Gilead Sciences’ HIV Prevention Trial Shows 100% Efficacy, Shares Surge

Gilead Sciences' HIV Prevention Trial Shows 100% Efficacy | The Enterprise World

(Source – STAT News)

Gilead Sciences (GILD) witnessed a significant rise in shares on Thursday following the announcement of their HIV treatment trial’s groundbreaking results. The biopharmaceutical company revealed that its Phase 3 trial for HIV prevention demonstrated 100% efficacy, marking it as the first such trial to achieve zero infections.

Unprecedented Success in HIV Prevention

The trial tested Gilead’s experimental medicine, lenacapavir, administered twice a year. Approximately 2,000 women received the lenacapavir injection, and none contracted HIV, according to an interim analysis. This prompted the independent data monitoring committee to recommend unblinding the trial and offering the treatment to all participants, some of whom had been taking standard daily pills.

“This is a significant step forward in HIV prevention,” said Jared Baeten, Gilead’s vice president of clinical development for HIV. “The world needs more PrEP options, allowing people to choose the one that best fits their needs.”

Before lenacapavir can be approved by the FDA, Gilead sciences must replicate these results in another Phase 3 trial. The company expects to release data later this year or early next year from a study involving men who have sex with men. If successful, lenacapavir could reach the market by late 2025.

Expanding HIV Treatment Options

Gilead sciences has been a pioneer in HIV treatment, with its drug Truvada becoming the first approved PrEP medication for those at high risk of HIV infection over a decade ago. While daily pills currently dominate the market, there is a growing focus on developing longer-acting shots to enhance adherence and efficacy.

PrEP, when taken correctly, reduces the risk of contracting HIV from sex by 99% and from injected drug use by 74%. However, only about a third of eligible individuals in the U.S. use PrEP, according to the CDC. Health policymakers and advocates are hopeful that longer-acting options like lenacapavir will reach those who cannot or do not want to take daily pills, thereby improving prevention efforts.

“It’s crucial to have more options than daily pills to end the epidemic,” said Bruce Richman, executive director of the nonprofit Prevention Access Campaign. “We need treatments that fit diverse lifestyles.”

The FDA approved the first injectable PrEP, Apretude, in 2021, which is administered every two months. However, lenacapavir’s twice-yearly regimen could be more appealing to patients who prefer fewer medical visits. RBC Capital Markets analyst Brian Abrahams anticipates that lenacapavir will significantly boost the number of individuals seeking preventive HIV medicine, estimating peak sales of nearly $2 billion.

Activists are calling for Gilead to ensure lenacapavir is accessible to people in low- and middle-income countries, where HIV incidence remains high. Gilead has faced criticism for the pricing of its HIV medications, with Descovy, another PrEP pill, carrying a list price of $26,000 annually.

In light of the trial results, Gilead announced plans to address accessibility issues in regions with high HIV rates. This commitment is crucial for broadening the impact of this groundbreaking treatment and ensuring that it reaches those most in need.

The promising results of Gilead’s lenacapavir trial signal a potential revolution in HIV prevention, offering hope for a more effective and convenient treatment option that could transform the landscape of HIV care globally.

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