Green light in Europe for HIV prevention injection

An injectable antiviral that prevents HIV infection with just two shots per year has received a positive recommendation from the European Medicines Agency (EMA), just weeks after its approval in the United States.

The drug, developed by Gilead Sciences, was hailed as a milestone by UNAIDS, the UN’s HIV/AIDS program, due to its potential to curb a pandemic that has persisted for 44 years.

Unlike daily oral PrEP (pre-exposure prophylaxis) pills, lenacapavir is easier to administer, which could be a significant advantage for rollout in developing countries—provided the cost drops in the coming years.

Named “Breakthrough of the Year” in 2024 by the journal Science, the injection showed nearly 100% effectiveness in clinical trials in preventing HIV infection.

Lenacapavir belongs to a new class of drugs called capsid inhibitors, which bind to the virus’s protein shell and block its replication. It is already approved in the US and EU for treating people with multi-drug-resistant HIV.

Following the EMA’s favorable opinion for its use as preventive therapy, the final approval now rests with the European Commission, which almost always aligns with the EMA’s recommendations. According to Gilead, the Commission’s decision is expected later this year.

Access in low-income countries is key

The most critical factor in curbing the global epidemic will be the drug’s availability in low- and middle-income countries, where most of the world’s 1.3 million new HIV cases annually occur.

Gilead has granted licenses to six generic drug manufacturers to produce and distribute lenacapavir in 120 low-income countries. Until generics become available, Gilead says it will provide the drug at no profit in the poorest nations.

Still, UNAIDS has criticized the company’s pricing strategy, citing a recent Lancet HIV study showing that the annual cost per patient could be reduced to just $25.

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