The twice-yearly HIV prevention shot developed by Gilead proves effective in a late-stage trial.

• Gilead's twice-yearly medicine to prevent HIV succeeded in a Phase 3 trial.
• No HIV cases were reported among the 2,000 women who received lenacapavir in the trial.
• Before seeking FDA approval, Gilead must replicate the results in another Phase 3 trial. The company anticipates sharing more data later this year or early next year.
• As soon as late 2025, lenacapavir for PrEP could be available in the market.

The company announced that its experimental twice-yearly medicine was 100% effective in preventing HIV in a late-stage trial, held on Thursday.

The independent data monitoring committee recommended that Gilead unblind the Phase 3 trial and offer lenacapavir to all participants after an interim analysis showed that none of the roughly 2,000 women who received the treatment had contracted HIV. The other participants had received standard daily pills.

Gilead's shares rose about 7% on Thursday as the company moves closer to introducing a new form of PrEP and expanding its HIV business.

Gilead's vice president of clinical development for HIV, Jared Baeten, stated that what the world requires is for individuals to have more PrEP options so they can choose the one that will work best for them.

Gilead will need to replicate the results before seeking FDA approval. The company anticipates sharing data from an ongoing Phase 3 study of men who have sex with men later this year or early next year. If the results are positive, lenacapavir for PrEP could be brought to market as soon as late 2025.

Over a decade ago, Gilead's Truvada was the first drug approved for people without HIV who were at high risk of getting it. Although daily pills currently dominate the market, pharmaceutical companies are now concentrating on creating longer-acting injections.

Although PrEP reduces the risk of HIV infection from sex by 99% and from injected drug use by 74%, only about one-third of eligible individuals in the U.S. use it, according to CDC data.

Advocates and policymakers hope that longer-acting alternatives could reach individuals who cannot or do not wish to take a daily pill, and better prevent the spread of the virus that resulted in approximately 1 million new infections worldwide in 2022.

""The epidemic can't be fully addressed with daily pills alone, as Bruce Richman, the founding executive director of Prevention Access Campaign, emphasized. We must ensure that individuals have choices that align with their lifestyles," he stated."

In 2021, the FDA approved the first injectable PrEP, Apretude, which is administered every other month or six times a year by a medical professional. Over 11,000 people are taking Apretude, according to its manufacturer, ViiV.

A longer acting option could be more attractive to patients, as some of Tim Oliver's friends have expressed a preference for taking a daily pill over getting an injection for their Apretude shots.

Gilead's newer PrEP pill Descovy recorded about $2 billion of revenue last year, and RBC Capital Markets analyst Brian Abrahams predicts that Gilead's shot will significantly increase the number of people interested in preventative HIV medicine, with peak sales estimated at nearly $2 billion.

Gilead has been urged by activists to make lenacapavir accessible to people in low and middle-income countries, where the company has faced criticism over the high cost of its HIV medicines, including Descovy, which costs $26,000 a year.

Gilead announced it will share an update on its plans to reach countries with limited resources and high incidence rates of HIV, as disclosed in the lenacapavir trial results on Thursday.