Efficacy and safety of ledipasvir/sofosbuvir for genotype 1b chronic hepatitis C patients with moderate renal impairment
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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.
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.
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.
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.
KeywordsChronic hepatitis C Sofosbuvir Ledipasvir Chronic kidney disease
This study has no funding sources, grants, or other types of financial support to disclose.
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.
This study was designed according to the ethical guidelines of the Helsinki Declaration in 2013.
- 12.Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 Clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int 2013;3(Suppl):1–150Google Scholar
- 17.Roth D, Nelson DR, Bruchfeld A, et al. Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4–5 chronic kidney disease (the C-SURFER study): a combination phase 3 study. Lancet. 2015;386(10003):1537–1545CrossRefPubMedGoogle Scholar
- 21.Common Terminology criteria for Adverse Events, version 4.0 https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf. Updated 14 June 2010. Accessed 14 Nov 2017
- 23.SOVALDI® (sofosbuvir) tablets, for oral use. 2015. Gilead Sciences, Inc. http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf. Accessed 14 November 2017
- 25.Singh T, Guirguis J, Anthony S, Rivas J, Hanouneh IA, Alkhouri N. Sofosbuvir-based treatment is safe and effective in patients with chronic hepatitis C infection and end stage renal disease: a case series. Liver Int 2016;36(6):802–806. https://doi.org/10.1111/liv.13078 Epub 2016 Feb 22 CrossRefPubMedGoogle Scholar
- 28.HCV Guidance: recommendations for testing, managing, and treating hepatitis C. AASLD and IDSA. http://www.hcvguidelines.org. Updated 21 September 2017. Accessed 14 Nov 2017