100% effective! Gilead's long-acting HIV prevention drug trial achieves positive results

According to the latest information from Zhitong Finance, Gilead Sciences (GILD.US) announced on Thursday that its research and development of "Lenacapavir" has shown 100% effectiveness in preventing HIV. The company stated on its official website that its experimental drug for preventing HIV with twice-yearly dosing has shown 100% effectiveness in late-stage trials. The company's stock price rose over 8% on Thursday.

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

Jared Baeten, Vice President of Clinical Development for HIV Drugs at Gilead, said, "What the world needs is for people to have more PrEP options so they can make the best choice for themselves."

Before seeking approval from the U.S. Food and Drug Administration (FDA), Gilead will need to replicate these results. The company expects to share data from an ongoing Phase 3 study on male sexual behavior later this year or early next year. If these results are positive, the company may launch lenacapavir for PrEP by the end of 2025.

Over a decade ago, Gilead's drug Truvada became the first PrEP drug approved for high-risk individuals not infected with HIV. The mainstream market for HIV prevention is currently daily dosing, but pharmaceutical companies are now focusing on developing long-acting drugs. When used correctly, PrEP reduces the risk of HIV transmission through sexual intercourse by 99% and through injection drug use by 74%. However, according to data from the Centers for Disease Control and Prevention (CDC), slightly over one-third of people in the U.S. take PrEP.

Health policy makers and advocates hope that the option of long-acting drugs can cover those who cannot or do not want to take medication daily and better prevent the spread of the virus. In 2022, HIV caused approximately 1 million new infections globally. Bruce Richman, Founding Executive Director of the Prevention Access Campaign, said, "Having more options besides daily medication is really important because oral medication alone cannot completely eradicate this epidemic. We need to ensure that people have choices that suit their lifestyles." The FDA approved the first injectable PrEP in 2021. This drug, called Apretude, is provided by healthcare professionals every one or six times a month or year. According to its manufacturer ViiV, about 11,000 people are taking Apretude. A long-acting option may be more attractive to patients.

Brian Abrahams, a capital markets analyst at Royal Bank of Canada, expects Gilead's drug to significantly increase the number of people interested in HIV prevention drugs. He estimates peak sales to be close to $2 billion. Gilead's latest PrEP drug, Descovy, generated approximately $2 billion in revenue last year.

Advocates urge Gilead to ensure that people in low- and middle-income dominant countries can access lenacapavir. The company has long faced criticism for the pricing of its HIV drugs. The list price for Descovy is $26,000 per year. In a statement announcing the results of the lenacapavir trial on Thursday, Gilead said it plans to share the latest developments on addressing drug access issues in high HIV prevalence countries