British drugmaker GSK has decided to allow low-cost generic versions of its long-acting HIV preventive drug to be used in the developing world, including sub-Saharan Africa, where the virus remains one of the leading causes of death.
According to reports, there are approximately 1.5 million new cases of HIV worldwide every year and a majority of them occur in countries with limited resources and disproportionately affect women and adolescent girls.
The deal involves GSK issuing a voluntary license, so the intellectual property doesn’t get in the way, to the United Nations-backed healthcare organization, the Medicines Patent Pool (MPP), according to a report by news agency Reuters.
Following this, the MPP offers generic manufacturers the opportunity to apply to make copycat versions of the injected drug, cabotegravir, for the 90 countries that accounted for 70 percent of all new HIV cases in 2020.
Although Pre-exposure prophylaxis (PrEP) is an effective way for an at-risk HIV-negative person to reduce the risk of infection, until recently, PrEP was only available in pill form, taken daily, or, in some cases, before and after sex.
GSK’s product is the first pill-free option, offering up to two months of protection against infection through a single intramuscular injection, and studies show it even outperforms oral pills. It gained US approval late last year, and on Thursday the World Health Organization also endorsed its use to help accelerate efforts to make injectable cabotegravir part of the arsenal of global HIV prevention tools. .
Campaigners have called for the drug to be made available as quickly, widely and cheaply as possible, fearing a repeat of the 1990s and early 2000s when poor countries had no access to HIV therapy. during years.
For that, the regulators of each country must authorize the use of injectable cabotegravir. Generic manufacturers must also meet required MPP and regulatory standards. Given these factors, the first generics will potentially only be available in 2026, said Deborah Waterhouse, head of GSK’s HIV division, ViiV Healthcare, as quoted by Reuters.
In the meantime, GSK is working to provide governments with a free regime to conduct studies to understand how best to implement the product. A six-dose regimen of injectable cabotegravir sells for $22,000 a year in the United States, the same as the US price of Gilead’s oral PrEP regimen, Descovy, Waterhouse, said.
After those studies are done, an annual course of injectable cabotegravir will cost governments “hundreds of dollars” per person, rather than thousands, Waterhouse said. That price includes the costs of ingredients, labor and electricity, he added, “no profit is made.”
With regulatory approvals and implementation studies yet to be read, it will likely take up to two years before a substantial order is placed, he said.
If the ‘non-profit’ price is hundreds of dollars a year, it is unlikely that the governments of the poorest countries and health financing bodies such as the Global Fund will be able to afford it, said UNAIDS Deputy Executive Director, Matthew Kavanagh as quoted by Reuters. But if it’s below $100 and closer to $60, then it could be a game changer, he added.
(With inputs from Reuters)