Poland Expands HCV Treatment to Children as Real-World Data Confirm High DAA Efficacy in Pediatric Patients
核心洞察
Over 200 Polish children aged 3–18 years have been treated with direct-acting antivirals since 2018, achieving an overall intention-to-treat SVR12 rate of 97.3%.
Poland included children aged ≥3 years in its national therapeutic HCV program on April 1, 2025, though only adult-dose formulations are currently reimbursed.
Significant liver fibrosis was detected in 7.3% of treatment-eligible children, with cirrhosis in 2%, underscoring the need for early intervention.
More than 200 Polish children and adolescents aged 3 to 18 years have received direct-acting antiviral (DAA) treatment for chronic hepatitis C (搜索) since 2018, well before the country officially included pediatric patients in its national therapeutic program on April 1, 2025. According to a comprehensive review published in Clinical and Experimental Hepatology, these real-world and clinical trial experiences demonstrate a 97.3% intention-to-treat sustained virologic response at 12 weeks post-treatment (SVR12), confirming that DAA regimens are highly effective in the pediatric population.
The review, authored by Maria Pokorska-Śpiewak and colleagues from the Department of Children's Infectious Diseases at the Medical University of Warsaw (搜索), consolidates all available Polish data on DAA use in children and provides guidance for clinicians now preparing to treat pediatric patients under the newly expanded national program.
Real-World Evidence Across Three Major Projects
The Polish experience with pediatric DAA treatment spans three major initiatives. The POLAC project, a real-life therapeutic program launched in August 2019 by the Medical University of Warsaw (搜索), initially enrolled children aged ≥12 years and expanded in April 2021 to include patients aged 3 years and above from all Polish regions. The PANDAA-PED study, a noncommercial, open-label trial funded by the Medical Research Agency, successfully treated 50 patients aged 6–18 years between January and October 2022 using a 12-week course of sofosbuvir/velpatasvir (SOF/VEL) adjusted for body weight. The Epiter-2 project, managed by the Polish Society of Epidemiology and Physicians of Infectious Diseases (搜索), retrospectively collects data through a nationwide database covering five pediatric infectious disease departments.
Among the more than 200 documented patients, 106 received glecaprevir/pibrentasvir (GLE/PIB), 50 received SOF/VEL, and 40 received sofosbuvir/ledipasvir (SOF/LDV). The cohort included 20 young children aged 3–5 years, 78 aged 6–11 years, and 98 teenagers aged 12–18 years. Polish participants were also included in two multicenter international trials evaluating sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) and elbasvir/grazoprevir (EBR/GZR), with all participants in those trials achieving SVR12.
The Case for Early Treatment
The review underscores the progressive nature of hepatitis C (搜索) in children. A recent Polish analysis of 150 children aged 3 to 17 years who received antiviral treatment revealed that baseline elastography detected significant fibrosis (corresponding to F≥2 on the METAVIR scale) in 11 of 150 participants (7.3%). Among them, three children (2%) had liver stiffness measurements consistent with cirrhosis (F4). Age greater than 10 years and duration of infection exceeding 10 years were identified as predictors of significant fibrosis.
Longitudinal data cited in the review, from a British study by Modin et al. involving nearly 1,500 patients, suggest that liver cirrhosis may develop in one-third of individuals infected with HCV during childhood over a median of 33 years after infection. "These findings indicate that available antiviral treatment options should be implemented in children, without postponing therapy to adulthood," the authors state.
Current Program Limitations
Despite the milestone inclusion of children in Poland's national therapeutic program, significant access barriers remain. The drug reimbursement list currently includes only adult doses and formulations of DAAs. Consequently, only patients older than 12 years or weighing at least 30 or 45 kg (depending on the regimen) may be eligible. Younger patients, or those weighing ≥30 kg but unable to swallow tablet formulations, can only access treatment through programs such as the POLAC Project, where pharmaceutical companies donate pediatric formulations.
The authors note that DAA efficacy is lower in the youngest age group (3–6 years), primarily due to treatment discontinuation or loss to follow-up rather than virological failure. "Medicines containing DAAs have a bitter taste and should not be chewed or split, which is often difficult for young children," they explain, adding that no syrup formulations are currently available.
Guidance for Pediatric Treatment
Drawing on experience with more than 170 patients treated at their department, the authors offer several practical recommendations. They advise against omitting monitoring visits during treatment, suggesting assessments at week 4 and at end of treatment, given that pediatric patients may struggle with medication adherence. They also recommend that centers conducting DAA treatment for children be equipped with both M and S probes for transient elastography, and they caution against replacing elastography with APRI or FIB-4 biomarker testing using adult cutoff values. A recent study showed that lower cutoff thresholds are needed to indicate significant fibrosis or cirrhosis in children: for APRI, a cutoff >0.53 (AUROC 0.706 for significant fibrosis; 0.879 for cirrhosis), and for FIB-4, a cutoff >0.24 for significant fibrosis (AUROC 0.802) and >0.40 for cirrhosis (AUROC 0.96).
The Diagnosis Gap
The review highlights a critical disconnect between estimated HCV prevalence and reported cases. While an estimated 3,500 children and adolescents in Poland are living with HCV, only 333 new cases were reported among those aged 0–19 years over the entire decade from 2014 to 2023. "Most children with hepatitis C (搜索) remain undiagnosed and are at risk of developing HCV-related complications," the authors warn. Mother-to-child transmission accounts for more than 80% of pediatric HCV cases in Poland, yet routine HCV testing during pregnancy has not substantially increased diagnoses in children, suggesting imperfect linkage to care.
To achieve the World Health Organization's 2030 hepatitis elimination goals, the authors call for a microelimination strategy focused on testing children and adolescents at high risk, including those born to HCV-infected mothers, those who inject drugs, those with inherited blood disorders, and migrants and refugees, whose numbers have significantly increased in Poland in recent years.