A randomized clinical study to evaluate the possible antifibrotic effect of zinc sulfate in chronic HCV patient receiving direct-acting anti-viral therapy

Inflammopharmacology. 2025 Jan;33(1):329-339. doi: 10.1007/s10787-024-01628-3. Epub 2025 Jan 9.

Abstract

Objective: This study aimed to assess the potential antifibrotic impact of zinc sulfate in chronic Hepatitis C Virus (HCV) patients receiving direct-acting antiviral therapy.

Methods: This randomized controlled study included 50 chronic HCV-infected patients with fibrosis stage (F1 & F2). Participants were randomly assigned to two groups: Group 1 (Control group, n = 25) received standard direct-acting antiviral therapy for 3 months, while Group 2 (Zinc group, n = 25) received 50 mg/day of zinc sulfate in addition to the standard direct-acting antiviral therapy for the same duration. Baseline and 3-month post-intervention assessments included evaluating serum levels of hyaluronic acid, transforming growth factor beta-1, and fibronectin. Furthermore, indices of liver fibrosis, such as the Fibrosis Index based on the 4 factors (FIB-4) and the Aspartate Transaminase-to-Platelet-Ratio Index (APRI), were calculated during these assessments.

Results: At baseline, the two studied groups had no statistical difference in demographic and laboratory data. After treatment, serum zinc levels significantly increased in the zinc-treated group compared to the control group. Additionally, serum fibronectin and hyaluronic acid levels were significantly reduced in group 2 (zinc group) compared to group 1 (control group). Moreover, zinc group showed lower APRI scores than the control group after a 3-month follow-up period, but there was non-significant difference in FIB-4 scores between the two groups after treatment. Furthermore, total bilirubin levels were reduced after zinc therapy for 3 months.

Conclusions: Administering zinc sulfate could potentially serve as a safe and efficient therapeutic strategy for the management of hepatic fibrosis in individuals with chronic hepatitis C virus.

Trial registration: ClinicalTrials.gov identifier: NCT05465434, On 19/7/2022.

Keywords: Fibronectin; Hyaluronic acid; Liver fibrosis; Transforming growth factor beta 1; Zinc.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Antifibrotic Agents* / administration & dosage
  • Antifibrotic Agents* / pharmacology
  • Antifibrotic Agents* / therapeutic use
  • Antiviral Agents* / administration & dosage
  • Antiviral Agents* / therapeutic use
  • Female
  • Fibronectins / blood
  • Hepatitis C, Chronic* / drug therapy
  • Humans
  • Hyaluronic Acid / blood
  • Liver Cirrhosis* / drug therapy
  • Male
  • Middle Aged
  • Transforming Growth Factor beta1 / blood
  • Treatment Outcome
  • Zinc Sulfate* / administration & dosage
  • Zinc Sulfate* / pharmacology
  • Zinc Sulfate* / therapeutic use

Substances

  • Zinc Sulfate
  • Antiviral Agents
  • Hyaluronic Acid
  • Fibronectins
  • Antifibrotic Agents
  • Transforming Growth Factor beta1

Associated data

  • ClinicalTrials.gov/NCT05465434