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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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Pennsylvania

Pa. House passes bill to codify marriage equality in state law

Governor supports gay state Rep. Malcolm Kenyatta’s measure

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Pennsylvania Capitol Building (Washington Blade file photo by Michael Key)

The Pennsylvania House of Representatives on Wednesday passed a bill that would codify marriage equality in state law.

House Bill 1800 passed by a 127-72 vote margin. Twenty-six Republicans voted for the measure.

The Republican-controlled Pennsylvania Senate will now consider the bill that state Rep. Malcolm Kenyatta (D-Philadelphia), who is the first openly gay person of color elected to the state’s General Assembly, introduced. Democratic Gov. Josh Shapiro supports the measure.

“Here in Pennsylvania, we believe in your freedom to marry who you love,” said Shapiro on Wednesday. “Today, the House has stepped up to protect that right.”

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Florida

DeSantis signs emergency bill that restores Fla. ADAP funding

Temporary funds to last through June 30

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Republican Florida Gov. Ron DeSantis (Screen capture/NBC News)

After the Florida Department of Health made huge cuts to the AIDS Drug Assistance Program in January, Republican Gov. Ron DeSantis has signed emergency legislation restoring HIV access to more than 12,000 Floridians.

Two months ago, as the Washington Blade reported, the Sunshine State cut the vast majority of those in ADAP by shifting the income levels required for eligibility — without following standard procedure when changing government policy outside of legislative or executive action.

The bill, signed by DeSantis on Tuesday, passed both chambers of the Florida Legislature unanimously and appropriates $30.9 million in emergency bridge funding through June 30, 2026. It restores Florida’s ADAP income eligibility to 400 percent of the Federal Poverty Level — the level it was prior to the January cuts. The legislation also requires the FDOH to submit detailed monthly financial reports to legislative leadership beginning April 1.

Under the old policy, eligibility would have been limited to those making no more than 130 percent of the federal poverty level, or $20,345 per year.

“For 10 weeks, 12,000 Floridians living with HIV did not know if they could fill their next prescription. Today, they can,” Esteban Wood, director of advocacy and legislative affairs at AIDS Healthcare Foundation, said in a statement.

The detailed reports now required to be sent to legislative leadership must include all federal revenues and expenditures, including manufacturer rebates; enrollment figures by county and insurance status; prescription utilization by drug class; and any projected funding shortfalls. This is the first time the Legislature has required this level of financial transparency from the program.

DeSantis signed the legislation one day after a Leon County Circuit Court judge denied AIDS Healthcare Foundation’s request for an injunction to block the significant changes the DeSantis administration is making to the program, which it claims faces a $120 million shortfall for calendar year 2026.

AIDS Healthcare Foundation, a national organization focused on protecting and expanding HIV healthcare access and prevention methods, filed a lawsuit over the change in eligibility, arguing the Florida Department of Health did not follow the laid out path for formally changing policy and was acting outside established procedures.

Typically, altering eligibility for a statewide program requires either legislative action or adherence to a multistep rule-making process, including: publishing a Notice of Proposed Rule; providing a statement of estimated regulatory costs; allowing public comment; holding hearings if requested; responding to challenges; and formally adopting the rule. According to AIDS Healthcare Foundation, none of these steps occurred.

The long-term structure of ADAP will be determined by the 2026–2027 fiscal year state budget, something that lawmakers have until June 30 to finish.

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Federal Government

Markwayne Mullin confirmed as next DHS secretary

Okla. senator to succeed Kristi Noem

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The U.S. Senate confirmed Markwayne Mullin as the next secretary of Homeland Security on Monday, as the agency continues to grapple with what lawmakers have described as a “never-ending” funding standoff, with Democrats attempting to withhold funding from one of the nation’s largest and most costly agencies.

Mullin — a Republican senator from Oklahoma, former mixed martial arts fighter, and plumbing business owner — was confirmed in a 54–45 vote. Two Democrats — U.S. Sens. John Fetterman (D-Pa.) and Martin Heinrich (D-N.M.) — sided with Republicans in supporting his confirmation.

The new agency head is expected to follow the policy direction set by President Donald Trump, emphasizing stricter immigration enforcement. This includes proposals to support immigration agents at polling sites and to cut funding to so-called “sanctuary cities.”

Mullin replaces Kristi Noem, who was fired earlier this month following a widely scrutinized 2-day congressional hearing on Capitol Hill.

During the hearing, Noem faced intense questioning over her response to several crises, including the fatal shooting of two American citizens in Minneapolis by U.S. Immigration and Customs Enforcement agents, a $220 million border security advertising campaign that featured her on horseback near Mount Rushmore amid one of the largest federal workforce reductions in U.S. history, and the federal response to major natural disasters such as the July 2025 Texas floods and Hurricane Helene in 2024.

Noem had previously drawn criticism for a series of policy decisions in South Dakota that broadly focused on restricting the rights of LGBTQ individuals. In 2023, she signed House Bill 1080, banning gender-affirming medical care for transgender minors. She also signed legislation and executive orders restricting trans athletes’ participation in women’s sports, as well as the state’s “Religious Freedom Restoration Act,” which critics argued enabled discrimination against LGBTQ individuals. Additionally, the state canceled contracts related to LGBTQ support services — including suicide prevention and health care navigation programs‚ and later agreed to a $300,000 settlement with trans advocacy group, The Transformation Project.

Despite her removal from DHS, Noem will remain in the Trump-Vance administration as a special envoy for the “Shield of the Americas,” an initiative aimed at promoting U.S. influence in the Western Hemisphere, including efforts to counter cartel networks, reduce Chinese influence, and manage migration.

The new head of DHS has served in Congress since 2013, in both houses of the federal legislature. While in the Senate and a member of the Health, Education, Labor, and Pensions (HELP) Committee, Mullin has been a vocal critic of policies aimed at expanding LGBTQ inclusion. He led a group of lawmakers in urging the Administration for Community Living to reverse a rule requiring states to prioritize Older Americans Act services based on sexual orientation and gender identity, arguing the policy could have unintended consequences.

Mullin also makes history as the first Native American — and a citizen of the Cherokee Nation — to lead the Department of Homeland Security. He was also among the 147 Republicans who voted to overturn the 2020 presidential election results despite no evidence of widespread fraud, and was present in the U.S. House of Representatives chamber on Jan. 6.

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