The U.S. Food and Drug Administration (FDA) on June 18 approved a newly developed HIV/AIDS prevention drug that only needs to be taken by injection once every six months.

The new drug, lenacapavir, which is being sold under the brand name of Yeztugo by the pharmaceutical company Gilead Sciences that developed it, is being hailed by some AIDS activists as a major advancement in the years-long effort to end the HIV/AIDS epidemic in the U.S. and worldwide.

Although HIV prevention drugs, known as pre-exposure prophylaxis medication or PrEP, have been available since 2012, they initially required taking one or more daily pills. More recently, another injectable PrEP drug was developed that required being administered once every two months.

Experts familiar with the PrEP programs noted that while earlier drugs were highly effective in preventing HIV infection – most were 99 percent effective – they could not be effective if those at risk for HIV who were on the drugs did not adhere to taking their daily pills or injections every two months.

“Today marks a monumental advance in HIV prevention,” said Carl Schmid, executive director of the D.C.-based HIV + Hepatitis Policy Institute, in a statement released on the day the FDA announced its approval of lenacapavir.

“Congratulations to the many researchers who spent 19 years to get to today’s approval, backed up by the long-term investment needed to get the drug to market,” he said.

Schmid added, “Long-acting PrEP is now not only effective for up to six months but also improves adherence and will reduce HIV infections – if people are aware of it and payers, including private insurers, cover it without cost-sharing as a preventive service.”

Schmid and others monitoring the nation’s HIV/AIDS programs have warned that proposed large scale cuts in the budget for the U.S. Centers for Disease Control and Prevention by the administration of President Donald Trump could seriously harm HIV prevention programs, including PrEP-related efforts.

“Dismantling these programs means that there will be a weakened public health infrastructure and much less HIV testing, which is needed before a person can take PrEP,” Schmid said in his statement.

“Private insurers and employers must also immediately cover Yeztugo as a required preventive service, which means that PrEP users should not face any cost-sharing or utilization management barriers,” he said.

In response to a request by the Washington Blade for comment,  a spokesperson for Gilead Sciences released a statement saying the annual list price per person using Yeztugo in the U.S. is $28,218. But the statement says the company is working to ensure that its HIV prevention medication is accessible to all who need it through broad coverage from health insurance companies and some of its own support programs.

“We’ve seen high insurance coverage for existing prevention options – for example, the vast majority of consumers have a $0 co-pay for Descovy for PrEP in the U.S. – and we are working to ensure broad coverage for lenacapavir [Yeztugo],” the statement says. It was referring to the earlier HIV prevention medication developed by Gilead Sciences, Descovy.

“Eligible insured people will get help with their copay,” the statement continues. “Gilead’s Advancing Access Copay Savings Program may reduce out-of-pocket costs to as little as zero dollars,” it says. “Then for people without insurance, lenacapavir may be available free of charge for those who are eligible, through Gilead’s Advancing Access Patient Assistance Program.”

Gilead Sciences has announced that in the two final trial tests for Yeztugo, which it describes as “the most intentionally inclusive HIV prevention clinical trial programs ever designed,” 99.9 percent of participants who received Yeztugo remained negative. Time magazine reports that among those who remained HIV negative at a rate of 100 percent were men who have sex with men. 

Time also reports that some HIV/AIDS researchers believe the success of the HIV prevention drugs like Gilead’s Yeztugo could complicate the so-far unsuccessful efforts to develop an effective HIV vaccine. 

To be able to test a potential vaccine two groups of test subjects must be used, one that receives the test vaccine and the other that receives a placebo with no drug in it. 

With highly effective HIV prevention drugs now available, it could be ethically difficult to ask a test group to take a placebo and continue to be at risk for HIV, according to some researchers. 

“This might take a bit of the wind out of the sails of vaccine research, because there is something so effective in preventing HIV infection,”  Time quoted Dr. David Ho, a professor of microbiology, immunology, and medicine at New York’s Columbia University as saying.

Politicians, LGBTQ activists, and allies gathered at the Lutheran Church of the Reformation in the Capitol Hill neighborhood of Washington, D.C. on Wednesday following the ruling by the United States Supreme Court in the case of U.S. v. Skrmetti. The Supreme Court upheld a Tennessee ban on gender-affirming healthcare for transgender adolescents in a 6-3 decision.

A rally outside the U.S. Supreme Court was called for by the American Civil Liberties Union, Lambda Legal and other organizations following the high court ruling on Wednesday. However, due to a thunderstorm and flood watch, the scores of activists who were to attend the rally were directed to a Lutheran church down the street from the court. Undeterred, activists and community leaders were joined by U.S. Senators Ed Markey (D-Mass.) and Jeff Merkley (D-Ore.) for an indoor rally at the church.

“We know that freedom is not inevitable,” Markey told the crowd. “It is fought for by people who said ‘no’ in the face of health cuts, ‘no’ in the face of discrimination, ‘no’ in the face of invasive laws that ban life-saving and life-affirming healthcare and ‘no’ to this anti-justice, anti-freedom agenda.”

Also speaking at the rally was Deirdre Schifeling, chief political advocacy officer of the National ACLU.

“We believe transgender rights matter,” Schifeling stated. “Transgender kids matter and deserve love, support and the freedom to shape their own futures. I am still processing how the Supreme Court could disagree with such an obvious truth.”

“Today’s ruling shows us that unfortunately these attacks on our freedom will not end here,” Schifeling continued. “The Trump administration and extremist politicians across the country are continuing to target our right — our human right — to control our own bodies.”

“If politicians think that we are going to sit back and be defeated, that we are going to let them strip our rights and freedoms away without a fight, they’ve got another think coming,” Schifeling said. “We will never back down. We will never back down or give up. We will organize, we will mobilize and we will fight to protect trans rights in our communities, in our legislatures, in our elections, and in court rooms across the country.”

“Today, the highest court in this land decided that the bodily autonomy of trans youth, specifically trans youth of Tennessee and states with bans harming youth across the country do not matter,” said trans advocate Hope Giselle-Godsey.

“The opponents of trans equality think that today is a victory, but history will remember it as a moment that sharpened us and not silenced us,” Giselle-Godsey continued.

“So yes, today we grieve for the people in those states where those bans exist, but we grieve in motion,” Giselle-Godsey said. “To the system that thinks that it won today, just like every other time before: you will lose again. Because we won’t bow to hatred: we outlive it. We out-organize it. We out-love it. We are still here and we are not finished yet.”

The Washington Blade’s second day of Pride on the Pier at The Wharf DC ended with a fireworks show on Saturday, June 7. The fireworks show was presented by the Leonard-Litz LGBTQ Foundation.

(Washington Blade photos by Michael Key)