Cuba Tests Medication against Hepatitis B and C

StephenW

Cuba Tests Medication against Hepatitis B and C

Havana, Jun 17 (Prensa Latina) Cuba´s Genetic Engineering and Biotechnology Center (CIGB) will carry out medical trials on a medication against chronic hepatitis B and C.   This interferon has a broader effect and reduces the intake dosage, Hugo Nodarse, head of the CIGB Oncology Research Department, told Juventud Rebelde daily at the National Workshop on the Use of Biotechnological Products to Treat Viver Disorders, held on Friday in Havana´s Center for Medical Surgery Research (CIMEQ). In this regard, Nodarse mentioned the successful administration of PEG-Heberón to treat hepatitis B and C, and opportunistic infections in AIDS/HIV patients. Specialist Pedro Lopez highlighted the successful three-decade research that resulted in a vaccine against hepatitis B, whose distribution eradicated the disease among children. jg/emw/mh/ro 古巴试验药物对乙型和丙型肝炎PDF格式Imprimir电子邮件    IMAGEN德muestraHavana，06月17日（拉丁新闻社）古巴遗传工程和生物技术中心（CIGB）将开展医疗上对慢性乙型肝炎和丙型肝炎的药物试验   这种干扰素有更广泛的影响和减少摄入量，雨果Nodarse CIGB肿瘤研究部负责人，告诉Juventud Rebelde每天使用生物技术产品的治疗Viver障碍，哈瓦那的中心在上周五举行的全国研讨会医疗手术研究（CIMEQ）。 在这方面，Nodarse提到的成功的管理PEG-Heberón的治疗乙型和丙型肝炎，艾滋病/艾滋病毒患者的机会性感染。 专家佩德罗·洛佩斯强调成功的三十年的研究，导致对B型肝炎，其分布根除儿童疾病的疫苗。

咬牙硬挺

新型干扰素

希望奇迹

期待中！

MP4

http://www.sld.cu/sitios/cimeq/

StephenW

回复 MP4 的帖子

谢谢.似乎是这个干扰素 40-kDa PEG-IFN alpha-2b :
Pharmacokinetic and pharmacodynamic comparison of two “pegylated” interferon alpha-2
formulations in healthy male volunteers: a randomized, crossover, double-blind study
Idrian García-García1*, Carlos A González-Delgado2, Carmen M Valenzuela-Silva1, Alina Díaz-Machado2, Marisol Cruz-Díaz1, Hugo Nodarse-Cuní1, Orlando Pérez-Pérez2, Cimara H Bermúdez-Badell1, Joel Ferrero-Bibilonia3, Rolando Páez-Meireles4, Iraldo Bello-Rivero1, Fidel R Castro-Odio4, Pedro A López-Saura1, for the FarmaPEG Study Group

Abstract
Background: Interferon (IFN) alpha conjugation to polyethylene glycol (PEG) results in a better pharmacokinetic profile and efficacy. The aim of this study was to compare the pharmacokinetic, pharmacodynamic and safety properties of a new, locally developed, 40-kDa PEG-IFN alpha-2b preparation with a reference, commercially available PEG-IFN alpha-2a in healthy male volunteers.
Methods: A randomized, crossover, double-blind study with a 3-weeks washout period, was done. A single 180 micrograms PEG-IFN alpha-2 dose was administered subcutaneously in both groups. Sixteen apparently healthy male subjects were included. Serum PEG-IFN concentration was measured during 336 hours by an enzyme immunoassay (EIA). Other clinical and laboratory variables were used as pharmacodynamic and safety criteria.
Results: The pharmacokinetic comparison by EIA yielded a high similitude between the formulations. In spite of a high subject variability, the parameters’ mean were very close (in all cases p > 0.05): AUC: 53623 vs. 44311 pg.h/mL;
Cmax: 333 vs. 271 pg/mL; Tmax: 54 vs. 55 h; half-life (t1/2): 72.4 vs. 64.8 h; terminal elimination rate (lambda): 0.011 vs. 0.014 h-1; mean residence time (MRT): 135 vs. 123 h for reference and study preparations, respectively. There were no significant differences with respect to the pharmacodynamic variables either: serum neopterin and beta-2
microglobulin levels, stimulation of 2’5’ oligoadenylate synthetase expression, and serum IFN antiviral activity. A strong Spearman’s rank order correlation (p < 0.01) between the pharmacokinetic and pharmacodynamic concentration-time curves was observed. Both products caused similar leukocyte counts diminution and had similar safety profiles. The most frequent adverse reactions were leukopenia, fever, thrombocytopenia, transaminases increase and asthenia, mostly mild.
Conclusions: Both formulations are fully comparable from the pharmacokinetic, pharmacodynamic, and safety profiles. Efficacy trials can be carried out to confirm clinical similarity.
Trial registration: Registro Público Cubano de Ensayos Clínicos RPCEC00000039.