Merck's Once-Monthly Oral PrEP Pill MK-8527 Enters Phase 3 Trial, Enrolling High-Risk Populations in Newark
核心洞察
Merck (搜索) has launched EXPrESSIVE-011, a Phase 3 randomized, double-blind clinical trial evaluating MK-8527, a once-monthly oral pill for HIV-1 (搜索) pre-exposure prophylaxis (PrEP).
The study is enrolling cisgender men who have sex with men, transgender women, trans men, and gender non-binary individuals aged 16 and older in Essex and Hudson counties, New Jersey.
MK-8527 represents a novel drug class and, if approved, would be the first once-monthly oral PrEP option, potentially improving adherence and expanding access in underserved communities.
Merck (搜索) has initiated a Phase 3 clinical trial evaluating MK-8527, an investigational once-monthly oral pill for HIV-1 (搜索) pre-exposure prophylaxis (PrEP), with enrollment now underway in Newark, New Jersey. The study, known as EXPrESSIVE-011, is a randomized, active-controlled, double-blind trial designed to assess both the efficacy and safety of this novel agent. Dr. Shobha Swaminathan, a physician at Rutgers New Jersey Medical School, serves as the principal trial investigator.
The trial represents a potential expansion of the PrEP landscape, which has been dominated by daily oral regimens and, more recently, injectable formulations administered every two months. MK-8527 belongs to a new class of drugs and, if approved, would be the first once-monthly oral option available for HIV prevention.
Addressing Gaps in PrEP Uptake
Despite the availability of FDA-approved PrEP medications for 14 years, uptake has remained "woefully limited," according to Swaminathan. "It's not reaching the people who could benefit. And there's a multitude of reasons for that. And among those is choice. We have limited options available for people who want to take something to protect themselves from HIV apart from complete abstinence or barrier protection, which aren't always practical," she said.
National data underscore the magnitude of the gap. In 2022, only 36% of the estimated 1.2 million Americans who could benefit from PrEP were taking any form of it. The once-monthly dosing schedule of MK-8527 may address adherence barriers associated with daily pills and logistical challenges tied to clinic-based injections.
Targeted Enrollment in High-Burden Communities
The EXPrESSIVE-011 study is specifically recruiting individuals who self-identify as cisgender men who have sex with men, transgender women, trans men, and gender non-binary individuals. "Most of the new infections of HIV in New Jersey are in Essex and Hudson counties. A much higher proportion self-identify as minority, about 35% black and about 50% Hispanic. We are hoping that we can provide this option to them, but not just for them, but definitely make sure that we include them," Swaminathan stated.
Eligibility criteria require participants to be 16 years or older, HIV-negative, assigned male at birth or identifying as a transgender man or gender non-binary, and to have had receptive anal sex without a condom in the past year. Additional criteria include having had receptive anal sex with two or more partners in the last three months, rectal or urethral infections such as gonorrhea, chlamydia, or syphilis in the last six months, or use of stimulant drugs during sex in the last three months.
The Broader Context of PrEP Decision-Making
The trial arrives amid growing recognition that expanding PrEP options and reducing stigma are critical to improving uptake. A separate pilot study published in PLOS Global Public Health, led by researchers now at the Rutgers School of Public Health, found that a two-page decision aid comparing daily oral PrEP with the injectable formulation helped patients choose without feeling judged. Notably, the tool carried no risk assessment, which participants said made them feel they did not have to justify their interest in PrEP.
"We need to move away from the stigma associated with conversations about HIV," Swaminathan emphasized. "It really needs to be addressed like other public health issues. We have to normalize those conversations, so it's OK to talk about, and OK to talk about PrEP."
Trial Information
Individuals interested in participating in EXPrESSIVE-011 can find more information at merckclinicaltrials.com. The study continues to enroll eligible residents in the Newark region for a limited time. Better health outcomes, experts note, come with expanded choices, and adherence to prevention protocols increases when regimens are easier to follow.