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. 2019 Aug 26;7(16):2247-2255.
doi: 10.12998/wjcc.v7.i16.2247.

Effects of dual sofosbuvir/daclatasvir therapy on, chronic hepatitis C infected, survivors of childhood malignancy

Mortada Hf El-Shabrawi  1 , Laila M Sherief  2 , Mostafa Yakoot  3 , Naglaa M Kamal  1 , Mohamed A Almalky  2 , Manal M AbdElgawad  4 , Aml A Mahfouz  4 , Sherine Helmy  5 , Enas M Kamal  6 , Dina Attia  7 , Hisham R El-Khayat  8
Affiliations

Effects of dual sofosbuvir/daclatasvir therapy on, chronic hepatitis C infected, survivors of childhood malignancy

Mortada Hf El-Shabrawi et al. World J Clin Cases. .

Abstract

Background: Childhood cancer survivors are potentially at a higher risk of infection with hepatitis C virus (HCV). The effects of all-oral direct-acting antiviral therapy (DAA) on both the HCV infection as well as the state of cancer remission have not been well investigated in this population.

Aim: To test the effects of dual sofosbuvir/daclatasvir (SOF/DCV) therapy in the treatment of chronic HCV in survivors of hematologic malignancy in pediatric age group.

Methods: We conducted a prospective, uncontrolled, open-label multicenter study. A total of 20 eligible, chronic HCV, genotype-4, infected children who had been in continuous complete remission from hematologic cancer (leukemia/lymphoma) for at least one year were included in the study. All patients were treated with combined SOF/DCV for 12 wk. Patients were monitored throughout the study till 12 wk after end of treatment for safety and efficacy outcomes including the sustained virologic response 12 (SVR12) rate, hematological indices, liver and kidney functions.

Results: The intent-to-treat SVR12 rate was 20 of 20 (100%; 95%CI: 84%-100%). All patients showed normalized liver enzymes from week-4. All hematological indices, liver and kidney functions were kept normal throughout the study. No fatalities or treatment-emergent serious or severe adverse events were reported throughout the study.

Conclusion: SOF/DCV combined therapy could be used safely and effectively in the treatment of chronic HCV genotype-4 infection in leukemia/lymphoma treated children. No relapses were detected during treatment and throughout the follow up period for either the original malignant disease or the HCV infection.

Keywords: Chronic hepatitis C; Daclatasvir; Efficacy; Sofosbuvir; Survivors of childhood cancer.

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Conflict of interest statement

Conflict-of-interest statement: Mostafa Yakoot had conducted clinical trials on Pharco products. Sherine Helmy works and has stocks in Pharco Corporate. Other authors have nothing to disclose.

Figures

Figure 1
Figure 1
Patient flowchart.
Figure 2
Figure 2
The mean serum alanine aminotransferase and aspartate aminotransferase (IU/L) at baseline and during follow up. ALT: Alanine aminotransferase; AST: Aspartate aminotransferase.
Figure 3
Figure 3
The mean serum bilirubin and creatinine at baseline and during follow up.
Figure 4
Figure 4
Mean hemoglobin and white blood cells count at baseline and during follow up. WBCs: White blood cells.
See this image and copyright information in PMC

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