Hapgen has been used in pediatrics for more than ten years. Hundreds of clinical researches indicated that intramuscular injection of IFN-a1b 1~2μg/kg and nebulization 2~4μg/kg for 5~7days both are effective in the treatment of children with viral infection.

For bronchiolitis, Hapgen will shorten the duration of fever, cough, rales and dyspnea significantly. A multicenter randomized controlled study enrolled 330 cases with bronchiolitis confirmed that nebulizing Hapgen 2~4μg/kg twice a day for 5~7 days is safety and efficacy. Both low dose at 2μg/kg (total efficacy: 92.3%) and high dose at 4 μg/kg(total efficacy:95.0%) showed better efficacy in wheezing, wheezes and three concave sign improvement compared with conventional therapy, and high dose group present a higher improvement rate [1].

For the pneumonia caused by RSV, PIV, ADV and HRV infection, Hapgen can significantly shorten the duration of dyspnea, cough, rales, fever and hospitalization, reduce complications, and improve the prognosis and efficacy, especially in RSV infection ( total efficiency: 95%). A multi center randomized controlled study enrolled 340 children with viral pneumonia confirmed that intramuscular injection of Hapgen 1μg/kg a day for 5 ~ 7 days had better efficacy and fewer adverse events compared with ribavirin[2].

A number of clinical studies showed that mild cases of HFMD treat with Hapgen in the early onset can shorten the duration of fever, skin rashes and oral ulcers recovery compared with conventional therapy. In addition, for severe HFMD patients such as HFMD complicated with viral encephalitis or CNS involvement, Hapgen also showed better efficacy in shortening nervous system syndrome duration and promoting temperature and cerebrospinal fluid leucocytes counts return to normal. It was confirmed by a multicenter randomized controlled study of 66 HFMD children with CNS complications (97% EV71 infected) nebulized Hapgen at a dose of 30μg twice a day [3].

For viral enteritis, treatment with Hapgen in the acute phase is helpful to relieve symptoms, shorten the course and time of viral shedding, reduce the risk of complications and contagion. A 119 cases with RV diarrhea of multicenter randomized controlled study showed that with intramuscular injection of Hapgen 1 μg / kg a day for 5 ~ 7 days can effectively shorten the duration of fever and diarrhea, improve the recovery rate and virus clearance rate compared with ribavirin[4].

Numerous clinical trials showed that the safety of Hapgen (IFN-a1b) treatment was better than that of ribavirin and other interferon subtypes for children infection.It is estimated that, in the field of pediatric applications IFN-a1b has a lower rate of adverse events (12.1‰) than IFN-a2a (37.0%) or IFN-a2b (49.0%).A phase I clinical trial about the tolerance and safety of Hapgen in children on viral pneumonia convalescence present the results that intramuscular injection 2.0μg/kg or nebulization 4.0μg/kg of Hapgen in children older than 4 months was safe and well tolerated, without serious adverse events occurred[5]. In addition, it is also reported that Hapgen treatment is neonatal safety [6-7].

Except for the above, Hapgen also showed potency and safety in herpangina, measles, chicken pox, mumps, infectious mononucleosis and other viral infection diseases.

References:

1.Shang YX, Huang Y,Liu EM,etal. A multicenter clinical study on the treatment for children’s acute bronchiolitis by nebulized recombinant human interferon α1b [J]. Chinese Journal of Practical Pediatrics, 2014,29(11):840-844.

2.Chen PL,Zhang TX,HuYH, etal. A multicenter randomized controlled clinical trial on the treatment with recombinant human interferon α1b for children’s viral pneumonia [J]. Journal of Clinical Pediatrics, 2005, 23(4):244-245.

3.Xun YL,Tian QL, Jiang TY, etal. Therapeutic effect of nebulized human recombinant interferon α1b on severe hand-foot-mouth disease children with early study of nervous system complications[J]. Chinese Journal of Applied Clinical Pediatrics, 2015, 30 (8): 627-630.

4.Xu XW,Wang HL,Wang GL, etal. Observation on the therapeutic effects of recombinant human interferon α1b for infantile rotavirus enteritis [J].Journal of Clinical Pediatrics, 2005,23(8):582-583.

5.Sun W, Qiao Y, Guo L, et al. Tolerance and safety of recombinant human interferon α1b injection in children with viral pneumonia [J]. Chinese Journal of New Drugs, 2011,20 (23):2340-2344.

6.Zhu HB, Mi HY. The effects of interferon on neonates with rotaviral enteritis [J]. Journal of Pediatric Pharmacy, 2012,18(7):28-30.

7.Duan ZM, Xia LP. Observation on the treatment of neonatal viral upper respiratory tract infection by ultrasonic nebulized recombinant human interferon α1b [J]. Chinese Journal of modern drug application, 2011,5(14):85-86.