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It can take years for generic drugmakers to be ready to produce a drug, and they need to have a sense of the potential market to commit to investing in production. So in the meantime, Gilead will aim to ship “sufficient volumes” of lenacapavir to low-income countries as soon as it gets regulatory approval, he said.
Lenacapavir and the two pills studied are all known as pre-exposure prophylaxis drugs, or PrEP. Another effective injectable PrEP drug is available in some African countries, but its introduction has been plagued by access issues. Long-acting cabotegravir, which is injected every two months, has also shown excellent results in clinical trials in Africa. It is made by ViiV Healthcare, majority-owned by pharmaceutical giant GSK; the company charges $180 per patient per year for cabotegravir in developing countries, a price that is out of reach for most people and healthcare systems in Africa.
South Africa’s current budget for oral PrEP is approximately $40 per patient per year.
Facing criticism from price activists, ViiV licensed it to the Medicines Patent Pool, a United Nations-backed agency that seeks to make medical technologies more accessible, and subsequently signed deals with three generic drugmakers. But none are expected to have a product available until 2027.
“Gilead needs to have a bold access plan, not countries checking who gets it because they can’t afford to give it to everyone, or this amazing clinical trial will have no impact on HIV,” said Carmen Peréz Casas, who works on access to HIV technologies at the global health initiative Unitaid.
The Aim 1 study is unusual because of the young age of the participants, who were between 16 and 25, and because it enrolled pregnant and breastfeeding women and kept women who became pregnant in the study. Although drug companies have historically been reluctant to test drugs in these groups, Mworeko said community participants were adamant that this study should include those most at risk for new infections, namely late adolescent girls who are sexually active.
Lenacapavir is also the first HIV prevention drug whose trial results have been made available to women before men; most are being tested on gay men in industrialized countries before trials reach African women, who have long been the most vulnerable population.
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