The Food & Drug Administration (FDA) approved a new drug Monday that will allow patients to ditch the daily pill and receive treatment every two months. The drug, named Apretude, is being considered the first long-acting injectable medication for use as pre-exposure prevention, or PrEP, against HIV.
“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” Dr. Debra Birnkrant, the director of antivirals division at the FDA’s Center for Drug Evaluation and Research, said in a statement. “This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option.”
According to the U.S. Centers for Disease Control and Prevention (CDC), notable gains have been made in increasing PrEP use for HIV prevention in the U.S. and preliminary data show that in 2020, about 25 percent of the 1.2 million people for whom PrEP is recommended were prescribed it, compared to only about 3 percent in 2015. However, there remains significant room for improvement.
PrEP requires high levels of adherence to be effective and certain high-risk individuals and groups, such as young men who have sex with men, are less likely to adhere to daily medication. Other interpersonal factors, such as substance use disorders, depression, poverty and efforts to conceal medication also can impact adherence. It is hoped that the availability of a long-acting injectable PrEP option will increase PrEP uptake and adherence in these groups.
The FDA tested the safety and efficacy of Apretude to reduce the risk of acquiring HIV were evaluated in two randomized, double-blind trials that compared Apretude to Truvada, a once daily oral medication for HIV PrEP. Trial 1 included HIV-uninfected men and transgender women who have sex with men and have high-risk behavior for HIV infection. Trial 2 included uninfected cisgender women at risk of acquiring HIV.
Participants who took Apretude started the trial with cabotegravir (oral, 30 mg tablet) and a placebo daily for up to five weeks, followed by Apretude 600mg injection at months one and two, then every two months thereafter and a daily placebo tablet.
Participants who took Truvada started the trial taking oral Truvada and placebo daily for up to five weeks, followed by oral Truvada daily and placebo intramuscular injection at months one and two and every two months thereafter.
Apretude includes a boxed warning to not use the drug unless a negative HIV test is confirmed. It must only be prescribed to individuals confirmed to be HIV-negative immediately prior to starting the drug and before each injection to reduce the risk of developing drug resistance.
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‘Taking Us All for Fools’: Critics Decimate Greg Abbott’s Claims and Defense of His Actions in Wake of School Shooting
Texas Republican Governor Greg Abbott in a press conference that left reporters frustrated defended his actions and insisted his earlier praise for law enforcement’s widely criticized response to the Uvalde school massacre was the result of being “misled.”
“I am livid about what happened,” Abbott declared, blaming others for his “recitation of what people in that room told me.”
“I was misled … the information that I was given turned out in part to be inaccurate. And I’m absolutely livid about that” — Greg Abbott on his initial false statement portraying Uvalde first responders as heroes pic.twitter.com/dUIdxnicjm
— Aaron Rupar (@atrupar) May 27, 2022
Critics aren’t buying his claims.
Abbott, who’s in the middle of a heated re-election campaign, appeared extremely defensive when reporters asked him questions.
“Let’s be clear about one thing. None of the laws I signed this past session had any intersection with this crime at all,” Abbott told reporters when asked if he would call the legislature back for a special session, as The Texas Tribune’s Sewell Chan noted.
“No law that I signed allowed him to get a gun,” Abbott insisted.
“The answers fell pretty flat,” opined MSNBC’s Nicolle Wallace, who noted the press event lasted just 36 minutes, less time than the police officers “stood outside and did nothing,” which was 47 minutes.
Abbott ended the press conference with many reporters almost begging him to take more questions. As the governor left one frustrated reporter was caught on a hot mic saying “unbelievable.”
Chan, who is the editor in chief of the Tribune, added on Twitter: “Abbott rejects background checks as a simplistic and ineffective fix. Wouldn’t have prevented Sutherland Springs and Santa Fe shootings, he says. Tries to turn focus to broken mental health system.”
Former FBI assistant director for counterintelligence Frank Figliuzzi on MSNBC delivered a strong rebuke to Governor Abbott’s remarks.
“No amount of free flights, no amount of free caskets, no amount of mental health counseling is going to bring back any one of those murdered children,” Figliuzzi said, referring to Abbott’s announcement an anonymous donor is putting up $175,000 for funeral expenses of those who were murdered in the shooting and said the state will pay for mental health treatment.
Abbott also insisted that since Texas became a state it’s been legal for 18-year-olds to buy long guns.
Fred Guttenberg, whose daughter Jaime was murdered in the Parkland school shooting, blasted Abbott:
.@GregAbbott_TX responding to a question on long rifles “it seems like only in the past decade or two we have had school shootings.” Governor, the assault weapons ban ended in 2004. See the connection? You have actively helped to sell millions of weapons since then.
— Fred Guttenberg (@fred_guttenberg) May 27, 2022
And long guns of today, as Figliuzzi noted, are often semi-automatic “killing machines.”
“The governor seems completely unable to understand that he can easily make a distinction when you’re talking about whether an 18-year-old should buy an assault rifle or not. And all he cares about is a century of history in Texas on long guns. We didn’t have the AR-15 style assault weapons back then. He can easily make a distinction and say, ‘you can go hunting, here are the rifles you can do, you can buy, you can possess – and here’s an assault-style rifle.'”
“If he thinks that people are stupid and unable to understand that there is a clear distinction between a killing machine and a hunting rifle, that he’s taking us all for fools.”
‘I Apologize for Interrupting Your Press Conference’: Tearful Texas Democrat Urges Greg Abbott to ‘Do Something’ on Guns
The Texas Democratic State Senator who represents Uvalde stood up during Greg Abbott’s Friday afternoon press conference and almost begged the Republican Governor to “do something” about gun violence after Tuesday’s massacre at Robb Elementary School that took 21 lives.
Abbott was trying to place the blame for the school shooting on mental health despite the gunman having no documented issues, and told attendees, “we’re focusing our attention on the wrong thing.”
That was not good enough for Democratic State Senator Roland Gutierrez, who politely introduced himself and said, “I’m not making a political speech.”
“My colleagues are asking for a special session, you’re getting a letter tomorrow,” from the Senate Democratic Caucus.
“We’ve asked for gun control changes – I’m asking you now, bring us back in three weeks.”
Gutierrez grew emotional, sounding as if he was choking up, and added, “I apologize for interrupting your press conference about the needs of this community. I’ve been here for three days with all of these elected officials – this county judge has been working his ass off,” he continued.
“I don’t know how to express the loss of the families that I’ve talked to,” he added.
“You have to do something, man,” Gutierrez said, all but begging the governor to take action, and saying his “own colleagues are calling me and telling me this is enough.”
“I’m sorry to interrupt your press conference… you have to do something” pic.twitter.com/OiRI1OQZWQ
— Acyn (@Acyn) May 27, 2022
Local Texas Cops Blocked Specialized Federal Tactical Team That Killed Shooter From Engaging for One Hour
When a specially equipped U.S. Border Patrol tactical team arrived on the scene of Tuesday’s school shooting in Uvalde, Texas, local police who were already on the scene wouldn’t allow them to engage with the shooter, The New York Times reports.
“The agents from Border Patrol and Immigration and Customs Enforcement arrived at some point between 12 p.m. and 12:10 p.m., according to the officials — far earlier than previously known,” The Times’ report stated. “But they did not breach the adjoining classrooms of the school where the gunman had locked himself in until a little before 1 p.m. Members of the federal tactical team killed the gunman.”
But officials speaking to The Times say the Uvalde Police Department prevented the agents from going in sooner.
The new details further call into the question the thinking behind how law enforcement responded to the shooting that killed 19 students and two teachers. The Border Patrol and ICE agents say they did not understand why they were force to wait. All of the 21 victims died in the area where 18-year-old Salvador Ramos had barricaded himself in.
Read the full report at The New York Times.
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