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A major clinical study in South Africa and Uganda has shown that a twice-yearly injection of a new drug called ‘Lenacapavir’ can provide young women with 100% protection against HIV infection.

The trial investigated whether the six-month injection of Lenacapavir would give greater protection against HIV infection than two similar pre-exposure prophylaxis (or PrEP) drugs.

The results bring hope in the fight against HIV, specifically for young women in Africa. The trial included 5,000 participants and took place at three sites in Uganda and 25 sites in South Africa.

Twice-a-year injections are ideal for young women in eastern and southern Africa who bear the biggest brunt of HIV infections on the continent. For these women, a daily PrEP regimen challenging to maintain for a number of social and structural reasons.

Principal investigator for the South African part of the study, Linda-Gail Bekker, says Lenacapavir is a ‘fusion capsid inhibitor’ and interferes with the protein shell that protects HIV’s genetic material and enzymes needed for replication. It is administered just under the skin, once every six months.

The trial compared three different pre-exposure prophylaxis, and found that in the trial’s first phase, Lenacapavir was 100% effective. By comparison, 16 of the 1,068 women (or 1.5%) who took Truvada and 39 of 2,136 (1.8%) who received Descovy contracted the HIV virus.

The findings of a recent independent data safety monitoring board evaluation have now suggested that the trial’s ‘blinded’ phase be halted and all participants be offered the option of PrEP.

Dr Yashna Singh from the Desmond Tutu HIV Centre at Groote Schuur says “the results are truly unprecedented”.

“This is huge for young women, especially in South Africa.”

Over the last year, there were 1.3 million new HIV infections worldwide. Although this is less than the 2 million infections reported in 2010, it is clear that at the current rate, we will not reach the HIV new infection target set by UNAIDS for 2025 (fewer than 500,000 globally), or maybe even the objective to eliminate Aids in 2030.

#GileadNews: Today we announced topline results of an interim analysis from the most comprehensive and diverse #HIV prevention trial program ever conducted. This study builds on our commitment to help serve the needs of people who need or want PrEP. https://t.co/1MMTeRoa59 pic.twitter.com/IihLB9XLmZ

— Gilead Sciences (@GileadSciences) June 20, 2024

The results of the studies will be submitted in the next few months, particularly to the Ugandan and South African governments. The World Health Organization will also review the data and may issue recommendations. Researchers hope that the WHO will also include the drug in their worldwide guidelines for the prevention of HIV.

The aim is to eventually offer the drug to all countries, who will then be able to disperse it to their citizens.

After decades of research and an untold number of deaths due to HIV infections, this is incredibly exciting news for millions of people who are at risk.

[source:theconversation&capetalk]