VIIV HEALTHCARE PTY LTD

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.

The FDA has approved Cabenuva, the first long-acting injectable HIV treatment administered monthly, offering an alternative to daily pill regimens for patients with HIV.

Quebec becomes the first Canadian province to provide public reimbursement for APRETUDE, a long-acting injectable HIV prevention drug, through RAMQ coverage for at-risk individuals.