National
FDA approves new twice-yearly HIV prevention drug
Experts say success could inhibit development of HIV vaccine
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. Experts also point out that large numbers of people at risk for HIV, especially members of minority communities, are not on PrEP and efforts to reach out to them should be expanded.
“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.
Florida
Former Fla. gubernatorial candidate Andrew Gillum arrested on drug charges
Democrat narrowly lost to DeSantis in 2018, later came out as bisexual
Andrew Gillum, the former Democratic nominee for governor of Florida and former mayor of Tallahassee, was arrested on drug possession charges in Alabama last week.
Police in Daphne, Ala., said they pulled Gillum over for erratic driving and found marijuana and methamphetamine in his vehicle. He was charged with possession of marijuana and unlawful possession of a controlled substance, according to the Daphne Police Department. Jail records show he was arrested on July 2 and released on July 3, the Associated Press reports.
Gillum, the first Black nominee of a major political party for governor in Florida, lost the 2018 election to current Republican Gov. Ron DeSantis in a highly contentious race.
Once considered a rising star in national politics, Gillum served in Tallahassee’s local government, first as a city commissioner and then as mayor of Florida’s capital from 2014- 2018.
The Daphne Police Department said officers stopped Gillum’s vehicle around 10:45 p.m. and initiated a probable cause search after one officer noticed a glass pipe on the center console.
During the search, officers found several rolled marijuana cigarettes and three packages containing a substance that tested positive for methamphetamine, police said.
The day after his arrest he was charged with possession of dangerous drugs, use or possession of drug paraphernalia, and possession of marijuana.
In 2020, Gillum was involved in a similar incident when he was found in a Miami Beach, Fla., hotel room with a man identified as an escort who had apparently overdosed on drugs. Police also found three bags of suspected crystal methamphetamine in the room. The man survived, and no one was ever charged with a crime.
Later that year, Gillum came out as bisexual during an appearance on “The Tamron Hall Show,” where he discussed his struggles with drug and alcohol addiction and his decision to seek treatment following the 2020 incident.
In the same interview he shed light onto this, saying his substance use was a byproduct of the emotional struggles he experienced after losing the 2018 gubernatorial race to DeSantis.
This is not the first time Gillum has faced legal scrutiny.
During his 2014 mayoral campaign, he faced allegations of misconduct after hiring private equity investor Adam Corey as his campaign treasurer, raising questions about a potential conflict of interest. However, the FBI ultimately concluded there was no conflict of interest.
Pennsylvania
Philadelphia murder suspect remains at large
Two killed, one injured in attacks motivated by victims’ sexual orientation
Police seek the public’s support in finding a suspect wanted in connection with three Philadelphia shootings, including two murders, who may have targeted his victims because they were gay. All three shootings took place near Hunting Park Recreation Center between May 29 and June 26.
The suspect is 21-year-old Jahylin Melchur, who has not been located by police and is not in police custody as of July 7. Police seek the public’s support in tracking down the suspect, whose image was captured on surveillance cameras. Previous reporting underlined that Melchur should be considered armed and dangerous.
Each of the victims was found partially clothed between 10 and 11 p.m.
On May 29, a 55-year-old in Juniata Park was found two miles from the rec center. The victim, who survived the encounter with critical injuries, said a man approached him and announced his intention to rob him, before shooting him in the elbow and torso.
Martin Higgins, 45, was pronounced dead on the bleachers of the rec center’s baseball field on June 20, suffering from a gunshot wound to the abdomen. Sharef Holman, 29, was found near the basketball courts on June 26, suffering from multiple gunshot wounds. He was transported to Temple University Hospital but died shortly thereafter.
Deputy Police Commissioner Frank Vanore declined to answer the Philadelphia Inquirer’s question regarding whether the victims may have met Melchur on a dating app, citing the ongoing investigation. Sources told the Philadelphia Inquirer that investigators are exploring this possibility
Although robbery may be at least part of the motive in the first shooting, other movies are unclear.
NBC10 reported that law enforcement sources told the station all three victims were targeted because they were gay, but the Philadelphia Police Department did not confirm this.
The Philadelphia Police Department replied to PGN’s questions with an email stating, “This remains a very active investigation, and investigators are looking at all aspects of the case, including underlying motivations for committing these crimes.
“At this point, we can confirm that Melchur is wanted for two homicides by shooting and one non-fatal shooting, all of which occurred in the Hunting Park area.
“The investigation has not established that the victims were specifically targeted because of their sexual orientation.”
The Philadelphia Police Department is urging anyone with information to contact the Homicide Unit at 215-686-3334 or submit an anonymous tip by calling the PPD Tip Line at 215-686-TIPS (8477).
(This story is republished with permission of the Philadelphia Gay News.)
National
Madonna roundup: Reviews, sales, and love for ‘Danceteria’
Pop legend’s new album ‘Confessions II’ earning raves
Madonna isn’t just back, she’s ubiquitous.
From a Times Square takeover to Graham Norton’s couch, the pop legend is busy promoting her new album, “Confessions II,” a sequel to 2005’s “Confessions on a Dance Floor,” that is earning rave reviews.
“Madonna’s back in peak form with a fresh and honest dance record that’s not only her best in 20 years, but a genuinely vital addition to her canon,” says Pitchfork.
“Facing grief and loss has made Madonna’s music deeper than it’s been in 20 years, but also more alive,” the Guardian proclaims.
“If everyone in the club is a work of art, as ‘Danceteria’ says, then to live loudly is to make an indelible mark,” according to Vulture.
The album features upbeat dance productions along with some melancholic views on death and loss. On the song “Betrayal,” she reflects on the recent death of her stepmother Joan, singing, “You’ll never take my mother’s place … you betrayed me, you enslaved me.”
On “L.E.S. Girl,” she revisits her early days living on the Lower East Side and struggling to pay the rent. “Bizarre” seems to reference her failed 1980s marriage to actor Sean Penn. “Test” is a duet with daughter Lola Leon, in which she sings, “I wish I knew / The pain I’ve caused / My butterfly / Was always being watched.”
But the emotional high point of the album comes on “Fragile,” which she wrote about the death of her brother Christopher. The two were close early in Madonna’s career and he designed sets for early tours, including “Blonde Ambition.” But they had a falling out after her marriage to Guy Ritchie and he wrote a scathing tell-all book about his sister that led to years of estrangement. The two reconciled after Christopher’s cancer diagnosis and shortly before he died in 2024 at age 63. She sings, “Late last night I was fast asleep/You came to me in a dream/You said, ‘Don’t forget about me/Don’t forget to be happy.’”
Death emerges again but in a much more upbeat context in “Danceteria,” an ode to the iconic New York nightclub that has emerged as a gay favorite single and seems destined to be the song of the summer in queer nightlife. She recounts her pre-fame days trying to convince a DJ to play her first single “Everybody” at the club and name checks Jean-Michel Basquiat, Keith Haring, best friend Debi Mazar, and DJ Mark Kamins on the track.
Streaming numbers and sales are strong for the new album with projected first week sales of 100,000 ensuring a No.1 debut in the U.S.
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