HCV Treatment Improves Health-Related Quality of Life in Pediatric Patients

The health-related quality of life (HRQoL) of children with chronic hepatitis C (HCV) improved after treatment with sofosbuvir/velpatasvir, according to findings from a study published in Liver International.¹

All 50 patients achieved sustained virologic response (SVR) after 12 weeks of treatment, with responses to the KIDSCREEN-27 questionnaire at the end of treatment, indicating a significant improvement in the physical well-being dimension.¹

“As our understanding of the clinical outcomes of HCV in pediatric patients improves, assessment of the impact of HCV infection on HRQoL from both the child's and caregiver's perspectives is of particular importance,” wrote a team of international investigators.¹

The World Health Organization estimates 58 million people have chronic HCV, with about 1.5 million new infections occurring every year. There are an estimated 3.2 million adolescents and children with chronic HCV infection.² HCV treatment in children often carries side effects and health risks, and some medicines have not yet been approved for children.³

To assess the HRQoL in children aged 6–18 years with chronic HCV before and after treatment with sofosbuvir/velpatasvir, senior investigator Giuseppe Indolfi, MD, PhD, associate professor in the pediatric and liver unit at Anna Meyer Children's University-Hospital in Italy, and a team of investigators administered the KIDSCREEN-27 questionnaire to patients and their caregivers at screening and at the assessment of SVR after 12 weeks of treatment. Data were collected as secondary endpoints of the PANDAA-PED study, a non-commercial, non-randomized, open-label trial of 50 pediatric patients aged 6–18 years with HCV treated with a fixed dose of sofosbuvir/velpatasvir.¹

The questionnaire consisted of 27 items divided into 5 health-related dimensions: physical well-being, psychological well-being, autonomy and parent relations, social support and peers, and school. Responses were scored on a 5-point scale ranging from never/not at all to always. The adult version had the same structure as the version for children but asked caregivers to assess their children's health-related quality of life from their own perspective.¹

Investigators calculated the intraclass correlation coefficient and used the Bland–Altman test to determine the agreement between children and their caregivers based on their responses to KIDSCREEN-27. The child and adolescent version of the KIDSCREEN-27 has been deemed suitable for children aged ≥8 years; therefore, the assessment was only made by caregivers in the case of children aged below 8 years.¹

Among the cohort, 54% of patients were female, the mean age was 10 years (8-12), and 68% had HCV genotype 1b. All 50 participants treated with sofosbuvir/velpatasvir achieved sustained virologic response. No serious adverse events related to the treatment were reported during the study.¹

In total, questionnaires were available from 42 patients at baseline and 44 patients at 12 weeks post-treatment, as well as all 50 caregivers before and after treatment. At baseline, compared to child self-reports, caregiver proxy reports indicated a lower assessment of their children's HRQoL for psychological well-being (49.48; standard deviation [SD], 9.55 for children compared to 47.10; SD, 10.46 for parents; P = .03) and social support and peers (49.86; SD, 10.45 for children compared to 45.26; SD, 9.90 for parents; P = .009). Investigators pointed out in cases of discrepancies, the parent's proxy assessment was usually lower than the child's self-report.¹

Further analysis revealed a significant improvement in the physical well-being dimension of the child self-assessments (48.53 at baseline to 51.21 at 12 weeks post-treatment; P = .03). After treatment, the proportion of children assessing their physical well-being as below normal significantly decreased from 17% to 5% (P = .007). Investigators also noted better scores in the social support and peers dimension of the parent proxy evaluation (45.98 at baseline compared to 48.66 at 12 weeks post-treatment; P = .06).¹

To analyze the influence of sex and age on the health-related quality of life evaluation, investigators performed a multivariate regression analysis for all 5 dimensions before and after treatment. Results indicated HRQoL was not associated with patients' sex, but younger age correlated with better HRQoL, especially in child self-reports at baseline.¹

“The results of the PANDAA-PED study indicate that a significant proportion of children with chronic HCV have decreased HRQoL in all dimensions, but effective treatment with sofosbuvir/velpatasvir leads to an improvement in some areas of well-being,” investigators concluded.¹ “This suggests not only clinical improvement after achievement of SVR but also a positive impact of treatment on patient-reported outcomes.”

References:

1. Pokorska-Śpiewak M, Talarek E, Aniszewska M, et al. Health-related quality of life in patients aged 6–18 years with chronic hepatitis C treated with sofosbuvir/velpatasvir. Liver Int. doi:10.1111/liv.15744
2. World Health Organization. Hepatitis C. Newsroom. July 18, 2023. Accessed September 28, 2023. https://www.who.int/news-room/fact-sheets/detail/hepatitis-c
3. Mount Sinai. Hepatitis C -children. Health Library. Accessed September 28, 2023. https://www.mountsinai.org/health-library/diseases-conditions/hepatitis-c-children