Long-Term Follow-Up of Thalassemia Major Patients with Hepatitis C Virus Treated with Sofosbuvir and Daclatasvir: A Cohort Study

Arch Med Res. 2022 Nov;53(7):666-672. doi: 10.1016/j.arcmed.2022.09.004. Epub 2022 Oct 8.

Abstract

Background: Treatment of Chronic Hepatitis C virus (HCV) infection in patients suffering from hereditary β-thalassemia major is a concern due to drug complications and liver malfunction. The aim of the present study was to evaluate treatment outcome of Direct-Acting Antiviral (DAA) therapy in thalassemia major patients infected with HCV in a three year follow-up.

Methods: In a cohort study, long-term safety and efficacy of DAA therapy were evaluated in a group of thalassemia major patients suffering from chronic HCV infection. Hematologic and biochemical parameters as well as liver Fibroscan monitoring were assessed at the onset and three years after the treatment.

Results: From among 84 patients enrolled in the study, 53.6% were males, 36.9% had cirrhosis, 96.4% had a history of Desferal usage, and 78.6% had a history of splenectomy. Unfortunately, 7 participants (8.3%) died prior to the end of follow-up with nearly half of them having Iron overload and heart failure complications. Fibroscan score, ALT, AST, and ferritin were significantly lower compared with baseline evaluation, while Hb, creatinine, and direct bilirubin increased significantly in the third year after the treatment.

Conclusion: Safety and efficacy of Sofosbuvir and Daclatasvir in thalassemia patients assessed previously but our three year follow-up showed their mild complications and death into a long-term period after DAAs treatment and 91.7% three year survival rate, which may affected by other confounding factors, such as liver malfunction and Iron overload.

Keywords: Direct-acting antiviral (DAA); Follow-up; Hepatitis C virus (HCV).

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antiviral Agents / therapeutic use
  • Cohort Studies
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Hepacivirus / genetics
  • Hepatitis C* / complications
  • Hepatitis C* / drug therapy
  • Hepatitis C, Chronic* / complications
  • Hepatitis C, Chronic* / drug therapy
  • Humans
  • Iron Overload*
  • Male
  • Pyrrolidines / therapeutic use
  • Sofosbuvir / therapeutic use
  • Treatment Outcome
  • beta-Thalassemia* / complications
  • beta-Thalassemia* / drug therapy

Substances

  • Sofosbuvir
  • Antiviral Agents
  • daclatasvir
  • Pyrrolidines