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.”

Thousands of people are expected to protest outside of the U.S. Supreme Court and the Heritage Foundation headquarters on Saturday as part of the first Gender Liberation March.

The march will unite abortion rights, transgender, LGBTQ, and feminist advocates to demand bodily autonomy and self-determination.

The Gender Liberation March follows the National Trans Liberation March that took place in D.C. in late August, and is organized by a collective of gender justice based groups that includes the organizers behind the Women’s Marches and the Brooklyn Liberation Marches. One of the core organizers, writer and activist Raquel Willis, explained the march will highlight assaults on abortion access and gender-affirming care by the Republican Party and right-wing groups as broader attacks on freedoms. 

“The aim for us was really to bring together the energies of the fight for abortion access, IVF access, and reproductive justice with the fight for gender-affirming care, and this larger kind of queer and trans liberation,” Willis said. “All of our liberation is bound up in each other’s. And so if you think that the attacks on trans people’s access to health care don’t include you, you are grossly mistaken. We all deserve to make decisions about our bodies and our destinies.”

The march targets the Heritage Foundation, the far-right think tank behind Project 2025, a blueprint to overhaul the federal government and attack trans and abortion rights under a potential second Trump administration. Protesters will also march on the Supreme Court, which is set to hear U.S. v. Skrmetti, a case with wide-reaching implications for medical treatment of trans youth, in October.

“This Supreme Court case could set precedent to further erode the rights around accessing this life-saving medical care. And we know that there are ramifications of this case that could also go beyond young people, and that’s exactly what the right wing apparatus that are pushing these bans want,” Eliel Cruz, another core organizer, said. 

According to the Human Rights Campaign, 70 anti-LGBTQ laws have been enacted this year so far, of which 15 ban gender-affirming care for trans youth.

The march will kick off at noon with an opening ceremony at Columbus Circle in front of Union Station. Trans rights icon Miss Major, and the actor and activist Elliot Page are among the scheduled speakers of the event. People from across the country are expected to turn out; buses are scheduled to bring participants to D.C. from at least nine cities, including as far away as Chattanooga, Tenn.

At 1 p.m. marchers will begin moving toward the Heritage Foundation and the Supreme Court, before returning to Columbus Circle at 3 p.m. for a rally and festival featuring a variety of activities, as well as performances by artists. 

Banned books will be distributed for free, and a youth area will host a drag queen story hour along with arts and crafts. The LGBTQ health organization FOLX will have a table to connect attendees to its HRT fund, and a voter engagement area will offer information on registering and participating in the upcoming election. A memorial space will honor those lost to anti-trans and gender-based violence. 

Cruz noted that the relentless ongoing attacks on the LGBTQ community and on fundamental rights can take a toll, and emphasized that the march offers a chance for people to come together.

“I’m really excited about putting our spin on this rally and making it a place that is both political, but also has levity and there’s fun and joy involved, because we can’t, you know, we can’t just only think about all the kind of massive amount of work and attacks that we’re facing, but also remember that together, we can get through it,” Cruz said.

Sign up for the march here. Bus tickets to the rally can be booked here.

The 9th U.S. Circuit Court of Appeals on Monday upheld a lower court’s decision that blocked enforcement of an Arizona law banning transgender girls from playing on public schools’ sports team that correspond with their gender identity.

Then-Gov. Doug Ducey, a Republican, in 2022 signed the law.

The Associated Press reported the parents of two trans girls challenged the law in a lawsuit they filed in U.S. District Court in Tucson, Ariz., in April 2023. U.S. District Judge Jennifer Zipps on July 20, 2023, blocked the law.

Arizona Superintendent of Public Instruction Tom Horne, who was named as a defendant in the lawsuit, appealed the ruling to the 9th Circuit. Democratic Attorney General Kris Mayes is not defending the law.

A three-judge panel on the 9th Circuit unanimously upheld Zipps’s ruling.

“We are pleased with the 9th Circuit’s ruling today, which held that the Arizona law likely violates the Equal Protection Clause and recognizes that a student’s transgender status is not an accurate proxy for athletic ability and competitive advantage,” said Rachel Berg, a staff attorney for the National Center for Lesbian Rights, in a press release.

NCLR represents the two plaintiffs in the case.