Hepatology International

, Volume 12, Issue 2, pp 133–142 | Cite as

Efficacy and safety of ledipasvir/sofosbuvir for genotype 1b chronic hepatitis C patients with moderate renal impairment

  • Tomomi Okubo
  • Masanori Atsukawa
  • Akihito Tsubota
  • Hidenori Toyoda
  • Noritomo Shimada
  • Hiroshi Abe
  • Keizo Kato
  • Korenobu Hayama
  • Taeang Arai
  • Ai Nakagawa-Iwashita
  • Norio Itokawa
  • Chisa Kondo
  • Chiaki Kawamoto
  • Etsuko Iio
  • Yasuhito Tanaka
  • Takashi Kumada
  • Katsuhiko Iwakiri
Original Article
  • 43 Downloads

Abstract

Background/aim

To evaluate the efficacy and safety of ledipasvir and sofosbuvir therapy for genotype 1b in chronic hepatitis C patients with chronic kidney disease (CKD) stage 3.

Methods

In a multicenter collaborative retrospective study, 706 patients who have received ledipasvir which is NS5A inhibitor, and sofosbuvir 400 mg which is NS5B nucleoside polymerase inhibitor daily for 12 weeks between September 2015 and January 2017 were subjected to this analysis. Virologic response and adverse events in patients with CKD stage 3 were compared with those in patients with CKD stages 1 and 2.

Results

The rates of sustained virologic response (SVR) were 97.0% in patients with CKD stage 1, 97.1% in patients with CKD stage 2, and 94.7% in patients with CKD stage 3, respectively. There were no significant differences in the SVR rates between CKD stages 1 and 2, and CKD stage 1 and stage 3. The incidence of adverse events over than grade 2 was 0% in patients with CKD stage 1, 0.5% in patients with CKD stage 2, and 3.0% in patients with CKD stage 3, respectively. For treatment and follow-up period, eGFR levels in the patients with CKD stage 3 were not worsened compared to those at baseline.

Conclusion

This study suggested that the virologic response of ledipasvir and sofosbuvir in patients with CKD stage 3 was not inferior to those with CKD stages 1 and 2. In addition, administration of ledipasvir and sofosbuvir did not affect eGFR levels in the patients with CKD stage 3.

Keywords

Chronic hepatitis C Sofosbuvir Ledipasvir Chronic kidney disease 

Notes

Compliance with ethical standards

All authors are in compliance with ethical standards for this study.

Conflict of interest

Tomomi Okubo, Masanori Atsukawa, Akihito Tsubota, Hidenori Toyoda, Noritomo Shimada, Hiroshi Abe, Keizo Kato, Korenobu Hayama, Taeang Arai, Ai Nakagawa-Iwashita, Norio Itokawa, Chisa Kondo, Chiaki Kawamoto, Etsuko Iio, Yasuhito Tanaka, Takashi Kumada, and Katsuhiko Iwakiri have no conflicts of interest to disclose.

Ethical approval

This study was designed according to the ethical guidelines of the Helsinki Declaration in 2013.

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Copyright information

© Asian Pacific Association for the Study of the Liver 2018

Authors and Affiliations

  • Tomomi Okubo
    • 1
  • Masanori Atsukawa
    • 1
    • 2
  • Akihito Tsubota
    • 3
  • Hidenori Toyoda
    • 4
  • Noritomo Shimada
    • 5
  • Hiroshi Abe
    • 6
  • Keizo Kato
    • 6
  • Korenobu Hayama
    • 2
  • Taeang Arai
    • 1
  • Ai Nakagawa-Iwashita
    • 2
  • Norio Itokawa
    • 1
  • Chisa Kondo
    • 2
  • Chiaki Kawamoto
    • 1
  • Etsuko Iio
    • 7
  • Yasuhito Tanaka
    • 7
  • Takashi Kumada
    • 4
  • Katsuhiko Iwakiri
    • 2
  1. 1.Division of Gastroenterology, Department of Internal MedicineNippon Medical School Chiba Hokusoh HospitalInzaiJapan
  2. 2.Division of Gastroenterology and Hepatology, Department of Internal MedicineNippon Medical SchoolTokyoJapan
  3. 3.Core Research Facilities for Basic Science, Research Center for Medical SciencesJikei University School of MedicineTokyoJapan
  4. 4.Division of Gastroenterology, Department of Internal MedicineOgaki Municipal HospitalOgakiJapan
  5. 5.Division of Gastroenterology and Hepatology, Department of Internal MedicineOtakanomori HospitalKashiwaJapan
  6. 6.Division of Gastroenterology and Hepatology, Department of Internal MedicineShinmatsudo Central General HospitalMatsudoJapan
  7. 7.Department of Virology and Liver Unit, Graduate School of Medical SciencesNagoya City UniversityNagoyaJapan

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