The Rus Biopharm group has registered the drug Raltiko (raltegravir) for treating HIV in children aged 2 to 12. It is a generic of the Merck’s Isentress tablets.
“A clinical study completed in 2024 confirmed the equivalence of Raltiko to the original drug—the 25 mg and 100 mg chewable Isentress tablets,” stated Evgenia Shapiro, General Director of PSK Pharma (the production site of Rus Biopharm.
Raltegravir is an integrase inhibitor that blocks the enzyme the virus needs to integrate its genetic material into human cell DNA.
It is noted that Raltiko is the fifth drug in the portfolio of PSK Pharma’s line of HIV medications, in addition to the adult-dose 400 mg Raltegravir PSK tablets and drugs based on etravirine, lopinavir, and ritonavir.
The registration dossier for the new drug includes an active pharmaceutical ingredient (API) whose synthesis was developed in the company’s own laboratory, and production is carried out at a plant in the Dubna special economic zone, PSK Pharma emphasized. At the same time, the State Register of Medicines lists both PSK Pharma and the Indian company Aktinos Pharma as manufacturers of the API for Raltiko.
According to the State Register of Medicines, 15 raltegravir drugs are available in Russia, including the original Merck & Co products in pediatric and adult dosages.
According to data from the Republican Clinical Infectious Diseases Hospital (St. Petersburg) at the end of 2024, there were over 10,000 children and adolescents with HIV in Russia. In 90% of cases, they contracted the infection from their mothers. However, most raltegravir drugs on the market are available in adult dosages. The emergence of chewable tablets in small doses is an important step for pediatrics, as young children have difficulty swallowing large tablets.
