VIIV HEALTHCARE PTY LTD

CVS Health, the largest U.S. pharmacy benefit manager, will not add Gilead's new HIV prevention drug Yeztugo to its commercial plans, citing clinical, financial, and regulatory factors despite the drug's proven 99.9% effectiveness.

Gilead Sciences' HIV prevention drug Yeztugo is performing "well ahead of expectations" following its recent US and European launch, with unaided awareness reaching 72% compared to typical industry launch levels.

ViiV Healthcare has expanded its voluntary licensing agreement with the Medicines Patent Pool to allow generic production of cabotegravir for HIV treatment in 133 countries, including all low-income and Sub-Saharan African nations.

ViiV Healthcare presented extensive real-world data at IAS 2025 demonstrating the effectiveness, safety, and tolerability of its long-acting injectable HIV treatments, including cabotegravir + rilpivirine LA for treatment and cabotegravir LA for prevention.

ViiV Healthcare, a joint venture between GSK and Pfizer, reported promising results from their Phase II trial showing strong viral suppression in HIV patients using their novel long-acting therapy.

Phase IIb EMBRACE study demonstrates N6LS (VH109), administered every four months with monthly cabotegravir, successfully maintained viral suppression in 96% of participants receiving intravenous treatment.

• Gilead Sciences is advancing lenacapavir, a potential once-yearly injectable HIV prevention drug, directly from Phase I to Phase III trials, bypassing mid-stage studies due to strong early results. • The investigational long-acting HIV prevention option demonstrated favorable pharmacokinetic profile and safety data in Phase I, addressing a significant unmet need for less frequent dosing regimens. • If successful in Phase III trials and subsequently approved, lenacapavir would represent a significant advancement over current daily oral PrEP options and bi-monthly injectable cabotegravir, potentially improving adherence and accessibility.

ACTG researchers found that HIV patients switching to integrase inhibitor-based antiretroviral regimens faced increased risks of obesity, diabetes, hypertension, and metabolic syndrome over five years.

Real-world data presented at CROI 2025 demonstrates zero HIV acquisitions and high persistence with Apretude (cabotegravir LA) for PrEP across diverse populations, reinforcing its effectiveness in HIV prevention.

Gilead Sciences has settled a significant patent dispute with ViiV Healthcare, agreeing to pay $1.25 billion plus ongoing royalties on Biktarvy sales until 2027, resolving litigation dating back to 2018.