Gilead Sciences, a Californian-based maker, has started trials with a new HIV prevention drug called lenacapavir, which, in its early stages, indicates 100% so far. The latest trial, PURPOSE One, is a twice-yearly injection that looks to fix PrEP’s problems. The widely used PrEP medication can be 99% effective at preventing the contraction of HIV, but unfortunately, in the real world, the infection rate is much higher. This higher infection rate is due to problems like missed dosages or, more importantly, in countries like Africa, the tablets face a stigma. Young girls and women in Africa struggle to maintain a total dose of PrEP because they fear taking the medication in case partners may think they are already HIV positive. Lenacapavir could fix this problem with the widely used PrEP as a twice-yearly injection could be easier to maintain and would keep the preventative dose high in the patient system.

The trial is yet to be peer-reviewed, but early results are promising. The most recent phase III trial studied cis women in South Africa and Uganda, which compared this twice-yearly injection of the antiviral drug lenacapavir against the widely used PrEP, where patients either took Truvada or Descovy. The study’s results, which began in August 2021, showed that those who took the oral PrEP had infection rates of about 2%, consistent with its indicated infection rates. In contrast, not a single woman who has been given lenacapavir has contracted HIV. As it stands, this trial suggests that the new twice-yearly injection has 100% efficiency. After this result, the Data Monitoring Committee recommended that Gilead stop its blind trial and offer lenacapavir to all study participants.

Lenacapavir isn’t a new drug; it was approved by the FDA in America in 2022 to treat multi-drug-resistant HIV. However, PURPOSE One is the first clinical trial to use it as a preventative drug. However, the cost is the problem with this drug, which promises a vaccine-like system. Currently, Gilead is yet to open it up to the UN-backed medicines patient pool, which would lead to cheaper generic versions being made at a fraction of the cost. Currently, the costs per patient are around $42,250 per year in countries such as the United States, France, Norway, and Australia. Unfortunately, in countries such as Africa, the medication must be less than £54 a year. The current PrEP widely used in Africa comes to less than £4 a month and is a much more achievable form of prevention for low-income countries. Countries like Africa must have access to medication like this, as two-thirds of the world’s people living with HIV are in sub-Saharan Africa, and around 4,000 teen girls and young women in Africa are infected every week.

At the AIDS 20224 conference, a group of MSF (Médecins Sans Frontières) activists called for immediate global action to break Gilead’s monopoly over the drug Lenacapavir. This was in response to new data that shows it is possible for a general version of the drug to be produced at $100 per year with the chance of further reductions of $40 a year. This price would be affordable to patients in low-income countries like Africa. Asia Russell, a representative of Health GAP, a global HIV advocacy organisation, stated, “100% effectiveness demands 100% access”. In response to this, a spokesperson for Gilead responded to NPR by email saying, “While Gilead awaits the results of this Phase III clinical trial and the potential FDA filing, it is too early to state the price of lenacapavir for HIV prevention,” stating that it “remains an investigation drug until approved by regulatory authorities.” The company’s full response can be found in its “Updated Statement on Global Access Planning.”

With all the trials and protests, the world may be a while away from this seemingly breakthrough drug becoming widely available. Still, with the 100% indicated success rates and the fact that not a single person who was given the injection has contracted HIV, there is a bright future for the prevention of HIV, and there is a path in place that may end AIDS by 2030.