According to Zhixin Finance, Gilead Sciences (GILD.US) stated on Thursday that its research and development of Lenacapavir has shown 100% effectiveness in preventing HIV. The company's official website indicates that its experimental drug, which has an annual dosage for preventing HIV twice a year, was 100% effective in late-stage trials. The company's stock rose more than 8% on Thursday.

The latest results were from a Phase III double-blind randomized study called "PURPOSE 1", which aimed to evaluate the safety and effectiveness of Lenacapavir and Descovy in more than 5,300 young women aged 16-25 at 25 sites in South Africa and 3 sites in Uganda. The results showed that there were zero cases of HIV infection among the 2,134 women in the Lenacapavir group. This prompted the independent data monitoring committee to recommend that Gilead unblind the Phase III trial and provide treatment to everyone in the study. Other participants took standard pills every day. This result brings Gilead one step closer to introducing a new pre-exposure prophylaxis (PrEP) and expanding its HIV business.

Jared Baeten, Vice President of Clinical Development for HIV at Gilead, said:"What the world needs is more choices for people with PrEP to make the best choice for themselves."

Before seeking approval from the U.S. Food and Drug Administration (FDA), Gilead needs to replicate these results first. The company is expected to share data from an ongoing Phase III study on men who have sex with men later this year or early next year. If those results are positive, the company could bring Lenacapavir to the market for PrEP by the end of 2025.

Over 10 years ago, Gilead's drug Truvada became the first approved PrEP drug for high-risk people not infected with HIV. The current mainstream market for HIV prevention is mainly daily medication, but pharmaceutical companies are now focusing on developing long-acting drugs. If PrEP is used correctly, the risk of HIV infection through sex can be reduced by 99%, and the risk of HIV infection through injection drug use can be reduced by 74%. However, according to data from the Centers for Disease Control and Prevention (CDC) in the United States, slightly over one-third of people in the U.S. take PrEP.

Health policy makers and advocates hope that a choice of long-acting drugs can cover those who cannot or do not want to take medication every day and better prevent the spread of the virus. Approximately one million new HIV infections were reported globally in 2022. Bruce Richman, founding executive director of the Prevention Access Campaign, said:"More options besides daily medication are really important, because oral medications do not get us out of this epidemic completely. We need to ensure people have choices that are suitable for their lifestyles."

In 2021, the FDA approved the first injectable PrEP, a drug called Apretude, which is provided once a month or six times a year by medical professionals. ****, its manufacturer, says about 11,000 people take Apretude. A long-acting option may be more attractive to patients.

Brian Abrahams, an analyst at RBC Capital Markets, expects Gilead's drug to greatly increase the number of people interested in preventive HIV drugs. He estimates the highest sales will be close to $2 billion. Gilead's latest PrEP drug Descovy generated about $2 billion in revenue last year.

Activists are urging Gilead to ensure that people in low- and middle-income countries are able to access lenacapavir. The company has long faced criticism over the price of its HIV drugs. The list price for Descovy's use rights is $26,000 per year. Gilead said in a statement on Thursday when it released the Lenacapavir trial results that it plans to share the latest progress on how to address drug access concerns in HIV high-burden countries.