WASHINGTON — U.S. pharmaceutical giant Merck (known as MSD outside the U.S. and Canada) has announced a multi-faceted global access strategy for its investigational, once-monthly oral HIV prevention pill, alimatravir (MK-8527). The drug is currently undergoing two large-scale clinical trials—EXPrESSIVE-10 and EXPrESSIVE-11—to study its safety and efficacy in high-exposure demographics across 16 countries, particularly focusing on adolescent girls and women in sub-Saharan Africa. Early research indicates that alimatravir becomes effective within just one hour of consumption and provides a full month of protection. It also features a “cushion of forgiveness,” meaning drug levels remain high enough to prevent infection even if a dose is delayed by a week.
In an unprecedented move for a drug still in clinical development, Merck has already signed royalty-free licensing agreements with seven generic manufacturers across India and sub-Saharan Africa to mass-produce and distribute the pill in 129 low- and lower-middle-income countries (LMICs). With global HIV cases reaching an estimated 40.9 million, more than half of which are concentrated in sub-Saharan Africa, this strategy marks the first time African manufacturers have been integrated into production rights from the absolute beginning. While final trial results are anticipated in the second half of next year, Merck is scaling up its production capacity immediately to ensure generic equivalents can hit the market rapidly upon regulatory approval.
