A 10-year study has found that Australia could become one of the first countries to “virtually eliminate” HIV transmissions, with new infections decreasing dramatically.
The findings, published inLancet HIV, showed that HIV infections decreased by 66 per cent between 2010 and 2019 in New South Wales and Victoria, while there was a 27 per cent rise in people accessing effective HIV treatment.
Increased access to HIV treatment and PrEP (pre-exposure prophylaxis) – the medication that prevents a person from contracting HIV – was cited as a key reason for decreased transmissions.
The journal also endorsed the public health strategy “treatment as prevention” or TasP, explaining that HIV treatment “results in virally suppressing the HIV virus”, which reduces a person’s risk of transmitting HIV to another person to zero.
“We examined 10 years of clinical data from over 100,000 gay and bisexual men in New South Wales and Victoria,” Dr Denton Callander, who led the research at UNSW’s Kirby Institute, told the University of New South Wales.
“We found that over time, as viral suppression increased, HIV incidence decreased. Indeed, every percentage point increase in successfully treated HIV saw a fivefold decrease in new infections, thus establishing treatment as prevention as a powerful public health strategy.”
Dr Callander also underlined the importance of access to HIV testing, as well as the “widespread availability” of PrEP.
Professor Mark Stoové from the Burnet Institute, co-senior author on the paper, added that the success of Australian measures such as education on HIV and reduced patient treatment costs could see the country “virtually eliminate” new HIV transmissions.
“Australia is on track to become one of the first countries globally to virtually eliminate the transmission of HIV,” Professor Stoové said.
“The results of this research show that further investment in HIV treatment – especially alongside PrEP – is a crucial component of HIV elimination.”
HIV experts have explained how medical breakthroughs have transformed the treatment and prevention of the virus.
In fact, U=U means that if a HIV-positive person has been taking effective HIV treatment, and their viral load has been undetectable for six months or more, they cannot pass the virus on through sex.
In the UK, former health secretary Matt Hancock committed to ending new HIV transmissions by 2030, however, charities and activists have expressed doubt that the country will be able to meet its target.
Richard Angell, campaigns director at the Terrence Higgins Trust, told PinkNews that it’s now “possible but not probable” that the UK will reach the 2030 goal.
Some “huge successes” were praised in terms of UK HIV prevention, but experts explained that inequality and stigma, as well as a lack of resources, were still hurdles to overcome in order to meet Hancock’s aim.
The U.S. Justice Department (DOJ) is appealing a judge’s decision to nullify a section of the Affordable Care Act (ACA) that requires insurance companies to cover the HIV prevention drug regimen PrEP.
Last week, U.S. District Juge Reed O’Connor struck down a section of the ACA requiring coverage of certain preventive health care services, which, in addition to PrEP, includes some cancer screenings, contraception, immunizations, and more. O’Connor’s decision leaves over 150 million people vulnerable to the added costs of this care.
A coordinated effort by right-wing media and lawmakers has decimated community-based programs addressing healthcare for LGBTQ+ people in Tennessee
O’Connor’s decision came about in response to a lawsuit filed by two Christian business owners and six individuals who felt being required to cover PrEP promotes “homosexual behavior” and is a violation of religious freedom. The plaintiffs also argued that being required to cover other preventive services makes them “complicit in facilitating… drug use, and sexual activity outside of marriage between one man and one woman.”
In a statement on the appeal, out White House Press Secretary Karine Jean-Pierre said President Joe Biden “is glad to see the Department of Justice is appealing the judge’s decision” and that the case “is yet another attack on the Affordable Care Act, which has been the law of the land for 13 years and survived three challenges before the Supreme Court.”
“Preventive care saves lives, saves families money, and protects and improves our health,” she continued. “Because of the ACA, millions of Americans have access to free cancer and heart disease screenings. This decision threatens to jeopardize critical care. The administration will continue to fight to improve health care and make it more affordable for hard-working families, even in the face of attacks from special interests.”
Michael Weinstein, the founder and president of the Aids Healthcare Foundation, said O’Connor’s decision “will have dangerous consequences” for millions of Americans.
“While we expect this unconstitutional ruling ultimately will fail, the decision creates uncertainty and is a threat to public health,” Weinstein said.
This is not the first ruling O’Connor has made against PrEP and the ACA. In September 2022, he ruled that a provision of the act requiring employee health insurance plans to provide full coverage of HIV-prevention drugs (as well as other preventive health care services) is a violation of religious freedom. That ruling only applied to the companies of the plaintiffs in the case.
Long known as an anti-LGBTQ+ extremist, O’Connor also ruled in 2021 that businesses that say they’re religious can fire LGBTQ+ people, chipping away at the protections granted by the Supreme Court’s decision in Bostock v. Clayton Co.
He ruled the same year that a Catholic hospital doesn’t have to follow federal anti-discrimination laws when it comes to the provision of health care because of the chance that they’d be forced to provide care for a transgender person that affirms their gender, even if the procedure is not one the hospital objects to. His reasoning for the sweeping religious exemption for the Catholic hospital was that Biden and Barack Obama have a “pattern” of religious animus, so they can’t be trusted to enforce the law correctly.
On Wednesday, March 22, 2023, the Survivors of HIV Advocating for Research Engagement (SHARE) Board conducted a webinar highlighting the results of their survey “Aging with HIV: What do you need to thrive?” They sought to answer questions such as, “What are the key health-related questions/issues that research should address around HIV and aging?,” “What matters most to people aging with HIV?,” and “What health outcomes are of most relevance to people aging with HIV?”
Sadly, the SHARE survey and report revealed nothing new.
Their overall conclusions were that:
Community members living with HIV can be and need to be included in research projects;
Care concerns in long-term survivor groups may reflect the loss of friends and the potential of stigma from family members, necessitating need for paid care;
Planning for older adulthood is challenged further when it living into advanced age wasn’t anticipated; and,
Significant need exists for financial management, housing, medication burden support.
It is notable that SHARE meant for the survey not only to identify priority research issues that matter to long-term HIV survivors, but also to facilitate collaboration among long-term HIV survivors, policy makers, clinicians, and researchers.
They recruited a group of 267 long-term survivors (whom they defined as 50 years or older who had lived with HIV for ten years or more), ranging in age from 42 to 77, with an average length of diagnosis of 29 years. Survey respondents were heterosexual (36%), gay (29%), bisexual (19%), and lesbian (13%), with reported race/ethnicities of Black or African American (33%), Hispanic (28%), and white (52%) from both rural and urban areas around the country. Participants completed a survey and interviews by phone, Zoom, or face-to-face.
The survey revealed slightly different priorities among those who have lived with HIV for less than twenty years compared with those who have lived with HIV for more than twenty years, but overall, the six most frequently reported needs among long-term survivors were: (1) enhancing quality of life (by far the most prominent issue), (2) addressing mental health and cognitive decline, (3) maintaining physical health, (4) addressing loneliness and isolation, (5) issues of medication, including polypharmacy concerns, and (6) accessing appropriate healthcare.
Care planning and caregiving were also identified as critical issues, with more than 50 percent of respondents stating “I’m not sure who would provide care for me,” particularly among those who were diagnosed more than twenty years ago. More than 80% of respondents also reported having experienced stigma based on race/ethnicity, gender identity, sexual orientation, age, and HIV status.
Since January 2016, I have studied and reported on issues faced by us long-term HIV survivors, including several community-based surveys and studies such as this one. I have attended (via Zoom) several webinars reporting on the findings of those studies. While I make no unwarranted claim to expertise in the field of HIV, I can and do claim a great deal of lived experience with HIV as well as knowledge gained through my studying and reporting.
For many years, we long-term survivors have known and made public our concerns about being included in research projects that affect our lives and other issues identified in the SHARE survey. One need look no further than The San Francisco Principals 2020, which five of us long-term survivors wrote and distributed after the virtual AIDS2020 conference.
In the Principles, we identified the same issues (stigma, financial stress, mental healthcare needs, the lack of trained geriatricians, concerns about the effects of the virus and our medications on our bodies, the lack of political will to address those issues, etc.) and proposed solutions. We were not alone — several major AIDS-related groups have long insisted on the inclusion of us long-term survivors in any and all research and clinical trials that affect us. Nothing about us without us is more than just a catchy slogan — it is a priority that many of us have demanded since as early as 1983 when people living with AIDS promulgated the Denver Principles.
For me, this webinar raised several questions: What is being done to get the results of this survey, and others, into the hands of policy makers, clinicians, and researchers who can actually do something with them?
What concrete actions are being taken as a result of these many community surveys?
How many times must we ask the same questions, getting the same answers, before our answers to those questions are implemented in meaningful ways?
It seems to me, and to many of my fellow survivors, that our needs — for informed healthcare, for financial help to afford medications and living expenses, for mental healthcare, for community-based solutions, etc. — have been known for long enough. What we need is policies and actions that address those needs.
We already know what we need. When, if ever, will those needs be met?
U.S. District Judge Reed O’Connor ruled in Braidwood Management v. Becerra that the federal government cannot enforce many of the preventative care coverage requirements in the Affordable Care Act, notably including a requirement that employers provide insurance coverage for PrEP (Pre-exposure prophylaxis), a medication that prevents the transmission of HIV. The judge ruled that the ACA mandate violates employers’ rights under the Religious Freedom Restoration Act. Read the ruling in the case, the final judgment after he granted a motion for summary judgment in September.
Adam Polaski(he/him pronouns), Communications Director at the Campaign for Southern Equality, said today:
“This is yet another example of blatant judicial overreach that targets the LGBTQ community, which already experiences significant health disparities. PrEP is a medication that keeps people safe and prevents the transmission of HIV. This ruling is an attack on privacy and science and, if it’s allowed to stand, will drastically limit Americans’ ability to protect themselves from HIV.”
“Whether it’s access to abortion, gender-affirming care, birth control, or PrEP, we are seeing dangerous action from rogue activist judges forcing themselves into Americans’ private health care decisions. Particularly here in the South, rulings like this restrict access to essential health care for precisely those communities already experiencing the greatest disparities in access to care. We must push back – and we will – to ensure that people have access to life-saving medications like PrEP and the health care they need and deserve.”
PrEP is a daily pill used widely for HIV prevention by individuals who are HIV-negative but at high risk for exposure, including men who have sex with men, people who are in a sexual relationship with an HIV-positive partner, and people who have recently injected drugs. Daily PrEP use can reduce the risk of HIV infection from sex by more than 90%.
PrEP is an especially critical strategy for HIV prevention in the South, the epicenter of the modern HIV crisis in the United States. According to 2016- 2017 CDC data, one-half of all HIV diagnoses occur in the South, 47% of HIV related deaths happened in the South, and 46% of people living with HIV live in the South. In the Campaign for Southern Equality’s Report of the 2019 Southern LGBTQ Health Survey(direct link to HIV data), we found that respondents’ reported rates of living with HIV more than 15 times higher than the national rate, with 5% of respondents saying they are living with HIV and 10.4% saying that they don’t know their status. Recent research published this month in Open Forum Infectious Diseases found that if such a ruling were to stand in this case, more than 2,000 otherwise-preventable HIV infections could develop within a year.
Judge O’Connor has a long, infamous history, of ruling against the Affordable Care Act, and a history of rulings that specifically harm the LGBTQ community, including on denying federal benefits to same-sex couples and a decision on anti-LGBTQ workplace discrimination that blatantly violated the U.S. Supreme Court’s ruling in Bostock v. Clayton County.
For many years, we’ve relied on daily oral medications to treat HIV and to prevent HIV. But long-acting injectable options for both PrEP and treatment are an exciting new strategy that may increase acceptability, accessibility, and effectiveness. An injectable option is now available for both HIV treatmentand PrEP, and new research is showing how PrEP and treatment injections may transform our response to the epidemic.
Long-acting injections for prevention
Late in 2021, the FDA approved the first long-acting injectable option for PrEP. Named Apretude®, the medication is a long-acting version of the integrase inhibitor cabotegravir, and is delivered as an injection once every two months. Long-acting injectable cabotegravir has no limitations on which groups can use this method of HIV prevention, which is notable given some early PrEP studies which failed to show efficacy with cisgender women.
“Those of you who followed the PrEP literature know that there’s been a lot of controversy about how well oral PrEP works for vaginal exposures in cisgender women,” said Raphael Landovitz, MD, MSc, professor of medicine at UCLA Center for Clinical AIDS Research & Education, during “State of the Science” presentation on injectable PrEP. “A lot of people at the beginning said, ‘It doesn’t work for women, it can’t work for women,’ And it turns out that’s not true.”
The problem, Landovitz explained, is that the medicine that’s used for oral PrEP (TDF/FTC, brand name Truvada), “doesn’t get into the tissues of the genital tract [for cisgender women] as well as it gets into rectal tissue. So you have to have much better adherence to daily oral products to get protection for vaginal exposures… You need to be pretty well perfect in your daily adherence to the oral PrEP to get the vaginal protection.”
Injectable options may be a game-changer–particularly for cisgender women and with other folks who may struggle with adherence. In the HPTN 084 study, researchers found an 89% reduction in HIV infections among cisgender women provided with injectable cabotegravir PrEP compared to those offered oral TDF/FTC.
“In my mind, this is stunning. It’s mind blowing,” said Landovitz.
Photo: Prepared syringe of cabotegravir, courtesy of ViiV Healthcare
A recent PrEP study, presented at the 2023 CROI by Sybil Hosek, PhD, showed that injectable long-acting cabotegravir for PrEP could be a feasible option for younger sexually active adolescent cisgender women (12 – 17 years old). The young women in the study had “exceptional” adherence to injection visits, were very interested in long-acting HIV prevention medication, and most (92%) chose to continue taking injectable cabotegravir for PrEP over PrEP oral medication when given a choice.
During a report-back on the study presentation for Getting To Zero San Francisco, Hyman Scott, MD, MPH, said that although injection site reactions (pain, swelling) were common in the study, no participants discontinued the study early because of these reactions and the frequency of reactions decreased over time.
In terms of acceptability, “a lot of the young women talked about receiving injections to protect against HIV being easier than other methods,” said Scott.
It is of note that researchers do not yet have much data on injectable PrEP with people who inject drugs, and transmasculine and non-binary people. “Those are huge gaps in our understanding of how to use this product,” said Landovitz.
With Black men who have sex with men and Black trans women disproportionately affected by HIV in the U.S., a recent study by Hyman Scott, MD, MPH, and colleagues looked at the efficacy of injectable cabotegravir for PrEP among U.S.-based Black and African American participants enrolled in the HPTN 083 study.
Cabotegravir PrEP worked even better to prevent HIV infections than oral PrEP. Over the course of the study, there were 15 infections among those taking oral PrEP, and only 4 infections among those receiving injectable PrEP.
“This showed that this [injectable cabotegravir PrEP] is a highly effective intervention in that we see a really decreased incidence among those who are taking CAB-LA [long-acting cabotegravir PrEP],” said Scott.
Unfortunately, cost and affordability may be one thing that prevents widespread uptake of long-acting cabotegravir PrEP.
“All the insurance companies are playing hot potato by making people go through all sorts of hoops and bells and whistles to use it [long-acting injectable PrEP]. And I’m really concerned, particularly outside of the US as well, that it’s not going to be implementable,” said Landovitz.
Long-acting injections for treatment
For HIV treatment, Cabenuva (cabotegravir/rilpivirine) has been available as a once-monthly injection since early 2021, and new studies are evaluating the benefits that long-acting injectable treatments offer.
“The individuals who were taking the oral medications talked about some psychological social cycle issues, challenges with daily oral therapy,” said Dr. Scott. At the end of the study, 90% of participants preferred the injectable treatment option over daily oral medication, and reported benefits including “I don’t have to worry as much about remembering to take HIV medication every day,” and “I do not have to think about my HIV status every day.”
Another study presented at CROI by Monica Gandhi, MD, MPH, shared results from a real-world roll-out of injectable HIV treatment at the Ward 86 HIV Clinic in San Francisco. The clinic serves publicly insured people with high rates of mental illness (38%), substance use (39%), and unstable housing (34%), which may contribute to more difficulty in taking daily oral HIV medications.
Although more than 40% of people beginning injectable HIV treatment had detectable viral loads at the start of the study, nearly all (98%) achieved viral suppression. The vast majority of participants (74%) received on-time HIV treatment injections, and 100% of those who started the study virally suppressed remained virally suppressed during the study.
“This worked well within a patient population that included individuals who had not been virally suppressed,” said Scott. “I think this is going to be important as we move forward with the rollout of injectable treatment, as it shows that in a population that is more of a ‘safety net population,’ that you can have high success with this regimen.”
A final study that Dr. Scott highlighted during the Getting To Zero report-back addressed the question of whether injectable cabotegravir/rilpivirine could be administered in the thigh versus the gluteal (butt) muscle.
“If someone has gluteal implants, or gluteal injections in the gluteal region, then that’s a contraindication to administering medication in those sites,” he explained. Franco Felizarta and colleagues presented data from the ATLAS-2M study, which compared medication levels and patient preferences of thigh versus gluteal injections at CROI.
Levels of medication in the body were similar after thigh and gluteal injections, and about 30% of people preferred thigh injections over gluteal injections. Participants who preferred thigh injections said that the convenience and easy access to this site on the body was preferred. Thigh injection pain was frequently reported, however, after about 40% of all injections administered.
“Injection site reactions are variable. I think that the location in the thigh would make sense anatomically, but it might give you more symptoms,” said Scott.
While the country remains in shock after Tennessee’s recent ban on public drag performances, another, more insidious attack on the LGBTQ+ community has been underway in the state.
A coordinated effort by right-wing media and conservative lawmakers has decimated community-based programs addressing healthcare for LGBTQ+ people in Tennessee, including efforts to combat HIV.
In January, Tennessee Gov. Bill Lee (R) announced his administration was rejecting $8.8 million in federal funds provided by the Centers for Disease Control and Prevention (CDC) for HIV prevention and treatment.
Left unsaid was the fact that some of those dollars had made their way to programs run by groups associated with trans healthcare. After a months-long outrage campaign by right-wing media, Gov. Lee finally threw the baby out with the bathwater.
The pressure campaign started in September, when right-wing provocateurs Matt Walsh and Ben Shapiro set their sights on the transgender care program at Nashville’s Vanderbilt University Medical Center, which Walsh described as “barbaric.”
“They now castrate, sterilize, and mutilate minors as well as adults,” Walsh said at the time.
Walsh amplified the accusations with an appearance on Tucker Carlson’s Fox News show on September 21 publicizing his “investigation,” while the Daily Wire co-founder Shapiro promoted the charges on his YouTube channel and podcast, detailing “nonsense garbage that a boy can be a girl and a girl can be a boy.”
The very next day, Gov. Lee issued a statement calling for a “thorough investigation.”
The accusations ignited a social media firestorm and surfaced the existence of the Tennessee Transgender Task Force, a volunteer team at Vanderbilt focused on trans health and HIV prevention, funded in part by those CDC dollars.
Weeks later, in November, the trans program’s director Dr. Pamela Talley told staff that federal dollars funding the task force, as well as Tennessee Planned Parenthood, would cease at year’s end.
Then in mid-January, the Lee administration announced it would not just end funding for those recipients, which totaled $235,000, but also that it would reject entirely a pair of CDC grants directed at HIV prevention, treatment and monitoring in the state worth more than $8.8 million.
“People have been crying all week,” one Tennessee Health Department staffer told NBC News after the announcement on January 20.
Ashley Coffield, the CEO of Planned Parenthood of Tennessee and Northern Mississippi, said the decision “felt like they were punching me in the gut.”
“I couldn’t believe that the governor would take the nuclear option,” she said, adding that she saw the move as a “political vendetta against abortion rights groups and transgender people.”
On Wednesday, newly appointed Tennessee Health Commissioner Ralph Alvarado told a state Senate committee that money from the grants would be replaced with $9 million in state funds.
Alvarado called the federal grants “cumbersome.”
“I think this is going to allow a bit of innovation, a little bit of liberty,” Alvarado testified. “I think it’s going to help vulnerable populations: people who are in human trafficking populations, mothers, children, first responders.”
But those populations, also identified by the governor’s office, are not the ones most affected by the HIV epidemic in Tennessee, experts say.
“Tennessee is preferring to fight a fictitious epidemic rather than their very real HIV epidemic,” Greg Millett, the director of public policy at amfAR, The Foundation for AIDS Research, told NBC News.
“First responders are just not at risk for HIV anywhere in the United States. Sexual trafficking is awful, but it’s not a major contributor for HIV cases in Tennessee or elsewhere.”
He added: “All of this is willful ignorance on the part of the state government.”
When State Sen. Jeff Yarbro (D-Nashville) asked Alvarado if future state funding would focus on the highest-risk groups, including men who have sex with men and intravenous drug users, the health commissioner was less than definitive.
“I imagine that the same populations they’ve been approaching will continue to receive benefits from this.”
A decade into the era of the HIV prevention pill, called PrEP, efforts to leverage its heralded power to curb new infections have stagnated in the United States.
This shortfall is a key reason the nation lags far behind many others in combating HIV, with a national epidemic long plagued by racial inequities and only a modestly declining new infection rate.
“We are reaching a scientific crisis in HIV prevention,” LaRon Nelson, an associate professor of nursing and public health at Yale University, said last month at the Conference on Retroviruses and Opportunistic Infections in Seattle. Nelson lamented the gulf between PrEP’s impressive performance in major studies and its moderate real-world impact.
On the bright side, PrEP, which is short for pre-exposure prophylaxis and involves taking either oral or injectable prescription antiretroviral medications in advance of potential HIV exposure, has indeed achieved substantial popularity — but only among white gay and bisexual men, who have long seen a dropping HIV rate.
Such inequity persists despite the efforts of a nationwide public-health army and countless millions of dollars spent promoting and facilitating PrEP use among Black and Latino gay and bi men. Of all major intersectional demographics, these groups contract HIV at the highest rates, and transmissions among them have flatlined or barely declined in recent years.
And so, even amid the national reckoning over racial inequity, PrEP has only served to widen HIV-transmission racial disparities among men who have sex with men.
According to the Centers for Disease Control and Prevention, gay and bi men account for 70% of new cases of the virus. Whites in this demographiccomprised 15% of the 34,800 HIV transmissions in 2019, while the much smaller populations of their Black and Latino peers comprised a respective 26% and 23% of new cases.
Additionally, more than a year after the approval of a long-acting injectable form of PrEP, ViiV Healthcare’s Apretude, few are receiving it. Insurers have mostly refused to cover the expensive drug. Consequently, even after clinical trials found injectable PrEPwas dramatically superior to oral PrEP at preventing HIV on a public health level, especially among Black gay men, Apretude’s potential will likely remain untapped for the foreseeable future.
Troubling statistics
Gilead Sciences’ two-drug combo pill Truvada was approved as PrEP in 2012 and was followed in 2019 by a similar drug, Descovy. When either drug is taken daily, this lowers the risk of HIV by at least 99% among gay and bi men and transgender women, according to multiple studies.
PrEP has helped drive down HIV rates in cities where it has achieved a critical mass of popularity, such as in New York, San Francisco andSeattle. But nationally, PrEP has failed to move the needle by much.
HIV prevention drug Descovy, at Pucci’s Pharmacy in Sacramento, Calif., on Oct. 7, 2019.Rich Pedroncelli / AP file
The CDC estimates annual HIV transmissions declined by only 8%between 2015 and 2019. Cases are even rising in some states where HIV prevention investment is lacking, such as Tennessee, where Republican Gov. Bill Lee recently compounded the factors worsening his state’s epidemic by blocking $8.3 million in annual CDC prevention funding.
Approximately 814,000 gay and bi menin the U.S. are good PrEP candidates, the CDC estimates. Between 2017 and 2022, the number of people using PrEP, who have always overwhelmingly been gay and bi men, at any point during each given year increased from 155,000 to 382,000. However, a CDC study presented in Seattle found that in September 2022, just 187,000 people were on PrEP within that 30-day window, suggesting that many people do not take it for long.
PrEP’s increasing popularity likely could have put a major dent in the national HIV rate had its use more closely reflected viral-transmission demographics, according to HIV prevention experts. Of the CDC’s estimate of 21,900 new HIV cases in 2019 (the most recent year for which the agency has produced a transmission estimate) in the three largest racial groups among gay and bi men, a respective 23%, 41% and 36% were in whites, Blacks and Latinos. But a lopsided 69% percent of PrEP users last year were white, while only a respective 9% and 18% were Black and Latino.
Apretude’s approval promised progress
Approved in December 2021, Apretude requires receiving an injection by a health care worker every two months. Compared with providing trans women and men who have sex with men Truvada as PrEP, giving them Apretude was associated with a 66% lower overall HIV diagnosis rate in a major clinical trial.
Apretude’s superior efficacy was driven by the fact that participants adhered better to the injection schedule than to the daily pill regimen.
Dr. Hyman Scott, an HIV prevention expert at the San Francisco Department of Public Health, reported at the Seattle conference that of the 844 Black American participants in the trial, those randomized to receive the injectable drug had a 72% lower HIV rate than those who got Truvada.
His analysis suggests that if 10,000 similar Black gay and bi men and trans women were followed for one year, approximately 50 would contract HIV if given Apretude, while 200 would test positive if provided Truvada.
Such sobering findings about Truvada’s shortcomings are in keeping with previous studies finding relatively low rates of adherence to the daily PrEP regimen among Black gay men. Such data suggests that even if HIV prevention advocates succeeded in vastly increasing oral PrEP access in this population, it might have only limited impact among them.
Referring to Apretude, Scott told NBC News, “Whether we can get this rolled out in communities is the real question.”
Mayor London Breed, right, shakes hands with Dr. Hyman Scott at Zuckerberg San Francisco Hospital on Sept. 10, 2019.Gabrielle Lurie / The San Francisco Chronicle via Getty Images file
Cost is a major rub. Since 2021, Truvada has been available from multiple generic manufacturers and now often costs as little as $25 to $35 per month, although in some cases up to $600. ViiV lists Apretude at $1,878 per month, and few insurers are covering it.
The recent CDC PrEP-use study presented in Seattle found that only about 1 in 200 PrEP prescriptions were for Apretude in September.
“There are patients who are getting Apretude now, but it’s people who have health care access, who have health care literacy, who call their insurance companies and yell at the right people,” said Dr. Anu Hazra, a physician at the LGBTQ-focused Howard Brown Health in Chicago.
Since 2021, almost all insurers have been obliged under the Affordable Care Act to cover oral PrEP with no out-of-pocket costs for the medications or the quarterly clinic visits and lab tests required to maintain a prescription. This is because in 2019, an advisory body known as the U.S. Preventive Services Task Force gave PrEP an “A” rating for being a worthy preventive tool.
In December, the task forceissued a draft decision granting Apretude its own “A” rating. If this rating is made official this year, insurers will be required to cover Apretude, and with no cost sharing — but not until January 2025.
Apretude updates
In addition to the associated burden of having to come in six times per year for injections, Apretude does have a notable shortcoming: Breakthrough HIV cases are apparently much more likely among those taking injectable versus oral PrEP.
Of the 25 people who contracted HIV in the 2,282-person Apretude arm of the injectable-versus-oral PrEP trial among gay and bi men and trans women, six did so after getting their injections on schedule, according to a presentation in Seattle by Dr. Susan Eshleman, a professor of pathology at Johns Hopkins Medicine.
Eshleman’s team has not yet calculated the per capita Apretude breakthrough infection rate, but when these researchers initially reported last year that the trial saw seven breakthrough infections (before revising this figure down to six), their calculations suggested that if 10,000 similar men and trans women were followed for one year, 15 would contract HIV despite receiving on-schedule Apretude injections.
Apretude.ViiV Healthcare
At the same Seattle conference, Hazra reported the first breakthrough HIV case in an Apretude patient outside of a clinical trial. By comparison, nearly four years passed after Truvada’s approval as PrEP before a breakthrough infection was first documented in someone faithfully taking that drug.
All this suggests that for those with a history of taking daily oral PrEP on schedule, switching to Apretude would actually increase their HIV risk; although the absolute risk of infection would remain low.
Optimism in the pipeline
HIV prevention experts report excitement about the PrEP pipeline and expectations that in the coming decade, more convenient and longer-acting forms will be approved.
“I’m wildly optimistic,” said Sharon Hillier, a prominent HIV prevention researcher at the University of Pittsburgh. “We just have to work through how to deliver these interventions and how to be less burdensome for health care systems.”
The Seattle conference heard promising early stage research findings regarding medication-infused suppositories that could be placed into the rectum or vagina up to 48 hours following sex and likely prevent HIV. And researchers are developing implants that could be placed under the skin and emit preventive medication for many months.
Gilead is also running major PrEP trials of the drug lenacapavir, which requires an injection only every six months. Dr. Jared Baeten, who leads Gilead’s HIV strategy, said the company hopes to provide initial study results by 2025.
But if Apretude’s pacing is any guide, it could be 2030 before lenacapavir is both approved and widely covered by insurers.
In the meantime, PrEP advocates continue to express dedication to work with the options currently on the table, albeit within a complex and fractured health care system that proves alienating to many of those most at risk of HIV.
The federal government is seeking public input concerning whether its Medicare department should cover HIV pre-exposure prophylaxis and PrEP medication nationwide, including a new injectable drug that has been developed.
Centers for Medicare and Medicaid Services (CMS) is considering whether it will cover HIV prevention pre-exposure prophylaxis drugs (PrEP) such as Apretude, a prescription injectable given every two months to individuals at risk of contracting HIV.
As part of the analysis, CMS seeks comments from the public, particularly those that include scientific evidence.
As of 2020, Medicare coverage for PrEP varies by state or county, but the average cost of the prevention is $2276 to $2430 per year, Endpoints News reports.
For a service to qualify for national coverage, it must be rated an A or B by the U.S. Prevention Services Task Force (USPSTF). The task force gave long-acting injectable PrEP an A rating last month. Oral PrEP received an A rating in 2019.
Under the Affordable Care Act, health insurance plans and private insurers that the ACA approves are required to cover preventive services that receive an A or B rating.
According to CMS, this analysis comes at the same time as the U.S. Preventive Services Task Force updated a recommendation for prescribing PrEP with effective antiretroviral therapy to HIV-infected individuals last month and gave the proposal an A.
ViiV Healthcare, a subsidiary of GSK, formally requested a national coverage determination last February after FDA approval in December 2021. Apretude is approved for use in adults and adolescents who weigh at least 77 pounds. Initiation injections for Apretude are given one month apart, followed by two monthly injections.
Representatives for the drug manufacturer asked government regulators to issue the passing certificate quickly.
“Given that the USPSTF’s current Grade A recommendation, by its terms, broadly applies to all PrEP therapies (even if it was based on clinical evidence supporting daily oral tenofovir disoproxil fumarate-emtricitabine), it is appropriate to apply the USPSTF’s current Grade A recommendation for PrEP to APRETUDE,” wrote Andrew Zolopa, head of ViiV North America Medical Affairs, in a letter to CMS. “Finally, provider-administered PrEP is appropriate for individuals enrolled under Medicare Part B. Data show that the Medicare program covers approximately 10% of individuals who could benefit from PrEP, including primarily younger individuals who are eligible for Medicare based on disability.”
On Black HIV/AIDS Awareness Day, we must remember the myriad ways the work to end the HIV epidemic overlaps with the work for LGBTQ justice and overlaps with the work to dismantle white supremacy. One of these overlaps is laws that criminalize HIV.
HIV criminalization is when a state criminalizes otherwise legal conduct or increases the penalties for illegal conduct based on a person’s HIV status. As of 2022, there are at least 35 states with HIV criminalization laws.
Each state’s laws vary. Some require the prosecution to prove the person intended to expose others to HIV, but in most states, simply not disclosing your HIV status is enough to convict. Apart from several state reforms over the last few years, no states require evidence of actual transmission or an intent to do harm.
Following a bad breakup, Suttle’s former partner reported him to the police, stating he was unaware of Suttle’s HIV status. Under Louisiana law, it is illegal to engage in sexual activity if you know your HIV status and do not disclose it. Suttle says he disclosed his status, but it was a case of he said, he said. At court, he took a plea deal to avoid trial and the possibility of the maximum sentence. As a result, he was charged with a felony and spent six months in prison.
After his release, Suttle was placed on the state’s sex offender registry, which places a mark on his driver’s license, and he was forced to publish a photo of himself in the newspaper.
Suttle’s story is a typical example of how HIV criminalization laws are used, and how they further criminalize marginalized and BIPOC communities.
States like Louisiana have laws that are outdated, based on obsolete science and misconceptions of HIV. Many of the HIV criminalization laws were drafted in the late 1980’s at the onset of the HIV epidemic and were driven by public fear when very little was known. In some states, spitting or biting — which has little possibility of transmission — are criminalized. In other states, safe sex practices (such as condom use) are irrelevant and cannot be used as defenses.
Most laws also do not take into account the fact that undetectable equals untransmittable. Once someone reaches a point in their treatment where the amount of the virus in their body is so low that it doesn’t show up on blood tests, they are said to have reached an undetectable viral load. A person with an undetectable viral load cannot pass the virus along to anyone.
Science has progressed by leaps and bounds, making treatment of STIs more manageable and HIV no longer a death sentence. The science has moved forward, it’s time for the law to follow suit.
What’s more, these laws are a barrier to preventing the spread of HIV. HIV criminal laws stigmatize HIV, discourage individuals from knowing their status and accessing medical treatment. That’s why almost all major public health organizations — including the American Medical Association, the Centers for Disease Control and Prevention, and the Presidential Advisory Council on HIV/AIDS — all urge a public health approach over criminalization.
New York is one state poised to update its archaic HIV laws, a law that was first written in 1909 to prevent the spread of “venereal diseases” among members of the military.
With the onslaught of World War II, combatting sexually transmitted infections (STIs) became a national priority as their treatment took soldiers out of commission for months. In 1943, the New York legislature increased the penalty to a felony. In 1946 the law was rewritten again making it applicable to the general public and a misdemeanor. It remains unchanged 76 years later.
The New York state law does not make sense in the age of modern medicine.
Pending before the New York state legislature is the REPEAL STI Discrimination Act. The act will repeal the state law that criminalizes STIs and provides for the expungement of past convictions. It also creates a defense so that having an STI does not mean potential criminal charges when engaging in consensual sex.
The New York legislature should pass the REPEAL STI Discrimination Act, and other states should quickly follow suit, because we are all only as safe as the members of our community most at risk and for HIV.
Public health advocates have long known that the best way to promote everyone’s health is an approach that treats people as individuals who need care rather than vectors for disease or criminals to be punished. Decreasing stigma and increasing access to testing, treatment and support are the best ways to combat disease.
On this Black HIV/AIDS Awareness Day, let us stand in solidarity and work to repeal all HIV criminalization laws.
Jose Abrigo is Lambda Legal’s HIV Project Director and Carl Baloney Jr. is AIDS United’s vice president and chief advocacy officer.
Tennessee’s recent decision to reject over $8 million in federal funds to combat HIV was motivated, at least in part, by right-wing provocateurs stoking anti-LGBTQ sentiment, according to four sources within the state Health Department.
The move by Republican Gov. Bill Lee will hamstring, if not cripple, efforts to combat one of the country’s most poorly controlled epidemics of the virus, HIV advocates said.
The announcement followed a political crisis in Tennessee that began in September when conservative media personalities, including Matt Walsh and Ben Shapiro, launched attacks on Vanderbilt University Medical Center over its care of transgender minors, which they alleged was barbaric.
Gov. Bill Lee delivers his inaugural address in the Legislative Plaza in Nashville, Tenn., on Jan. 21, 2023.John Amis / AP file
In October, the pressure wound its way to the unit that combats HIV, sexually transmitted infections and viral hepatitis at the Tennessee Health Department.
On Oct. 24, the unit’s director, Dr. Pamela Talley, told employees that because of the social media firestorm over Vanderbilt, information about the Tennessee Transgender Task Force — a volunteer team the unit established in 2018 to focus on trans health and HIV prevention — and other trans resources had been scrubbedfrom the department’s website. That is according to two staffers present, who, like two of their colleagues, spoke anonymously because they were not authorized to speak to the media.
Then, on Nov. 7, Talley told the unit that federal HIV funding from the Centers for Disease Control and Prevention for both the task force and Planned Parenthood in Tennessee would terminate at the end of the year, according to three staffers at the meeting, which took place in person and on a conference call.
“There were at least three different levels of leadership on the call,” a staffer said. “It was discussed that there had been media attention around the Vanderbilt trans health clinic, which led those reporters to learn about the trans task force, and that they were funded by [the state Health Department] HIV prevention program and that all HIV prevention contracts were being reviewed.”
People walk outside Vanderbilt University Medical Center in Nashville, Tenn., on July 16, 2013.Mark Humphrey / AP file
In mid-January, the Lee administration announced it would pull the plug not just on federal HIV-prevention funds for Planned Parenthood and the task force, which total $235,000, but on all $8.3 million from a pair of CDC grants for HIV prevention, treatment and monitoring in the state. The move shocked HIV experts and advocates.
In addition, the Lee administration, which has said it will replace the federal funds with state dollars, has pledged a shift in funding priorities that would effectively steerHIV prevention efforts away from groups at substantial risk of contracting the virus, including gay men and people who inject drugs.
“All of this is willful ignorance on the part of the state government,” said Greg Millett, the director of public policy at amfAR, The Foundation for AIDS Research. “People at risk for HIV are going to suffer because of these decisions.”
Right-wing media pile-on
A leading voice in the right’s opposition to the treatment of gender dysphoria in minors, Matt Walsh, a columnist for the conservative media outlet Daily Wire, published a series of widely read tweets on Sept. 20 targeting Vanderbilt University Medical Center’s treatment of minors at its Transgender Health Clinic. “They now castrate, sterilize, and mutilate minors as well as adults,” Walsh said.
The next day, Walsh appeared on Tucker Carlson’s Fox News show to publicize his investigation, and Ben Shapiro, a conservative commentator who co-founded Daily Wire, further amplified Walsh’s attacks on Vanderbilt on his YouTube channel and podcast, decrying the “nonsense garbage that a boy can be a girl and a girl can be a boy.”
Matt Walsh speaks about firm traditional gender roles and definitions in Phoenix on Dec. 18. 2022.John Rudoff / Sipa USA via AP file
The same day, Lee issued a statement calling for a “thorough investigation.”
“We should not allow permanent, life-altering decisions that hurt children or policies that suppress religious liberties, all for the purpose of financial gain,” he said. “We have to protect Tennessee children.”
Walsh, Shapiro, Daily Wire and Fox News did not respond to requests for comment, and the Lee administration did not respond to questions about the impact right-wing media personalities had on the state’s rejection of federal HIV funds.
Ray Holloman.Emily April Allen
A Daily Wire article published on Oct. 20, which denounced the Tennessee Transgender Task Force as an “extreme” activist group, appears to have drawn the Lee administration’s attention. The task force, according to its chair, Ray Holloman, is staffed by trans-identified volunteers and focuses on providing HIV educational resources, sharing health insurance information and connecting people to supportive health providers — including those at Vanderbilt.
The article took a victory lap, saying that the Lee administration and the state Health Department denounced the task force “in response to a Daily Wire inquiry” and that information about the task force on the department’s website was “only removed after the Daily Wire asked about it.”
Around the same time, two Health Department supervisors told staffers in private conversations that critical media coverage provoked the Lee administration to scrutinize the source of the task force’s $10,000 in annual funding — a $6.2 million CDC HIV prevention and surveillance grant — two Health Department employees said.
Also under new scrutiny after the article was published, fouremployees said, was Tennessee’s Planned Parenthood program, which received $225,000 a year from the CDC grant, largely for condom distribution.
In a Nov. 7 email that was among a collection of correspondence shared with NBC News by Ashley Coffield, the CEO of Planned Parenthood of Tennessee and Northern Mississippi, Talley informed Coffield that the Health Department’s separate arrangement to supply Planned Parenthood with about 500 HIV test kits a year would be canceled. Talley subsequently wrote to Coffield, “I want to thank you for your statewide efforts in HIV testing and reassure you that this discontinuation was not based on performance concerns.”
Ashley Coffield is the CEO of Planned Parenthood of Tennessee and Northern Mississippi.Planned Parenthood
Three days later, Coffield said, she got a call from a director at the United Way of Greater Nashville, which distributes the CDC grant funds to dozens of community-based organizations in Tennessee, including Planned Parenthood. The director, Niki Easley, said Planned Parenthood would lose its $225,000 in CDC HIV prevention grant funds at year’s end. Coffield said Easley told her that politics were behind the funding cut. “I think you should fight back,” Coffield recalled Easley’s saying.
But there was a wrinkle in the state’s plan:Because of a 2013 legal injunction, the Lee administration could not legally block HIV-related federal funds specifically for Planned Parenthood.
In the collection of emails and letters Planned Parenthood provided to NBC News, the nonprofit’s attorneys threatened to sue. In an emailed response, the Health Department’s attorney, Mary Katherine Bratton, denied having tried to disqualify the organization for the funds but said the department was “currently reviewing all” CDC grants.
Several officials at the Health Department, including Talley, Bratton and communications staffers, did not respond to requests for comment.
After it contacted Easley and several of her colleagues at the United Way of Greater Nashville, NBC News heard from a spokesperson, who said the group “is working closely with the Tennessee Department of Health to understand the changes being made to this grant funding,” adding that “the details of the changes and how our partner agencies will be affected are still developing” and that “all funding decisions are made by” the Health Department.
‘The nuclear option’
Ultimately, instead of focusing on cutting funds for Planned Parenthood and the Tennessee Transgender Task Force, the Lee administration decided to pull the plug on the entire $8.3 million in CDC grants for HIV prevention, surveillance and treatment.
On Jan. 17, Health Department officials held an 8 a.m. meeting with HIV prevention staffers and informed them of the decision to end all CDC HIV grant funding effective June 1, according to two employees who were present.
“People have been crying all week,” a staffer said in a Jan. 21 interview.
Coffield said “it felt like they were punching me in the gut” when she found out the state was abandoning the grants.
“I couldn’t believe that the governor would take the nuclear option,” she said, adding that she views the decision as the culmination of a “political vendetta against abortion rights groups and transgender people.”
Tennessee Department of Health in Nashville, Tenn.Google Maps
The rejected grants consist of the $6.2 million for HIV prevention and surveillance and $2.1 million for Shelby County, home to Memphis. The latter sum comes from a national plan focused, in part, on improving treatment and prevention of HIV in 50 local hot spots that account for about half of new HIV diagnoses nationally — a plan President Donald Trump endorsed in his 2020 State of the Union address.
Friends for Life, a nonprofit Memphis group that provides services to those living with and at risk for HIV, will lose about $500,000 a year, chief programs officer Mia Cotton said. The imminent lack of any federal grants will also render the organization’s health clinic ineligible for pharmaceutical rebates through a separate federal program that last year brought in $1.2 million to an overall operating budget of $8.5 million, Cotton said.
Molly Quinn, the executive director of OUTMemphis, Tennessee’s largest LGBTQ nonprofit group, said her organization would lose $120,000 a year, or 10% of its operating budget, compromising efforts to provide HIV testing, help clients access the HIV prevention pill, PrEP, and give financial assistance to people with the virus.
‘A fictitious epidemic’
The Lee administration says it will replace the $8.3 million in CDC grants with state funds, giving it freedom to target such resources as it sees fit.
“We think we can do that better than the strings attached with the federal dollars that came our way, and that’s why we made that decision,” Lee said Jan. 20.
Currently, the priority populations for the CDC grant for Shelby County, for example, include LGBTQ people, sex workers and those who inject drugs, are unhoused or are formerly incarcerated.
Lee’s press officer, Jade Byers, said in an email that the administration “is committed to maintaining the same level of funding, while more efficiently and effectively serving vulnerable populations, such as victims of human trafficking, mothers and children, and first responders.”
Those priorities, HIV prevention experts said, are in egregious conflict with the actual demographics of the people most at risk of the virus.
“Tennessee is preferring to fight a fictitious epidemic rather than their very real HIV epidemic,” said Millett, of amfAR. “First responders are just not at risk for HIV anywhere in the United States. Sexual trafficking is awful, but it’s not a major contributor for HIV cases in Tennessee or elsewhere.”
Women comprised 9% of HIV diagnoses in Tennessee in 2019, down from 14% in 2016, and only 1 to 6 babies were born with HIV in the state annually from 2016 to 2020.
More than half of new diagnoses in Tennessee were in men who have sex with men in 2019, according to the state Health Department’s surveillance reports. And in 2016, the CDC released a report warning that 220 of the country’s counties, including 41 in Tennessee, were at high risk of HIV and hepatitis C outbreaks among people who inject drugs (that population accounted for 5% of new Tennessee HIV diagnoses in 2019).
New U.S. HIV cases, the CDC estimates, declined by 8% from 2015 to 2019, but that masks considerable progress in some states and either stagnancy or increases in most Southern states, where the bulk of transmissions occur. Even as HIV has steadily declined in, for example, New York and California, where liberal governments have invested heavily in evidence-based HIV treatment and prevention programs, the CDC estimates that Tennessee’s transmissions increased slightly from 2017 to 2019.
While Lee announced Jan. 20 that the state would forgo the federal HIV dollars, a CDC spokesperson said Thursday that the agency had received no word from Tennessee that it intends to block the $8.3 million in grants.
The political climate has become increasingly toxic for LGBTQ people in Tennessee, advocates in the state say.
Since he took office in 2019, Lee has signed several bills that target transgender youths, including one that bars trans students from joining sports teams that align with their gender identities. And so far this year, conservative Tennessee lawmakers have filed at least 11 bills targeting LGBTQ people, including one, which Lee said he supports, that would ban gender-affirming medical care for all minors.
Nationally, lawmakersin at least 21 states have proposed bills to ban or restrict gender-affirming care for minors this year. Trump released a video Tuesday on Truth Social pledging to “stop” such care, which he described as “child sexual mutilation.”
