It can take years for generic drug makers to prepare to produce a drug, and they need to have an idea of the potential market before committing to investing in production. So in the meantime, Gilead will work to ship “sufficient volumes” of lenacapavir to low-income countries as soon as it gains regulatory approval, she 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 rollout has been hampered by access issues. Long-acting cabotegravir, administered as an injection every two months, has also shown excellent results in clinical trials in Africa. It is manufactured by ViiV Healthcare, majority owned by pharmaceutical giant GSK; the company charges $180 per patient per year for cabotegravir in developing countries, a price out of reach for most populations and health systems in Africa.
South Africa’s current budget for oral PrEP is approximately $40 per patient per year.
Faced with criticism from activists on prices, ViiV licensed it to the Medicines Patent Pool, a United Nations-backed agency that attempts to make medical technologies more accessible, and which subsequently contracted with three generic manufacturers. But no product should be available before 2027.
“Gilead must have a bold access plan – not countries determining who gets it because they can’t afford to give it to everyone – otherwise this incredible clinical trial will have no impact on the HIV,” Carmen said. Peréz Casas, who works on access to technologies to fight the virus as part of the global health initiative Unitaid.
The Aim 1 trial is unusual because of the young age of the participants, who were between 16 and 25, and because it recruited pregnant and breastfeeding women and kept the women in the trial if they became pregnant. While pharmaceutical companies have historically been reluctant to test drugs in these groups, Mworeko said community participants were adamant that this trial should include those most at risk of further infection, namely sexually active adolescent girls.
Lenacapavir is also the first HIV prevention drug for which trial results are now available for women before men; most are tested on gay men in industrialized countries before trials reach African women, who have long been the most vulnerable population.
