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New twice-a-year HIV prevention drug found highly effective

Gilead announces 99.9% of participants in trial were HIV negative

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New HIV prevention drug Lenacapavir would replace oral medicines with twice-yearly injections.

The U.S. pharmaceutical company Gilead Sciences announced on Sept. 12 the findings of its most recent Phase 3 clinical trial for its twice-yearly injectable HIV prevention drug Lenacapavir show the drug is highly effective in preventing HIV infections, even more so than the current HIV prevention or PrEP drugs in the form of a pill taken once a day.

There were just two cases of someone testing HIV positive among 2,180 participants in the drug study for the twice-yearly Lenacapavir, amounting to a 99.9 percent rate of effectiveness, the Gilead announcement says.

The announcement says the trial reached out to individuals considered at risk for HIV, including “cisgender men, transgender men, transgender women, and gender non-binary individuals in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States who have sex with partners assigned male at birth.”

“With such remarkable outcomes across two Phase 3 studies, Lenacapavir has demonstrated the potential to transform the prevention of HIV and help to end the epidemic,” Daniel O’Day, chair and CEO of Gilead Sciences said in the announcement.

 “Now that we have a comprehensive dataset across multiple study populations, Gilead will work urgently with regulatory, government, public health, and community partners to ensure that, if approved, we can deliver twice-yearly Lenacapavir for PrEP worldwide for all those who want or need it,” he said.

Carl Schmid, executive director of the D.C.-based HIV+ Hepatitis Policy Institute, called Lenacapavir a “miracle drug” based on the latest studies, saying the optimistic findings pave the way for the potential approval of the drug by the U.S. Food and Drug Administration in 2025.

“The goal now must be to ensure that people who have a reason to be on PrEP are able to access this miracle drug,” Schmid said in a Sept. 12 press release. “Thanks to the ACA [U.S. Affordable Care Act], insurers must cover PrEP without cost sharing as a preventive service,” he said.

“Insurers should not be given the choice to cover just daily oral PrEP, particularly given these remarkable results,” Schmid said in the release. “The Biden-Harris administration should immediately make that clear. To date, they have yet to do that for the first long-acting PrEP drug that new plans must cover,” he said.

Schmid, through the HIV+ Hepatitis Policy Institute, has helped to put together a coalition of national and local HIV/AIDS organizations advocating for full coverage of HIV treatment and prevention medication by health insurance companies.

A statement by Gilead says that if approved by regulatory agencies, “Lenacapavir for PrEP would be the first and only twice-yearly HIV prevention choice for people who need or want PrEP. The approval could transform the HIV prevention landscape for multiple populations in regions around the world and help end the epidemic.”

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State Department

HIV/AIDS activists protest at State Department, demand full PEPFAR funding restoration

Black coffins placed in front of Harry S. Truman Building

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HIV/AIDS activists place black Styrofoam coffins in front of the State Department on April 17, 2025. (Washington Blade photo by Michael Key)

Dozens of HIV/AIDS activists on Thursday gathered in front of the State Department and demanded the Trump-Vance administration fully restore President’s Emergency Plan for AIDS Relief funding.

Housing Works CEO Charles King, Health GAP Executive Director Asia Russell, Human Rights Campaign Senior Public Policy Advocate Matthew Rose, and others placed 206 black Styrofoam coffins in front of the State Department before the protest began.

King said more than an estimated 100,000 people with HIV/AIDS will die this year if PEPFAR funding is not fully restored.

“If we continue to not provide the PEPFAR funding to people living in low-income countries who are living with HIV or at risk, we are going to see millions and millions of deaths as well as millions of new infections,” added King.

Then-President George W. Bush in 2003 signed legislation that created PEPFAR.

The Trump-Vance administration in January froze nearly all U.S. foreign aid spending for at least 90 days. Secretary of State Marco Rubio later issued a waiver that allows the President’s Emergency Plan for AIDS relief and other “life-saving humanitarian assistance” programs to continue to operate during the freeze.

The Washington Blade has previously reported PEPFAR-funded programs in Kenya and other African countries have been forced to suspend services and even shut down because of a lack of U.S. funding. Two South African organizations — OUT LGBT Well-being and Access Chapter 2 — that received PEPFAR funding through the U.S. Agency for International Development and the Centers for Disease Control and Prevention in recent weeks closed down HIV-prevention programs and other services to men who have sex with men.

Rubio last month said 83 percent of USAID contracts have been cancelled. He noted the State Department will administer those that remain in place “more effectively.”

“PEPFAR represents the best of us, the dignity of our country, of our people, of our shared humanity,” said Rose.

Russell described Rubio as “ignorant and incompetent” and said “he should be fired.”

“What secretary of state in 90 days could dismantle what the brilliance of AIDS activism created side-by-side with George W. Bush? What kind of fool could do that? I’ll tell you who, the boss who sits in the Harry S. Truman Building, Marco Rubio,” said Russell.

Health GAP Executive Director Asia Russell, center, speaks in front of the State Department on April 17, 2025. (Washington Blade photo by Michael Key)
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U.S. Military/Pentagon

Pentagon urged to reverse Naval Academy book ban

Hundreds of titles discussing race, gender, and sexuality pulled from library shelves

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U.S. Defense Secretary Pete Hegseth (Washington Blade photo by Michael Key)

Lambda Legal and the Legal Defense Fund issued a letter on Tuesday urging U.S. Defense Secretary Pete Hegseth to reverse course on a policy that led to the removal of 381 books from the Nimitz Library of the U.S. Naval Academy in Annapolis, Md.

Pursuant to President Donald Trump’s executive order 14190, “Ending Radical Indoctrination in K-12 Schooling,” the institution screened 900 titles to identify works promoting “diversity, equity, and inclusion,” removing those that concerned or touched upon “topics pertaining to the experiences of people of color, especially Black people, and/or LGBTQ people,” according to a press release from the civil rights organizations.

These included “I Know Why the Caged Bird Sings” by Maya Angelou, “Stone Fruit” by Lee Lai, “The Hate U Give” by Angie Thomas, “Lies My Teacher Told Me: Everything Your American History Textbook Got Wrong” by James W. Loewen, “Gender Queer: A Memoir” by Maia Kobabe, and “Democracy in Black: How Race Still Enslaves the American Soul” by Eddie S. Glaude, Jr. 

The groups further noted that “the collection retained other books with messages and themes that privilege certain races and religions over others, including ‘The Clansman: A Historical Romance of the Ku Klux Klan’ by Thomas Dixon, Jr., ‘Mein Kampf’ by Adolf Hitler, and ‘Heart of Darkness’ by Joseph Conrad.

In their letter, Lambda Legal and LDF argued the books must be returned to circulation to preserve the “constitutional rights” of cadets at the institution, warning of the “danger” that comes with “censoring materials based on viewpoints disfavored by the current administration.”

“Such censorship is especially dangerous in an educational setting, where critical inquiry, intellectual diversity, and exposure to a wide array of perspectives are necessary to educate future citizen-leaders,” Lambda Legal Chief Legal Officer Jennifer C. Pizer and LDF Director of Strategic Initiatives Jin Hee Lee said in the press release.

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Federal Government

White House sues Maine for refusing to comply with trans athlete ban

Lawsuit follows months-long conflict over school sports in state

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U.S. Attorney General Pam Bondi (Washington Blade photo by Michael Key)

The Justice Department is suing the state of Maine for refusing to comply with President Donald Trump’s executive order banning transgender athletes from participating in school sports, U.S. Attorney General Pam Bondi announced on Wednesday.

DOJ’s lawsuit accuses the state of violating Title IX rules barring sex discrimination, arguing that girls and women are disadvantaged in sports and deprived of opportunities like scholarships when they must compete against natal males, an interpretation of the statute that reverses course from how the law was enforced under the Biden-Harris administration.

“We tried to get Maine to comply” before filing the complaint, Bondi said during a news conference. She added the department is asking the court to “have the titles return to the young women who rightfully won these sports” and may also retroactively pull federal funding to the state for refusing to comply with the ban in the past.

Earlier this year, the attorney general sent letters to Maine, California, and Minnesota warning the blue states that the department “does not tolerate state officials who ignore federal law.”

According to the Maine Principals’ Association, only two trans high school-aged girls are competing statewide this year. Conclusions from research on the athletic performance of trans athletes vis-a-vis their cisgender counterparts have been mixed.

Trump critics and LGBTQ advocates maintain that efforts to enforce the ban can facilitate invasive gender policing to settle questions about an individual athlete’s birth sex, which puts all girls and women at risk. Others believe determinations about eligibility should be made not by the federal government but by school districts, states, and athletics associations.

Bondi’s announcement marked the latest escalation of a months-long feud between Trump and Maine, which began in February when the state’s Democratic governor, Janet Mills, declined to say she would enforce the ban.

Also on Wednesday, U.S. Education Secretary Linda McMahon said the findings from her department’s Title IX investigation into Maine schools — which, likewise, concerned their inclusion of trans student-athletes in competitive sports — was referred to DOJ.

Earlier this month, the Justice Department pulled $1.5 million in grants for Maine’s Department of Corrections because a trans woman was placed in a women’s correctional facility in violation of a different anti-trans executive order, while the U.S. Department of Agriculture paused the disbursement of funds supporting education programs in the state over its failure to comply with Title IX rules.

A federal court last week ordered USDA to unfreeze the money in a ruling that prohibits the agency from “terminating, freezing, or otherwise interfering with the state’s access to federal funds based on alleged Title IX violations without following the process required by federal statute.” 

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