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In a landmark study that could set a new standard in HIV prevention, researchers from South Africa and Uganda have found that a twice-yearly injection of the pre-exposure prophylaxis (Prep) drug, lenacapavir, gives complete protection against HIV infection.
The discovery validates the effectiveness of current daily pill regimens.
It also offers a more practical and potentially transformative solution for millions at risk of HIV worldwide, says Prof Linda-Gail Bekker, director of the Desmond Tutu HIV Centre at the University of Cape Town.
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She is leading the SA clinical research. She said the finding holds the promise of a significant shift in the global fight against HIV/Aids.
“A second long-acting Prep option could be highly beneficial and can significantly impact those at high risk of HIV acquisition by expanding choices in the HIV prevention toolkit.
“Allowing individuals to select an intervention that fits their lifestyle and preferences enhances the uptake of medical interventions as shown by contraception use,” she added.
But Bekker stressed that it would only be of value if it was rolled out and became accessible to people who need it.
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“If that is the case, then I imagine many people could be very well protected against HIV, which will hopefully then reduce the number of new infections.
“So what I hope is going to happen is we’re really going to see a reduction in new infections, but of course, we have to get it out to everyone who needs it.”
The study compared the sixmonth injection to two other daily pill regimens, both also Prep drugs.
Lenacapavir, which only has to be taken once every six months, should be made available in SA. A recent study showed that none of the 2 134 women who received lenacapavir contracted HIV, but the drug is not yet registered with SA’s medicine regulator.
Bekker stressed that lenacapavir should be offered as a choice alongside oral Prep in SA’s HIV prevention programmes to cater to those who may be resistant to a long-acting pre-exposure prophylaxis.
“We are not saying, throw the pills out. We are saying this should come alongside for people who maybe can’t trust themselves to do the daily Prep or struggle to remember to take a pill every day.
“For those people, an injectable may just be the answer. I think it is about integrating it within our pre-exposure prophylaxis programme, which this country has done very well to roll out in the public sector,” she said.
Currently, there are two registrational trials looking at the lenacapavir injection for HIV prevention. The one in young women and adolescents that was just reported is called Purpose 1.
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Purpose 2, a similar study conducted in men, transgender people and gender non-binary individuals who have sex with men, is ongoing and will show if lenacapavir works for others.
The research is ongoing all over the world, including in North America, South America, and Southeast Asia. The programme lead at the HIV Vaccine Trials Network, Dr Azwi Takalani, said the interim clinical study was a significant scientific breakthrough for HIV prevention.
“But we should strive to achieve licensure and make lenacapavir widely available in public health programmes as quickly as possible.
“Integration into existing prevention methods should begin with raising public awareness about lenacapavir, health education on its effective use and ensuring understanding of its side effect profile,” said Takalani.
