GileadThe experimental, twice-yearly HIV prevention drug was 100% effective in a late-stage study, the company said Thursday.
According to an interim analysis, none of the approximately 2,000 women in the study who received the lenacapavir shot had become infected with HIV, leading the independent data monitoring committee to recommend that Gilead unblind the Phase 3 trial and extend treatment to all participants to offer a study. Other participants had received standard pills daily.
The results bring Gilead one step closer to introducing a new form of pre-exposure prophylaxis (PrEP) and expanding its HIV business. The company’s shares rose about 7% Thursday.
“What the world needs is for more PrEP options to be available to people so they can choose the option that works best for them,” said Jared Baeten, Gilead’s vice president of clinical development for HIV.
Before Gilead can seek approval from the Food and Drug Administration, it must first reproduce these results. The company expects to report data from an ongoing Phase 3 study in men who have sex with men later this year or early next year. If these results are positive, the company could bring lenacapavir for PrEP to market as early as the end of 2025.
More than a decade ago, Gilead’s Truvada became the first approved PrEP for people without HIV who are at high risk of contracting it. Daily pills dominate the market, but drugmakers are now focusing on developing longer-acting injections.
When taken correctly, PrEP reduces the risk of contracting HIV through sex by 99% and through injection drug use by 74%. However, according to the Centers for Disease Control and Prevention, only a little more than a third of people in the U.S. who could benefit from PrEP are taking it.
Health policymakers and advocates hope Longer-acting options could reach people who can’t or won’t take a pill every day and better prevent the spread of a virus that caused about 1 million new infections worldwide in 2022.
“It’s really important to have more options than daily pills because oral intake is not going to get us the end of the epidemic,” said Bruce Richman, founding executive director of the nonprofit Prevention Access Campaign. “We need to make sure people have options that fit their lifestyle.”
The FDA approved the first injectable PrEP in 2021. This medication, Apretude, is given by a doctor every two months or six times a year. According to the manufacturer ViiV, around 11,000 people take Apretude.
Tim Oliver, a 28-year-old public health worker in New York, said he doesn’t mind going to the doctor for his Apretude shots. But he added that some of his friends have told him they would rather continue taking a pill every day than get a shot. A longer-acting option may be more attractive to patients.
Brian Abrahams, an analyst at RBC Capital Markets, expects Gilead’s vaccine to significantly increase the number of people interested in preventative HIV medicine. He estimates peak sales at nearly $2 billion. Descovy, Gilead’s newer PrEP pill, had sales of about $2 billion last year.
Activists have called on Gilead to ensure that people in low- and middle-income countries have access to lenacapavir. The company has long been criticized for the prices of its HIV drugs. For Descovy use, the list price is $26,000 per year.
In its statement announcing the results of the lenacapavir trial on Thursday, Gilead said it plans to provide an update on how it plans to address access in countries where people suffer from high HIV incidence rates.
—CNBC’s Leanne Miller contributed to this report.
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2024-06-20 16:22:16
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