On April 29, 2020, the logo of Gilead Sciences Pharmaceutical Company appeared in Oceanside, California.
Mike Black | Reuters
GileadCompany’s experimental twice-yearly HIV prevention drug shows 100% effective in late-stage trial explain Thursday.
None of the roughly 2,000 women who received Gilead’s shot of lenacavir in the trial were infected with HIV, according to an interim analysis, prompting an independent data monitoring committee to recommend that Gilead remove the blinding from the Phase 3 trial and provide additional coverage for the study. Treatment is provided to everyone. Other participants took a standard pill 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 share price rose about 7% Thursday.
“What the world needs is more PrEP options for people so they can choose the option that’s best for them,” said Jared Baeten, vice president of HIV clinical development at Gilead.
Gilead first needs to replicate these results before seeking FDA approval. The company expects to share data from its 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 Lenacapavi to market for PrEP as early as late 2025.
More than a decade ago, Gilead’s Truvada became first Approval of PrEP for HIV-uninfected groups who are at high risk of infection. Daily pills dominate the market, but drugmakers are now focused on developing long-acting injectables.
pre-exposure prophylaxis reduce risk If taken correctly, the chance of contracting HIV through sexual intercourse is reduced by 99%, and the chance of contracting HIV through injection drug use is reduced by 74%. However, according to data, only slightly more than one-third of people in the United States could benefit from PrEP. data From the Centers for Disease Control and Prevention.
Health policymakers and advocates hope Long-acting options could help people who can’t or don’t want to take daily medications and better prevent the spread of a virus that has killed an estimated 1 million people new infection 2022 worldwide.
“It’s really important to have more options besides daily pills because oral medications are not going to allow us to end this epidemic,” said Bruce Richman, founding executive director of the nonprofit Campaign for Preventing Access. “We need to make sure people have options that fit their lifestyle.”
U.S. Food and Drug Administration officially recognized The first injectable form of PrEP will be available in 2021. About 11,000 people take Apretude, according to its manufacturer, ViiV.
Tim Oliver, a 28-year-old public health worker in New York, doesn’t mind going to the doctor to get the Apretude vaccine. But he said some of his friends have told him they would rather continue taking their daily pills than get the shot. Longer-acting options may be more attractive to patients.
RBC Capital Markets analyst Brian Abrahams expects Gilead’s vaccine to significantly increase the number of people interested in HIV prevention drugs. He estimates peak sales will be close to $2 billion. Gilead’s new PrEP drug Descovy generated about $2 billion in revenue last year.
Activists are urging Gilead to ensure people in low- and middle-income countries have access to Lenapavir. The company has long been criticized for the price of its HIV drugs. Descovy is priced at $26,000 per year.
In a statement announcing the lenacapavi trial results on Thursday, Gilead said it planned to share an update on how it plans to reach countries with limited resources and high HIV rates.
—CNBC Leanne Miller contributed to this report.
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