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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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Commentary

Journalists are not the enemy

Wednesday marks five years since Blade reporter detained in Cuba

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The Hungarian Parliament in Budapest, Hungary, on April 4, 2024. Prime Minister Viktor OrbƔn and his government over the last decade has cracked down on the country's independent media. (Washington Blade photo by Michael K. Lavers)

Wednesday marked five years since the Cuban government detained me at Havana’s JosĆ© Marti International Airport.

I had tried to enter the country in order to continue the Washington Blade’s coverage of LGBTQ and intersex Cubans. I found myself instead unable to leave the customs hall until an airport employee escorted me onto an American Airlines flight back to Miami.

This unfortunate encounter with the Cuban regime made national news. The State Department also noted it in its 2020 human rights report.

Press freedom and a journalist’s ability to do their job without persecution have always been important to me. They became even more personal to me on May 8, 2019, when the Cuban government for whatever reason decided not to allow me into the country.  

Washington Blade International News Editor Michael K. Lavers after the Cuban government detained him at Havana’s JosĆ© Marti International Airport on May 8, 2019. (Washington Blade photo by Michael K. Lavers)

‘A free press matters now more than ever’

Journalists in the U.S. and around the world on May 3 marked World Press Freedom Day.

Reporters without Borders in its 2024 World Press Freedom Index notes that in Cuba “arrests, arbitrary detentions, threats of imprisonment, persecution and harassment, illegal raids on homes, confiscation, and destruction of equipment ā€” all this awaits journalists who do not toe the Cuban Communist Party line.” 

“The authorities also control foreign journalistsā€™ coverage by granting accreditation selectively, and by expelling those considered ‘too negative’ about the government,” adds Reporters without Borders.

Cuba is certainly not the only country in which journalists face persecution or even death while doing their jobs.

ā€¢ Reporters without Borders notes “more than 100 Palestinian reporters have been killed by the Israel Defense Forces, including at least 22 in the course of their work” in the Gaza Strip since Hamas launched its surprise attack against Israel on Oct. 7, 2023. Media groups have also criticized the Israeli government’s decision earlier this month to close Al Jazeera’s offices in the country.

ā€¢ Wall Street Journal reporter Evan Gershkovich, Washington Post contributor and Russian opposition figure Vladimir Kara-Murza and Radio Free Europe/Radio Liberty’s Alsu Kurmasheva remain in Russian custody. Austin Tice, a freelance journalist who contributes to the Post, was kidnapped in Syria in August 2012.

ā€¢ Reporters without Borders indicates nearly 150 journalists have been murdered in Mexico since 2000, and 28 others have disappeared.

The Nahal Oz border crossing between Israel and the Gaza Strip on Nov. 21, 2016. Reporters without Borders notes the Israel Defense Forces have killed more than 100 Palestinian reporters in the enclave since Hamas launched its surprise attack against Israel on Oct. 7, 2023. (Washington Blade photo by Michael K. Lavers)

Secretary of State Antony Blinken in his World Press Freedom Day notes more journalists were killed in 2023 “than in any year in recent memory.”

“Authoritarian governments and non-state actors continue to use disinformation and propaganda to undermine social discourse and impede journalistsā€™ efforts to inform the public, hold governments accountable, and bring the truth to light,” he said. “Governments that fear truthful reporting have proved willing to target individual journalists, including through the misuse of commercial spyware and other surveillance technologies.”

U.S. Agency for International Development Administrator Samantha Power, who is a former journalist, in her World Press Freedom Day statement noted journalists “are more essential than ever to safeguarding democratic values.” 

“From those employed by international media organizations to those working for local newspapers, courageous journalists all over the world help shine a light on corruption, encourage civic engagement, and hold governments accountable,” she said.

President Joe Biden echoed these points when he spoke at the White House Correspondents’ Association Dinner here in D.C. on April. 27.

“There are some who call you the ‘enemy of the people,'” he said. “Thatā€™s wrong, and itā€™s dangerous. You literally risk your lives doing your job.”

I wrote in last year’sĀ World Press Freedom Day op-edĀ that the “rhetoric ā€” ‘fake news’ and journalists are the ‘enemy of the people’ ā€”Ā thatĀ the previous president and his followers continue to use in order to advance an agenda based on transphobia, homophobia, misogyny, islamophobia, and white supremacyĀ has placed American journalists at increased risk.” I also wrote the “current reality in which we media professionals are working should not be the case in a country that has enshrined a free press in its constitution.”

“A free press matters now more than ever,” I concluded.

That sentiment is even more important today.

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Health

MISTR announces itā€™s now prescribing DoxyPE

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MISTR, the telemedicine provider that offers free online PrEP and long-term HIV care in all 50 states, D.C., and Puerto Rico, announced it is now prescribing Doxycycline Post-Exposure Prophylaxis (DoxyPEP), an antibiotic that reduces bacterial STIs, including gonorrhea, chlamydia, and syphilis. Patients can now use MISTRā€™s telehealth platform to receive DoxyPEP online for free, according to a release from the company.

With this launch, MISTR plans to offer patients access to post-exposure care, in addition to its existing preventive and long-term HIV treatment options, which include PrEP and antiretroviral therapy (ART). This comes at a time when the rate of STIs continue to rise. In 2022, more than 2.5 million cases of syphilis, gonorrhea, and chlamydia were reported in the U.S; of that population, gay and bisexual men are disproportionately affected, the company reported.

ā€œDespite an ongoing STI epidemic affecting the LGBTQ+ community, there are few resources available for this underserved, vulnerable community to get the preventative medication they need,ā€ said Tristan Schukraft, CEO and founder of MISTR. ā€œIā€™m proud that MISTR is democratizing access to PrEP, HIV care, and now DoxyPEP.ā€

An NIH-funded study published by the New England Journal of Medicine in April 2023 found that doxycycline as post-exposure prophylaxis, now known as DoxyPEP, reduced syphilis by 87%, chlamydia by 88%, and gonorrhea by 55% in individuals taking HIV PrEP, and reduced syphilis by 77%, chlamydia by 74% and gonorrhea by 57% in people living with HIV. 

MISTR is a telemedicine platform offering free online access to pre-exposure prophylaxis (PrEP) and long-term HIV care Visit mistr.com for more information.

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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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