BRIEF RESEARCH REPORT article
Front. Med.
Sec. Infectious Diseases: Pathogenesis and Therapy
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1576654
Efficacy and safety of sofosbuvir plus daclatasvir in hemodialysis patients with genotype 1b or 2a hepatitis C virus infection: A single-arm, prospective real-world study
Provisionally accepted
- Senior Department of Hepatology, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China
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Background/Aims: This investigation assessed the clinical outcomes and adverse effects of combination therapy using sofosbuvir (SOF) and daclatasvir (DCV) among dialysisdependent patients infected with hepatitis C virus (HCV) genotypes 1b or 2a in real-world settings.We conducted a prospective, single-arm interventional trial comprising 16 maintenance hemodialysis patients (14 with HCV-1b, 2 with HCV-2a). Participants received SOF-DCV combination therapy over 24 weeks with monitoring at weeks 4, 12, and 24 during treatment, plus a follow-up assessment 12 weeks post-treatment completion.The primary outcome measure was sustained virologic response at 12 weeks post-treatment (SVR12). Secondary endpoints included therapeutic tolerance and safety profiles.Results: All 16 participants completed the prescribed treatment regimen. Demographic characteristics revealed a mean age of 57.0 years, male predominance (75%), average dialysis duration of 7.0 years, and mean body weight of 63.0 kg. Five patients (31.3%) had compensated cirrhosis. Liver function parameters remained stable throughout the study period. Rapid virologic response (RVR) was documented in 87.5% (14/16) of participants, while end-of-treatment response (ETR) and SVR12 were both achieved in 93.8% (15/16) of cases. All cirrhotic patients (5/5) ultimately attained SVR12. The therapeutic regimen demonstrated favorable tolerability, with no treatment discontinuations due to adverse events. One participant was lost to follow-up. APRI scores significantly decreased from baseline (0.56) to week 24 (0.20, p<0.001). Reported adverse reactions included headache, fatigue, nausea (each 6.3%), and anemia (18.8%).The 12-week SOF-DCV combination demonstrated robust therapeutic efficacy and acceptable safety profiles in hemodialysis patients infected with HCV genotypes 1b or 2a, including those with compensated cirrhosis.
Keywords: Daclatasvir, Sofosbuvir, Chronic hepatitis C virus, hemodialysis, Sustained virologic response, Direct-acting antiviral agents
Received: 14 Mar 2025; Accepted: 25 Jun 2025.
Copyright: © 2025 Wang, Yao, Zhou, Liu and Zhao. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Hongling Liu, Senior Department of Hepatology, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China
Jun Zhao, Senior Department of Hepatology, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China
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