Game changer treatment for HIV - 12th August 2024

A revolutionary new injection for HIV prevention, utilising the drug lenacapavir, has been hailed as “a miracle” by leading experts.

A clinical trial in South Africa and Uganda showed that two injections per year provide 100 percent protection against HIV for women aged 16 to 25. Professor Linda-Gail Bekker, the principal investigator, was overwhelmed by the outcome. “I literally burst into tears,” she said.

If left untreated, HIV severely weakens the immune system, allowing secondary infections to take hold. Nearly fifty years since the deadly disease was first identified in 1981, a cure or vaccine for HIV is yet to be produced. However, researchers have developed antiretroviral therapies which keep the virus at undetectable and untransmittable levels, and pre-exposure prophylaxis drugs such as lenacapavir prevent infection when there is exposure to HIV.

These advances are not universally available and sub-Saharan Africa remains heavily impacted with one in 25 adults HIV positive. This amounts to two-thirds of the global HIV population, with young women and teenage girls especially vulnerable to infection due to social and economic factors that limit their ability to negotiate safer practices within relationships.

In the subset of trial participants who had lenacapavir provided as a daily tablet, HIV infection rates remained high due to limitations presented by adherence to this regime. The contrast between this and the injection’s complete efficacy underlines its impact.

Of the participants, 193 became pregnant while receiving lenacapavir, something which usually leads to withdrawal from a medical trial. However, since mother-to-child transmission accounts for many new HIV infections during pregnancy, childbirth, and breastfeeding, the health of babies exposed to this drug was also measured. With no adverse effects observed and ongoing monitoring in place, the aim is to establish lenacapavir’s safety and efficacy in preventing such transmissions.

The drug's potential to impact the HIV pandemic can only be achieved when delivery and price make universal access a reality. Lenacapavir’s creator, Gilead Sciences, has committed to working with other manufacturers to produce cost-effective generic versions following success in securing regulatory approval for this use of the drug to ensure it can be widely distributed.