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Community groups working in prevention, as well as experts and senior figures at international organizations fighting HIV, called on the company to ensure it will be priced so it is affordable for low- and middle-income countries (LMICs), which account for 95 percent of HIV infections.

“It is no exaggeration to call lenacapavir a game changer. It could be life-changing for some populations. We need to see it produced generically and supplied to all low- and middle-income countries to the people who need it,” said Dr. Helen Bygrave, chronic disease advisor at Medecins sans Frontiere’s (MSF) Access Campaign.

During the event, data from a trial of lenacapavir, a twice-yearly injectable, were presented. The results of the trial were announced by pharmaceutical firm Gilead last month and showed the drug offered 100% protection to more than 5,000 women in South Africa and Uganda.

Many experts and community leaders helping deliver HIV interventions who spoke to IPS described the drug as a real “game changer,” offering not just spectacular efficacy but relative ease and discretion in delivery—the latter key in combating stigma connected with HIV prevention intervention in some societies—compared to other interventions, such as oral PrEP.

But they warned there were likely to be challenges to access, with cost expected to be the main barrier.

Lenacapavir is currently approved only as a form of HIV treatment at a price of USD 42,000 per person per year.

While as a PrEP intervention it would be expected to be sold at a much lower price, an abstract presented at the conference showed that it could cost just USD 40 a year for every patient.

In a statement put out following the protests, Gilead said it was developing “a strategy to enable broad, sustainable access globally” but that it was too early to give details on pricing.

Critics claimed Gilead was not being transparent in its statement—the company talked of being committed to access pricing for high-incidence, resource-limited countries rather than specifically low- and middle-income countries—and there are fears that the price at which it is eventually made available as PrEP will be so high as to put it out of reach of the countries that are struggling most with the HIV epidemic.

“Cabotegravir, a two-month injectable form of PrEP, is currently being procured by MSF for low-income countries for USD 210 per person per year. We would not expect [the price for lenacapavir] to be higher than that, and we would hope it would be more ‘in the ballpark’ of  USD 100 per person per year,” said Bygrave.

She added that “questions have been asked of Gilead about its pricing for lenacapavir, and the company has been pretty vague in its answers.”

“Civil society needs to put continued pressure on Gilead about this issue because, without that pressure, I do not trust Gilead to do the right thing,” Bygrave, who took part in protests at the conference against Gilead’s pricing, said.

Some speakers at the conference set out a series of demands for the firm.

Winnie Byanyima, Executive Director of UNAIDS, called on Gilead to license generic manufacturers to produce it more affordably through mechanisms such as the Medicines Patent Pool (MPP), a UN-backed programme negotiating generics agreements between originators and generic pharmaceutical companies.

Others, such as keynote speaker Helen Clark, Chair of the Global Commission on Drug Policy, said such interventions must be seen as “common global goods, and ways must be found to make them accessible to all.”

“The pharmaceutical industry has been the beneficiary of much public research investment. With respect to HIV/AIDS, it has benefited from the mobilization of scientists and engaged communities who have advocated for investment in R&D and treatments. Prima facie, the notion that the companies can then make great profits from and not share the intellectual property created is wrong,” she said.

Others went even further, accusing some pharmaceutical firms of being parties to the creation of a de facto global two-tier system for medicine supply.

“Companies must share their medicines. We cannot accept an apartheid in access to medicine in which the lives of those living in the Global South are not regarded as having the same value as the lives in the North,” Archbishop Dr Thabo Makgoba, Archbishop of the Anglican Church of Cape Town and HIV advocate, said at a UNAIDS press event during the conference.

Some of those who work with key populations stressed the need to push through all necessary approvals and set lenacapavir’s price at an accessible level as quickly as possible to save lives.

“It’s great to have innovation and get important new tools in the fight against HIV. But the question is: how long will it take to get them to the people who need them? Until then, they are just a great announcement—like a beautiful picture hanging up there that you can see but cannot actually touch. We need to give communities the funding and the tools they need to do their vital work,” Anton Basenko, Chair of the Board of the International Network of People who Use Drugs (INPUD), told IPS.

The calls came as campaigners stressed the exceptional potential of lenacapavir. It is not only its astonishing efficacy, but also its relative ease and discretion of delivery, which experts are excited about.

Stigma around HIV prevention, such as oral PrEP, which involves taking daily tablets, has been identified as a major barrier to the uptake of HIV interventions in some regions.

Some HIV healthcare specialists at the conference told IPS they had seen cases of women leaving clinics with bottles of tablets and, as soon as they heard them rattling in the bottle, threw them into the bin outside the clinic because the noise would tell others they were taking the tablets and leave them open to potential discrimination, or even gender-based violence.

“The lack of oral PrEP uptake and adherence among women and girls is due to a number of factors, such as stigma and worries about being seen with a huge bottle of pills. What about if you are in a relationship and your partner sees the bottle and starts asking whether you are cheating on them or something?

“A woman could go and get a lenacapavir injection a couple of times a year and no one would have to even know and she wouldn’t have to think about taking pills every day and just get on with her life. This drug could change lives completely. I would definitely take it if it was available,” Sinetlantla Gogela, an HIV prevention advocate from Cape Town, South Africa, told IPS.

The concerns around access to lenacapavir at an affordable price for low and middle income countries come against a background of record debt levels among poor countries, which experts say could have a severe negative impact on the HIV epidemic.

A recent report from the campaign group Debt Relief International showed that more than 100 countries are struggling to service their debts, resulting in them cutting back on investment in health, education, social protection and climate change measures.

Speakers at the conference repeatedly warned these debts had to be addressed to ensure HIV programmes, whether they include lenacapavir or not, continue. Many called for immediate debt relief in countries.

“African debt needs to be restructured to let countries get hold of the medicines they need,” said Byanyima.

“Drop the debt; it is choking global south countries, denying us what we need for health. Please let us breathe,” said Makgoba.

IPS UN Bureau Report

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