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FDA approves injectable PrEP to reduce the risk of sexual HIV infection

Manufactured as Apretude, it will be available to at-risk adults & adolescents who weigh at least 77 pounds & have tested negative for HIV

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FDA headquarters, Silver Spring, MD (Photo Credit: U.S. government/FDA)

SILVER SPRING, Md. ā€“ The U.S. Food and Drug Administration announced Monday that the agency had approved the first injectable treatment for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.

Manufactured under the name Apretude, it will be available to at-risk adults and adolescents who weigh at least 77 pounds and have tested negative for HIV immediately beforehand the agency said in a press release.

By granting its approval, the FDA opens up the option for patients to receive the injectable drug instead of a daily HIV prevention oral medication, such as Truvada.

“Todayā€™s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,ā€Ā said Debra Birnkrant, M.D., director of the Division of Antivirals in the FDAā€™s Center for Drug Evaluation and Research.Ā ā€œThis injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option.ā€

According to the U.S. Centers for Disease Control and Prevention, notable gains have been made in increasing PrEP use for HIV prevention in the U.S. and preliminary data show that in 2020, about 25% of the 1.2 million people for whom PrEP is recommended were prescribed it, compared to only about 3% in 2015.

However, there remains significant room for improvement. PrEP requires high levels of adherence to be effective and certain high-risk individuals and groups, such as young men who have sex with men, are less likely to adhere to daily medication.

Other interpersonal factors, such as substance use disorders, depression, poverty and efforts to conceal medication also can impact adherence. It is hoped that the availability of a long-acting injectable PrEP option will increase PrEP uptake and adherence in these groups.

The safety and efficacy of Apretude to reduce the risk of acquiring HIV were evaluated in two randomized, double-blind trials that compared Apretude to Truvada, a once daily oral medication for HIV PrEP.

Trial 1 included HIV-uninfected men and transgender women who have sex with men and have high-risk behavior for HIV infection. Trial 2 included uninfected cisgender women at risk of acquiring HIV.

Participants who took Apretude started the trial with cabotegravir (oral, 30 mg tablet) and a placebo daily for up to five weeks, followed by Apretude 600mg injection at months one and two, then every two months thereafter and a daily placebo tablet.

Participants who took Truvada started the trial taking oral Truvada and placebo daily for up to five weeks, followed by oral Truvada daily and placebo intramuscular injection at months one and two and every two months thereafter.

In Trial 2, 3,224 cisgender women received either Apretude or Truvada. The trial measured the rate of HIV infections in participants who took oral cabotegravir and injections of Apretude compared to those who took Truvada orally.

The trial showed participants who took Apretude had 90% less risk of getting infected with HIV when compared to participants who took Truvada.

Apretude includes a boxed warning to not use the drug unless a negative HIV test is confirmed. It must only be prescribed to individuals confirmed to be HIV-negative immediately prior to starting the drug and before each injection to reduce the risk of developing drug resistance.

Drug-resistant HIV variants have been identified in people with undiagnosed HIV when they use Apretude for HIV PrEeP. Individuals who become infected with HIV while receiving Apretude for PrEP must transition to a complete HIV treatment regimen.

The drug labeling also includes warnings and precautions regarding hypersensitivity reactions, hepatotoxicity (liver damage) and depressive disorders.

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Health

UNAIDS to commemorate Zero Discrimination Dayā€™s 10th anniversary

UN agency urges global action to protect human rights

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A UNAIDS anti-discrimination exhibit at Tocumen International Airport in Panama in 2018. (Washington Blade photo by Michael K. Lavers)

As the world marks the 10th anniversary of Zero Discrimination Day; UNAIDS is sounding the alarm on the increasing threats to human rights, calling for renewed efforts to protect the rights of all individuals as a fundamental step towards ensuring health for everyone.

Established by UNAIDS a decade ago, Zero Discrimination Day aims to promote equality and fairness regardless of gender, age, sexuality, ethnicity or HIV status. The progress achieved over the past years is now in jeopardy, however, due to rising attacks on the rights of women, LGBTQ people and other marginalized communities.

UNAIDS Executive Director Winnie Byanyima emphasized the critical link between protecting human rights and safeguarding public health. 

“The attacks on rights are a threat to freedom and democracy and are harmful to health,ā€ she said in a press release. ā€œStigma and discrimination obstruct HIV prevention, testing, treatment and care and hold back progress towards ending AIDS by 2030. It is only by protecting everyoneā€™s rights that we can protect everyoneā€™s health.”

Despite challenges, there has been notable progress. 

At the onset of the AIDS pandemic more than 40 years ago, two-thirds of countries criminalized consensual same-sex sexual relations. They are now decriminalized in two-thirds of countries. An additional 38 countries around the world have pledged to end HIV-related stigma and discrimination, contributing to positive changes that include 50 million more girls attending school compared to 2015.

To sustain and enhance these advancements; UNAIDS urges global support for womenā€™s rights movements, LGBTQ rights, racial justice, economic justice, climate justice and peace initiatives. By standing with communities advocating for their rights, the U.N. aims to reinforce the collective effort towards a more inclusive and equitable world.

Zero Discrimination Day is observed on March 1.

Events and activities that will take place around the world throughout the month will serve as reminders of the essential lesson and call to action: Protecting everyoneā€™s health is synonymous with protecting everyoneā€™s rights.

“Through upholding rights for all, we will be able to achieve the Sustainable Development Goals and secure a safer, fairer, kinder and happier world ā€” for everyone,” said Byanyima.

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New CDC report finds transgender women at higher risk for HIV

More than 1,600 people in seven cities surveyed

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The Centers for Disease Control and Prevention in Atlanta (Photo courtesy of the CDC)

The Centers for Disease Control and Prevention issued a new study report this week that revealed that restricted by employment and housing discrimination and lack of access to needed gender-affirming healthcare for transgender women increasing the risk of contracting HIV. 

Researchers reviewed data from a 2019-2020 survey, theĀ National HIV Behavioral Surveillance Among Transgender Women, which found that the demographics of HIV/AIDS have been disproportionally high, especially among Black and Latina trans women, who had experienced employment and housing discrimination coupled with lack of access to gender-affirming healthcare.

The Jan. 25Ā Morbidity and Mortality Weekly Report was based on data studies of more than 1,600 trans women in seven major urban locales. Participants from Atlanta, Los Angeles, New Orleans, New York, Philadelphia, San Francisco and Seattle were chosen by referrals from people and community-based organizations who knew or were part of the local population of trans women.

The studyā€™s researchers noted: ā€œEmployment discrimination occurs at the overlapping nexus of poverty, homelessness, incarceration, health insurance, disability, food insecurity and survival sex work. These issues are interconnected.ā€

The study stated that trans womenā€™s inability to access quality healthcare, including gender-affirming treatment or access to PrEP, and can expose them to potential incarceration as many turn to ā€œsurvival sex workā€ and violence, which increases the risk of contracting HIV. 

The studyā€™s authorā€™s pointed out: ā€œWhen economically marginalized transgender women are refused employment, this refusal cyclically contributes to economic hardships. This analysis ā€¦demonstrates the importance of transgender women working and living with dignity and without fear of unfair treatment.ā€

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Health

A Whole New Perspective on Well-Being

The Matherā€™s team recognizes that everyoneā€™s wellness journey is completely unique to their life experiences and influences.

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The Mather is incorporating biophilic designā€”a design approach to facilitate access to nature or things that replicate natural patterns.

Itā€™s easy to spot the distinctive, elegant silhouette of The Mather, a Life Plan Community for those 62+ opening this spring in Tysons, Virginia. What is not apparent to the naked eye is The Matherā€™s unique wellness philosophy, which is literally built into the community.Ā 

The Matherā€™s team recognizes that everyoneā€™s wellness journey is completely unique to their life experiences and influences.

Nature is one of the important factors that contribute to well-being. So The Mather is incorporating biophilic designā€”a design approach to facilitate access to nature or things that replicate natural patterns. This can include interior spaces with sightlines to a garden, choosing natural wood and stone as interior materials, or incorporating fragrant flowers and plants indoors to spark memories and provide tactile opportunities such as gardening.Ā 

Residents of The Mather will be able to select from plentiful amenities, programs, and other offerings to target their personal wellness goals and preferences.

ā€œProviding biophilic design within interior settings connects residents to the natural world,ā€ says Mary Leary, CEO and President of Mather, the organization behind The Mather. ā€œResearch shows that a connection to nature provides positive benefits to mental states and overall well-being. At The Mather, biophilic design is the intersection of buildings and programs with nature in an urban setting.ā€

ā€œThe Mather is attracting a diverse group of older adults,ā€ says Mary. ā€œAs a result, we aim to incorporate wellness practices from around the world, including Wyda movement theory of the Celtic Druids, which helps people achieve harmony with nature and contentment through mindfulness.ā€ This holistic regenerative approach is similar to Qi Gong and yoga, while born in a different part of the world. Mather Institute has a special focus on mindfulness to support older adultsā€™ practice of present moment awareness, which can lead to increased overall well-being, compassion, and joy.

A very different example of a wellness offering at The Mather is the Gharieni Welnamis spa wave bed, which uses computer-controlled vibrational therapy and audio frequencies to train the brain to relax. ā€œThe bed increases mindfulness, concentration, and creativityā€”all of which support our mission of creating Ways to Age Well,SMā€ says Mary.

These and other personalized ways to wellness will ensure that residents of The Mather can choose from seemingly countless ways to focus on their well-being. In other words, the skyā€™s the limit!

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