It can take years for generic drug manufacturers to be ready to produce a drug, and they need some understanding of the potential market before they can commit to production investments. So in the meantime, Gilead aims to ship “sufficient amounts” of lenacapavir to low-income countries as soon as it receives regulatory approval, she said.
Lenacavir and the two drugs studied are known as pre-exposure prophylaxis (PrEP). PrEP, another effective injectable drug, is available in some African countries, but its rollout 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 produced by ViiV Healthcare, a company majority-owned by pharmaceutical giant GlaxoSmithKline (GSK); the company charges $180 per patient per year for cabotegravir in developing countries, a price that is unaffordable for most people and health care in Africa. The system is out of reach.
South Africa’s current oral PrEP budget is approximately US$40 per patient per year.
Facing criticism from activists over the pricing, ViiV licensed the medicine to the Medicines Patent Pool, a U.N.-backed body that works to make medical technology more accessible, and subsequently signed contracts with three generic drugmakers. But no company is expected to launch a product before 2027.
“Gilead must develop a bold access plan, rather than countries weighing who will get it because they cannot afford to make the drug available to everyone, otherwise this amazing clinical trial will not have a positive impact on HIV,” Kamen said. virus has any impact.
The Aim 1 trial was unusual in that the participants were young, aged 16 to 25, and that it recruited pregnant and breastfeeding women, with pregnant women continuing to participate in the trial. Ms. Mworeko said that while pharmaceutical companies have historically been reluctant to test drugs in these groups, community participants insisted that the trial must include those most vulnerable to new infections, namely sexually active late adolescent girls.
Lenacapavi is also the first HIV prevention drug to have trial results in women before men; most drugs are tested on gay men in industrialized countries before they are tested on African women, who have long been the most vulnerable .
