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AIDS groups, activists cautious over ‘prevention’ pill

Anti-retroviral drug reduced HIV infections by 44 percent

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Truvada, gay news, Washington Blade

Gilead Sciences Truvada pill. (Image courtesy of Gilead)

Leaders of AIDS advocacy organizations joined researchers in expressing both optimism and caution over a study released last week showing that the use of a daily anti-retroviral pill significantly lowered the chance of becoming infected by HIV.

The study found that a sample of mostly gay men who were assigned to take a daily tablet of the widely used HIV medication Truvada experienced an average of 43.8 percent fewer HIV infections than participants who received a placebo pill.

Findings of the study were published Nov. 23 in the New England Journal of Medicine.

The study, which began in 2007 and included a total of 2,499 participants in the U.S., Brazil, Ecuador, Peru, South Africa and Thailand, was funded by the National Institutes of Health and the Bill & Melinda Gates Foundation. It was coordinated by the Gladstone Institutes, an arm of the University of California at San Francisco.

Participants were limited to mostly men who have sex with men and a smaller number of transgender women who have sex with men. Researchers conducting the study said the sample was chosen to represent a population group considered at high risk for contracting HIV.

“All study participants received a comprehensive package of prevention services designed to reduce their risk of HIV infection throughout the trial, including HIV testing, intensive safer sex counseling, condoms and treatment and care for sexually transmitted infections,” the Gladstone Institute said in a statement.

NIH official Dr. Anthony Fauci triggered a wave of optimism over the study findings when he told the New York Times last week that the Truvada pill was more than 90 percent effective in preventing HIV infections among a smaller number of study participants who faithfully adhered to the prescribed daily regimen.

The 43.8 percent reduction figure for HIV infections was based on findings from all 1,251 participants who were given the Truvada pill, including many who did not take the daily pill consistently, according to a detailed summary of the study released by the Gladstone Institutes.

The summary says 1,248 participants received a placebo pill as part of what Gladstone officials called a “double blind” study, in which both participants and employees dispensing the pills did not know who received the drug or the placebo.

In addition to interviewing participants to obtain their own accounts of whether they took the pills every day, researchers conducting the study administered regular blood tests of all participants and were able to confirm which ones took the Truvada pill as directed.

Dr. Kenneth Mayor, medical research director of the Fenway Institute in Boston, an HIV treatment facility that was one of two U.S. sites involved in the study, called the findings “a tremendous step forward” in the quest to lower the rate of HIV infection.

“For more than 15 years, the rate of new infections in the U.S. has been stuck at about 56,000 per year,” Mayor said in a statement. “There has been no downward movement in this number, which has meant that we desperately needed a new approach.

“It’s now possible that within the next few years, we can significantly reduce the number of new infections,” he said.

Other AIDS specialists, including Dr. Ray Martins, medical director of D.C.’s Whitman-Walker Clinic, expressed caution over the implications of the study and the widespread use of a prevention pill approach that researchers call “pre-exposure prophylaxis” or “PreP.”

Martins said the average reduction rate in the study for HIV infections of fewer than 44 percent was lower than he expected and shows a tendency of non-compliance by a large percentage of participants.

Similar to other AIDS specialists assessing the study, Martins expressed concern that a lack of adherence to a daily pill regimen of Truvada or other anti-retroviral medications could result in strains of the HIV virus that are resistant to Truvada or other HIV drugs.

The study showed that just a few participants developed resistant viral strains; they were believed to have become infected before they joined the study, with their infections undetectable at the time.

Martins called Truvada “the major backbone to almost all our current HIV regimens” for treating people with HIV and AIDS.

“So if we increase resistance to those meds and people start transmitting more resistant virus, this could be very bad for the HIV community as a whole,” he said. “To me, that was the most worrisome thing.”

He said Whitman-Walker has no immediate plans to dispense Truvada as a prevention pill for D.C.-area residents who might request it. However, he said the Clinic does prescribe Truvada to people who come to the Clinic for “post-exposure prophylaxis” – a short-term drug regimen used for people who seek treatment immediately after engaging in unsafe sex.

“I think more studies have to be done before we would recommend this as a kind of generalized use,” he said.

Martins said the Clinic would welcome the chance to participate in another study that might offer pre-exposure prophylaxis for patients at its sexually transmitted disease clinic program, who are considered to be among the highest risk group for HIV.

Longtime AIDS researcher and physician Dr. Joseph Sonnabend of San Francisco, where the other U.S. site for the prevention pill study was located, said the reduction rate for HIV infections was far too low to make a Truvada prevention pill useful for large populations.

“Daily Truvada reduced new HIV infections by only 44 percent,” he said in a statement. “This is useless, so how on earth can this be construed as a triumph?”

He said the far higher reduction rate for study participants who adhered to the daily pill regimen was meaningless in drawing conclusions for widespread use of a prevention pill “in real world conditions.”

Some AIDS advocacy organizations also expressed concern that the availability of an HIV prevention pill could result in less adherence to condom use and other safer sex practices.

Jose Zuniga, president of the International Association of Physicians in AIDS Care, called the study “an important first step in validating biomedical prevention of HIV in adults.” However, he pointed to a number of potential drawbacks to the use of Truvada as a prophylaxis in addition to the concern over viral resistance to the drug.

Possible side effects to the medication include kidney-related problems with the potential of forcing people to stop taking the medication, Zuniga noted. He said the average cost of $10,000 or more per year for the drug, which likely would not be picked up by health insurance, is also a major concern in considering its widespread use for prevention.

“The bottom line message is that condoms, clean syringes and behavioral interventions must remain our first line of defense against HIV transmission,” Zuniga said.

The study’s organizers at the Gladstone Institutes say the findings show participants increased rather than curtailed safer sex practices during their involvement in the study.

“In fact, self-reported HIV risk behavior decreased among participants in both arms of the study and condom use increased,” Gladstone said in its summary statement.

Among the groups expressing optimism over the study’s findings is Project Inform, a San Francisco-based advocacy organization for the development of effective HIV treatment and prevention options.

“A study showing that a daily pill reduces HIV risk in gay men is reason for great hope,” the group said in a statement. “U.S. agencies should waste no time in assessing the ability of pre-exposure prophylaxis to slow the HIV/AIDS epidemic.”

The group’s four-page analysis of the study is available here.

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1 Comment

1 Comment

  1. John-Manuel Andriote

    December 3, 2010 at 9:41 pm

    As Jose Zuniga points out in the article, the $10,000/year cost of the antiretroviral drug Truvada isn’t likely to be covered by health insurance. I can’t imagine any insurance company is going to be willing to spring for medication so gay men can have unprotected sex. And that’s not even counting the public relations cost for the gay community. Just imagine what the right-wing nutjobs will say about this one! It seems the best we can say is it’s great that we know Truvada, taken faithfully every day, can reduce the chance of HIV infection. How useful that information will be in the real world is another matter. Changing unhealthy behavior and using condoms is still the two most effective (and cheapest) ways to avoid HIV transmission and infection.

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Commentary

Should we vacation in homophobic countries?

Secret gay bar in St. Petersburg seemed unfathomable

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(Image by Askonsat Uanthoeng via Pexels)

ST. PETERSBURG, Russia — The tiny rainbow light projecting onto the corner baseboard of the bar and tipsy people constantly belting out Mariah Carey karaoke songs clued me in. There was something unique happening here. It wasn’t until a gentleman with glittered cheeks approached me to say how fabulous my dress was that I suddenly clocked it. I’d unknowingly ended up in a gay bar in the middle of Saint Petersburg, Russia.

A flood of overwhelming joy first took over. Before coming to Russia on vacation, I knew all too well the discrimination and fear LGBTQ Russians lived in. A gay bar in Russia, even a secret one like this, seemed unfathomable, so being where people could unapologetically be out and proud — even if it was only in the compounds of these four walls — was emotionally profound.

But within seconds, dread took over. Were we all safe? If you didn’t know what to look out for, you’d assume this was just like every other neighboring non-gay bar — it wasn’t hidden or anything. I wondered what was stopping a homophobe, if they found out, from vandalizing the bar or doing something much worse.

After all, Russia approved a legislation in 2013 prohibiting the distribution of information about LGBTQ matters and relationships to minors. The legislation, known as the “gay propaganda law,” specifies that any act or event that authorities believe promotes homosexuality to individuals under the age of 18 is a punishable felony. According to a 2018 report by the international rights organization Human Rights Watch, anti-LGBTQ violence in the country spiked after it passed. The bill perpetuates the state’s discriminatory ideology that LGBTQ individuals are a “danger” to traditional Russian family values.

A recent poll indicated that roughly one-fifth of Russians want to “eliminate” gay and lesbian individuals from society. In a poll conducted by the Russian LGBT Network — a Russian queer advocacy group — 56 percent of LGBTQ respondents said they had been subjected to psychological abuse, and disturbing reports of state-sanctioned detention and torture of gay and bisexual men in Chechnya, a semi-autonomous Russian region, have surfaced in recent years.

Considering this, it was no surprise that most of my gay friends refused to come on vacation with me to Russia. In our everyday, gay people don’t march around with a gay Pride flag so homophobic Russians would probably never be able to tell which tourists are gay. However, many LGBTQ people will never travel to Russia or any other homophobic country for one logical reason: Fear.

Unfortunately, many exotic locations abroad are dangerous territory for the LGBTQ community to be in. Physical safety isn’t guaranteed in countries like Nigeria, Iran, Brunei and Saudi Arabia where same-sex relationships are punishable by the death penalty. Not to mention the numerous transgender people who’ve been detained and refused entry to similar countries — even when it’s only been a layover! However, an alternative reason why someone may refuse to vacation in a homophobic country is having a conscience.

When you pay for accommodation, nights out and sightseeing tours, your money doesn’t just reach the hotel staff and waiters pockets — you’re also financially supporting that country’s government. Money talks so not giving homophobic countries tourism puts pressure on them. Ethically, why would anybody ever want to support a country through tourism that treats their LGBTQ community like dirt? Homophobia shouldn’t be shrugged off simply as a local “culture.”

Other LGBTQ people firmly embrace the right to go anywhere they choose, and that choosing to go gives them power. Homophobic countries still have closeted LGBTQ folks living there running underground gay spaces and groups. Is turning our back on the wonderful people and beautiful culture of a new place turning our back on their gay community too? There are countries where gay marriage is legal and trans rights are progressive, but abortion laws remain backwards. Do we boycott these countries too? And, how do we collectively define what a homophobic country is? Is legalizing gay marriage a requisite? Gay marriage is still illegal in Thailand when it is one of the most gay and trans-friendly countries in the world.

Increasingly the line of what is “right” and “wrong” erases all grey areas. Morality and activism — particularly when politics is involved — is never straightforward. The biggest surprise about Russia was how my own stereotypes I’d picked up from the media weren’t always true. Saint Petersburg in Russia is far more liberal and gay-friendly compared to rural Russia but the fact still stands that my bisexual friend and I actively chose to go to a homophobic country for pleasure. In an ideal world, anybody of any sexual orientation or gender identity would be able to vacation wherever they want but that’s sadly not reality. In the meantime, the wanderlust LGBTQ community will go on gay cruises that guarantee safe refuge or put civil rights and ideological differences aside to experience the world’s natural wonders and incredible cultures.

Ash Potter is a writer and radio host.

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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

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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.

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Health

FDA slow in responding to calls for end to ban on MSM tissue donors

‘Scientific evidence does not support these restrictions’

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Tammy Baldwin, gay news, Washington Blade
Sen. Tammy Baldwin (D-Wis.) is a lead signer of the letter to the FDA. (Washington Blade photo by Michael Key)

As of early this week, the U.S. Food and Drug Administration had yet to respond to a Nov. 29 joint letter by 52 members of the U.S. House and U.S. Senate calling on the FDA to end its policy of restricting the donation of human tissues such as corneas, heart valves, skin, and other tissue by men who have sex with men, or MSM.

The letter is addressed to Acting FDA Commissioner Janet Woodcock and Department of Health and Human Services Secretary Xavier Becerra. The FDA is an agency within the HHS.

The letter says the FDA’s restrictions on MSM tissue donation date back to a 1994 U.S. Public Health Service “guidance” related to the possible transmission of HIV, which stated that any man “who has had sex with another man in the preceding five years” should be disqualified from tissue donation.

“We also call your attention to the broad consensus within the medical community indicating that the current scientific evidence does not support these restrictions,” the letter states. “We have welcomed the FDA’s recent steps in the right direction to address its discriminatory MSM blood donation policies and urge you to take similar actions to revise the agency’s tissue donation criteria to align with current science so as not to unfairly stigmatize gay and bisexual men.”

The letter adds, “In fact, a recent study in the medical journal JAMA Ophthalmology estimated that between 1,558 and 3,217 corneal donations are turned away annually from otherwise eligible donors who are disqualified because of their sexual orientation, an unacceptable figure given widespread shortages of transplantable corneas.”

The letter continues, saying, “FDA policy should be derived from the best available science, not historic bias and prejudice. As with blood donation, we believe that any deferral policies should be based on individualized risk assessment rather than a categorical, time-based deferral that perpetuates stigma.”

U.S. Sen. Tammy Baldwin (D-Wisc.), the nation’s only out lesbian U.S. senator, and U.S. Rep. Joe Neguse (D-Colo.) are the two lead signers of the letter. All 52 signers of the letter are Democrats.

Among the others who signed their names to the FDA letter are four of the nine openly gay or lesbian members of the U.S. House. They include Reps. David Cicilline (D-R.I.), Richie Torres (D-N.Y.), Mondaire Jones (D-N.Y.), and Mark Takano (D-Calif.). 

Also signing the letter are D.C. Congressional Del. Eleanor Holmes Norton (D-D.C.), and Rep. Jamie Raskin (D-Md.). 

In response to a Dec. 21 email inquiry from the Washington Blade, FDA Press Officer Abigail Capobianco sent the Blade a one-sentence statement saying, “The FDA will respond to the letter directly.”

The statement didn’t say to whom the FDA would respond or when it would issue its response.

https://neguse.house.gov/imo/media/doc/FINAL%20-%20Letter%20to%20FDA%20and%20HHS%20on%20Corneal%20Tissue%20Donations.pdf

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