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Background <p>We currently advise all pediatric patients with hepatitis C virus (HCV) infection to take oral direct-acting antivirals (DAA), especially pan-genotypic medications. This study looks at how well, safely, and tolerably sofosbuvir-velpatasvir (SOF/VEL) combination therapy works for kids and teens in Bangladesh who have chronic HCV infection.</p> Material and methods <p>The study was prospective and carried out from January 2022 to July 2024. Three -to-18-year-olds who tested positive for HCV by polymerase chain reaction (PCR) were recruited using sequential non-probability sampling. Clinical characteristics were documented, and investigations were conducted. Every patient received SOF-VEL (150/37.5&#xa0;mg for &lt; 17&#xa0;kg, 200/50&#xa0;mg for 17 − &lt; 30&#xa0;kg, and 400/100&#xa0;mg for ≥ 30&#xa0;kg) for 12&#xa0;weeks. All children were subjected to clinical and laboratory monitoring on a 4-weekly basis.</p> Results <p>The male–female ratio was 1.2:1, and the mean age was 11.22 ± 2.76&#xa0;years. Thirty-eight patients (92.7%) had a sustained virological response (SVR), which means that their HCV PCR test was negative even 12&#xa0;weeks after treatment. Three patients (7.3%) exhibited unresponsiveness or virological failure, as positive PCR results showed. After treatment, patients’ biochemical (hepatic enzymes with serum bilirubin) and clinical (jaundice, dark urine, abdominal pain, and hepatomegaly) conditions got a lot better. Almost half of the study participants said the medicine was well tolerated and had no negative effects. The most prevalent adverse effects in 6–18-year-olds were headache (23.7%), nausea with vomiting (13.2%), fatigue (7.9%), vomiting with diarrhea (33.3%), and rhinorrhea (33.3%) in the 3–5-year age group. The majority of side effects were minor and were treated symptomatically.</p> Conclusion <p>The SOF/VEL pan-genotypic regimen is very efficacious and well tolerated for treating chronic HCV infection in children, with no major side effects.</p>

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Effectiveness and safety of sofosbuvir/velpatasvir in chronic hepatitis C virus infection of Bangladeshi children

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年6月28日

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  • Salahuddin Mahmud,
  • Md. Belayet Hossain,
  • Emdadul Haque,
  • Madhabi Baidya,
  • Rafia Rashid,
  • Ahmed Rashidul Hasan,
  • Tanzila Farhana,
  • Farhana Tasneem,
  • Syed Shafi Ahmed

摘要

Background

We currently advise all pediatric patients with hepatitis C virus (HCV) infection to take oral direct-acting antivirals (DAA), especially pan-genotypic medications. This study looks at how well, safely, and tolerably sofosbuvir-velpatasvir (SOF/VEL) combination therapy works for kids and teens in Bangladesh who have chronic HCV infection.

Material and methods

The study was prospective and carried out from January 2022 to July 2024. Three -to-18-year-olds who tested positive for HCV by polymerase chain reaction (PCR) were recruited using sequential non-probability sampling. Clinical characteristics were documented, and investigations were conducted. Every patient received SOF-VEL (150/37.5 mg for < 17 kg, 200/50 mg for 17 − < 30 kg, and 400/100 mg for ≥ 30 kg) for 12 weeks. All children were subjected to clinical and laboratory monitoring on a 4-weekly basis.

Results

The male–female ratio was 1.2:1, and the mean age was 11.22 ± 2.76 years. Thirty-eight patients (92.7%) had a sustained virological response (SVR), which means that their HCV PCR test was negative even 12 weeks after treatment. Three patients (7.3%) exhibited unresponsiveness or virological failure, as positive PCR results showed. After treatment, patients’ biochemical (hepatic enzymes with serum bilirubin) and clinical (jaundice, dark urine, abdominal pain, and hepatomegaly) conditions got a lot better. Almost half of the study participants said the medicine was well tolerated and had no negative effects. The most prevalent adverse effects in 6–18-year-olds were headache (23.7%), nausea with vomiting (13.2%), fatigue (7.9%), vomiting with diarrhea (33.3%), and rhinorrhea (33.3%) in the 3–5-year age group. The majority of side effects were minor and were treated symptomatically.

Conclusion

The SOF/VEL pan-genotypic regimen is very efficacious and well tolerated for treating chronic HCV infection in children, with no major side effects.