1. Functional cure induced by tenofovir alafenamide plus peginterferon-alpha-2b in young children with chronic hepatitis B: a case series study.
- Author
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Zeng QL, Chen RY, Lv XY, Huang S, Li WZ, Pan YJ, Wang FS, and Yu ZJ
- Subjects
- Humans, Male, Female, Child, Child, Preschool, Treatment Outcome, Interferon alpha-2 therapeutic use, Interferon alpha-2 administration & dosage, Hepatitis B Surface Antigens blood, Hepatitis B e Antigens blood, Hepatitis B virus genetics, Hepatitis B virus drug effects, DNA, Viral blood, Alanine therapeutic use, Alanine analogs & derivatives, Tenofovir therapeutic use, Tenofovir administration & dosage, Tenofovir analogs & derivatives, Hepatitis B, Chronic drug therapy, Hepatitis B, Chronic virology, Antiviral Agents therapeutic use, Antiviral Agents adverse effects, Antiviral Agents administration & dosage, Recombinant Proteins therapeutic use, Recombinant Proteins administration & dosage, Recombinant Proteins adverse effects, Polyethylene Glycols therapeutic use, Polyethylene Glycols adverse effects, Polyethylene Glycols administration & dosage, Interferon-alpha therapeutic use, Interferon-alpha administration & dosage, Interferon-alpha adverse effects, Drug Therapy, Combination
- Abstract
Background and Aims: Data on the safety and effectiveness of tenofovir alafenamide (TAF) plus peginterferon-alpha (Peg-IFN-α) in children with chronic hepatitis B (CHB) are lacking. The current study aimed to present the characteristics of four pediatric CHB patients who obtained a functional cure by using TAF and Peg-IFN-α., Methods: In this case series study initiated in May 2019, ten children who had no clinical symptoms or signs received response-guided (HBV DNA undetectable, hepatitis B e antigen [HBeAg] loss or seroconversion, and hepatitis B surface antigen [HBsAg] loss or seroconversion) and functional cure-targeted (HBsAg loss or seroconversion) TAF (25 mg/d, orally) plus Peg-IFN-α-2b (180 µg/1.73m
2 , subcutaneously, once weekly) in combination (9/10) or sequential (1/10) therapy. The safety and effectiveness of these treatments were monitored., Results: As of April 2024, four out of ten children obtained a functional cure after a mean of 31.5 months of treatment, and the other six children are still undergoing treatment. These four cured children, aged 2, 4, 8, and 6 years, were all HBeAg-positive and had alanine aminotransferase levels of 80, 47, 114, and 40 U/L; HBV DNA levels of 71200000, 93000000, 8220, and 96700000 IU/mL; and HBsAg levels of 39442.8, 15431.2, 22, and 33013.1 IU/mL, respectively. During treatment, all the children (10/10) experienced mild or moderate adverse events, including flu-like symptoms, anorexia, fatigue, and cytopenia. Notably, growth retardation (8/10) was the most significant adverse event; and it occurred in three cured children (3/4) treated with combination therapy and was present to a low degree in the other cured child (1/4) treated with sequential therapy. Fortunately, all three cured children recovered to or exceeded the normal growth levels at 9 months posttreatment., Conclusions: TAF plus Peg-IFN-α-2b therapy is potentially safe and effective for pediatric CHB patients, which may provide important insights for future clinical practice and study designs targeting functional cures for children with CHB., (© 2024. The Author(s).)- Published
- 2024
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