It can take years for generic drugmakers to be ready to produce a drug, and they need to understand the potential market before they can commit to investing in production. So in the meantime, she said, Gilead aims to ship “sufficient quantities” of lenacaprevir to low-income countries as soon as it wins regulatory approval.
Lenacaprevir and the two pills studied are known as pre-exposure prophylaxis, or PrEP. Another effective injectable PrEP drug is available in some African countries, but its rollout has been plagued by access issues. Long-acting cabotegravir, injected every two months, has also shown excellent results in clinical trials in Africa. It is made by ViiV Healthcare, which is majority-owned by pharmaceutical giant GlaxoSmithKline; the company charges $180 per patient per year for cabotegravir in developing countries, a price that is unaffordable for most people and health systems in Africa.
South Africa’s current budget for oral PrEP is approximately US$ 40 per patient per year.
Facing criticism from activists over pricingViiV issued a license to the Medicines Patent Pool, a United Nations-backed group that aims to make medical technology more accessible, which then signed contracts with three generic drugmakers. But none is expected to launch a product before 2027.
“Gilead must have a bold access plan, rather than letting countries weigh in on who gets this drug because they can’t afford to give it to everyone, or else this amazing clinical trial will have no impact on HIV,” said Carmen Peréz Casas, who leads access to technologies to fight the virus at the global health initiative Unitaid.
The Purpose 1 trial was unusual in that its participants were very young, between 16 and 25 years old, and that it recruited pregnant and breastfeeding women, who would remain 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 insisted that the trial include those most at risk of contracting the new virus — sexually active late adolescent girls.
Renalinavir is also the first HIV prevention drug to publish results in women before men; most drugs are tested on gay men in industrialized countries before being tested on African women, who have long been the most vulnerable population.
