Trogarzo affects the restoration of immunity
The results of the 3 phase clinical trials of ibalizumab confirmed that the agent not only reduces the level of replication of drug-resistant strains of HIV, but also has a beneficial effect on restoration of immunity. According to scientists at Yale University, the use of the drug in conjunction with existing tools for the treatment of HIV infection is a promising strategy for patients who, due to the resistance of the virus, do not already have effective treatment options. The results of the work were published on August 16 in the journal New England Journal of Medicine.
As explained by the researchers, the mechanism of action of the genetically modified monoclonal antibody ibalizumab, approved in the US as an ARV therapy in March this year (Trogarzo), is aimed at binding to CD4 receptors of T lymphocytes and blocking the penetration of the virus into the cell.
Forty people with resistant HIV strains participated in the study. All volunteers received intravenous ibalizumab for one week in addition to their ineffective ARV regimen. After that, for six months, patients took the drug in combination with optimized regimens.
The researchers found that in a week after the start of taking ibalizumab, the majority of patients (83%) reported a decrease in viral load. Within 25 weeks, almost half of them reached the undetectable level of HIV.
In addition, the specialists also found that the level of CD4 T cells - markers of the immune system - gradually increased in the blood of the participants in the study.
For the entire time of observation, only one person was forced to stop taking ibalizumab because of side effects.
"Ibalizumab is a promising treatment option for people who have tried other drugs," said lead author Dr. Brinda Emu.
Due to the new mechanism of action, the expert believes, there is no risk of adverse consequences against the background of the combination of ibalizumab with other ARVs. In addition, it is administered intravenously every other week and lasts longer than most HIV drugs.
"He opens up a whole class of medicines and a new way of delivering funds for HIV treatment," explained Emu.
Nevertheless, she believes, it must be remembered that ibalizumab was approved in the US, based on data from a much smaller number of patients with HIV than other drugs. The reason for this is the relatively low prevalence of such a phenomenon as the multiple drug resistance of HIV.
This, the expert explained, should be a signal to maintain vigilance regarding side effects and adverse events that may be associated with the taking of a new drug.