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Functional cure induced by tenofovir alafenamide plus peginterferon-alpha-2b in young children with chronic hepatitis
Qing-Lei Zeng1, Ru-Yue Chen2, Xue-Yan Lv2
1Department of Infectious Diseases and Hepatology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China. zengqinglei2009@163.com.
Insights
Tenofovir alafenamide (TAF) plus peginterferon-alfa (Peg-IFN-α) showed potential for functional cure in pediatric chronic hepatitis B (CHB) patients. While adverse events like growth retardation occurred, they were manageable, offering hope for CHB treatment.
Area of Science:
- Hepatology
- Pediatric Gastroenterology
- Virology
Background:
- Limited data exists on tenofovir alafenamide (TAF) and peginterferon-alfa (Peg-IFN-α) for pediatric chronic hepatitis B (CHB).
- Assessing the safety and effectiveness of this combination therapy is crucial for pediatric CHB management.
Purpose of the Study:
- To evaluate the safety and effectiveness of TAF plus Peg-IFN-α therapy in pediatric CHB patients.
- To report on the characteristics of pediatric CHB patients achieving a functional cure.
Main Methods:
- A case series study involving ten pediatric CHB patients receiving TAF and Peg-IFN-α-2b.
- Treatment involved combination or sequential therapy, guided by response and targeting functional cure (HBsAg loss/seroconversion).
- Safety and effectiveness were monitored over a mean treatment duration of 31.5 months.
Main Results:
- Four out of ten children achieved a functional cure, with the remaining six still undergoing treatment.
- Mild to moderate adverse events were observed in all patients, with growth retardation being the most significant.
- Growth retardation resolved in cured children within 9 months post-treatment.
Conclusions:
- TAF plus Peg-IFN-α-2b therapy demonstrates potential safety and effectiveness for pediatric CHB patients.
- This approach may inform future clinical practices and study designs for achieving functional cures in children with CHB.
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/1.73m2, 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.
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