United States: Two yearly regimens of an antiretroviral drug developed by Gilead Sciences Inc. were 100 percent effective in preventing HIV infections in a late-stage clinical trial, Gilead said Thursday.
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Of the around 2000 women in the trial who received the lenacapavir shot, none of them converted to HIV during the interim analysis; hence, the independent data monitoring committee has advised Gilead to unblind phase 3 treatment control arm of HIV and offer treatment to everyone in the study.
Some participants had been taking perhaps standard daily pills.
The outcomes are beneficial in principle to Gilead as they work towards bringing a new type of pre-exposure prophylaxis (PrEP) closer to the market and expanding its HIV segment. The company’s stocks increased about 7 percent on Thursday.
What more have the experts stated?
Jared Baeten, Gilead’s vice president of clinical development for HIV, said, “What the world needs is people to have more PrEP options so they can make the choice of the option that’s going to work best for them,” as CNBC reported.
Even in the case where Gilead replicates these results, they will first need to clear the Food and Drug Administration (FDA).
The company has recently a Phase 3 clinical trial in men who have sex with men, which is anticipated to report data in Q4 this year or early next year. Should those outcomes be favorable, the firm may launch lenacapavir for PrEP by the end of 2025.
Truvada is a PrEP prescribed to people without HIV and at high risk of contracting HIV, and it is a product of Gilead that was approved over a decade ago. Most pills are taken daily, and manufacturers are shifting their efforts to designing vaccinations with long-lasting injections.
In terms of reduction of the risk of acquiring HIV, PrEP reduces the risk of acquiring it through sexual practices by 99 percent and through sharing of injection equipment by 74 percent if taken as prescribed.
For instance, a recent CDC report shows that while people in the US who could benefit from it are on PrEP, only slightly more than one-third are using it.
Health policymakers and advocates hope that there might be a possibility for the longer-acting drugs to target individuals who do not have the option or will of taking a daily pill as well as stop the spread of a virus which contributes to about 1 million new infections globally in 2022.
According to Bruce Richman, founding executive director of the nonprofit Prevention Access Campaign, “It’s really important to have more options than daily pills because the orals aren’t going to get us to the end of the epidemic,” as CNBC reported.
“We need to make sure that people have options to fit with their lifestyles,” he continued.
The FDA approved the first injectable PrEP in 2021. That drug, Apretude, is administered by a medical expert, and these doses are given six times a year or every other month. Its manufacturer, ViiV, reported that there are close to 11,000 individuals who are being administered Apretude.