A clinical trial has shown a method that gives total protection from HIV infection. A large clinical trial in South Africa and Uganda has shown that injection of a new pre-exposure prophylaxis drug taken twice a year would give young women total protection from HIV infection.
The trial tested on whether the injection of lenacapavir, taken on six months gap, would provide better protection against HIV infection than the two other drugs that are tested. All the three are pre-exposure prophylaxis (PrEP) drugs.
The principal investigator for the study conducted in South Africa, physician-scientist Linda-Gail Bekker said that the Purpose 1 trail with 5,000 participants took place at three sites in Uganda, and 25 sites in the South Africa in order to test the efficiency of lenacapavir and two other drugs.
Lenacapavir, also known as LenLA is a fusion capside inhibitor. The drug interferes with the HIV capsid, a protein shell that protects HIV’s genetic material and enzymes needed for replication. The drug is administered just under the skin, once every six months, as reported by media.
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The trial, which was sponsored by drug developers Gilead Sciences tested several things. The first among the tests was if the six-monthly injection of lenacapavir was safe and would provide better protection against HIV infection as PrEP for women between 16 and 25 year, than the Truvada F/TDF, a daily PrEP pill in the wide use that has been available for more than a decade.
Secondly, the trial tested if the Descovy F/TAF, a newer daily pill was as effective as F/TDF. The newer F/TAF has superior pharmacokinetic properties than the F/TDF. Pharmacokinetic is known as the movement of a drug into, through, and out of the body. F/TAF is a smaller pill and is in use among men and transgender women in high-income countries.
The clinical trial had three arms. In the first, young women were randomly assigned in a 2:2:1 ratio (Len LA: F/TAF oral: F/TDF oral) in a double blinded fashion. In this way, neither the participants, nor the researchers knew which treatment participants were receiving until the clinical trial is over.
Reportedly, in the eastern and southern Africa, young women are often at the receiving end of the HIV infections, and they also face a daily PrEP regimen challenging to maintain, for a number of social and structural reasons.
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During the randomised phase of the trial, none of the 2,134 women who received the lenacapavir contracted HIV, showing 100 percent efficiency. At the same time, 16 of the 1,068 women (1.5 percent) who took Truvada (F/TDF), and 39 of 2,136 (1.8 percent) of who received Descovy (F/TAF) contracted the HIV virus.
The trial gives great hope in cracking the highly effective prevention tool to protect people from HIV. Last year, there were 1.3 million new HIV infections globally. Though it is fewer than the 2 million infections seen in 2010, the figures make it clear that at this rate the UNAIDS aim for 2025 (fewer than 500,000 globally) or potentially even the goal to end Aids by 2030.
A sister trial is also on its way. Purpose 2 is being conducted in a number of regions including some sites in Africa among cisgender men, transgender and nonbinary people who engage in physical intimacy with men.
The World Health Organisation will review the data and issue recommendations.