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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.
“Long-acting 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 infection.
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.
This update, 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 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.”
[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).
“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.
Community response
"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."
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