WHO Releases Guidelines For Injectable HIV Prevention Drug, Generics Deal Reached

ViiV Healthcare has agreed to allow selected manufacturers to produce generic versions of its long-acting injectable cabotegravir, Apretude.

MONTREAL, July 29 – The World Health Organization (WHO) announced Thursday new guidelines for long-acting cabotegravir (CAB-LA), the first injectable medication to prevent HIV, calling for countries to make the drug readily available for those who need it.

The news follows the release of the UNAIDS Global Aids Update 2022 report that showed increases in annual HIV infections over the past decade in several regions, including in Asia and the Pacific – the world’s most populous region – where they had previously been falling.

“We hope these new guidelines will help accelerate country efforts to start to plan and deliver CAB-LA alongside other HIV prevention options,” WHO’s global HIV, hepatitis and sexually-transmitted infection programmes director Meg Doherty told reporters at a pre-conference session at AIDS 2022, the 24th International AIDS Conference, organised by the International AIDS Society (IAS) in Montreal, Canada.

Cabotegravir is an injectable, long-acting medicine that needs to be taken only once every two months, as opposed to the daily pills that characterise most pre-exposure prophylaxis (PrEP) regimes, which significantly reduces a person’s chance of contracting HIV.

Oral PrEP was first approved by the US Food and Drug Administration (FDA) a decade ago, but both uptake and adherence have been limited, partly due to difficulties faced by some individuals to take daily pills.

In recent years, studies have shown that CAB-LA is a safe and effective alternative to oral PrEP. CAB-LA is approved for PrEP only in the US, but its producer, 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,” said Dr Adeeba Kamarulzaman, president of the AIS which convenes AIDS 2022. “Scaling up affordable access to this game-changing prevention tool must be a top global priority.”

Expanding Access Through Generics

Thursday’s pre-conference also witnessed an announcement of a deal that will see ViiV Healthcare allow selected manufacturers to produce generic versions of cabotegravir.

ViiV Healthcare and the Medicines Patent Pool (MPP) said 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.

The MPP is a United Nations-backed public health organisation working to increase access to and facilitate the development of life-saving drugs for low- and middle-income nations.

The deal will provide access to the injectable version of cabotegravir in 90 countries where over 70 percent of all new HIV infections occurred in 2020.

Under the agreement, selected generic manufacturers will have the opportunity to develop, manufacture and supply generic, and likely cheaper, versions of CAB-LA for PrEP, subject to required regulatory approvals, MPP said in a statement.

“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,” said MPP executive director Charles Gore.

ViiV has pledged that, until a generic becomes available, it will supply the drug “at a non-profit price” for public programmes in low-income, least developed and all sub-Saharan African nations. But concerns remain that the price is too high for most countries.

It was reported that the price of the injectable is US$3,700 (RM16,475) per dose. CAB-LA injections are given a month apart upon which, injections are given every two months.

Global Coalition To Accelerate Access To Long-Acting PrEP

A new coalition was also announced at the Montreal pre-conference to accelerate access to long-acting PrEP.

The coalition will coordinate key stakeholder activities on PrEP access, including overcoming access challenges for new PrEP options, including ViiV’s long-acting injectable cabotegravir called Apretude, its generics, as well as future PrEP products.

The coalition is convened by the WHO, Unitaid, UNAIDS and The Global Fund, and with AVAC (previously AIDS Vaccine Advocacy Coalition) as the secretariat.

Unitaid deputy executive director Tenu Avafia said new HIV prevention options such as injectable cabotegravir hold the promise to transform HIV prevention. “But we must move far more quickly than we did with oral PrEP if we are to have a real impact on the epidemic.”

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