Sofosbuvir/Daclatasvir versus Grazoprevir/Elbasvir in Patients with Chronic Hepatitis C on Haemodialysis: A Multicentre, Single-Blind, Randomised Controlled Trial

Authors

  • Andri Sanityoso Sulaiman Hepatobiliary Division, Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia – Dr. Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia.
  • Pringgodigdo Nugroho Nephrology and Hypertension Division, Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia – Dr. Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia
  • Muhammad Begawan Bestari Gastroenterology Hepatology Division, Hasan Sadikin Hospital, Bandung, Indonesia.
  • Afiatin Afiatin Nephrology and Hypertension Division, Hasan Sadikin Hospital, Bandung, Indonesia.
  • Fardhah Akil Gastroenterology Hepatology Division, Wahidin Sudirohusodo Hospital, Makassar, Indonesia.
  • Akhyar Albaar Nephrology and Hypertension Division, Wahidin Sudirohusodo Hospital, Makassar, Indonesia.
  • Hery Djagat Purnomo Gastroenterology Hepatology Division, Kariadi Hospital, Semarang, Indonesia.
  • Dwi Lestari Nephrology and Hypertension Division, Kariadi Hospital, Semarang, Indonesia.
  • Triyanta Yuli Pramana Nephrology and Hypertension Division, Kariadi Hospital, Semarang, Indonesia.
  • Agung Susanto Gastroenterology Hepatology Division, Moewardi Hospital, Solo, Indonesia.
  • Desti Rachmani Nephrology and Hypertension Division, Moewardi Hospital, Solo, Indonesia.
  • Lawrence Ho Khek-Yu Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.

Keywords:

Hepatitis C, chronic, Chronic Kidney Disease, Hemodialysis, sofosbuvir, daclatasvir, grazoprevir, elbasvir

Abstract

Background: Patients with chronic kidney disease undergoing hemodialysis are at risk of hepatitis C virus exposure due to nosocomial transmission and the duration of hemodialysis. The treatment for hepatitis C in patients with chronic kidney disease undergoing hemodialysis is oral direct-acting antiviral (DAA) therapy, which works directly as an antiviral. Currently, the DAA considered safe for use in patients with chronic kidney disease is grazoprevir/elbasvir. However, this DAA is expensive and effective in patients with genotypes 1 and 4. Recent studies have shown that sofosbuvir-based regimens are safe. Therefore, this study aimed to compare the efficacy and safety of sofosbuvir/daclatasvir with grazoprevir/elbasvir in patients with chronic hepatitis C undergoing hemodialysis. Methods: We conducted a multicenter, single-blind, randomized clinical trial that included 120 treatment-naïve, HCV-infected hemodialysis patients. We randomized only participants with fibrosis < F4. Patients with cirrhosis (F4) were assigned to sofosbuvir/daclatasvir per guideline-based contraindications for grazoprevir/elbasvir. Participants received sofosbuvir/daclatasvir or grazoprevir/elbasvir. The primary endpoints were sustained virologic response at week 12 (SVR12) and treatment-related adverse events. Statistical comparisons were conducted using the Mann–Whitney U test for continuous variables and the chi-square test for categorical variables. Results: 120 patients completed the study, with no dropouts or missing SVR12 data. All patients (100%) achieved SVR12 in both treatment groups. Sofosbuvir/daclatasvir and grazoprevir/elbasvir achieved 100% SVR at 12 weeks, with good safety and no adverse events in 98.3% of patients. Conclusion: Both sofosbuvir/daclatasvir and grazoprevir/elbasvir are highly effective and safe for treating hepatitis C in patients undergoing hemodialysis. Sofosbuvir/daclatasvir offers broader applicability across all fibrosis stages and genotypes, with substantially lower treatment costs.

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Published

2026-10-07

How to Cite

Sulaiman, A. S., Nugroho, P., Bestari, M. B., Afiatin, A., Akil, F., Albaar, A., Purnomo, H. D., Lestari, D., Pramana, T. Y., Susanto, A., Rachmani, D., & Khek-Yu, L. H. . (2026). Sofosbuvir/Daclatasvir versus Grazoprevir/Elbasvir in Patients with Chronic Hepatitis C on Haemodialysis: A Multicentre, Single-Blind, Randomised Controlled Trial. Acta Medica Indonesiana, 58(3), 415. Retrieved from https://www.actamedindones.org/index.php/ijim/article/view/3295

Issue

Vol. 58 No. 3 (2026): Acta Medica Indonesiana

Section

ORIGINAL ARTICLE

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Copyright (c) 2026 Andri Sanityoso Sulaiman, Pringgodigdo Nugroho, Muhammad Begawan Bestari, Afiatin Afiatin, Fardhah Akil, Akhyar Albaar, Hery Djagat Purnomo, Dwi Lestari, Triyanta Yuli Pramana, Agung Susanto, Desti Rachmani, Lawrence Ho Khek-Yu

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