GileadThe company's twice-yearly experimental drug for HIV prevention was 100% effective in a late-stage trial, the company said Thursday.
None of the nearly 2,000 women in the trial who received the lenacapavir injection tested positive for HIV by an interim analysis, prompting an independent data monitoring committee to recommend to Gilead to unblind the phase 3 trial and offer the treatment to all study participants. The other participants received standard daily pills.
The results bring Gilead one step closer to offering a new form of pre-exposure prophylaxis, or PrEP, and expanding its HIV business. The company's shares rose about 7% on Thursday.
“What the world needs is for people to have more pre-exposure prophylaxis options so they can choose the one that works best for them,” said Jared Payten, vice president of HIV clinical development at Gilead.
Before seeking FDA approval, Gilead will first need to replicate these findings. The company expects to share data later this year or early next year from an ongoing phase 3 study of men who have sex with men. If these results are positive, the company could bring lenacapavir for PrEP to market as soon as late 2025.
More than a decade ago, Gilead's Truvada became the first approved preventative drug for people who do not have HIV and are at high risk of contracting it. Daily pills dominate the market, but drug makers are now focusing on developing longer-acting doses.
PrEP reduces the risk of contracting HIV from sex by 99%, and from injecting drug use by 74% when taken correctly. However, just over a third of people in the United States who could benefit from a pre-exposure prophylaxis program take it, according to data from the Centers for Disease Control and Prevention.
Policymakers and health advocates hope long-acting options will reach people who can't or don't want to take daily pills and prevent the spread of the virus, which has caused about 1 million new infections globally in 2022.
“It's really important to have more options than daily pills because taking them orally is not going to get us to the end of the epidemic,” said Bruce Richman, founding executive director of the nonprofit Prevention Campaign. “We need to make sure people have choices that fit their lifestyles.”
The US Food and Drug Administration (FDA) approved the first injectable PrEP medication in 2021. The medication, Apetude, is administered every two months, or six times a year, by a medical professional. About 11,000 people are taking Apretitude, according to its manufacturer, ViiV.
Tim Oliver, a 28-year-old public health worker in New York, said he doesn't mind going to the doctor to get the Apretitude shots. But he added that some of his friends told him they would rather continue taking the pill daily than get an injection. A longer-acting option may be more attractive to patients.
RBC Capital Markets analyst Brian Abrahams expects the Gilead shot will lead to a significant increase in the number of people interested in HIV preventative medicine. Peak sales are estimated at around $2 billion. Gilead's newest PrEP pill, Descovy, generated about $2 billion in revenue last year.
Campaigners have urged Gilead to make sure people in low- and middle-income countries can access lenacapavir. The company has long faced criticism over the prices of its HIV drugs. Using Descovy carries a list price of $26,000 per year.
In its statement revealing the results of the lenacapavir trial on Thursday, Gilead said it plans to share an update on how it plans to address access in these countries where people have high rates of HIV infection.
— CNBC's Leanne Miller contributed to this report.
