Injection against HIV
The positive results of a clinical study led by researchers from Queen Mary University of London indicate that the monthly administration of a new injectable drug for the treatment of HIV is no less effective than traditional therapies, and is preferable for 90% of the patients included in the study.
According to the head of the study, Professor Chloe Orkin, this first-of-its-kind HIV injection therapy should significantly ease the lives of patients who are currently forced to carefully follow a protocol involving daily oral administration of several antiretroviral drugs.
Within the framework of a multicenter phase 3 open clinical trial, called FLAIR (from the English "First Long-Acting Injectable Regimen" – the first long-acting injectable protocol), the injection of a long-acting combination of cabotegravir and rilpivirine every 4 weeks was compared with the standard protocol consisting in daily oral administration of a combination of 3 drugs: dolutegravir, abacavir and lamivudine.
The study involved 629 HIV-infected men and women from the UK, Canada, France, Germany, Italy, Japan, the Netherlands, the Russian Federation, South Africa, Spain and the USA. At the end of the 20-week induction therapy with a three-component combination of drugs, patients whose viral load at week 16 was below 50 cells/ml were randomly divided into 2 groups of 283 people (566 people in total). The oral protocol was replaced with an injection protocol for the participants of one group, while the second group continued receiving three-component oral therapy.
The observations showed that the degree of suppression of HIV activity at the 48th week of the study was comparable for both therapeutic approaches (more than 93%).
A survey conducted at the 48th week of the study showed that 90.8% of participants in the experimental therapy group preferred a long-acting injectable drug, while only 0.7% of participants preferred traditional oral therapy.
The inability to suppress the activity of the virus was a rare phenomenon in both groups. In three confirmed cases of treatment failure in the injection therapy group, patients had an unusual HIV subtype that developed resistance to therapy.
In general, long–acting injection therapy was well tolerated by patients and caused serious adverse events only in 6.4% of cases and adverse events that led to exclusion from the study - in 3.2%.
The most common side effects of the new therapy were reactions at the injection site (inflammation or damage to surrounding tissues, in some cases due to the development of an allergic reaction), but they were all mild or moderate and resolved, on average, within three days after administration. The frequency of such manifestations decreased over time.
According to experts, if the new HIV therapy protocol is approved for clinical use, it will give patients monthly breaks in treatment, reducing the number of days of use of antiretroviral drugs from 365 days a year to 12. The developers plan to submit an application to the regulatory authorities this year.
The results of the work in the form of an abstract by Chloe Orkin et al. Long-acting cabotegravir + rilpivirine for hiv maintenance: flair week 48 results presented at the Conference on Retroviruses and Opportunistic Infections, held March 4-7 in Seattle, Washington.
Evgenia Ryabtseva, portal "Eternal Youth" http://vechnayamolodost.ru based on the materials of Queen Mary University of London: First ever injectable HIV drug is a 'paradigm-shift' for patients.