ViiV Healthcare Expands Generic License for Long-Acting HIV Treatment to 133 Countries
Key Insights
ViiV Healthcare has expanded its voluntary licensing agreement with the Medicines Patent Pool (search) to allow generic production of cabotegravir for HIV (search) treatment in 133 countries, including all low-income and Sub-Saharan African nations.
The updated license enables three generic manufacturers—Aurobindo (search), Cipla, and Viatris—to develop and supply the long-acting injectable treatment for use with Johnson & Johnson's rilpivirine.
The World Health Organization recently recommended long-acting cabotegravir and rilpivirine as a treatment option for people who are virologically suppressed but struggle with adherence to daily oral regimens.
ViiV Healthcare, the HIV (search)-focused joint venture majority owned by GSK, announced on Monday an expansion of its voluntary licensing agreement with the Medicines Patent Pool (search) (MPP) to include patents for cabotegravir's use in long-acting HIV treatment. The updated license will enable generic production of the injectable treatment for 133 countries worldwide, including all least-developed, low-income, lower middle-income, and Sub-Saharan African countries.
The announcement follows the World Health Organization's recent recommendation of long-acting injectable cabotegravir combined with rilpivirine as a treatment option for people who are virologically suppressed but face adherence challenges with daily oral regimens.
Generic Manufacturing Partnership
Three existing generic licensees—Aurobindo (search), Cipla, and Viatris—will now be able to develop, manufacture, and supply generic versions of long-acting cabotegravir for use in combination with Johnson & Johnson's rilpivirine, subject to required regulatory approvals. ViiV Healthcare has been supporting these generic manufacturers with technical know-how to enable development and access to the treatment as soon as possible.
"As leaders in long-acting innovation we're proud to be expanding our voluntary licence with the MPP to now include treatment of HIV (search) in addition to prevention," said Deborah Waterhouse, CEO at ViiV Healthcare. "Long-acting injectables have the potential to transform HIV treatment and we welcome the latest recommendations from WHO to expand treatment options."
Treatment Innovation and Access
ViiV's regimen represents the only approved long-acting injectable treatment for HIV (search), administered once every one or two months as an alternative to daily pills. The treatment is indicated for HIV-1 (search) infection in adults and adolescents weighing at least 35kg who are virologically suppressed with HIV-1 RNA levels below 50 copies/mL on a stable antiretroviral regimen.
Charles Gore, Executive Director at MPP, emphasized the significance of the expanded agreement: "CAB LA is a vital addition to the HIV (search) treatment toolbox—especially for people facing adherence challenges with oral regimens. Expanding access to long-acting options like this supports a more person-centred, choice- and needs-driven approach, which is exactly what an equitable and effective HIV response requires."
Building on Prevention Success
The updated agreement extends ViiV's existing voluntary license for cabotegravir for HIV (search) pre-exposure prophylaxis (PrEP), signed in 2022. The company's previous agreement with MPP for dolutegravir has already enabled the supply of generic DTG-based HIV treatments in 129 countries, providing a model for the potential reach of the cabotegravir license.
Dr. Meg Doherty, Director Global HIV (search), Hepatitis and STI Programmes at the World Health Organization, welcomed the expansion: "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."
Global Access Initiative
The announcement comes amid broader efforts to expand access to innovative HIV (search) medicines in the Global South. Last week, Gilead Sciences and the Global Fund to Fight AIDS, Tuberculosis and Malaria (search) finalized a separate deal to supply long-acting HIV prevention drug lenacapavir to low-income countries at cost.
ViiV Healthcare is majority-owned by GSK, with Pfizer and Shionogi (search) as shareholders. The company's mission emphasizes ensuring no one living with HIV (search) is left behind, with the expanded licensing agreement representing a significant step toward achieving equitable access to advanced HIV treatment options globally.