According to Melissa Barber of the Yale Collaboration for Regulatory Rigor, Integrity and Transparency, certain countries most likely to benefit from broad, rapid access to lenacapavir were shut out by the licensing deal, countries where H.I.V. is spreading among marginalized groups such as migrants, sex workers and injecting drug users who would likely be addressed via the public health system.
The people in need are those out of reach of the health systems, which makes them hard to reach-that’s the central problem facing the pandemic Mitchell Warren, executive director of the HIV prevention organization AVAC, commented that it was deeply disappointing to learn that Brazil, Peru, Mexico, and Argentina were excluded from the generics deal, The clinical trials that established the drug’s effectiveness were performed in those countries, Gilead has indicated it will provide lenacapavir to the trial participants until it becomes available in their respective countries.
8,000 people in a dozen countries participated in these two trials, but did not do so alone, instead they did so alongside their communities, says Mr. Warren Trial sites were chosen on the basis of where the epidemics of HIV were most serious.
The voluntary licence has an odd clause that says that the generics makers cannot sell a pill to any country not mentioned in the pact — so, for instance, although developing world power house Brazil will be able to manufacture a cheaper version of the drug, it will not be able to purchase it from a rising economic power house India.
Lenacapavir has been patented in Brazil by Gilead. However, under even the most basic trade regimes nations possess the ability to make what are known as compulsory licenses, which effectively trump any sort of IP rights. But even if Brazil decided to grant a license for lenacapavir, the generics makers would be barred from supplying the Brazilian health system. While the Pan American Health Organization purchase drugs in volume for Latin American countries in an effort to reduce the costs, the Gilead patent also locks Brazil out of that route to a cheaper form of the medication.
Brazil has not benefited from any other drug licensing strategies seen in the past few years He continues by saying ‘’The cost is borne by 25 per cent of Brazilians who live below the poverty line.’ ‘ That is not so sensible for us to give to people new forms of medicine, she said.
We are a very large nation with a public health system and with great inequality and many at risk such as those with H.I.V. A spokeswoman for Gilead said that the firm was considering a number of strategies to assure access, including volume-based pricing to make the drug affordable as PrEP in Latin America. Ms. van der Ploeg said that she thought the company would give a price much lower than the current US price, though much higher than what the Brazilian public health system can afford.
At the end of June, a data review compelled Gilead to terminate the trial of lenacapavir early, revealing a baffling, 100 percent efficacy. Out of the 5,300 cisgender women aged 16 to 25 that participated in the study across Uganda and South Africa, none in the vaccinated arm had a diagnosis of H.I.V.
A second trial of the preparation, involving gay men and trans and non-binary folk aged 16 and over, returned similarly astounding results: In September, Gilead announced that among 3,200 trial participants in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States, there were just two H.I.V. infections among those who got the shots.
“It’s highly unusual to sign these agreements so quickly for a new potentially transformative product like lenacapavir before any global regulatory submission for PrEP, much less approval, in H.I.V.,” she added. “It’s a clear symbol of our pledge to end the epidemic for every person, everywhere.”
Generic versions could start to trickle out by late 2027, Mr. Warren said. In theory, a competitive frenzy would then drive down prices, with six different groups vying for large orders.
Until then, the company will provide lenacapavir. Before the year ends, Gilead said it will fill in regulators for approval of the drug. They also promised to continue supplying it at a “no profit” price to the countries that signed the voluntary license until it was clear that the generic companies could operate effectively and also obtain regulatory approval for their generic formulations. Gilead remained vague on business specifics like price and eventual volume to be supplied.
Reference
New York Times, “Gilead Agrees to Allow Generic Version of Groundbreaking H.I.V. Shot in Poor Countries” https://nytimes.com/2024/10/02/health/lenacapavir-hiv-shot-prep.html
