ViiV Healthcare Broadens Voluntary Licensing Deal with MPP to Include Long-Acting Injectable HIV Treatment in Global Access Push
GSK plc (LSE/NYSE: GSK) announced that its majority-owned subsidiary, ViiV Healthcare—a global leader in HIV treatment and prevention, with Pfizer and Shionogi as minority shareholders—has expanded its voluntary licensing agreement with the Medicines Patent Pool (MPP) to encompass patents related to cabotegravir’s use in long-acting HIV treatment regimens. This development significantly widens global access to a transformative therapeutic option, aligning with newly issued guidance from the World Health Organization (WHO), which now recommends long-acting injectable cabotegravir combined with rilpivirine as an alternative HIV treatment for certain patient populations.
Expanding the Reach of Long-Acting HIV Therapies
The updated licensing agreement marks a strategic milestone in the global fight against HIV/AIDS. By amending the existing deal—which previously covered cabotegravir for HIV pre-exposure prophylaxis (PrEP)—ViiV Healthcare and MPP are enabling broader access to long-acting injectable cabotegravir (CAB LA) as part of a dual-drug injectable regimen for treatment. The regimen consists of cabotegravir and rilpivirine, offering an innovative alternative to traditional daily oral antiretroviral therapy (ART).
Under the revised terms, existing generic licensees that were already authorized to manufacture CAB LA for prevention—namely Aurobindo, Cipla, and Viatris—are now permitted to develop, produce, and distribute generic formulations of cabotegravir for treatment purposes as well. The license covers 133 countries, comprising all least-developed nations, low-income and lower-middle-income countries, Sub-Saharan Africa, and additional territories where ViiV Healthcare does not hold cabotegravir patent rights. Regulatory approvals will be required prior to commercial distribution, but the updated agreement lays the foundation for expanded global access.
A New Chapter in HIV Treatment Access
Deborah Waterhouse, CEO of ViiV Healthcare, emphasized the company’s commitment to equitable healthcare access:
“As leaders in long-acting innovation we’re proud to be expanding our voluntary licence with the MPP to now include treatment of HIV in addition to prevention. Long-acting injectables have the potential to transform HIV treatment and we welcome the latest recommendations from WHO to expand treatment options. In line with our mission to ensure no one living with HIV is left behind, we’re committed to working with partners like MPP to continue to increase access and reach those most impacted by HIV.”
This move reflects ViiV’s broader strategic aim to support global health equity by removing barriers to innovative HIV medications. By enabling lower-cost generics in countries with limited resources, the company helps governments and public health organizations deploy treatment options that are both clinically advanced and financially viable.
WHO Endorsement Strengthens Momentum
The updated licensing deal is also closely aligned with the WHO’s latest clinical guidance. Dr. Meg Doherty, Director of Global HIV, Hepatitis, and STI Programmes at the WHO, expressed strong support for the initiative:
The World Health Organization welcomes the expansion of the voluntary licence agreement for long-acting cabotegravir to include HIV treatment. 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.”
She noted that many individuals living with HIV struggle with the daily burden of oral treatment, whether due to stigma, logistical difficulties, or side effects. Long-acting injectables—administered as infrequently as every two months—offer a solution that is more discreet, manageable, and aligned with patients’ real-world needs.
This agreement aligns with our global goals to ensure equitable access to essential medicines and improve health outcomes for all,” added Dr. Doherty. “We are committed to supporting countries in implementing these new guidelines and ensuring that no one is left behind.”
MPP’s Role in Scaling Access
The Medicines Patent Pool, a United Nations-backed public health organization, is instrumental in bridging the gap between pharmaceutical innovation and affordability. Charles Gore, Executive Director of MPP, hailed the updated licensing agreement as a landmark step:
We’re delighted to extend the CAB LA licence to cover HIV treatment, reflecting the latest WHO recommendations. Our previous agreement with ViiV for dolutegravir has already enabled the supply of generic DTG-based HIV treatments in 129 countries, and we hope that over time a similar coverage can be achieved for CAB LA.”
According to Gore, the inclusion of treatment within the scope of the license reflects a shared commitment between MPP and ViiV to address real-world barriers to care. CAB LA holds particular promise for individuals facing difficulties adhering to daily regimens—a known risk factor for viral resistance, treatment failure, and disease progression.
CAB LA is a vital addition to the HIV treatment toolbox — especially for people facing adherence challenges with oral regimens,” Gore stated. “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.”
How the Updated Agreement Works
Originally, ViiV Healthcare’s agreement with MPP focused solely on enabling access to generic cabotegravir for HIV prevention (PrEP). In 2022, ViiV became the first company to sign a voluntary license agreement with MPP for a long-acting injectable PrEP medication. Now, the expanded agreement goes further—covering cabotegravir’s use in therapeutic HIV regimens.
The three generic manufacturers already licensed under the initial deal—Aurobindo, Cipla, and Viatris—will now be able to:
- Develop generic formulations of CAB LA for HIV treatment,
- Manufacture the treatment at scale for eligible countries,
- Supply the product pending regulatory approval, and
- Distribute it for use in combination with long-acting rilpivirine, a Janssen (Johnson & Johnson)-developed medication also administered via injection.
The treatment is indicated for adults and adolescents weighing at least 35 kilograms who are virologically suppressed and eligible for switching from oral therapy to long-acting injectable regimens. In practice, this means patients will receive one injection of cabotegravir and rilpivirine every two months—eliminating the need for daily pills.
A Game-Changer for Treatment Adherence and Stigma
The development of long-acting injectables marks a paradigm shift in the global approach to HIV care. For individuals who face challenges with adherence—due to stigma, memory issues, transportation limitations, or unstable living conditions—bimonthly injections offer a powerful alternative. Such innovations also help to destigmatize treatment, reduce the psychological burden of daily pill-taking, and support better health outcomes.
Moreover, the impact is particularly significant in regions where HIV remains a major public health challenge. Sub-Saharan Africa, for example, continues to bear the highest global burden of HIV/AIDS, with millions of people still lacking regular access to high-quality treatment. The ability to distribute low-cost, long-acting injectable therapies in these regions could dramatically improve viral suppression rates and curb transmission.
Technical Support to Enable Rapid Rollout
ViiV Healthcare is actively supporting licensees through the transfer of technical know-how, enabling them to accelerate development and manufacturing of generic CAB LA. This collaboration ensures that once regulatory authorizations are secured, manufacturers can bring products to market rapidly and at scale—helping national health systems meet patient demand.
The proactive technical support mirrors ViiV’s earlier approach with dolutegravir, which also saw successful generic manufacturing rollouts under MPP licenses. It reflects a broader trend in global health: pharmaceutical companies increasingly recognize the value of partnering with public health actors to ensure that innovation is not just developed but also delivered to those who need it most.
As ViiV Healthcare continues to lead innovation in the HIV space, this expanded licensing agreement reaffirms the company’s commitment to access, equity, and patient-centered care. By leveraging its product portfolio and working collaboratively with MPP, WHO, and generic manufacturers, ViiV is taking meaningful steps toward a world where HIV treatment is effective, discreet, and universally available.
The long-acting cabotegravir and rilpivirine injectable regimen is more than a scientific breakthrough—it is a tool for dismantling the systemic barriers that prevent millions from living longer, healthier lives. As WHO, ViiV, MPP, and industry partners work together to make these therapies widely accessible, the global HIV response enters a promising new chapter focused on choice, dignity, and health for all.
