The pharmaceutical company Gilead has announced that its new pre-exposure prophylactic (PrEP) injectable medication has passed a Phase III clinical trial demonstrating its safety and effectiveness against other current PrEP treatments. The trial found that the medication protected cisgender women from HIV in 100% of cases.
Clinicians found that the twice-yearly shot, lenacapavir, worked in all patients during the blind trials. The trial’s success led researchers to recommend that the full dose be given to all participants, including those who had previously received the standard daily oral PrEP medication.
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“Twice-yearly lenacapavir for PrEP, if approved, could provide a critical new choice for HIV prevention that fits into the lives of many people who could benefit from PrEP around the world — especially cisgender women,” said Linda-Gail Bekker, Director of the Desmond Tutu HIV Center at the University of Cape Town, in Gilead’s press release.
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“While we know traditional HIV prevention options are highly effective when taken as prescribed, twice-yearly lenacapavir for PrEP could help address the stigma and discrimination some people may face when taking or storing oral PrEP pills, as well as potentially help increase PrEP adherence and persistence given its twice-yearly dosing schedule,” Bekker added.
The trial’s findings now require replication in future tests on other populations, including on men who have sex with men (MSM), before it can be approved by the Food and Drug Administration (FDA). Gilead is expected to release results from a trial with MSM later this year.
If testing continues to go as planned, it is expected that lenacapavir will hit the market in late 2025.
Adverse side effects weren’t extremely common among the trial’s sample of 2,000 cisgender women. Around 2% reported symptoms like diarrhea, nausea, headaches, fatigue, and abdominal pain. The study was randomized and double-blinded, meaning that neither the participants nor researchers knew which women had received the new medication.
PrEP is widely regarded as one of the most effective means by which to prevent HIV. PrEP lowers the risk of getting HIV through sex by upwards of 99% and through injections by 74%, according to the Centers for Disease Control (CDC).
HIV disproportionately affects LGBTQ+ individuals, particularly LGBTQ+ people of color. According to the CDC, men who have sex with men comprise 70% of all cases, with a substantial majority of these individuals being Black or Latine men. Additionally, transgender people are at a much higher risk of the disease.
“With zero infections and 100% efficacy, twice-yearly lenacapavir has demonstrated its potential as an important new tool to help prevent HIV infections,” said Merdad Parsey, Chief Medical Officer of Gilead
“We look forward to additional results from the ongoing … clinical program and continuing toward our goal of helping to end the HIV epidemic for everyone, everywhere,” Parsey added.
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