GileadThe experimental, twice-yearly HIV prevention drug has been shown to be 100 percent effective in a late-stage study, the company said on Thursday.
According to an interim analysis, none of the approximately 2,000 study participants who received the lenacapavir injection had become infected with HIV. The independent data monitoring committee therefore recommended that Gilead unblind the Phase 3 study and offer the treatment to all study participants. The other participants had received standard tablets every day.
The results bring Gilead one step closer to launching a new form of pre-exposure prophylaxis (PrEP) and expanding its HIV business. The company's shares rose on Thursday.
“What the world needs is more PrEP options for people so they can choose the option that works best for them,” said Jared Baeten, vice president of HIV clinical development at Gilead.
Before Gilead can seek approval from the Food and Drug Administration, the company must first reproduce those results. The company expects to release data from an ongoing Phase 3 trial 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 was the first PrEP approved for people with HIV who are at high risk of infection. Daily pills dominate the market, but drug companies are now focusing on developing longer-acting injections.
When used correctly, PrEP reduces the risk of HIV infection through sex by 99 percent and through drug use by 74 percent. Yet only a little more than a third of people in the U.S. who could benefit from PrEP are taking it, according to data from the Centers for Disease Control and Prevention.
Health politicians and advocates hope Longer-acting options could reach people who cannot or do not want to 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 we're not going to end the epidemic with oral medications,” said Bruce Richman, founding 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. The drug, called Apretude, is administered by a doctor every two months or six times a year. According to the manufacturer ViiV, about 11,000 people are taking 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'd rather continue taking a daily pill than get a shot. A longer-acting option might 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 HIV prevention drugs. He estimates peak sales will be nearly $2 billion. Gilead's newer PrEP pill, Descovy, generated 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. Descovy costs $26,000 a year to take.
In its statement announcing the release of the lenacapavir trial results on Thursday, Gilead said the company plans to provide an update on how it plans to improve access in countries where populations suffer from high HIV incidence rates.
— CNBC's Leanne Miller contributed to this report.
