On Thursday (June 20) local time, Gilead Scientific, an American biopharmaceutical company, announced a blockbuster experiment result on its official website. Its "Lenacapavir" (Lenacapavir) showed 100% effectiveness in HIV prevention.
Gilead Science official website
The latest released results are a phase 3 double-blind randomized trial called "PURPOSE 1" aimed at evaluating the safety and efficacy of Lenacapavir and Descovy on over 5300 16-25 year old women at 25 sites in South Africa and 3 sites in Uganda.
More than 5300 participants were randomly assigned to receive Lenacaavir, Descovy, and Truvada for pre exposure prevention of HIV (PrEP) in a ratio of 2:2:1.
It is understood that Descovy and Truvada are oral medications taken once a day; Lenacapavir is a shell inhibitor, administered every six months through subcutaneous injection.
The results showed that out of 2134 women in the Lenacapavir group, there were 0 cases of HIV infection.
Source: Gilead Science Press Release
Among 1068 people in Truvada group, 16 were infected with HIV, and the incidence rate was 1.69 cases/100 people; Among 2136 people in the Descovy group, 39 cases were diagnosed, and the incidence rate was 2.02/100 people.
According to the official website of Gilead Science, this is the first batch of data generated by its landmark PURPOSE project, which is the most comprehensive and diversified AIDS prevention pilot project in history.
Merdad Parsey, Global Chief Medical Officer of Gilead, wrote that Lenacapavir, administered twice a year, has zero infection rates and 100% efficacy, demonstrating its potential as an important new tool for preventing HIV infection.
Parsey said, "We look forward to the ongoing PURPOSE clinical program achieving more results and continuing to move towards our goal of helping everyone around the world end the HIV pandemic."
Linda Gail Bekker, director of the Desmond Tutu AIDS Center at the University of Cape Town, South Africa, said in a press release, "If approved, Lenacapavir will provide an important new choice for AIDS prevention, so that many people around the world can benefit from PrEP (preventive medicine before AIDS exposure) drugs, especially women."
Bekker is the former president of the International AIDS Association. She pointed out that traditional AIDS prevention methods are also very effective, but taking it once a day may expose some people to the risk of discrimination.
It is worth mentioning that according to CNBC, Gilead needs to replicate these results before seeking approval from the US Food and Drug Administration. The company is expected to share data from the ongoing third phase of research targeting men who engage in same-sex sexual activity later this year or early next year. If these results are positive, the company can use lenacaavir for PrEP listing as early as the end of 2025.
More than a decade ago, Truvada from Gilead became the first approved PrEP, suitable for those who do not have HIV but are at high risk of infection. This daily tablet dominates the PrEP market, but now pharmaceutical companies are focusing on developing longer lasting injections.
RBC Capital Markets analyst Brian Abrams predicts that Gilead's injection will significantly increase the number of people interested in preventive HIV drugs. He estimates peak sales to be close to $2 billion. Gilead's relatively new PrEP oral drug "Descovy" achieved revenue of approximately $2 billion last year.
In the secondary market, the US stock market closed on Thursday, with Gilead Scientific (GILD) up 8.46% to $68.49, and its market value surged overnight by $6.654 billion (approximately RMB 48.3 billion), with the latest value reaching $85.328 billion (approximately RMB 619.519 billion).
