(Bloomberg) -- Gilead Sciences Inc.’s twice-yearly HIV prevention shot prevented almost all HIV cases in a large trial in men and transgender people, a result that will allow the company to file for approval by end of this year.
Just two of 2180 people who received the company’s drug, lenacapavir, contracted HIV in the trial, 96% lower than the background incidence of HIV in the group, the company said Thursday in a statement. In the trial, the twice yearly shot also proved superior to its HIV prevention pill Truvada, Gilead said.
It’s the second successful trial of the drug this year, and the results are likely to lead to a powerful new prevention option. In June, Gilead said that a trial of the same shot in women and adolescent girls in Africa had prevented 100% of HIV cases.
Armed with the new results, Gilead said it would move quickly to file for global regulatory approvals of the shot by the end of this year, and that initial launches of the product could occur in 2025. The company is certain to face pressure to get the shot at an affordable price to lower- and middle-income countries in need.
The company’s shares rose 2% at the New York market open.
In its filings, Gilead “will prioritize high-incidence, low-resource countries, which are primarily low- and lower-middle income countries,” the company said in a statement. It said it is “actively working to finalize” voluntary licensing contracts, that would allow generic drug makers to produce low-cost versions of the shot.
The new trial included 3200 cisgender men and transgender people in the US and other countries around the world. They were assigned to either get the shot or Gilead’s Truvada pill for prevention. Those on the shot had a 89% lower incidence of HIV than those who took pills, Gilead said. Since it was viewed as unethical to give people a placebo, the primary goal of the trial was to compare the HIV rate in those on the shot to the background rate of HIV in that population, resulting in the 96% reduction figure.
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