It can take years before generic drug makers are ready to produce a drug, and they need to have an idea 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 wins regulatory approval, he said.
Lenacapavir and the two pills studied are all known as pre-exposure prophylaxis, or PrEP, drugs. Another effective injectable PrEP drug is available in some African countries, but its introduction has been plagued by access problems. Long-acting cabotegravir, which is given by injection every two months, has also shown excellent results in clinical trials in Africa. It is produced by ViiV Healthcare, majority-owned by pharmaceutical giant GSK; the company charges $180 per patient per year for cabotegravir in developing countries, a price beyond the reach of most people and health systems in Africa.
South Africa's current budget for oral PrEP is approximately $40 per patient per year.
Facing criticism from pricing activists, ViiV granted a license to the Medicines Patent Pool, a United Nations-backed agency that seeks to make medical technologies more accessible, and which subsequently contracted with three generic drug makers. But none are expected to have a product available before 2027.
“Gilead must have a bold access plan – not countries vetting who will receive it because they can't afford to give it to everyone – otherwise this extraordinary clinical trial will not result in any impact on HIV,” said Carmen Peréz Casas, who works on access to technologies to fight the virus 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 years old, and because it enrolled pregnant and breastfeeding women and kept women who became pregnant in the study. Although pharmaceutical companies have historically been reluctant to test drugs in these groups, Mworeko said community participants were adamant that this study should include those who are most at risk of new infections, namely late adolescent girls who sexually active.
Lenacapavir is also the first HIV prevention drug for which study results became available for women before men; most are tested on gay men in industrialized countries before the tests reach African women, who have long been the most vulnerable population.