EMORY UNIVERSITY

A study estimates 56-62% of U.S. depression patients, or 5.1-5.6 million individuals, could qualify for psilocybin therapy if approved by the FDA, highlighting the need for further research and preparation for equitable treatment delivery.

Gilead Sciences' lenacapavir, an HIV treatment repurposed as a twice-yearly preventive shot, reduced HIV infection risk by 96% in a trial involving over 3200 individuals. The drug's high cost as a treatment ($3450/month) raises concerns about its affordability as PrEP. Gilead plans to submit lenacapavir for FDA approval by end of 2024, aiming to make it accessible globally.

Gilead’s lenacapavir reduced HIV infections by 96% in the PURPOSE 2 trial, outperforming once-daily Truvada. The trial's early unblinding allows open-label access. Lenacapavir, administered twice-yearly, showed 99.9% HIV-free rate and 89% greater efficacy over Truvada. Gilead plans global regulatory filings by year-end, aiming for lenacapavir to become the first twice-yearly HIV prevention therapy.

A study estimates 5.1 to 5.6 million Americans receiving depression treatment could qualify for psilocybin therapy if approved by the FDA, based on criteria from recent clinical trials.

New research suggests psilocybin-assisted therapy could benefit millions of Americans with depression, with 56-62% of current treatment recipients potentially eligible if FDA approves. The study, involving Emory University, UW-Madison, and UC Berkeley, highlights the importance of understanding practical implementation challenges.

Lenacapavir reduced HIV infections by 96% in a Phase 3 trial, with 99.9% of participants not acquiring HIV. Gilead will offer open-label lenacapavir to all participants.

Gilead's Phase III PURPOSE 2 trial shows lenacapavir, a twice-yearly HIV drug, outperformed daily Truvada, reducing HIV infections by 96% compared to background HIV incidence. The trial enrolled cis- and transgender men, transgender women, and gender non-binary individuals, with lenacapavir proving 89% more effective than Truvada. Based on these results, the independent Data Monitoring Committee recommended offering lenacapavir to all participants.

Lenacapavir, a long-acting HIV-prevention drug requiring dosing every six months, showed 89% more effectiveness than daily oral medication in preventing HIV among gay, bisexual, and transgender individuals, and 100% effectiveness in cisgender women. Despite its potential to significantly reduce HIV infections, concerns over its high cost may hinder widespread adoption.