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GenZStyle > Blog > Lgbtq > FDA Approves PrEP Drug Requiring Only Two Injections Per Year
Lgbtq

FDA Approves PrEP Drug Requiring Only Two Injections Per Year

GenZStyle
Last updated: June 22, 2025 12:38 am
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FDA Approves PrEP Drug Requiring Only Two Injections Per Year
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Photo: Saskekun via 123RF

The US Food and Drug Administration has approved a highly effective HIV prophylactic drug that outweighs oral drugs in halting HIV infection.

The drug Lenacapavir, developed by Gilead Sciences, is sold as Yeztugo, but requires only one injection every six months.

It functions by injectable pre-exposure prevention (PREP) by infecting immune cells with HIV and replicating it in the body.

Like other PREP drugs, if enough medication is present when a person is exposed to HIV, the virus can prevent it from colonizing and causing lifelong infections. Because lenacapavir works for a long time, only two injections per year are required.

Previous studies have found that lenacapavir is 89% more effective than oral preparation in preventing HIV infection in gay, bisexual and transgender individuals.

in Similar exams Among the cisgender women in sub-Saharan Africa, none of the participants who received Yeztugo signed up for HIV.

Injectable drugs are considered to be much more effective than oral preparation, as they eliminate the challenge of adhesion to daily tablet regimens, where the medication must be taken every day at the same time to maintain protection.

“This is the only best opportunity in HIV prevention over the past 44 years,” said Mitchell Warren, executive director of HIV Adocacy Nonprofit Group AVAC. NBC News.


Scientists hope that the drug will help accelerate the stubbornly slow reduction in HIV infection in the United States. This is a much lower percentage than other developed countries.

Among the reasons cited for that disparity include the lack of national health care systems or sexual health clinic networks, fragmented and underfunded public health systems, state laws criminalizing exposure to HIV, lack of insurance coverage, and mistrust of healthcare providers, particularly among communities of color.

“This is an incredible step forward, but science alone can’t save lives. Access does.” The NMAC said in a statement. “Without a strong HIV prevention infrastructure, long-acting preparations like Renacapaville will not reach the communities that need it most.”

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The barriers to accessing Renacapaville start with cost and are numerous and difficult. Each injection reportedly equals $14,109, or $2,352 per month.

Barriers to accessing Renacapaville are many challenges starting with costs.

Each injection reportedly costs $14,109. This means more than $28,000 a year, or about $2,350 a month when averaged.

Insurance could potentially cover the costs of the drug, but it is unclear whether the insurer would choose to do so. For example, insurance companies could cover only oral prep medicines that include cheaper and more common versions of Truvada pills, or they could impose high copey on Renacapaville, Lenacapaville, director of health care access at Harvard Law School’s Health Law and Policy Clinic.

Insurance could potentially cover the costs of the drug, but it remains unclear whether the insurance company will. Some may choose to cover only oral prep medications, such as the cheaper generic version of Truvada, or to impose a higher copey of lenacapavir. Elizabeth Kaplan told NBC News that she is director of health care access for Harvard Law School’s Health Law and Policy Clinic.

Compounding insurance coverage is a future Supreme Court decision that could break down the provisions of the Affordable Care Act, allowing insurers to require insurance companies to cover a variety of preventive health interventions or screenings for free.

Such a judgment effectively gives insurance companies a green light to raise their own out-of-pocket costs for prep. And increased out-of-pocket costs will discourage many people from pursuing treatment.

Furthermore, the Trump administration proposes Cut domestic HIV funding As part of a broader effort to reduce government spending, it closed $1.5 billion or 35% while closing centres for the HIV prevention division of disease control and prevention.

As much of the CDC’s HIV prevention and surveillance budget is distributed through grants to state and local health departments and nonprofits, such reductions could hinder efforts to educate patients and physicians about Renacapavil and to make the medication more widely available.

Yet another hurdle is the issue of adherence. Inconsistent use of PREP reduces its effectiveness Recent The survey found that less than half of oral preparation users remained compliant for more than six months. We hope that injectable renacapavil will improve compliance, but there is no scientific evidence to confirm this.

Additionally, preparation of another injectable format – Apretude, generated by VIIV Healthcare, requires patients to schedule four visits a year to receive the injection, failing to gain traction among at-risk populations, and only 21,000 people using preventive treatment.

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Another injectable form of PREP from Apretude, produced by VIIV Healthcare, requires only four clinic visits a year, but fails to gain traction among at-risk populations, with only 21,000 people taking advantage of the treatment.

Mist Torthe Telehealth Company, which focuses on providing access to preparation for at-risk populations, primarily members of the LGBTQ community, says it intends to connect users to in-person injection services. The company has lined up seven providers in historic or primarily LGBTQ districts of various cities in West Hollywood, California. Around Castro in San Francisco. Hell’s Kitchen District in New York. Wilton Manor, Florida. Northernalstead district of Chicago. Oak Lawn District, Dallas. Las Vegas – Manage your shots.

Misttr, a Telehealth Company focused on providing preparedness access to at-risk populations, including the LGBTQ community, says it will connect users to in-person injection services.

The company has lined up seven providers in West Hollywood, California, historic or primarily LGBTQ districts. Castro in San Francisco. Hell’s Kitchen in New York. Wilton Manor, Florida. Northstead, Chicago. Oak Lawn in Dallas; Las Vegas – Manage shots.

MISTR plans to connect patients outside these hubs with a network of providers who can manage injections regardless of insurance situation.

“The Renacapaville is a true game-changer in HIV prevention,” said Tristan Schukraft, CEO of Misttr, in a statement. “It’s just two injections a year. That’s it. It’s modest and effective, and ultimately makes long-term preparation adherence simple and practical for more people.”

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Source: Metro Weekly – www.metroweekly.com

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