A large clinical trial conducted in South Africa and Uganda has demonstrated a new pre-exposure prophylaxis drug (PrEP) injection taken twice a year offers total protection against HIV infection, the virus which causes AIDS.
The trial assessed whether a six-monthly injection of lenacapavir provided better protection than existing and novel oral daily PrEP pills, with 5,000 female patients participating across 28 sites.
Of the 2,134 participants in the lenacapavir arm of the trail, there was not a single instance of HIV infection.
HIV infections still growing
In eastern and southern African nations, young women tend to bear the brunt of new HIV infections. About 13.9% of South Africa’s population, or 8.45 million, were living with HIV in 2022.
For people aged 15 to 49, that number goes up to 19.6%, almost 1 in 5.
Lenacapavir (Len LA) is administered subcutaneously once every six months. It’s a fusion capside inhibitor that interferes with the protective protein shell around the virus’ genetic material and replication enzymes.
Current PrEP drugs must be taken orally every day. There are structural, economic and social reasons why maintaining that medication schedule can be extremely challenging for young people in African nations – a twice-a-year injection would offer a much more accessible treatment regime.
The lenacapavir shots are also demonstrably more effective in protecting patients from infection – 16 women of 1,068 (1.5%) given the current gold standard of oral PrEP drugs contracted HIV during the study, while 39 of 2,136 (1.8%) who took a new form of oral PrEP drug were also infected by HIV.
The results led the safety monitoring board to end the blinded phase of the study so that all patients could be offered their choice of prevention treatment.
Offering realistic solutions
The significance of this new HIV prevention treatment is not only in its efficacy, but also in its ease of use.
Preventing HIV with current methods of control require daily use of oral prevention medications, condoms, regular screening and access to contraception.
Missing a single one of these steps can be enough to fall ill, and many people simply do not have ready access to the tools or resources required to stay healthy.
Researchers hope that reducing the complications around treatment by using a simple twice-a-year injection alongside other prevention and monitoring methods could materially reduce the rate of HIV infections, especially among young people.
There were 1.3 million new HIV infections in the past year. While that’s a significant drop from the 2 million infections of 2010, we are not currently on track to meet the UNAIDS goal to end AIDS by 2030.
The patent owner, Gilead Sciences (NASDAQ:GILD), has stated it will offer licences for companies to create generic versions of the drug, which could be critical for affordability.
While the treatment will require further testing in clinical trials, and review and assessment by both the World Health Organization and individual governments, it’s a bright ray of hope for those vulnerable to HIV infections the world over.