HIV Prevention Breakthrough: Twice-Yearly Injection Reduces Infections by 96%

New Drug Shows Promise in Reducing HIV Risk

A groundbreaking new drug, lenacapavir, has been shown to dramatically reduce the risk of HIV infection. According to data reported by the drugmaker Gilead Sciences, two annual injections of the drug reduced HIV infections by an impressive 96%.

Trials Monitored High-Risk Groups

The trial, known as PURPOSE 2, monitored cisgender men, transgender men, transgender women, and gender nonbinary individuals in Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the United States who have sex with partners assigned male at birth. The study involved 2,180 participants, and only two people contracted HIV during the trial.

Potential to Transform HIV Prevention

Gilead Sciences’ chair and CEO, Daniel O’Day, hailed the results as a potential game-changer in the fight against HIV. “With such remarkable outcomes across two Phase 3 studies, lenacapavir has demonstrated the potential to transform the prevention of HIV and help to end the epidemic,” he said.

Seeking Regulatory Approval

Gilead Sciences is now seeking regulatory approval for the drug. O’Day emphasized the company’s commitment to making the drug available worldwide, stating, “Now that we have a comprehensive dataset across multiple study populations, Gilead will work urgently with regulatory, government, public health, and community partners to ensure that, if approved, we can deliver twice-yearly lenacapavir for PrEP worldwide, for all those who want or need PrEP.”

Challenges Ahead: Cost and Accessibility

While the results are promising, the drug is expensive. The National Institutes of Health estimate that the two injections of the drug could cost more than $40,000 a year. This raises concerns about accessibility and affordability, particularly in low- and middle-income countries where HIV treatment is often lacking.

Global Impact Hoped For

Researchers are hopeful that the drug could have a significant impact in places where treatment is lacking. “In the United States, the stubbornly high rate of HIV diagnoses — especially in the U.S. South, and particularly among gay and bisexual men of color and transgender people — demands novel approaches to help people prevent HIV acquisition,” said Colleen Kelley, a professor of medicine at Emory University and a PURPOSE 2 principal investigator.

Not Yet Approved for Use

The drug has not been approved for use anywhere globally by itself, although lenacapavir has been authorized by the U.S. Food and Drug Administration for the treatment of HIV infection in adults, in combination with other medicines. Gilead Sciences is planning to use the results from the PURPOSE 2 trial to start the drug approval process throughout different countries.

Conclusion

The results of the PURPOSE 2 trial are a significant breakthrough in the fight against HIV. With a 96% reduction in HIV infections, lenacapavir has the potential to transform HIV prevention and help end the epidemic. While challenges around cost and accessibility remain, researchers are hopeful that the drug could have a global impact.

FAQs

Q: What is lenacapavir?
A: Lenacapavir is a new HIV prevention drug that has been shown to reduce the risk of HIV infection by 96%.

Q: How does lenacapavir work?
A: Lenacapavir is administered as a twice-yearly injection and works by preventing HIV from entering the body.

Q: Who was involved in the trial?
A: The trial, known as PURPOSE 2, monitored cisgender men, transgender men, transgender women, and gender nonbinary individuals in Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the United States who have sex with partners assigned male at birth.

Q: How many participants were involved in the trial?
A: The trial involved 2,180 participants.

Q: What is the estimated cost of the drug?
A: The National Institutes of Health estimate that the two injections of the drug could cost more than $40,000 a year.

Q: Has the drug been approved for use?
A: The drug has not been approved for use anywhere globally by itself, although lenacapavir has been authorized by the U.S. Food and Drug Administration for the treatment of HIV infection in adults, in combination with other medicines.