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Published on: October 1, 2015
Hemodialysis Patients Treated for Hepatitis C Using a Sofosbuvir-based Regimen
Sanjay Kumar Agarwal1, Soumita Bagchi1, Raj Kumar Yadav1
1Department of Nephrology, All India Institute of Medical Sciences, New Delhi, India.
Introduction:
There is paucity of data on sofosubvir (SOF)-based therapy in patients on maintenance hemodialysis (MHD). The objective of this report is to describe our experience using SOF-based direct antiviral agent (DAA) therapy in MHD patients in India.
Methods:
All patients on MHD and treated with SOF-based therapy were included in this study. Before starting treatment, viral load, genotype, liver fibroscan, and upper gastrointestinal endoscopy were performed in all patients. SOF 400 mg/d or on an alternate day, ribavirin 200 mg/d and daclatasvir 60 mg/d were used in different regimens. Hepatitis C virus RNA was assessed at day 10 and at 4 weeks, at end of therapy, and at 12 weeks after stopping therapy.
Results:
A total of 62 treatment-naïve patients were included. Mean age was 33.3 ± 10.2 years; 66% were men. Median number of copies were 106/dl. None had clinical evidence of cirrhosis. The most common genotype was genotype 1 in 64.5% of cases, followed by genotype 3 in 29% of cases. Thirty-nine patients were treated with SOF every other day/ribavirin, 2 patients with SOF daily/ribavirin, 6 with SOF every other day/daclatasvir, and 15 patients with SOF daily/daclatasvir. All patients were treated for 12 weeks. Fifty-nine (95.2%) patients had a sustained viral response (SVR). There was no impact of genotype on SVR. Twenty-three patients (37%) had complications while on therapy; 13 (20.3%) had dyspepsia, 4 had tuberculosis, and 3 had bacterial pneumonia. Most of the patients (n = 23; 56%) in the ribavirin group required an increase in the erythropoietin dose. No patient discontinued therapy due to complications.
Discussion:
SOF-based DAAs were well tolerated and efficacious in this cohort of patients on MHD.
Insights
Sofosbuvir (SOF)-based direct-acting antiviral (DAA) therapy is effective and well-tolerated in patients undergoing maintenance hemodialysis (MHD). This study found a high sustained viral response (SVR) rate of 95.2% in MHD patients treated with SOF-based regimens.
Area of Science:
- Hepatology
- Virology
- Nephrology
Background:
- Limited data exists on sofosbuvir (SOF)-based therapy efficacy in patients on maintenance hemodialysis (MHD).
- Hepatitis C virus (HCV) infection poses a significant challenge in MHD patients.
- This study addresses the paucity of information on direct-acting antiviral (DAA) treatment in this specific population.
Purpose of the Study:
- To evaluate the safety and efficacy of sofosbuvir (SOF)-based direct-acting antiviral (DAA) therapy in patients undergoing maintenance hemodialysis (MHD).
- To describe the treatment experience and outcomes of MHD patients receiving SOF-based regimens in India.
Main Methods:
- A cohort of 62 treatment-naïve patients on MHD receiving SOF-based therapy was studied.
- Patients underwent baseline assessments including viral load, genotype, liver fibroscan, and endoscopy.
- Treatment regimens included sofosbuvir (SOF) with ribavirin or daclatasvir for 12 weeks, with viral load monitoring.
Main Results:
- A sustained viral response (SVR) of 95.2% was achieved across all genotypes.
- The most common genotypes were genotype 1 (64.5%) and genotype 3 (29%).
- While generally well-tolerated, 37% experienced complications such as dyspepsia, tuberculosis, and pneumonia; no patients discontinued therapy.
Conclusions:
- Sofosbuvir (SOF)-based direct-acting antiviral (DAA) therapies are safe and effective for treating Hepatitis C virus (HCV) in patients on maintenance hemodialysis (MHD).
- High SVR rates indicate the potential for widespread use of these regimens in MHD populations.
- Further research may explore optimizing DAA regimens to minimize side effects in this vulnerable group.
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