With 35 million people infected, the drug may help to stop the spread of the AIDS epidemic.
Two American research groups have conducted two studies that demonstrate the protective effect of the drug GSK744, developed by the multinational pharmaceutical company GlaxoSmithKline (GSK), against vaginal HIV infection, the most common route of transmission. The new drug was tested in macaque monkeys female.
With 35 million people worldwide infected with HIV, many of them women, the drug, which protects against the virus with an injection every three months, could help stop the spread of this epidemic.
The results of these two studies, conducted by researchers at the Centers for Disease Control (CDC) in Atlanta and AIDS Research Center at Rockefeller University (USA), published in the journal Science Translational Medicine.
GSK744 is very powerful inhibitor of HIV working by blocking the integration of the virus into the cell. It contains analogue of dolutegravir, an approved by the FDA (US Food and Drug Administration) for the treatment of HIV, which is prescribed for administration orally or by injection drug trafficking. Injection the formulation is long-acting and is dissolved nanocrystals liquid drug, so called nanosuspension.
One of the strategies for the fight against AIDS today is known as pre-exposure prophylaxis (PrEP), which is part of drug Truvada. This drug, approved in 2012, is given as a daily pill. It also inhibits virus reverse transcriptase and serves to prevent HIV infection in people at high risk.
Truvada first tested on monkeys having virus simian immunodeficiency, later clinical trials showed that the drug worked in humans.
The problem is that for Truvada should be given to work well and many people find hard to take one pill a day. The advantage we have the long-acting GSK744. It is administered by injection every three months, what is more convenient and secure.
In both investigations in GSK744, whose results are published now, 14 female macaques were treated once a month with this new drug, including 12 resisted HIV infection vaginally, while 10 females who received no treatment succumbed to the virus.
When the drug could reach human? There are two Phase 2 trials underway in which the safety and tolerability of GSK744 is investigated. The researchers await the results of these tests in two or three years. If they are positive, the next step would be to conduct the Phase 3 studies (human volunteers) to see whether it can prevent infection.