A series of announcements have been made today ahead of AIDS 2022, the 24th International AIDS Conference – including late-breaking study results, new WHO guidelines, a major voluntary licensing agreement and a new global coalition – built momentum for global access to long-acting cabotegravir (CAB-LA) as pre-exposure prophylaxis (PrEP) for HIV prevention.
Oral PrEP was first approved by the US Food and Drug Administration a decade ago, but uptake and adherence have been limited, partly because some people have difficulty taking daily pills.
In recent years, studies have shown that CAB-LA, administered by injection once every two months, is a safe and effective alternative to oral PrEP. CAB-LA is approved for PrEP only in the US, but its maker, ViiV Healthcare, has submitted marketing applications in additional countries.
Adeeba Kamarulzaman, President of conference host, the International AIDS Society (IAS), and International Co-Chair of AIDS 2022, says long lasting PrEP could make a major difference in the fight against HIV.
“Long-acting PrEP could play a major role in ending the HIV pandemic, but right now, very few people can get it,” Kamarulzaman said. “Scaling up affordable access to this game-changing prevention tool must be a top global priority.”
At a press conference ahead of the conference opening, researchers presented new data confirming that CAB-LA is safe and effective for PrEP in trans and cisgender women, WHO released its first guidelines for CAB-LA for PrEP, ViiV Healthcare and the Medicines Patent Pool announced that they have signed a voluntary licensing agreement for patents relating to CAB-LA for PrEP.
Finally, WHO, Unitaid, UNAIDS and The Global Fund announced the launch of a global coalition to accelerate access to long-acting PrEP with the AIDS Vaccine Advocacy Coalition (AVAC) as the secretariat.
New WHO guidelines recommend CAB-LA for HIV prevention
Also at today’s press conference, the World Health Organisation (WHO) released new guidelines for the use of CAB-LA as PrEP for HIV and called for countries to consider this safe and highly effective prevention option for people at substantial risk of HIV infection.
Officials said the guidelines will support countries as they plan for CAB-LA introduction and facilitate urgently needed operational research. Meg Doherty , Director of WHO’s Global HIV, Hepatitis and Sexually Transmitted Infections Programmes, said she hoped the guidelines would speed up delivery of new method of tackling HIV.
“Long-acting cabotegravir is a safe and highly effective HIV prevention tool, but isn’t yet available outside study settings,” Doherty said. “We hope these new guidelines will help accelerate country efforts to start to plan and deliver CAB-LA alongside other HIV prevention options, including oral PrEP and the dapivirine vaginal ring.”
ViiV Healthcare and the Medicines Patent Pool sign voluntary licensing agreement to expand access to CAB-LA for PrEP
Also today, ViiV Healthcare and the Medicines Patent Pool (MPP) announced that they have signed a voluntary licensing agreement for patents relating to CAB-LA for HIV PrEP to help enable access in least developed, low-income, lower-middle-income and sub-Saharan African countries.
Through this agreement, selected generic manufacturers will have the opportunity to develop, manufacture and supply generic versions of CAB-LA for PrEP in 90 countries, subject to required regulatory approvals.
ViiV Healthcare and MPP will now work closely with stakeholders and selected generic manufacturers to enable access to generic CAB-LA for PrEP as soon as possible.
“We are delighted to sign this voluntary licence with ViiV for cabotegravir LA for PrEP,” Charles Gore , MPP Executive Director, said. “Long-acting technologies open up a whole new dimension that facilitates medicine uptake, and this product brings a much-needed option for those at risk.
“This licence was negotiated in double-quick time and is another example of MPP’s continued commitment to making innovation available and affordable in low- and middle-income countries in the shortest possible time. Rapid access to new technologies is our only hope of hitting the Sustainable Development Goal targets.”
“Today’s announcement represents a potentially game-changing moment in HIV prevention,” Deborah Waterhouse , CEO at ViiV Healthcare, said. “Enabling at-scale access to generic cabotegravir LA for PrEP could play a significant role in averting the transmission of HIV, particularly amongst women and adolescent girls, and help end the HIV epidemic.
“I am proud that through our long-standing partnership with MPP, we continue to play our part in widening access for people in resource-limited countries to new innovative medicines.” Warerhouse said.
The ViiV Healthcare CEO had been facing widespread calls to make the medication more accessible with high profiles scientists and celebrities from music and acting joining forces to lobby the business leader.
Global coalition launched to accelerate access to long-acting PrEP
Today also marked the launch of the new Coalition to Accelerate Access to Long-Acting PrEP.
Convened by WHO, Unitaid, UNAIDS and The Global Fund, and with AVAC as the secretariat, the coalition will coordinate key stakeholder activities on PrEP access, including jointly developing strategies to identify and overcome access challenges for new PrEP options in the near to medium term (especially related to ViiV’s injectable CAB, including generics) and the medium to longer term (related to future PrEP products).
“New HIV prevention options now reaching the market, such as injectable cabotegravir, hold the promise to transform HIV prevention,” Tenu Avafia , Deputy Executive Director of Unitaid, said.
“But we must move far more quickly than we did with oral PrEP if we are to have real impact on the epidemic. This new coalition being formed will prioritize the acceleration of affordable, equitable and widespread access to injectable long-acting cabotegravir for PrEP without delay.
OIP Staff
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