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FDA Approves First-Ever Injectable to Prevent HIV

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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.

Apretude has been granted a Priority Review and Breakthrough Therapy designation. The FDA granted the approval of Apretude to ViiV Healthcare, which is majority owned by GlaxoSmithKline.

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Trump ‘Laser-Focused’ on Affordability Says White House After Calling It a ‘Hoax’

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The White House says President Donald Trump has been “laser-focused on making America affordable” since taking office. Just one month ago, President Trump called affordability a “hoax” perpetrated by Democrats.

President Trump has recently attempted to preserve his sweeping tariffs amid Supreme Court review, has engaged in foreign policy messaging involving Venezuela, Iran, and Greenland — including promoting himself as the “acting President of Venezuela” — and has responded sharply to protests involving federal officers.

The president campaigned on lowering the cost of living on “day one,” but nearly 51 weeks into his second term, inflation remains high.

White House Press Secretary Karoline Leavitt told Fox News that the president would travel to Detroit on Tuesday to deliver a speech about “all of the positive economic news that we continue to see as a result of his agenda.”

READ MORE: ‘Organized Gangs of Wine Moms’ Are Impeding Federal Agents Says Fox Columnist

“So tomorrow, he looks forward to traveling to the great state of Michigan, a state he won big, to not only tour a factory that produces Ford F-150s, and is going to be hiring more, and producing more trucks right here in the USA because of President Trump’s effective tariff policies,” Leavitt said.

Trump narrowly won Michigan, taking less than half of the vote and besting Vice President Kamala Harris by 1.4 percentage points.

Leavitt said that “mortgage rates that are falling under 6% for the first time in years,” “the national average of gasoline is the lowest that it’s been in five years,” and core inflation is “at its lowest level in five years.”

She suggested that “with a little bit of patience, the American people are going to continue to see that the best is yet to come,” and claimed that Trump “has a proven economic formula that works.”

Leavitt also said that Trump has a housing plan “in the works” and a healthcare plan “in the works,” and vowed that Americans will “continue to hear from the president, and he’ll continue to hit the road across the country to speak directly with the people he loves most, the American people.”

READ MORE: Trump ‘Losing Political Fight’ to Fed Chair: Analyst

 

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Trump DOJ Fires Attorney Who Refused to Prosecute James Comey

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The Trump Department of Justice has terminated a 64-year old attorney, the number-two official in the U.S. Attorney’s Office for the Eastern District of Virginia, after he refused to prosecute former FBI Director James Comey in a highly-controversial case.

MS NOW on Monday reported that Robert McBride, a senior DOJ prosecutor and former Navy lawyer, “was brought into the prominent satellite office of the Justice Department to serve as first assistant to U.S. Attorney Lindsey Halligan and took a more prominent role as her status was in question and after a judge ruled in late November that she was not legally appointed to run the office.”

McBride reportedly had held private meetings with judges, MS NOW reported, calling it a move that was “viewed as undermining the Administration.”

He had declined to prosecute Comey, sources said, reportedly telling top Justice Department officials that it would be difficult to do that and also run the office.

MS NOW’s Carol Leonnig added that McBride was also suspected of “gunning for” the top job.

The New York Times reported that there was a “disagreement about whether he would take charge of the Trump administration’s effort to re-indict James B. Comey,” and called McBride’s firing “the latest development in the fallout in the Justice Department over President Trump’s effort to punish Mr. Comey, the former F.B.I. director and his longtime nemesis, whom the president blames for past investigations of his conduct.”

The Times added that meeting with judges is considered “commonplace.”

 

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‘Screwed’: Trump Warns Supreme Court on Tariffs

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With many Americans awaiting a Supreme Court decision on the sweeping Trump tariffs and some experts believing the Court will rule on them any day nowpossibly as soon as Wednesday — the president is once again sending a clear warning to the justices: allow the tariffs or America is “screwed.”

During the November oral arguments, liberal and conservative justices appeared skeptical of the administration’s claim it has the power to impose global tariffs by declaring a national emergency.

President Trump has repeatedly said the tariffs are necessary for national security, and said that if the court does not allow them the U.S. would be in no position to give refunds of billions of dollars. Treasury Secretary Scott Bessent late last week said refunds “won’t be a problem.”

Trump on Monday appeared to disagree.

READ MORE: ‘Organized Gangs of Wine Moms’ Are Impeding Federal Agents Says Fox Columnist

“The actual numbers that we would have to pay back if, for any reason, the Supreme Court were to rule against the United States of America on Tariffs, would be many Hundreds of Billions of Dollars,” Trump wrote on Truth Social Monday afternoon. It is possible the Court could rescind the Trump tariffs and not require refunds.

The president then added that “the amount of ‘payback’ that Countries and Companies would require for the Investments they are making on building Plants, Factories, and Equipment, for the purpose of being able to avoid the payment of Tariffs. When these Investments are added, we are talking about Trillions of Dollars!”

He claimed any negative ruling would create “a complete mess,” and make it “almost impossible for our Country to pay.”

Despite his Treasury Secretary’s remarks, Trump added, “Anybody who says that it can be quickly and easily done would be making a false, inaccurate, or totally misunderstood answer to this very large and complex question.”

“It may not be possible but, if it were, it would be Dollars that would be so large that it would take many years to figure out what number we are talking about and even, who, when, and where, to pay,” he claimed.

And he warned point-blank, “if the Supreme Court rules against the United States of America on this National Security bonanza, WE’RE SCREWED!”

READ MORE: Trump ‘Losing Political Fight’ to Fed Chair: Analyst

 

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