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

ACTA MEDICA INDONESIANA · Vol. 58 No. 3 (2026)

ISSN
2338-2732, 0125-9326
Terbit
2026-10-07
Penerbit
The Indonesian Society of Internal Medicine
Bahasa
eng
Lisensi
creativecommons.org/licenses/by/4.0

Abstrak

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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Juferdy KurniawanAfiliasi tidak diketahui9
Irsan HasanAfiliasi tidak diketahui7
Rino Alvani GaniAfiliasi tidak diketahui6
Hamzah ShatriAfiliasi tidak diketahui5
Chyntia Olivia Maurine JasirwanAfiliasi tidak diketahui5
Alvina WidhaniAfiliasi tidak diketahui3
Ika Prasetya WijayaAfiliasi tidak diketahui3
Cosmas Rinaldi A LesmanaAfiliasi tidak diketahui3
Kemal Fariz KalistaAfiliasi tidak diketahui3
Ikhwan RinaldiAfiliasi tidak diketahui3
Evy YunihastutiAfiliasi tidak diketahui3
Ni Made HustriniAfiliasi tidak diketahui3
Marcellus SimadibrataAfiliasi tidak diketahui3
Cosmas Rinaldi Adithya LesmanaAfiliasi tidak diketahui3
Eka Surya NugrahaAfiliasi tidak diketahui2
Siti Aminah AbdurachmanAfiliasi tidak diketahui2
Kuntjoro HarimurtiAfiliasi tidak diketahui2
Aida LydiaAfiliasi tidak diketahui2
Suhardjono SuhardjonoAfiliasi tidak diketahui2
Em YunirUniversity of Indonesia2
Maruhum Bonar H MarbunAfiliasi tidak diketahui2
Maruhum Bonar Hasiholan MarbunAfiliasi tidak diketahui2
Dadang MakmunAfiliasi tidak diketahui2
Murdani AbdullahAfiliasi tidak diketahui2
Adityo SusiloAfiliasi tidak diketahui2
Nenny AgustantiAfiliasi tidak diketahui2
Gita ApriliciaAfiliasi tidak diketahui2
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Sumber metadata: OAI-PMH (metadata jurnal) http://www.actamedindones.org/index.php/ijim/oai, pertama di-harvest 8 Nov 2026, terakhir terlihat 8 Nov 2026.
Metadata asli (oai_dc) 
<oai_dc:dc xmlns="http://www.openarchives.org/OAI/2.0/" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:oai_dc="http://www.openarchives.org/OAI/2.0/oai_dc/" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="http://www.openarchives.org/OAI/2.0/oai_dc/  http://www.openarchives.org/OAI/2.0/oai_dc.xsd">
	<dc:title xml:lang="en-US">Sofosbuvir/Daclatasvir versus Grazoprevir/Elbasvir in Patients with Chronic Hepatitis C on Haemodialysis:  A Multicentre, Single-Blind, Randomised Controlled Trial</dc:title>
	<dc:creator>Sulaiman, Andri Sanityoso</dc:creator>
	<dc:creator>Nugroho, Pringgodigdo</dc:creator>
	<dc:creator>Bestari, Muhammad Begawan</dc:creator>
	<dc:creator>Afiatin, Afiatin</dc:creator>
	<dc:creator>Akil, Fardhah</dc:creator>
	<dc:creator>Albaar, Akhyar</dc:creator>
	<dc:creator>Purnomo, Hery Djagat</dc:creator>
	<dc:creator>Lestari, Dwi</dc:creator>
	<dc:creator>Pramana, Triyanta Yuli</dc:creator>
	<dc:creator>Susanto, Agung</dc:creator>
	<dc:creator>Rachmani, Desti</dc:creator>
	<dc:creator>Khek-Yu, Lawrence Ho </dc:creator>
	<dc:subject xml:lang="en-US">Hepatitis C</dc:subject>
	<dc:subject xml:lang="en-US">chronic</dc:subject>
	<dc:subject xml:lang="en-US">Chronic Kidney Disease</dc:subject>
	<dc:subject xml:lang="en-US">Hemodialysis</dc:subject>
	<dc:subject xml:lang="en-US">sofosbuvir</dc:subject>
	<dc:subject xml:lang="en-US">daclatasvir</dc:subject>
	<dc:subject xml:lang="en-US">grazoprevir</dc:subject>
	<dc:subject xml:lang="en-US">elbasvir</dc:subject>
	<dc:description xml:lang="en-US">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 &amp;lt; 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.</dc:description>
	<dc:publisher xml:lang="en-US">The Indonesian Society of Internal Medicine</dc:publisher>
	<dc:date>2026-10-07</dc:date>
	<dc:type>info:eu-repo/semantics/article</dc:type>
	<dc:type>info:eu-repo/semantics/publishedVersion</dc:type>
	<dc:format>application/pdf</dc:format>
	<dc:identifier>http://www.actamedindones.org/index.php/ijim/article/view/3295</dc:identifier>
	<dc:source xml:lang="en-US">Acta Medica Indonesiana; Vol. 58 No. 3 (2026): Acta Medica Indonesiana; 415</dc:source>
	<dc:source>2338-2732</dc:source>
	<dc:source>0125-9326</dc:source>
	<dc:language>eng</dc:language>
	<dc:relation>http://www.actamedindones.org/index.php/ijim/article/view/3295/900</dc:relation>
	<dc:rights xml:lang="en-US">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</dc:rights>
	<dc:rights xml:lang="en-US">https://creativecommons.org/licenses/by/4.0</dc:rights>
</oai_dc:dc>