28 July 2022 (Montreal, Canada) – A series of announcements 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.
PrEP could play a major role in ending the HIV pandemic, but right now, very few people can get it,” Adeeba Kamarulzaman, President of conference host IAS – the International AIDS Society – and International Co-Chair
of AIDS 2022, said. “Scaling up affordable access to this game-changing prevention tool must be a top global priority.”
At today’s press conference, 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 AVAC as the secretariat.
Analysis confirms CAB-LA is highly effective for PrEP in trans women; findings
suggest gender-affirming hormonal therapy does not impact CAB concentrations
Researchers announced that the first trans-specific analysis of data from the landmark HPTN 083 study confirms that CAB-LA is a safe and highly effective HIV prevention option for trans women.
HPTN 083 is a Phase 3 study comparing CAB-LA to daily oral TDF/FTC for HIV prevention in cisgender men and trans women who have sex with men. In 2020, researchers announced that HPTN 083 had demonstrated a 66% reduced risk of HIV acquisition
for CAB-LA compared to TDF/FTC.
The new analysis, which will be presented at AIDS 2022 by Beatriz Grinsztejn of the Evandro Chagas National Institute of Infectious Diseases – Fiocruz (Brazil), reports on the
safety, prevention efficacy and pharmacokinetics of CAB-LA in trans women during the blinded phase of HPTN 083. Of 4,566 study participants, 570 (12.5%) were trans women, 330 (57.9%) of whom reported use of gender-affirming hormonal therapy. HIV incidence
among trans women was lower in the CAB-LA group (0.54%) than in the TDF/FTC group (1.80%). CAB-LA was well tolerated in trans women and, importantly, initial findings suggest there is no impact of gender-affirming hormonal therapy on CAB concentrations. [Summary
is based on abstract; final data presented at the conference may change.]
CAB-LA continues to be superior to TDF/FTC for PrEP in cisgender women
New data from the HPTN 084 study shows that among individuals assigned female at birth, CAB-LA continues to be superior to daily oral TDF/FTC in preventing HIV
HPTN 084 is an ongoing Phase 3 randomized controlled trial of CAB-LA for PrEP in individuals assigned female at birth. In late 2020, a planned interim review found that CAB-LA was superior to daily oral TDF/FTC for HIV prevention
in this population. The blinded portion of the trial was then stopped; participants were subsequently unblinded and continued on their original randomized study regimen pending a protocol amendment to offer open-label CAB-LA.
to be presented at AIDS 2022 by Sinead Delany-Moretlwe of the University of the Witwatersrand (South Africa), reports that 23 incident infections (3 CAB-LA, 20 TDF/FTC) were detected in the 12-month unblinded period. Of these, two
(1 CAB-LA, 1 TDF/FTC) occurred during the blinded phase, and only one of the CAB-LA cases had ever received an injection. Cumulatively, 62 incident HIV infections (6 CAB, 56 TDF/FTC) have been observed over 6,626 person-years of follow up (HIV incidence 0.94%).
In addition, no new safety concerns were identified. [Summary is based on abstract; final data presented at the conference may change.]
[For more information, see the HPTN 084 news release]
New WHO guidelines recommend CAB-LA for HIV prevention
Also at today’s press
conference, 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. The guidelines will support countries as they
plan for CAB-LA introduction and facilitate urgently needed operational research. [See press release from WHO for additional information]
“Long-acting cabotegravir is a safe and highly effective HIV prevention tool, but isn’t yet available outside
study settings,” Meg Doherty, Director of WHO’s Global HIV, Hepatitis and Sexually Transmitted Infections Programmes, 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
“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.”
[See press release from Medicines Patent Pool here]
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).
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.
"Afrocab and our community partners are excited about today’s announcement,” Jacque Wambui, Global CAB facilitator at Afrocab, said. “Since we began mobilizing community
partners around the world almost six months ago, we have been encouraged to see the responsiveness and engagement from global partners that have made this announcement possible.
"However, we recognize this is just the first step on this path for
long-acting cabotegravir for PrEP. Speedy technology transfer and low-cost pricing have still not been secured. Until then, the promise of accessible, affordable CAB-LA will not be realized. Afrocab and our community partners will continue to advocate around
these issues until they are resolved."