Kobayashi, Tomoe; Inoue, Jun; Terasita, Katsumi; Ohara, Masatsugu; Kawagishi, Naoki; Izumi, Takeshi; Nakai, Masato; Sho, Takuya; Natsuizaka, Mitsuteru; Morikawa, Kenichi; Ogawa, Koji; Sakamoto, Naoya

doi:10.1007/s00535-019-01556-y

Cited by 26 publications

(23 citation statements)

References 43 publications

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“…Among the patients with cirrhosis, patients with decompensated cirrhosis have a lower susceptibility to DAA therapy compared to those with compensated cirrhosis 19 . The SVR12 rate in this study was 85% (28 of 33 patients) based on intention to treat analysis, which is lower than in other recent studies of DAA‐treated patients with chronic hepatitis or compensated cirrhosis 3–7 . The SVR12 rate in this study was also lower than the 92% reported in the phase III clinical trial for SOF/VEL therapy for patients with HCV‐related decompensated cirrhosis in Japan 13 .…”

Section: Discussioncontrasting

confidence: 73%

“…19 The SVR12 rate in this study was 85% (28 of 33 patients) based on intention to treat analysis, which is lower than in other recent studies of DAA-treated patients with chronic hepatitis or compensated cirrhosis. [3][4][5][6][7] The SVR12 rate in this study was also lower than the 92% reported in the phase III clinical trial for SOF/VEL therapy for patients with HCV-related decompensated cirrhosis in Japan. 13 The lower SVR12 in this real-world study seems to be due to the inclusion of more refractory patients, including older patients and those with advanced liver fibrosis, high frequencies of Child C, histories of non-curative treatment for HCC (transarterial chemoembolization), and other complicating diseases.…”

Section: Discussioncontrasting

confidence: 72%

“…Chronic hepatitis C virus (HCV) infection is associated with progressive liver disease that can lead to cirrhosis, liver failure, and hepatocellular carcinoma (HCC) 1,2 . Treatment for HCV‐infected patients has progressed drastically with the development of direct‐acting antivirals (DAAs) 3–7 . Direct‐acting antiviral treatment for HCV has shown high efficacy and safety, but until recently, the treatment was limited to patients with chronic hepatitis and compensated cirrhosis because some regimens containing non‐structural protein (NS)3/4A protease inhibitors have been associated with hepatotoxicity and hepatic decompensation in patients with advanced cirrhosis.…”

Section: Introductionmentioning

confidence: 99%

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Real‐world efficacy of sofosbuvir plus velpatasvir therapy for patients with hepatitis C virus‐related decompensated cirrhosis

Ohya

Imamura

Teraoka

et al. 2020

Hepatology Research

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Aim: Combination therapy with sofosbuvir (SOF) plus velpatasvir (VEL) is approved for patients with hepatitis C virus (HCV)-related decompensated cirrhosis. We analyzed the real-world efficacy of SOF/VEL therapy. Methods: Thirty-three patients with HCV-related decompensated cirrhosis (25 and eight patients with Child B and C, respectively) were treated with SOF/VEL for 12 weeks. The HCV non-structural protein (NS)5A and NS5B drug resistance-associated substitutions (RASs) were determined by direct sequencing. Result: Thirty-two of 33 patients completed the treatment, but the remaining patient discontinued the therapy during third week of the treatment due to aggravation of hepatic encephalopathy. Serum HCV-RNA became negative during the treatment in all patients but relapsed after the end of therapy in five patients. In total, 28 out of 33 patients (85%) achieved sustained vi-rological response 12 weeks following completion of treatment (SVR12). The SVR12 rate was 96% in patients with Child B, but significantly lower, at 50%, in patients with Child C (P<0.05). In genotype 1b HCV-infected patients, all eight patients without baseline NS5A RASs, but only three of seven patients with RASs, achieved SVR12. Multivariate analysis identified Child B (odds ratio, 35.8 for Child C; P=0.045) as an independent predictor of SVR12. Median serum albumin levels significantly increased only in patients who achieved SVR12. Child-Pugh scores improved in 16 of 28 patients (57%) following achievement of SVR12. Conclusion: The effect of SOF/VEL therapy is lower for patients with Child C. Improvement of hepatic function is expected after viral eradication with SOF/VEL therapy in patients with decompensated cirrhosis.

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Section: Discussioncontrasting

confidence: 73%

Section: Discussioncontrasting

confidence: 72%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Real‐world efficacy of sofosbuvir plus velpatasvir therapy for patients with hepatitis C virus‐related decompensated cirrhosis

Ohya

Imamura

Teraoka

et al. 2020

Hepatology Research

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“…The evaluation of the efficacy and effect of ETV on renal function were analyzed simultaneously according to renal function. In addition, because we actively undertake many clinical studies regarding antihepatitis therapy for hemodialysis patients, we could include a moderate number of hemodialysis patients in this study.…”

Section: Discussionmentioning

confidence: 99%

Entecavir treatment of hepatitis B virus‐infected patients with severe renal impairment and those on hemodialysis

Suzuki

Suda

Yamamoto

et al. 2019

Hepatology Research

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Aim Entecavir (ETV), tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide (TAF) are first‐line nucleos(t)ide analogues for hepatitis B virus (HBV)‐infected patients. However, consecutive TDF treatment causes renal dysfunction, and the safety and efficacy of TAF have not been established in severe renal dysfunction patients, including hemodialysis patients. The efficacy and safety of ETV in these populations has not been clarified. The study aimed to clarify this. Methods In this retrospective multicenter study, between 2006 and 2018, a total of 567 HBV‐infected patients treated with ETV monotherapy were screened. Patients were included if >20 years old, treated with ETV monotherapy for >1 year, and had proper clinical information. The efficacy of ETV and changes in renal function were evaluated according to renal function. Results A total of 273 patients were included: 9.2% (25/273), 1.8% (5/273), and 3.7% (10/273) had chronic kidney disease (CKD) stage G3, CKD stage G4/5, and were on hemodialysis, respectively. Overall, 84.2%, 94.0%, and 96.2% of patients experienced serum HBV‐DNA disappearance at 1, 2, and 3 years, respectively, after treatment initiation. In patients with CKD stage G3–5, estimated glomerular filtration rate tended to restore with time, which was in contrast to patients without renal dysfunction. The rate of disappearance in serum HBV‐DNA, alanine transaminase normalization, and virological breakthrough was similar between patients with or without renal dysfunction. ETV showed high efficacy for all 10 hemodialysis patients without virological breakthrough. Conclusions Entecavir for HBV‐infected patients with severe renal dysfunction, including hemodialysis patients, is highly effective and does not affect renal function.

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“…The SOF‐based IFN‐free DAA treatment is not indicated for patients with severe renal impairment in several countries including Japan. At present, the treatment of chronic hepatitis C has become mainstream from IFN‐based treatment to IFN‐free DAA treatment, and various regimens are also available in patients with severe renal impairment before RT . Recently, several reports showed the high rate of SVR among RT recipients by SOF , however there were a limited number of reports of DAA use for living donor RT in Japan .…”

mentioning

confidence: 99%

Safety of Direct‐Acting Antiviral Therapy for Renal Function in Post‐Kidney Transplant Patients Infected with Hepatitis C Virus and a 100% 12‐Week Sustained Virologic Response: A Single‐Center Study

et al. 2019

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Treatment of chronic hepatitis C infection after renal transplantation has been controversial due to the high rate of graft rejections with interferon (IFN)‐based therapies. The aim of this study is to review our experience of direct acting antiviral therapy for the recipients of renal transplantation. Eleven recipients who were hepatitis C virus‐polymerase chain reaction (PCR) positive were eligible for the treatment with direct acting antivirals. Six recipients were treated with sofosbuvir and ledipasvir, three were treated with elbasvir and grazoprevir, and one was treated with sofosbuvir and ribavirin for 12 weeks. One recipient was treated with glecaprevir and pibrentasvir for 8 weeks. All of the 11 recipients exhibited sustained virologic response at week 12 after the end of treatment. Adverse events were scarce including the two recipients who switched to tacrolimus from cyclosporine at the beginning of the treatment. The direct acting antiviral therapy including new agents appears to be safe and highly efficacious for the recipients after renal transplantation.

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Safety and efficacy of glecaprevir and pibrentasvir in Japanese hemodialysis patients with genotype 2 hepatitis C virus infection

Cited by 26 publications

References 43 publications

Real‐world efficacy of sofosbuvir plus velpatasvir therapy for patients with hepatitis C virus‐related decompensated cirrhosis

Real‐world efficacy of sofosbuvir plus velpatasvir therapy for patients with hepatitis C virus‐related decompensated cirrhosis

Entecavir treatment of hepatitis B virus‐infected patients with severe renal impairment and those on hemodialysis

Safety of Direct‐Acting Antiviral Therapy for Renal Function in Post‐Kidney Transplant Patients Infected with Hepatitis C Virus and a 100% 12‐Week Sustained Virologic Response: A Single‐Center Study

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