Gilead PrEP lenacapavir succeeds in Phase 3 trial

Gilead‘s experimental twice-yearly medicine to forestall HIV was 100% effective in a late-stage trial, the corporate said Thursday.

Not one of the roughly 2,000 women within the trial who received the lenacapavir shot had contracted HIV by an interim evaluation, prompting the independent data monitoring committee to recommend Gilead unblind the Phase 3 trial and offer the treatment to everyone within the study. Other participants had received standard day by day pills.

The outcomes bring Gilead one step closer to introducing a recent type of pre-exposure prophylaxis, or PrEP, and broadening its HIV business. Shares of the corporate rose about 7% on Thursday. 

“What the world needs is people to have more PrEP options in order that they could make the selection of the choice that is going to work best for them,” said Jared Baeten, Gilead’s vice chairman of clinical development for HIV. 

Before looking for approval from the Food and Drug Administration, Gilead will first need to duplicate these results. The corporate expects to share data later this 12 months or early next 12 months from an ongoing Phase 3 study of men who’ve sex with men. If those results are positive, the corporate could bring lenacapavir for PrEP to market as soon as late 2025.

Greater than a decade ago, Gilead’s Truvada became the first approved PrEP for people without HIV who’re at high risk of acquiring it. Each day pills dominate the market, but drugmakers at the moment are specializing in developing longer-acting shots.

PrEP slashes the danger of getting HIV from sex by 99%, and from injected drug use by 74% when taken appropriately. Yet only a bit of greater than one-third of individuals within the U.S. who may gain advantage from PrEP take it, based on data from the Centers for Disease Control and Prevention.

Health policymakers and advocates hope longer-acting options could reach individuals who cannot or don’t need to take a day by day pill and higher prevent the spread of a virus that caused about 1 million recent infections globally in 2022. 

“It’s really essential to have more options than day by day pills since the orals aren’t going to get us to the top of the epidemic,” said Bruce Richman, founding executive director of the nonprofit Prevention Access Campaign. “We want to ensure that folks have options to suit with their lifestyles.”

The FDA approved the primary injectable PrEP in 2021. That drug, Apretude, is given every other month, or six times a 12 months, by a medical skilled. About 11,000 people take Apretude, based on its manufacturer, ViiV.

Tim Oliver, a 28-year-old public medical examiner in Recent York, said he doesn’t mind going to the doctor for his Apretude shots. But he added that a few of his friends have told him they’d moderately keep taking a day by day pill than get an injection. An extended-acting option may very well be more attractive to patients.

RBC Capital Markets analyst Brian Abrahams expects Gilead’s shot will significantly increase the number of individuals concerned with preventive HIV medicine. He estimates peak sales of nearly $2 billion. Gilead’s newer PrEP pill, Descovy, notched about $2 billion of revenue last 12 months. 

Activists have urged Gilead to be certain that people in countries where low- and middle-incomes predominate can get access to lenacapavir. The corporate has long faced criticism over the value of its HIV medicines. Descovy usage carries an inventory price of $26,000 a 12 months.

In its statement disclosing the lenacapavir trial results Thursday, Gilead said it plans to share an update on the way it plans to handle access in such countries where people suffer high incidence rates of HIV. 

— CNBC’s Leanne Miller contributed to this report.