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Efficacy and safety of glecaprevir and pibrentasvir treatment for 8 or 12 weeks in patients with recurrent hepatitis C after liver transplantation: a Japanese multicenter experience

Abstract

Background

Efficacy of 8-week regimen with direct-acting antivirals (DAA) for patients with hepatitis C after liver transplantation has not been clarified. This study aimed to clarify the efficacy and safety of glecaprevir and pibrentasvir therapy for 8 and 12 weeks in Japanese patients with recurrent hepatitis C after liver transplantation.

Methods

A cohort study of liver transplant recipients with recurrent hepatitis C treated with glecaprevir (300 mg/day) and pibrentasvir (120 mg/day) was performed at nine liver transplant centers in Japan.

Results

Twenty-five patients with hepatitis C after liver transplantation were treated with glecaprevir and pibrentasvir. Twenty-four patients completed the treatment protocol; treatment was discontinued in one patient who had nausea at 3 days after the initiation of treatment. All the 24 patients who completed the 8- or 12-week treatment protocol achieved a sustained virological response 12 weeks after completion of treatment (SVR12). The SVR12 rates in patients with HCV genotype 1 and 2 were 100% (21 of 21 patients) and 75% (3 of 4 patients), respectively. All patients with prior DAA therapy failure (n = 6), jaundice (n = 4), and liver cirrhosis (n = 4) achieved SVR12. Seven of 8 patients (88%) with severe renal impairment achieved SVR12. Adverse events occurred in 6 of 25 patients (24%), including serious adverse events in 2 patients (8%). Treatment-related adverse events were nausea, pruritus, and mild renal dysfunction.

Conclusions

Eight- or 12-week regimen of glecaprevir and pibrentasvir is efficacious and safe in patients with recurrent HCV infection after liver transplantation, even in difficult-to-treat populations, including patients with severe renal impairment, prior DAA experience, liver cirrhosis, or jaundice after liver transplantation.

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Fig. 1

Abbreviations

HCC:

Hepatocellular carcinoma

HCV:

Hepatitis C virus

LDLT:

Living donor liver transplantation

DAA:

Direct-acting antivirals

SVR:

Sustained virological response

PCR:

Polymerase chain reaction

ITT:

Intent-to-treat

eGFR:

Estimated glomerular filtration rate

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Acknowledgements

This research is supported by the Research Program on Hepatitis from Japan Agency for Medical Research and development (Grant no. JP18fk0210023h0002), AMED.

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Correspondence to Toru Ikegami.

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Ueda, Y., Kobayashi, T., Ikegami, T. et al. Efficacy and safety of glecaprevir and pibrentasvir treatment for 8 or 12 weeks in patients with recurrent hepatitis C after liver transplantation: a Japanese multicenter experience. J Gastroenterol 54, 660–666 (2019). https://doi.org/10.1007/s00535-019-01561-1

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Keywords

  • Hepatitis C
  • Liver transplantation
  • Glecaprevir
  • Pibrentasvir