GPO-VIR Z30

GPO-VIR Z30 is a pediatric fixed-dose combination (FDC) tablet containing zidovudine (ZDV), lamivudine (3TC), and nevirapine (NVP) at specific dosages of 30/15/28 mg per tablet. It is developed as an alternative to stavudine-containing FDC tablets for HIV treatment in children weighing between 6-30 kg. The tablet is administered orally every 12 hours. Pharmacokinetic studies showed therapeutically adequate NVP exposure, similar ZDV AUC compared to liquid formulations, and significantly higher 3TC exposure (though comparable to historical data for branded tablets). No major safety concerns were identified in the studies, although the study population was limited to children stable on NVP. Notably, NVP exposure varied based on CYP2B6 polymorphisms, with higher AUCs in children with the TT genotype. GPO-VIR Z30 is clinically significant for simplifying antiretroviral treatment in HIV-infected children and offering an alternative to stavudine formulations with potential long-term toxicity concerns.

Brand names

GPO-VIR Z30