Activist countries

Pharmaceutical deal gives 90 countries access to cheaper HIV prevention injectables

ViiV’s Deborah Waterhouse and MPP’s Charles Gore announce the new licensing agreement.

MONTREAL – Ninety countries will benefit from a voluntary licensing agreement announced Thursday that will allow generic manufacturers to produce a long-acting injectable antiretroviral, cabotegravir (CAB-LA), to protect people from infection with HIV.

The maker of CAB-LA, British pharmaceutical company ViiV, has granted the license to the Medicines Patent Pool (MPP) for patents in least developed, low-income, lower-middle-income and sub-Saharan African countries.

CAB-LA is given as an injection every two months for pre-exposure prophylaxis (PrEP) and aims to protect those most at risk of HIV infection, including healthcare workers. sex, people who inject drugs, men who have sex with men and transgender people.

These groups, designated “key populations” by UNAIDS because of their vulnerability to HIV, accounted for 70% of new infections in 2021, according to UNAIDS.

“From there, we will work with the MPP to help enable generic manufacturing as quickly as possible. We are committed to offering non-profit pricing for public programs in low-income, least developed countries and all countries in sub-Saharan Africa until a generic becomes available,” said Deborah Waterhouse of ViiV at a press conference Thursday, on the eve of the opening of the International AIDS Conference on Friday.

ViiV also produces the antiretroviral drug, dolutegravir, and has a voluntary license for this from the MPP.

“By applying this proven modern model to prevention and by sharing our intellectual property and enabling generic versions of CAB-LA for PrEP, we hope we can play an important role in preventing new cases of HIV, especially in women and girls, where challenges around adherence, limited effectiveness and stigma have hindered the impact of current PrEP options,” Waterhouse said.

Currently, PrEP is limited to oral pills that must be taken daily, which is often difficult for the high-risk groups for whom PrEP is intended.

New coalition to fight prices

MPP executive director Charles Gore said the license “allows MPP to issue sub-licenses to qualified manufacturers who will then develop generic versions.”

In addition to the 90 countries covered, the wording of the license indicates that other countries where there are no patents or patent applications can also benefit from generic versions, Gore said.

“License holders will need to obtain pre-qualification approval from WHO or a strict regulatory authority. The sales are almost all royalty-free. In only 10 countries will they have a 5% royalty on net sales,” Gore said.

CAB-LA was approved for the prevention of HIV infection by the United States Food and Drug Administration (FDA) in December 2021, but its price per vial is approximately $3,700.

Held Avafia, Deputy Executive Director of Unitaid

A new coalition to accelerate access to long-acting PrEP was also announced on Thursday. Convened by the World Health Organization (WHO), Unitaid, UNAIDS and the Global Fund, and with HIV prevention advocacy group AVAC as its secretariat, the coalition will develop strategies to overcome barriers to access to new PrEP options, including price in wealthier countries.

ViiV is also collaborate with Unitaid, MedAccess and donors Children’s Investment Fund Foundation (CIFF) and the Gates Foundation, to accelerate equitable access to its product.

“New HIV prevention options now coming to market, such as the injectable cabotegravir, promise to transform HIV prevention,” said Tenu Avafia, Deputy Executive Director of Unitaid.

“But we need to act much faster than we did with oral PrEP if we are to have a real impact on the epidemic. This new coalition being formed will prioritize accelerating affordable, equitable, and widespread access to long-acting injectable cabotegravir for PrEP without delay.

AVAC Executive Director Mitchell Warren described the agreement as “a great step forward, and we commend ViiV Healthcare and MPP for agreeing to a voluntary license.”

“But this is just one step, and there is still a long way to go. All stakeholders need to step up their efforts to accelerate access to CAB for PrEP at the lowest possible price while creating a sustainable market for the generics.

Community representative Jacque Wambui of Afrocab said community partners had been encouraged to see the responsiveness and commitment of global partners.

“However, we recognize that this is only the first step on the road to long-acting cabotegravir for PrEP. Rapid technology transfer and low cost pricing have still not been assured. Until then, the promise of an accessible and affordable CAB-LA will not be realized. Afrocab and our community partners will continue to advocate around these issues until they are resolved.

New WHO guidelines, new research

The WHO has also published new guidelines for CAB-LA use on Thursday.

“Long-acting cabotegravir is a safe and highly effective HIV prevention tool, but it is not yet available outside of study settings,” said Meg Doherty, WHO director for HIV, hepatitis and sexually transmitted infections.

“We hope these new guidelines will help accelerate countries’ efforts to begin planning and providing CAB-LA alongside other HIV prevention options, including oral PrEP and the dapivirine vaginal ring.

Meanwhile, the results of a recent study who followed 3,223 women who were using PrEP – both oral pills and CAB-LA injections – were also released at the press conference.

The women, based in Botswana, Eswatini, Kenya, Malawi, South Africa, Uganda and Zimbabwe, had initially participated in a clinical trial to compare oral and injectable PrEP (CAB-LA).

The trial opened in November 2020 after proving that CAB-LA was 66% more effective than oral PrEP, but trial participants continued to use oral or injectable PrEP pending an amendment to the protocol to allow everyone to obtain open-label CAB-LA.

Within a year of unblinding, three participants using CAB-LA became infected with HIV and 20 in the group using the oral pills.

“Women in sub-Saharan Africa carry a disproportionate burden of HIV and while there have been incredible efforts to expand access to oral PrEP, many women have encountered social and structural barriers to taking the pills daily. “, said Dr. Sinead Delany-Moretlwe, the trial protocol. chair and research professor at the University of the Witwatersrand in South Africa.

The researchers also announced that the first trans-specific analysis data has confirmed that CAB-LA is a safe and highly effective HIV prevention option for trans women.

The study involved 570 transgender women, 58% of whom were using gender-affirming hormone therapy, and CAB-LA was also safe and effective for those on hormone therapy.

The agreement is “limited”

Reacting to the announcement of the authorization, Médecins sans frontières (MSF) described it as “a welcome but limited step given its restrictive geographical scope”.

“The license allows only three generic companies globally to produce and supply,” said Leena Menghaney, MSF Access Campaign Manager for South Asia. “It is disappointing that a number of developing countries with generic manufacturing capabilities in Latin America and Asia are currently excluded from this licensing agreement.”

Health GAP executive director Asia Russell said the deal was the result of pressure from activists because “just four months ago, ViiV announced it would not pursue voluntary licensing for CAB-LA to enable generic manufacturing and affordable prices for low- and middle-income countries.

“But generics won’t reach the market for years and years. ViiV now needs to reduce the price to an equivalent of the price of oral PrEP and make sufficient supply available that people can actually access it,” Russell added.

“This license is not open, does not include transfer of technology and does not include all countries where it is necessary. With the current direct and indirect territorial coverage included in this license agreement, there are still far too many people left behind, including those who will benefit the most from this scientific breakthrough. Brazil is an excluded country – when gay men and other men who have sex with men and trans women participated in clinical trials that provided the data needed to make CAB-LA a marketable product for ViiV .

Image credits: Diana Polekhina/Unsplash.

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