Generic manufacturers can take years to get ready to produce a drug and must have a sense of the potential market in order to commit to investing in production. So, in the meantime, Gilead will seek to ship “adequate volumes” of lencapavir to low-income countries once it gets regulatory approval, he said.
Lencapavir and the two pills studied are both known as pre-exposure prophylaxis medications, or PrEP. Another effective injectable drug, PrEP, is available in some African countries, but its uptake has been stymied by questions of access. Long-acting cabotegravir, which is given as an injection every two months, has also shown excellent results in clinical trials in Africa. It is manufactured by ViiV Healthcare, which is 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 people and health systems in Africa.
South Africa’s current budget for oral PrEP is approximately $40 per patient per year.
Facing criticism from activists over the pricing, ViiV licensed it to the Medicines Patent Pool, a United Nations-backed agency that tries to make medical technologies more affordable, which then contracted with three generic makers. But none are expected to have a product available before 2027.
“Gilead needs to have a bold access plan — not countries weighing who gets it because they can’t afford to give it to everyone — or this amazing clinical trial won’t translate into 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 trial is unusual for the young age of the participants, who were between 16 and 25 years, and for the fact that it enrolled pregnant and lactating women and kept women in the trial if they became pregnant. While pharmaceutical companies have historically been reluctant to test drugs in these groups, Ms Mworeko said community participants were adamant that this trial should include those most at risk of new infection – namely, sexually active girls in their late teens.
Lencapavir is also the first HIV prevention drug for which trial results have become available for women before men. Most are tested on gay men in industrialized countries before testing reaches African women, who have long been the most vulnerable population.
