The UN health agency on Thursday recommended the use of a new long-acting “safe and highly effective” prevention option for people at “substantial risk” of HIV infection, known as cabotegravir (CAB-LA).
New World Health Organization (WHO) guidelines advise countries to use the new potentially game-changing drug which is not yet available for sale, as a pre-exposure prophylaxis (PrEP) for HIV, and as part of a comprehensive approach to prevent the virus from spreading.
Those using most PrEP medications on the market, have to remember to take their medication daily, a greater challenge for what is a preventative medicine.
“Long-acting cabotegravir is a safe and highly effective HIV prevention tool, but isn’t yet available outside study settings,” said Meg Doherty, Director of WHO’s Global HIV, Hepatitis and Sexually Transmitted Infections Programmes.
The drug was approved in the United States last December, and the United Kingdom the following month.
Key populations – including sex workers, men having sex with men, intravenous drug users, people in prisons, transgender individuals, and their sexual partners –accounted for 70 per cent of global HIV infections last year.
Moreover, 4,000 new infections that occurred every day in 2021, were within that group.
As HIV prevention efforts have stalled, the new guidelines were released ahead of the 24th International AIDS Conference (AIDS 2022) - which officially begins on Friday - with 1.5 million new HIV infections last year, the same as in 2020.
“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,” said the WHO official.
CAB-LA is an intramuscular injectable, long-acting form of PrEP.
The first two injections are administered four weeks apart, followed thereafter by an injection every eight weeks.
In randomized controlled trials, the antiretroviral was shown to be safe and highly effective among cisgender women, cisgender men who have sex with men, and transgender women who have sex with men.
Together, these landmark studies found that use of CAB-LA resulted in a 79 per cent relative reduction in HIV risk compared with oral PrEP, where adherence to taking daily oral medication was often a challenge, according to WHO.
Long-acting injectable products have also been found to be acceptable and sometimes preferred in studies examining community PrEP preferences.
The UN health agency also launched a new coalition to accelerate global access to the drug.
Convened by WHO, Unitaid, UNAIDS and The Global Fund, the coalition will identify interventions needed to advance near and long-term access to CAB-LA, establish financing and procurement for the drug, and issue policy guidance, among other activities.
“To achieve UN prevention goals, we must push for rapid, equitable access to all effective prevention tools, including long-acting PrEP,” said Rachel Baggaley, WHO’s Lead of the Testing, Prevention and Populations Team at Global HIV, Hepatitis and STI Programmes.
“That means overcoming critical barriers in low and middle-income countries, including implementation challenges and costs.”
WHO will continue to support evidence-based strategies to increase PrEP access and uptake, such as through adopting and including CAB-LA in HIV prevention programmes.
It is also working with Unitaid and others to develop projects that answer outstanding safety issues and implementation challenges.
And the WHO Global PrEP Network will host webinars to provide up-to-date information on CAB-LA to increase awareness.
In April, it was added to WHO’s list of Expressions of Interest for prequalification evaluation by the health agency.
Both oral PrEP and CAB-LA are highly effective.
The new CAB-LA guidelines are based on a public health approach that considers effectiveness, acceptability, feasibility and resource needs across a variety of settings.
They are designed to help CAB-LA delivery and the urgently needed operational research on address implementation and safety and will inform decisions on how to successfully provide and scale up CAB-LA.
The guidelines highlight critical research gaps, and also recognize that accessing current PrEP services are challenging for some.
“Communities must be involved in developing and delivering HIV prevention services that are effective, acceptable and support choice,” WHO spelled out.
UNITAID announces developing countries access deal
Selected manufacturers will be able to develop, manufacture and supply lower-cost generic versions of CAB-LA, in line with a deal reached with pharmaceutical firm ViiV Healthcare (ViiV) UN agency UNITAID announced on Friday.
“The Medicines Patent Pool, a structure created and largely funded by UNITAID, has reached a voluntary licensing agreement for patents relating to Cabotegravir long-acting, an injectable form of HIV prevention, or PrEP, to generic formulations of the product in least-developed, low-income, lower-middle income and sub-Saharan African countries,” said UNITAID spokesperson, Hervé Verhoosel.
“In the 90 countries that we are talking about, 80 countries are royalty-free, meaning that ViiV won’t ask for any royalty on the product and for 10 of those countries, ViiV is asking for a smaller-than-usual royalty,” Mr. Verhoosel explained.
The agreement comes after UNITAID-led discussions began in May this year with ViiV, a subsidiary of pharma giant GlaxoSmithkline. It is only seven months since Cabotegravir LA received regulatory approval.
But the process of selecting the companies that will develop, manufacture and supply generic versions of Cabotegravir will take much longer.
“This product will not be there for everybody, that’s first for people who are there the most at risk,” said Mr. Verhoosel, who noted that the cost of the medicine in the US when it comes onstream there “really soon”, was likely to be around $20,000. “That’s a lot of money; that’s why that product cannot be used in low and middle-income countries.”
According to UNITAID, the deal offers the possibility of making the injectable prophylactic medicine available in 90 countries where more than 70 per cent of all new HIV infections occurred in 2020.