Korean J Intern Med.  2022 Sep;37(5):958-968. 10.3904/kjim.2021.486.

Safety and effectiveness of direct-acting antivirals in patients with chronic hepatitis C and chronic kidney disease

• Ryu JE
• Song MJ
• Kim SH
• Kwon JH
• Yoo SH
• Nam SW
• Nam HC
• Kim HY
• Kim CW
• Yang H
• Bae SH
• Song DS
• Chang UI
• Yang JM
• Lee SW
• Lee HL
• Lee SK
• Sung PS
• Jang JW
• Choi JY
• Yoon SK

• KMID: 2533139
• DOI: http://doi.org/10.3904/kjim.2021.486

Abstract

Background/Aims
To evaluate the effectiveness and safety of direct acting antivirals (DAAs) available in chronic kidney disease (CKD) patients with hepatitis C virus (HCV) infection in Korea.
Methods
In a retrospective, multicenter cohort study, 362 patients were enrolled from 2015 to 2019. The effectiveness and safety of DAAs including glecaprevir/pibrentasvir, sofosubvir/ribavirin, ledipasvir/sofosbuvir, and daclatasvir/asunaprevir were analyzed for patients according to CKD stage. We evaluated sustained virologic response at week 12 after treatment (SVR12) as primary endpoint. The effectiveness and safety were also evaluated according to CKD stage.
Results
Among 362 patients, 307 patients completed DAAs treatment and follow-up period after end of treatment. The subjects comprised 87 patients (62 with CKD stage 3 and 25 with CKD stage (4–5), of whom 22 were undergoing hemodialysis). HCV patients with CKD stage 1 and 2 (estimated glomerular filtration rate [eGFR] ≥ 60 mL/min/1.73 m2) showed SVR12 of 97.2% and 95.4% respectively. SVR12 of CKD stage 3 and 4–5 (eGFR < 60 mL/min/1.73 m2) patients was 91.9% and 91.6% respectively. Patients undergoing hemodialysis achieved SVR12 (90.9%). Treatment failure of DAAs in stage 1, 2, 3, and 4–5 was 2.8%, 2.7%, 1.6%, and 4%. DAAs showed good safety profile and did not affect deterioration of renal function.
Conclusions
DAAs shows comparable SVR12 and safety in CKD patients (stage 3, 4, and 5) with HCV compared with patients with stage 1 and 2. The effectiveness and safety of DAAs may be related to the treatment duration. Therefore, it is important to select adequate regimens of DAAs and to increase treatment adherence.

Keyword

Renal insufficiency; chronic; Hepatitis C; Sustained virologic response