Connect with us

Health

FDA approves injectable PrEP to reduce the risk of sexual HIV infection

Manufactured as Apretude, it will be available to at-risk adults & adolescents who weigh at least 77 pounds & have tested negative for HIV

Published

on

FDA headquarters, Silver Spring, MD (Photo Credit: U.S. government/FDA)

SILVER SPRING, Md. – The U.S. Food and Drug Administration announced Monday that the agency had approved the first injectable treatment for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.

Manufactured under the name Apretude, it will be available to at-risk adults and adolescents who weigh at least 77 pounds and have tested negative for HIV immediately beforehand the agency said in a press release.

By granting its approval, the FDA opens up the option for patients to receive the injectable drug instead of a daily HIV prevention oral medication, such as Truvada.

“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,” said Debra Birnkrant, M.D., director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research. “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, 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% of the 1.2 million people for whom PrEP is recommended were prescribed it, compared to only about 3% 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 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.

In Trial 2, 3,224 cisgender women received either Apretude or Truvada. The trial measured the rate of HIV infections in participants who took oral cabotegravir and injections of Apretude compared to those who took Truvada orally.

The trial showed participants who took Apretude had 90% less risk of getting infected with HIV when compared to participants who took Truvada.

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.

Drug-resistant HIV variants have been identified in people with undiagnosed HIV when they use Apretude for HIV PrEeP. Individuals who become infected with HIV while receiving Apretude for PrEP must transition to a complete HIV treatment regimen.

The drug labeling also includes warnings and precautions regarding hypersensitivity reactions, hepatotoxicity (liver damage) and depressive disorders.

Continue Reading
Advertisement

National

Roe leak stokes fears that LGBTQ rights are now at heightened risk

Legal experts diverse on degree of threat to marriage

Published

on

Legal experts diverge on the degree Samuel Alito's opinion would threaten same-sex marriage.

Fears that same-sex marriage and other LGBTQ rights could be on the chopping block are at a new high after a leaked draft opinion from the U.S. Supreme Court that would explicitly overturn precedent in Roe. v. Wade, although the degree of perceived danger differs among legal observers.

Although language in the leaked draft by U.S. Associate Justice Samuel Alito, which was published late Monday by Politico and confirmed as “authentic” by the Supreme Court, specifically distances the potential ruling from Obergefell v. Hodges, the general reasoning against finding unenumerated rights in the U.S. Constitution could apply to challenges to the landmark 2015 marriage decision.

Karen Loewy, senior counsel for the LGBTQ group Lambda Legal, told the Washington Blade if the draft decision were to become final it would “have no good implications” for either the Obergefell or Lawrence decisions.

“The analysis that Justice Alito has laid out really calls into question the sort of underlying liberty and dignity jurisprudence that really was the underpinning of cases like Lawrence and Obergefell,” Loewy said. “It requires a really cramped vision of what is constitutionally protected, that is tied to histories of oppression that are really, really concerning.”

Alito obliterates long-standing precedent, as defined in the 1973 Roe. v. Wade decision and subsequently affirmed in the 1992 decision in the Planned Parenthood v. Casey, finding a woman’s right to have an abortion is protected under the 14th Amendment.

“We hold that Roe and Casey must be overruled,” Alito writes. “The Constitution makes no references to abortion, and no such right is implicitly protected by any constitutional provision, including the one on which the defenders of Roe and Casey now chiefly rely — the Due Process Clause of the 14th Amendment.”

Alito makes clear for the Supreme Court to find any unenumerated rights under the 14th Amendment, the right must be “deeply rooted in this Nation’s history and tradition” and “implicit in the concept of ordered liberty.”

Such an analysis would directly impact LGBTQ rights found under the 14th Amendment. In fact, three separate times over the course of the draft opinion, Alito compares the right to abortion to rights for LGBTQ people as defined by the U.S. Supreme Court.

Those references, however, aren’t to threaten those decisions, but to bolster the case for overturning precedent as established by Roe and limit the impact of the draft opinion.

“Roe’s defenders characterize the abortion right as similar to the rights recognized in past decisions involving matters such as intimate sexual relations, contraception, and marriage,” Alito writes, “but abortion is fundamentally different, as both Roe and Casey acknowledged, because it destroys what those decisions called ‘fetal life’ and what the law now before us describes as an ‘un-born human being.'”

In another instance, Alito includes Obergefell and Lawrence among a multitude of cases in a multi-page footnote giving examples of where the Supreme Court has decided to overturn precedent, which the draft opinion would do for Roe v. Wade. Another time, Alito rejects arguments from the U.S. solicitor general that abortion and marriage are connected, asserting “our decision concerns the constitutional right to abortion and no other right.”

Loewy, however, said the fundamental nature of the draft opinion, despite Alito’s rejection that abortion is comparable to LGBTQ rights, undermines that analysis no matter how many times he articulates it.

“The third time is where he offers a fig leaf saying, ‘This analysis is just about abortion rights. It’s not about anything else,’ and so suggests that it would leave untouched a case like Obergefell, when the analysis that he has offered in this opinion clearly leads to the opposite result,” Loewy said.

Indeed, the sweeping nature of Alito’s reasoning against finding unenumerated rights under the Constitution has led some observers to believe the draft was written by Alito alone and without the input of the other eight justices, which could mean the final decision would be a consensus different from the opinion that was leaked. (Upon publishing the leaked opinion, however, Politico did report the Supreme Court has five justices who will vote in favor of overturning Roe, which means without question such a ruling has a majority.)

Not all observers see the opinion in the same way and are interpreting Alito’s references to Obergefell and Lawrence as less threatening.

Dale Carpenter, a conservative law professor at Southern Methodist University who’s written about LGBTQ rights, downplayed the idea the draft opinion against Roe would be a prelude to overturning Obergefell based on Alito’s words denying the connection.

“The opinion tries to make it clear that it does not affect other unenumerated rights, like Lawrence and Obergefell and other fundamental rights cases, like contraceptive cases and other marriage cases,” Carpenter said. “So that’s comforting, I think, to LGBT rights advocates. Second, it says that there’s a fundamental distinction between those other cases and the abortion cases in that the abortion cases involve fetal life or potential life. And so, that I think, is a ground for setting a difference between them.”

Carpenter, however, conceded the mode of analysis in the opinion overturning Roe “is not very friendly to unenumerated rights like marriage and sexual intimacy,” so while Obergefell and Lawrence may face no immediate threat “there might be a longer term concern about decisions like those.”

A follow-up ruling from the Supreme Court rolling back the right for same-sex couples to marry would be consistent with a 2020 dissent from Alito and U.S. Associate Justice Clarence Thomas essentially declaring war on the Obergefell decision, urging justices to revisit the case to make greater accommodations for religious objections.

Jim Obergefell, the lead plaintiff in the marriage equality case and now a candidate for a seat in the Ohio state legislature, said in a statement after the leak of the draft Alito opinion he was fearful that the same forces seeking to overturn precedent for abortion rights would go after LGBTQ rights next.

“It’s also concerning that some members of the extreme court are eager to turn their attention to overturning marriage equality,” Obergefell said. “The sad part is in both these cases, five or six people will determine the law of the land and go against the vast majority of Ohioans and Americans who overwhelmingly support a woman’s right to make her own health decisions and a couple’s right to be married.”

The Supreme Court, of course, couldn’t willy nilly reverse the Obergefell decision, which would require some case or controversy to wind its way through the judicial system before justices could revisit the ruling. Mostly likely, such a hypothetical case would be a state passing a law banning same-sex marriage or simply declaring it would no longer allow same-sex couples to wed in defiance of the Obergefell decision.

No state, however, is engaged in a serious effort to challenge marriage rights for same-sex couples. The last such challenge was in 2020 and from the solicitor general of Indiana, who was seeking to challenge the decision on the basis of birth certificates for the children of women in same-sex marriages. Even the current 6-3 conservative majority on the court declined to hear the case.

Additionally, as polls demonstrate, the nation is in a different place with abortion rights compared to the right for same-sex couples to marry. A recent Fox News poll found six in 10 registered voters still think the U.S. Supreme Court should uphold Roe v. Wade, but more than half of those responders favored banning abortions after 15 weeks. Comparatively, a Gallup poll in September 2021 found support for marriage equality is at a record high of 70 percent and, for the first time, a majority of Republicans back same-sex marriage.

A question also remains about what the draft opinion means for decisions on LGBTQ rights that have yet to come before the Supreme Court but may come at a later time, such as a legal challenge to the “Don’t Say Gay” measure recently signed into law by Florida Gov. Ron DeSantis.

Carpenter said he doesn’t think the observers can glean anything about a potential ruling on the “Don’t Say Gay” law based on the fact the legal challenge would be different than challenges to abortion or same-sex marriage.

“That kind of challenge would more than likely be brought under the First Amendment,” Carpenter said. “And I don’t see the First Amendment being affected by the Dobbs decision. I suppose that someone might want to bring an Equal Protection challenge to the ‘Don’t Say Gay’ law in Florida, but it just doesn’t seem like it would have an immediate impact on even that kind of claim.”

Continue Reading

Health

HRC names Chase Brexton ‘Leader in LGBTQ Healthcare Equality’

Perfect HEI score for Baltimore provider

Published

on

Chase Brexton Health (Washington Blade file photo by Michael Key)

The Human Rights Campaign has again awarded the title of “Leader in LGBTQ Healthcare Equality” to Chase Brexton Health Care in Baltimore. 

The designation was reported in the recently released 2022 edition of the Healthcare Equality Index (HEI). Chase Brexton was one of only two Maryland healthcare providers, and 496 nationwide, to earn the honor.

To be named a Leader in LGBTQ+ Healthcare Equality, Chase Brexton achieved a perfect score of 100 points across strict criteria implemented by the Healthcare Equality Index. The categories measured included staff training and benefits, patient services and engagement, and responsible citizenship.

Continue Reading

Health

AIDS Healthcare Foundation opens first Healthcare Center in Virginia

Clients at AHF’s Falls Church Healthcare Center will receive care from Danbi Martinez, a provider with 19 years of HIV and primary care experience.

Published

on

Dr. Danbi Martinez (Photo courtesy of Aids Healthcare Foundation).

The AIDS Healthcare Foundation (AHF) just opened a new Healthcare Center in Falls Church, Virginia—the organization’s very first Healthcare Center in the state. AHF’s mission is to eradicate HIV/AIDS and to provide cutting-edge medicine and advocacy regardless of ability to pay.

As of 2019, there were 23,691 people living with HIV in Virginia, and 56.4% of those people were black Americans. AHF is rooted in providing needed services to the most vulnerable demographics. With every AHF Healthcare Center, AHF Wellness Center, and AHF Pharmacy that caters to underserved communities, AHF hopes to close the gap on HIV/AIDS disproportionately affecting a single community. 

In 2019, the Commonwealth of Virginia also saw 822 new HIV diagnoses. This further highlights the need for the free-to-low-cost HIV services and linkage to care that AHF offers. For instance, AHF is now the largest provider of PrEP (Pre-exposure Prophylaxis), an HIV prevention medication in the U.S. 

In Virginia, The prEP-to-need ratio (PNR) went from 0.30 in 2012 to 4.37 in 2019. The lower the number is, the larger the need is for HIV prevention. And although the PNR has steadily increased, among females in Virginia, the PNR was far lower at 1.48. o

AHF’s new Falls Church Healthcare Center is another step in the right direction in providing at-risk populations with HIV prevention medication, getting them tested for HIV regularly, and getting them linked to care within 72 hours of a positive test result.

Clients at AHF’s Falls Church Healthcare Center will receive care from Danbi Martinez, a provider with 19 years of HIV and primary care experience. The location offers free STI and HIV testing, linkage to care, and access to a specialty pharmacy. Operating hours are Monday, Tuesday, Thursday, and Friday from 8:30 am to 5:00 pm, as well as, Wednesday from 10:00 am to 6:30 pm. 

To welcome Danbi Martinez to the AHF family, and to celebrate their first Healthcare Center in Virginia, AHF is hosting a grand opening event and reception on March 10th, 12 pm at 2946 Sleepy Hollow Road Suite 4B Falls Church VA 22044. Please call (703) 962-1528 for further information on the event or services offered.

Continue Reading
Advertisement
Advertisement

Follow Us @washblade

Sign Up for Blade eBlasts

Popular