Peptide News Digest

#Twice-Yearly

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Clinical Trials · View digest

AIDS 2026 Wednesday July 29 Also Features Gilead Sciences 52-Week Open-Label Extension (OLE) Data From the Phase 3 PURPOSE 1 and PURPOSE 2 Trials of Twice-Yearly Subcutaneous Lenacapavir (Yeztugo) for HIV Prevention (Pre-Exposure Prophylaxis, PrEP): Continued High Efficacy, High Adherence, and Consistent Safety Across the Broad Geographically Diverse Populations Already Using the Drug in 10 Priority Sub-Saharan African Countries

Gilead Sciences (NASDAQ: GILD) presented 52-week open-label extension (OLE) long-term data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials of twice-yearly subcutaneous lenacapavir (Yeztugo, FDA-approved June 2025) for HIV prevention (pre-exposure prophylaxis, PrEP) at AIDS 2026 Wednesday July 29, 2026. PURPOSE 1 documented zero new HIV infections among participants receiving twice-yearly lenacapavir across more than 7,178 person-years of open-label follow-up at Week 52; PURPOSE 2 documented one HIV infection among participants continuing lenacapavir across 5,295 person-years. The 52-week OLE data confirms continued high efficacy, high adherence (participants generally reliably return for the twice-yearly injection), and consistent safety profile across broad and geographically diverse populations. Yeztugo has now been deployed in 10 priority sub-Saharan African countries including South Africa (national program launched June 5, 2026 by President Cyril Ramaphosa in Secunda, Mpumalanga), Zambia, and Eswatini through PEPFAR and Global Fund investments. Generic versions from Dr. Reddy's Laboratories, Hetero Labs, and four other manufacturers are expected in 2027 at approximately $40 per person per year across 120 low- and lower-middle-income countries.

Clinical Trials · View digest

26th International AIDS Conference (AIDS 2026) Opens Sunday July 26, 2026 in Rio de Janeiro, Brazil and Runs Through Friday July 31; Gilead Sciences to Present Twice-Yearly Lenacapavir (First-in-Class HIV Capsid Inhibitor) Long-Term Extension Data From the Phase 3 PURPOSE 1 Trial (Zero New HIV Infections Across 7,178 Person-Years of Follow-Up at Week 52) and the Phase 3 PURPOSE 2 Trial (One HIV Infection Across 5,295 Person-Years of Follow-Up), and Gilead-Merck Once-Weekly Oral Islatravir/Lenacapavir ISLEND-1 and ISLEND-2 Phase 3 Detailed Data Late-Breaker on Wednesday July 29

The 26th International AIDS Conference (AIDS 2026) opens Sunday July 26, 2026 in Rio de Janeiro, Brazil and runs through Friday July 31. Two peptide-adjacent HIV modality readouts anchor the industry program. Gilead Sciences (NASDAQ: GILD) will present twice-yearly lenacapavir (first-in-class HIV capsid inhibitor) long-term open-label extension data from the Phase 3 PURPOSE 1 trial, where zero new HIV infections occurred among participants receiving lenacapavir across more than 7,178 person-years of follow-up at Week 52, and from PURPOSE 2, where one HIV infection occurred among participants continuing lenacapavir across 5,295 person-years of follow-up. Separately, Gilead and Merck's once-weekly oral single-tablet islatravir 2 mg / lenacapavir 300 mg (ISL/LEN) Phase 3 ISLEND-1 and ISLEND-2 detailed data is scheduled for the late-breaking session on Wednesday July 29. Topline released July 21 showed 0% of ISLEND-1 once-weekly ISL/LEN participants had HIV-1 RNA at 50 copies/mL or higher at Week 48 (versus 0.3% remaining on daily Biktarvy). Merck plans separate presentations across its daily, weekly, and monthly HIV treatment and prevention pipeline including alimatravir (MK-8527), the investigational once-monthly oral HIV prevention pill licensed Friday July 24 to Aspen Pharmacare and six other generic manufacturers for 129 low- and middle-income countries.