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

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 inhib...

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Published in:Hepatology international 2018-03, Vol.12 (2), p.133-142
Main Authors: Okubo, Tomomi, Atsukawa, Masanori, Tsubota, Akihito, Toyoda, Hidenori, Shimada, Noritomo, Abe, Hiroshi, Kato, Keizo, Hayama, Korenobu, Arai, Taeang, Nakagawa-Iwashita, Ai, Itokawa, Norio, Kondo, Chisa, Kawamoto, Chiaki, Iio, Etsuko, Tanaka, Yasuhito, Kumada, Takashi, Iwakiri, Katsuhiko
Format: Article
Language:English
Subjects:
Antiviral drugs
Colorectal Surgery
Epidermal growth factor receptors
Genotypes
Hepatitis
Hepatitis C
Hepatology
Inhibitors
Interferon
Medicine
Medicine & Public Health
Original Article
Patients
Renal function
Safety
Surgery
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Summary: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.
ISSN:1936-0533
1936-0541
DOI:10.1007/s12072-018-9859-9