GSK Expands Patent Pool Agreement for HIV Treatment Cabotegravir, Enhancing Global Access

GSK has broadened its voluntary licensing agreement with the United Nations-backed Medicines Patent Pool (MPP) for cabotegravir, a move that will significantly expand access to HIV treatment in low- and middle-income countries. This development comes on the heels of updated World Health Organization (WHO) guidance recommending long-acting injectable treatments as an alternative to daily oral therapy for virally suppressed patients.

Expanded Access to Cabotegravir

The expanded agreement allows three generic drugmakers - Aurobindo, Cipla, and Viatris - to produce and supply generic versions of cabotegravir to 133 countries, including all of Sub-Saharan Africa and nations classified as low-income and lower-middle-income. This expansion builds upon a 2022 licensing deal that permitted specified generic manufacturers to produce cabotegravir for pre-exposure prophylaxis (PrEP).

Meg Doherty, director of the WHO's global HIV, hepatitis, and STI programs, emphasized the alignment of this move with recent WHO recommendations, stating, "This step is closely aligned with WHO's new recommendation of long-acting injectable antiretrovirals as an alternative for people who are virologically suppressed but face adherence challenges with daily oral regimens."

Long-Acting HIV Treatments Gain Traction

The expanded agreement for cabotegravir reflects a growing trend towards long-acting HIV treatments. Cabotegravir, when combined with rilpivirine, forms the long-acting injectable treatment Cabenuva. The FDA approved cabotegravir as a single agent for HIV prevention under the brand name Apretude in 2021, administered as an injection every two months.

This development follows Gilead's recent agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria to provide its newly approved long-acting, injected PrEP drug Yeztugo at a not-for-profit rate to poorer nations. Gilead's deal aims to provide coverage for up to 2 million people over three years. Additionally, Gilead has established agreements with six generic drug manufacturers to produce and distribute Yeztugo across 120 high-incidence, resource-limited countries.

Industry Implications and Future Outlook

The expansion of access to long-acting HIV treatments represents a significant shift in the global approach to HIV management. Charles Gore, executive director of the MPP, highlighted the importance of this development, saying, "Expanding access to long-acting options like this supports a more person-centered, choice- and needs-driven approach, which is exactly what an equitable and effective HIV response requires."

As the pharmaceutical industry continues to innovate in HIV treatment and prevention, these agreements between major drug manufacturers and international health organizations pave the way for more equitable global access to cutting-edge therapies. The move towards long-acting treatments may address adherence challenges associated with daily oral regimens, potentially improving patient outcomes and reducing HIV transmission rates in high-burden areas.