Real-World Efficacy and Safety of an 8-Week Glecaprevir/Pibrentasvir Regimen in Children and Adolescents with Chronic Hepatitis C—Results of a Multicenter EpiTer-2 Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Population
2.2. Data Collection
2.3. Assessment of Liver Disease Severity
2.4. HCV Treatment Regimen
2.5. Assessment of Safety
2.6. Ethics
2.7. Statistical Analysis
3. Results
3.1. Patients’ Baseline Characteristics and Laboratory Parameters
3.2. Treatment Effectiveness and Safety
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Parameters | Values n = 23 |
---|---|
Age, mean (SD) (years), (min–max) | 9.61 (3.68), (3–17) |
Gender, n (%) (female/male) | 13/10 (56.5/43.5) |
BMI, mean (SD) | 18.64 (4.37) |
Genotypes, n (%) | |
1 | 15 (65.2) |
1a | 6 (26.1) |
1b | 9 (39.1) |
2 | 0 (0) |
3 | 5 (21.7) |
4 | 3 (13) |
Fibrosis/stiffness, n (%) | |
F0 | 11 (47.8) |
F1 | 1 (4.3) |
F2 | 0 |
F3 | 0 |
F4 | 0 |
Unknown | 11 (47.8) |
HCC history, n (%) | 0 |
Liver transplantation history, n (%) | 0 |
HIV coinfection, n (%) | 0 |
HBV coinfection, n (%) | 1 (4.3) |
Any comorbidity, n (%) | 1 (4.3) |
Renal diseases | 1 (4.3) |
Concomitant medications, n (%) | 0 |
Parameters | Tablets n = 10 | Granules n = 13 |
---|---|---|
Age, mean (SD) (years), (min–max) | 13.20 (1.72), (11–17) | 7 (2.03), (3–10) |
Gender, n (%) (female/male) | 5/5 (50/50) | 8/5 (61.5/38.5) |
BMI, mean (SD) | 22.51 (3.59) | 15.65 (1.86) |
Genotypes, n (%) | ||
1 | 6 (60.0) | 9 (69.2) |
1a | 1 (10.0) | 5 (38.5) |
1b | 5 (50.0) | 4 (30.8) |
2 | 0 (0) | 0 (0) |
3 | 3 (30.0) | 2 (15.4) |
4 | 1 (10.0) | 2 (15.4) |
Fibrosis/stiffness, n (%) | ||
F0 | 5 (50) | 6 (46.2) |
F1 | 1 (10) | 0 (0) |
F2 | 0 (0) | 0 (0) |
F3 | 0 (0) | 0 (0) |
F4 | 0 (0) | 0 (0) |
Unknown | 4 (40) | 7 (53.8) |
HCC history, n (%) | 0 (0) | 0 (0) |
Liver transplantation history, n (%) | 0 (0) | 0 (0) |
HIV coinfection, n (%) | 0 (0) | 0 (0) |
HBV coinfection, n (%) | 1 (10) | 0 (0) |
Any comorbidity, n (%) | ||
Kidney diseases | 1 (10) | 0 |
Concomitant medications, n (%) | 0 | 0 |
Parameters | Values n = 23 |
---|---|
HCV RNA, median (IQR) [IU/L] | 645,000 (229,324–1,865,000) |
ALT, median (IQR) [IU/L] | 46 (37.5–58.5) |
Albumin, median (IQR) [g/dL] | 4.63 (4.46–4.87) |
Biblirubin, median (IQR) [mg/dL] | 0.46 (0.37–0.56) |
Platelets ×1000/µL, median (IQR) | 323 (260–378.5) |
Creatinine, median (IQR) [mg/dL] | 0.46 (0.4–0.57) |
Hemoglobin, median (IQR) [g/dL] | 13.6 (12.75–13.9) |
INR, median (IQR) | 1.08 (1.05–1.12) |
Parameters | Tablets n = 10 | Granules n = 13 |
---|---|---|
HCV RNA, median (IQR) [IU/mL] | 521,500 (353,000–1,437,500) | 735,000 (107,000–2,030,000) |
ALT, median (IQR) [IU/L] | 47.5 (42.75–64.25) | 43 (33–49) |
Albumin, median (IQR) [g/dL] | 4.70 (4.63–5.1) | 4.57 (4.30–4.72) |
Biblirubin, median (IQR) [mg/dL] | 0.51 (0.45–0.68) | 0.43 (0.34–0.50) |
Platelets ×1000/µL, median (IQR) | 242 (197–313) | 367 (305–416) |
Creatinine, median (IQR) [mg/dL] | 0.62 (0.54–0.77) | 0.42 (0.39–0.45) |
Hemoglobin, median (IQR) [g/dL] | 13.80 (13.60–13.90) | 13 (12.40–13.8) |
INR, median (IQR) | 1.10 (1.06–1.11) | 1.06 (1.04–1.12) |
Parameter | Values |
---|---|
Number of patients, n | 23 |
Treatment course, n (%) | |
According to schedule | 23 (100) |
Therapy modification | 0 |
Therapy discontinuation | 0 |
Patients with at least one AE, n (%) | |
Nausea | 1 (4.3) |
Fatigue | 1 (4.3) |
Parameter | Tablets | Granules |
---|---|---|
Number of patients, n | 10 | 13 |
Treatment course, n (%) | ||
According to schedule | 10 (100) | 13 (100) |
Therapy modification | 0 (0) | 0 (0) |
Therapy discontinuation | 0 (0) | 0 (0) |
Patients with at least one AE, n (%) | ||
Nausea | 1 (10.0) | 0 (0) |
Fatigue | 1 (10.0) | 0 (0) |
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Pawlowska, M.; Dobrowolska, K.; Moppert, J.; Pokorska-Śpiewak, M.; Purzynska, M.; Marczynska, M.; Zarebska-Michaluk, D.; Flisiak, R. Real-World Efficacy and Safety of an 8-Week Glecaprevir/Pibrentasvir Regimen in Children and Adolescents with Chronic Hepatitis C—Results of a Multicenter EpiTer-2 Study. J. Clin. Med. 2023, 12, 6949. https://doi.org/10.3390/jcm12216949
Pawlowska M, Dobrowolska K, Moppert J, Pokorska-Śpiewak M, Purzynska M, Marczynska M, Zarebska-Michaluk D, Flisiak R. Real-World Efficacy and Safety of an 8-Week Glecaprevir/Pibrentasvir Regimen in Children and Adolescents with Chronic Hepatitis C—Results of a Multicenter EpiTer-2 Study. Journal of Clinical Medicine. 2023; 12(21):6949. https://doi.org/10.3390/jcm12216949
Chicago/Turabian StylePawlowska, Malgorzata, Krystyna Dobrowolska, Justyna Moppert, Maria Pokorska-Śpiewak, Mariola Purzynska, Magdalena Marczynska, Dorota Zarebska-Michaluk, and Robert Flisiak. 2023. "Real-World Efficacy and Safety of an 8-Week Glecaprevir/Pibrentasvir Regimen in Children and Adolescents with Chronic Hepatitis C—Results of a Multicenter EpiTer-2 Study" Journal of Clinical Medicine 12, no. 21: 6949. https://doi.org/10.3390/jcm12216949