It can take years for generic drug makers to get a drug ready to manufacture, and they need to know potential markets before they can commit to manufacturing investments, so in the meantime, Gilead aims to ship “sufficient quantities” of lenacapavir to low-income countries as soon as it gets regulatory approval, she said.
Both lenacapavir and the two tablets studied are known as pre-exposure prophylaxis (PrEP). Another effective injectable PrEP drug is available in African countries, but its implementation has been hampered by access issues. Long-acting cabotegravir, administered as an injection every two months, has also shown good results in clinical trials in Africa. The drug is manufactured by ViiV Healthcare, majority-owned by pharmaceutical giant GSK, which sells cabotegravir in developing countries for $180 per patient per year, a price that is 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.
ViiV has faced criticism from activists over pricing, licensed it to the Medicines Patent Pool, a United Nations-backed organization that aims to make medical technologies more accessible, and has since struck deals with three generic drug makers, though none are expected to have a product on the market by 2027.
“Gilead needs to come up with a bold vaccine delivery plan, instead of letting countries decide who gets the vaccine because they can’t afford it for everyone. Otherwise this exciting trial will have no impact on the HIV response,” said Carmen Pérez Casas, who works on access to technologies to fight HIV at the global health initiative UnitAid.
The Objective 1 trial is unusual in that participants are young, between the ages of 16 and 25, and it will also enroll pregnant and breastfeeding women, continuing the trial if they become pregnant. Drug companies have previously been reluctant to test drugs in such groups, but Mwoleko says community participants insisted that the trial must include those most at risk of new infections: sexually active late adolescent girls.
Lenacapavir is also the first HIV-prevention drug to have clinical trial results published in women before men. Most trials have been conducted in gay men in developed countries before expanding to women in Africa, long considered the most vulnerable population.
