The Global Fund to Fight AIDS, Tuberculosis and Malaria will work with Gilead and other private backers to ensure the HIV preventive Yeztugo, approved last month by the FDA, is available in low- and middle-income countries, concurrent with high-income nations.
Gilead has reached an agreement with the international non-profit the Global Fund to Fight AIDS, Tuberculosis and Malaria to make its twice-yearly HIV pre-exposure prophylactic Yeztugo accessible to low- and middle-income countries.
The partnership marks “the first time in history” that a preventive HIV medicine will become available in low- and middle-income countries “at the same time as in high-income countries,” according to a Wednesday release from the Global Fund. The non-profit will select beneficiary countries based on HIV epidemiology, prevention programs already in place, as well as the availability of local resources.
Some countries, especially those in the sub-Saharan region and those with high HIV incidence rates, have already registered “strong interest” in the Fund’s program, according to Wednesday’s release.
As for price, it is not clear if Gilead has agreed to provide Yeztugo to the Global Fund at a discount. Instead, the non-profit is leaning on private-sector funders, alongside support from global philanthropic organization the Children’s Investment Fund Foundation, to make the introduction and roll-out of Yeztugo “more affordable for the countries and communities” that will receive the drug.
BioSpace has reached out to Gilead for more information regarding its participation in the Fund’s program.
The FDA approved Yeztugo, a twice-yearly injection that works to prevent HIV infection, last month. Analysts see the approval as a big win for Gilead, with Mizuho analysts at the time telling investors that Yeztugo “has the potential to ‘redefine’ the PrEP market.” In Phase III studies, Yeztugo showed a 96% to 100% prevention efficacy in different patient populations.
In a June 25 analysis, GlobalData Infectious Disease Analyst Anaelle Tannen called Yeztugo’s approval “a momentous step in improving PrEP options” for HIV, particularly in vulnerable populations. Still, key opinion leaders told the analytics firm that Yeztugo’s price tag could hinder its uptake.
Gilead has priced each dose of Yeztugo at $14,109, meaning the shot will cost $28,218 for a year’s worth of protection. This comes slightly above the price tag for GSK and ViiV Healthcare’s Apretude, another long-acting PrEP that provides two-month protection, which costs $4,125.85 per dose, equaling around $24,000 per year.
According to GlobalData, insurance companies could refuse to cover Yeztugo, given that other PrEP options, particularly daily oral pills that need refilling every 3 months, are not only more widely available but also “much less expensive.”
