To mark the 12th anniversary of the Affordable Care Act (ACA), the Department of Health & Human Services (HHS) is hosting a weeklong celebration to praise its accomplishments. But in the name of health equity for transgender people, who are adversely affected by HIV/AIDS, HHS is also asking for more.
In a letter shared exclusively with LGBTQ Nation, the HIV/AIDS Bureau (HAB) of the Health Resources and Services Administration (HRSA) is asking the Ryan White HIV/AIDS Program (RWHAP) to leverage its existing infrastructure and resources to not only continue providing direct HIV/AIDS care to transgender people, but to provide gender-affirming care as well.
Established thirty years ago, RWHAP serves low-income people with HIV. Today, approximately 50% of those diagnosed with HIV receive support through it annually.
Rates of HIV viral suppression among transgender patients of RWHAP are lower than the organization’s overall average – 84.5 percent versus 89.4 percent. As such, the letter says more must be done to ensure transgender people are not left behind.
“HRSA’s HIV/AIDS Bureau sent this to Ryan White HIV/AIDS Program service providers to reaffirm the importance of providing culturally-affirming health care and social services to the transgender community as a key component to improving the lives of transgender people with HIV and eliminating health disparities,” Dr. Laura Cheever, Associate Administrator of the HRSA HIV/AIDS Bureau, told LGBTQ Nation.
“While not a new policy or approach to the services delivered by the program, The letter builds on initiatives that support patient-centered, trauma-informed, and inclusive environments of care for Ryan White HIV/AIDS Program clients. The goal is to help reduce medical mistrust and other barriers to antiretroviral therapy adherence for transgender people with HIV.”
The letter asserts that “providing gender-affirming care is an important strategy to effectively address the health and medical needs of transgender people with HIV.” The program, it says, already serves about 11,600 trans people (2.1% of those served overall) that would benefit from these services.
It goes on to say that funds directed toward RWHAP are allowed to be used for certain types of gender-affirming care and support, including hormone therapy, behavioral and mental health services for those experiencing discrimination and/or gender dysphoria, and cost-sharing assistance for insurance coverage, which would give trans people greater access to the care they need. It also said several RWHAP AIDS Drug Assistance Programs already provide access to hormone therapy.
Because it is an outpatient ambulatory health care program, though, the letter says RWHAP cannot provide surgeries or inpatient care.
The letter also urges RWHAP to provide other types of support to transgender people living with HIV/AIDS, such as housing, case management, and treatment services for substance abuse.
The letter, signed by Cheever, emphasizes the need to “provide affirming, whole person care to transgender people with HIV.”
“This is true especially of Black and Hispanic/Latino/a transgender women who are disproportionally impacted by HIV and other intersecting social and health challenges,” it says.
“While transgender Ryan White HIV/AIDS Program clients receiving HIV medical care have reached higher viral suppression rates than the national average, we recognize that we need to do more to support this community,” Cheever said in a press release.
“To help achieve the goals of the National HIV/AIDS Strategy, including achieving health equity and ending the HIV epidemic, we will continue to support and share evidence based, evidence informed, and emerging interventions that focus on the specific needs of this community to improve the health and lives of transgender and gender diverse people with HIV.”
Also in recognition of the 12th anniversary of the ACA, HHS is hosting a weeklong celebration, with each day focusing on different communities the ACA has reached.
Today’s focus is “Celebrating Health of LGBTQI+ and Communities of Color.” According to HHS, the ACA has reduced the number of uninsured LGBTQ people by almost 50% since 2010.
Since taking office, the Biden administration has also restored an ACA provision banning discrimination in its health care programs on the basis of sex, which includes sexual orientation and gender identity.
HHS also said the ACA has also helped community organizations dedicate more resources to HIV/AIDS care through RWHAP.
While the One Male Condom is not markedly different from the hundreds of other condoms on the market, it is the first that will be allowed to use the “safe and effective use” label for reducing sexually transmitted infections during anal sex. It is also approved for use as a contraceptive and as a means to reduce STIs during vaginal intercourse.
“This landmark shift demonstrates that when researchers, advocates, and companies come together, we can create a lasting impact in public health efforts,” Davin Wedel, president and founder of Boston-based Global Protection Corp, maker of the One Male Condom, said in a statement. “There have been over 300 condoms approved for use with vaginal sex data, and never before has a condom been approved based on anal sex data.”
Courtney Lias, director of the FDA’s Office of GastroRenal, ObGyn, General Hospital and Urology Devices, noted that the risk of STI transmission during anal intercourse is “significantly higher” than during vaginal intercourse.
“The FDA’s authorization of a condom that is specifically indicated, evaluated and labeled for anal intercourse may improve the likelihood of condom use during anal intercourse,” Lias said in a statement. “Furthermore, this authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations.”
Anal sex poses the highest risk for contracting HIV, with the risk of HIV transmission from receptive anal sex about 18 times higher than receptive vaginal sex. Gay and bisexual men accounted for 69 percent of the 36,801 new HIV/AIDS diagnoses in the U.S. in 2019, according to the Centers for Disease Control and Prevention. Queer men of color were overrepresented within this group, with Black men representing 37 percent, Latino men representing 32 percent and white men representing 25 percent of these new diagnoses, according to the CDC.
One Male Condoms are available in standard, thin and fitted versions, and the fitted version is available in 54 different sizes.
A clinical trial of 252 men who have sex with men and 252 men who have sex with women found the One Male Condom has a failure rate of 0.68 percent for anal sex and 1.89 percent for vaginal sex, according to the FDA, which defined condom failure as condom slippage or breakage.
Dr. Will DeWitt, clinical director of anal health at the Callen-Lorde Community Health Center in New York City, said the newly approved condoms could be a helpful tool for HIV/AIDS prevention.
“The hope would be that people would be more willing to use condoms for anal sex and to have that direct encouragement would increase the rates of people using them,” DeWitt said. “Condoms still remain an important tool for people who don’t want to or can’t use PrEP.”
PrEP, or pre-exposure prophylaxis, is typically taken in the form of a daily pill to prevent HIV/AIDS in people who are not diagnosed with the virus. Last year, the FDA also approved an injectable PrEP shot that can be given every two months.
DeWitt did, however, add that he is worried the One Male Condom name and marketing could alienate those who engage in anal sex but do not identify as male.
“Anal sex really does belong to everyone,” DeWitt said. “Even if it’s the perspective of who has to wear the condom, it’s not just male bodies and male identified folks who need to use it.”
While health experts have long encouraged the use of condoms for STI prevention through anal sex, DeWitt said FDA’s official approval is long overdue.
“Here we are in 2022, and we are only now getting condoms approved for anal sex,” DeWitt said, noting that it’s been more than three decades since the start of the HIV crisis. “It’s a little frustrating that it’s taken this long to have this kind of official endorsement.
In a large clinical trial assessing Apretude, ViiV Healthcare’s recently approved injectable drug, as a form of HIV prevention, seven participants contracted the virus despite receiving their injections on schedule.
The new findings indicate that, just as with those who take daily pills to prevent HIV, breakthrough infections are possible among people receiving Apretude.
Dr. Raphael J. Landovitz, who led the Apretude clinical trial in question, told NBC News that he expects such cases of PrEP failure to remain what he characterized as rare, regardless of which form of preventive antiretroviral medication people at risk of HIV receive.
Apretude is nevertheless so efficacious, Landovitz said, that the drug has “the potential to end the HIV epidemic, particularly for people who are challenged with taking oral PrEP.”
Landovitz, an infectious disease specialist at UCLA, said it might always remain unclear why the breakthrough infections among those receiving Apretude occurred. He and his colleagues already know that the blood concentrations of the drug in the first four people to experience such infections weren’t unexpectedly low.
The Food and Drug Administration approved Apretude for use as what’s known as pre-exposure prophylaxis, or PrEP, against HIV on Dec. 20. The long-acting drug, which is meant to be injected every two months by a health care worker, joined two daily pills — Gilead Sciences’ Truvada and Descovy — that were approved as PrEP in 2012 and 2019, respectively.
HIV advocates have looked to Apretude as a potential solution to this enduring medication-adherence problem. And yet, receiving Apretude requires a clinic visit every two months, compared with visits every three months to maintain a prescription to Descovy or Truvada as PrEP.
Men who have sex with men account for an estimated 70 percent of the approximately 35,000 HIV transmissions in the United States each year, according to the Centers for Disease Control and Prevention.
Apretude vs. Truvada
One of the two double-blinded clinical trials that prompted the FDA to approve Apretude for use as PrEP included 4,566 cisgender MSM and transgender women in the U.S. and six other nations in Latin America, Asia and Africa. (A second trial included cisgender women in Africa.) Half of the 1,698 U.S. study members were Black.
The participants, who were all deemed at substantial risk of contracting HIV, were randomized to receive Truvada or Apretude, with each group receiving a corresponding placebo.
In 2020, Landovitz and his colleagues announced that after a median of about 17 months of follow-up during the study’s blinded phase, those who received Apretude had about a two-thirds lower HIV acquisition rate compared with those who got Truvada. This stark difference was driven by suboptimal adherence to the daily Truvada regimen and, by comparison, greater Apretude coverage of the participants’ sex acts.
Dr. Raphael J. Landovitz speaking at the International AIDS Society conference in Paris in 2017.Benjamin Ryan
During that period, the rate of new HIV cases rose in both the Apretude and Truvada groups. This phenomenon, Landovitz suggested, was likely driven by two factors. Firstly, participants’ adherence to both the injection schedule and the pill regimen was lower after the unblinding. Additionally, during this latter trial phase, a greater proportion of the participants were living in Latin America, where the background HIV transmission rates were relatively high.
Nevertheless, Apretude injections maintained about the same rate of superior overall protection against HIV compared with oral PrEP as seen during the trial’s blinded period.
During the combined study periods, 25 people in the Apretude group and 72 people in the Truvada group contracted HIV during a nearly identical amount of cumulative follow-up time.
Breakthrough cases
The seven breakthrough infections among people who received their injections on schedule occurred during a cumulative 4,660 years of follow-up among all those in the Apretude arm of the trial. (During that time, an additional 18 people contracted HIV who did not receive Apretude on schedule.) This means that if a group of 10,000 people in similar circumstances were given Apretude, about 15 of them would be expected to experience breakthrough HIV infections over one year.
Transmission of HIV that is resistant to Apretude’s antiretroviral class, Landovitz said, is “vanishingly rare.” So he said that drug resistance cannot explain breakthrough infections among those receiving the injectable as PrEP.
Breakthrough infections also occurred in at least one, possibly two, people in the Truvada group of the Apretude trial including trans women and MSM. One additional such breakthrough case occurred in the corresponding trial of cisgender women. Further analyses are needed to determine if after each trial’s unblinding, additional people contracted HIV while adhering well to the Truvada regimen.
Research has indicated that compared with concentrations of Apretude in the blood, concentrations of the drug are about 90 percent to 92 percent lower in rectal tissues but only about 80 percent lower in tissues in the vagina and on the cervix. Landovitz told NBC News that these disparities could possibly help explain the emergence of the seven breakthrough infections among those in the Apretude arm of the PrEP study including trans women and MSM. So far, ViiV is able to report that in the PrEP trial including cisgender women, there were no cases of Apretude failure during its blinded phase; further analysis is needed to determine if such breakthrough infections occurred after that study’s unblinding.
Cost and availability
Apretude is not yet widely available in the United States. ViiV is campaigning for insurers to add the injectable preventive to their lists of covered medications.
The pharmaceutical company is up against the fact that multiple generic versions of Truvada hit the market last year and now cost as little as $26 per month. Apretude is priced at the equivalent of $1,850 per 30-day period, similar to Gilead’s pricing of Descovy and brand-name Truvada. The CDC reported at this week’s retrovirus conference that during the first three quarters of 2021, about 42 percent of U.S. PrEP prescriptions were for generic Truvada.
In a paper that Landovitz wrote with Dr. Anne M. Neilan of Harvard Medical School and others and published in the Annals of Internal Medicine on Feb. 1, they conclude that Apretude would need to have a monthly cost no greater than $308 over generic Truvada’s price to remain cost-effective.
Due to the U.S. Preventive Services Task Force granting it an “A” rating in 2019, oral PrEP must now be covered by almost all private insurers with no cost sharing. That means both the medication and the quarterly clinic visits should be free to people with private health plans. Medicaid and Medicare also cover pill-form PrEP, but they may still demand out-of-pocket payments for the prescription.
In the meantime, ViiV will offer a copay card to people with private insurance that will cover up to $7,500 in out-of-pocket expenses related to the injectable drug each calendar year, plus $350 toward injection-administration fees.
Dr. Rupa R. Patel, the PrEP Clinic Lead atWhitman-Walker Health in Washington, told NBC News that Apretude’s considerable efficaciousness notwithstanding, the drug’s every-other-month dosing schedule “is still not ideal.”
“Something taken every six months or 12 months would be better, of course,” Patel said.
Multiple additional forms of long-acting PrEP, dosed as seldom as twice per year, are indeed in the pharmaceutical pipeline. However, Merck announced in December that the company was putting a hold on all clinical development of its experimental drug islatravir after the long-acting antiretroviral was linked to declines in some trial participants’ CD4 immune cells — white blood cells that provide a key indication of immune health. This trend occurred both among those receiving the drug as HIV treatment and in those receiving it as PrEP.
A new highly-infectious and damaging strain of HIV, resulting from a mutation in the virus, has been discovered in the Netherlands.
Scientists working on the BEEHIVE project, a study of HIV genomics and virulence across Europe and Uganda, published their findings in the journal Science on Thursday (3 February).
According to UNAIDS, 38 million people around the world are currently living with the most prominent strain of the virus, HIV-1, and it has caused, to date, around 33 million deaths. HIV-2 is the other most prominent type of HIV, and is most commonly seen in West Africa.
The newly discovered mutation, a subtype of HIV-1, has been named “virulent subtype B” or the “VB variant”, and it showed “significant differences before antiretroviral treatment compared with individuals infected with other HIV variants”.
Measuring the viral load, or level of virus in the blood, of those with the VB variant, scientists found that it was between 3.5 and 5.5 times higher than those with other variants of HIV.
The new strain also damaged the immune system twice as fast, “placing them at risk of developing AIDS much more rapidly”, and those with the VB variant were at a higher risk of transmitting the virus to others.
Thankfully, scientists found that after starting treatment, “individuals with the VB variant had similar immune system recovery and survival to individuals with other HIV variants”.
But they emphasised the need to get tested often for early diagnosis, because of the rapid progression of the variant.
Lead study author Dr Chris Wymant, from the University of Oxford’s Big Data Institute and Nuffield Department of Medicine, said: “Before this study, the genetics of the HIV virus were known to be relevant for virulence, implying that the evolution of a new variant could change its impact on health.
“Discovery of the VB variant demonstrated this, providing a rare example of the risk posed by viral virulence evolution.”
Senior author professor Christophe Fraser, of the University of Oxford’s Big Data Institute and Nuffield Department of Medicine, added: “Our findings emphasise the importance of World Health Organization guidance that individuals at risk of acquiring HIV have access to regular testing to allow early diagnosis, followed by immediate treatment.
“This limits the amount of time HIV can damage an individual’s immune system and jeopardise their health.
“It also ensures that HIV is suppressed as quickly as possible, which prevents transmission to other individuals.”
According to the Terrence Higgins Trust, one in 20 people with HIV are unaware they have it, which increases the risk of damage to the immune system, and of passing it on to sexual partners.
New Jersey is set to decriminalise HIV transmission, ending an historic law that “fuels stigma”.
Under current New Jersey law, a person who engages in sexual penetration by any body part without disclosing they are HIV-positive could face up to five years in prison.
For other sexually-transmitted infections, the sentence is limited to 18 months.
On Monday (10 January), state senators voted 26-11 to pass a bill, S-3707, that would put an end to this.
The bill would still criminalise the transmission of non-airborne infectious or communicable diseases, but will no longer target those living with HIV or STIs.
“This legislation is a step in the right direction [to] removing the stigmatisation that surrounds individuals living with HIV,” said Senate majority leader Teresa Ruiz, one of the bill’s co-sponsors.
“The criminal code is meant to punish actions that harm others, not discriminate against people living with a chronic health condition.”
New Jersey state senator Teresa Ruiz speaks at the 25th Anniversary of Kid Witness News. (Paul Zimmerman/Getty Images for Kid Witness News)
Co-sponsor senator Joe Vitale said the bill would bring New Jersey in line with “what we now know about the transmissions of certain diseases, especially in light of the advances in treatment”.
It’s a law that has been a “huge priority” for activists, he said.
“I am thankful to the advocates who brought this issue to our attention, not only for leading the way on solid public health policy,” Vitale added, “but also in serving those in need in New Jersey.”
‘Criminalisation does not prevent HIV transmission’
Even activists across the pond celebrated the news, who said that such laws are based on long-outdated conceptions of what HIV is and deepen animosity.
Matthew Hodson, a British HIV activist and executive director for NAM aidsmap, which monitors HIV criminalisation law, told PinkNews: “Criminalisation of HIV creates barriers to HIV testing and treatment, which only serves to increase opportunities for HIV to be transmitted.
“Criminalisation does not prevent HIV transmission.
“There is a shameful history of such laws being used against people in cases where not only has HIV not been passed on but there was no actual possibility of HIV being passed on.
“Criminalisation fuels stigma and is often used against those who are already marginalised or vulnerable, including against LGBT people in countries with state-sanctioned homophobia.
A history of the US criminalising the transmission of HIV
At least 35 US states, many in the Midwest and Deep South – still have laws on the books that criminalise “HIV exposure”, according to the Centers for Disease Control and Prevention.
A 2017 analysis of 393 HIV-related convictions in Arkansas, Florida, Louisiana, Michigan, Missouri and Tennessee found the average sentence was nearly eight years in prison for having sex without first informing their partner of their status.
In Arkansas, ‘intentional HIV exposure’ carries a minimum of six years and a maximum of 30 years alongside thousands of dollars in fines.
People convicted of ‘intentional exposure’ in South Dakota and Louisiana are also required to register as sex offenders, the Center for HIV Law and Policy says.
Ohio and Tennessee enforce this requirement regardless of intentionality, while in Arkansas it is not a statutory requirement but a court may order it.
A man holding a PrEP tablet. (Daniel Born/The Times/Gallo Images/Getty)
At least six states even have laws that enhance sentences for sexual offences if the person convicted is living with HIV, the Movement Advancement Project found.
The Movement Advancement Project said nearly three in every 10 LGBT+ people live in a state with such outdated law in place. Such laws are often used to punish people who have done no harm, the American Academy of HIV Medicine has warned.
Michigan, for example, exempts those living with HIV who have sex without disclosing their status as long as they are on viral suppression medication.
Many states scrambled to roll out laws criminalising people living with HIV amid the paranoia of the early HIV epidemic, when acquiring the virus was considered a death sentence.
Science in no way supports laws that single out people living with HIV, and activists have argued that these laws are tinged with racism and transphobia.
People living with HIV are more likely to be trans, Black and Latinx, meaning that they are disproportionately targeted by the laws, Lambda Legal and Injustice Watch have found. Some prosecutors even weaponise hateful stereotypes of these demographics to justify the charges.
If New Jersey repeals its law, it would join Illinois and Texas in throwing out entirely their HIV-specific criminal laws.
Missouri, California, Iowa, North Carolina, Nevada, Virginia and Michigan, meanwhile, have all softened their anti-HIV laws since 2014, according to the CDC.
As the world marks 40 years of the first HIV cases to be diagnosed, an urgent new campaign and storytelling initiative is focusing attention on living with HIV and reforming laws in more than 30 states that treat HIV status as a crime. The Centers for Disease Control says these laws “discourage HIV testing, increase stigma, and exacerbate disparities,” noting they are outdated and do not reflect the significant advances to treat and prevent HIV transmission, such as effective treatments that can suppress the virus to the point of it being undetectable and therefore untransmittable (U=U). President Biden also prioritized reforming the laws in his administration’s strategy for defeating HIV by 2030, announced on World AIDS Day on December 1.
GLAAD 2021 State of HIV Stigma Study, Published August 26, 2021
For nearly two years, The Elizabeth Taylor AIDS Foundation (ETAF), in collaboration with Gilead Sciences, Inc, the Health Not Prisons Collective, other national and state coalitions have been working to modernize the outdated laws that continue to criminalize individuals for their HIV status. ETAF’s “HIV Is Not A Crime” initiative uses storytelling to communicate that these laws need to catch up with modern science. GLAAD research shows a dramatic need for such storytelling efforts to educate Americans, increase compassion and decrease stigma: with the finale of Pose this year, there will be zero characters living with HIV in any scripted television or streaming program; on film, GLAAD research notes “a complete absence of stories of people living with HIV from the previous year.”
On December 6, 2021, The Elizabeth Taylor AIDS Foundation invited Hollywood screenwriters, producers, and studios to a presentation of ‘Unjust,’ a 10 minute, one-act play about the fight to end criminalization against people living with HIV. The event also included the premiere of the Foundation’s latest video in the ‘True (Not) Crime’ series narrated by actress Annaleigh Ashford and a Q&A panel moderated by Variety’s Senior Entertainment Editor Adam Vary.
The play, written by Lee Raines and directed by Jenny Sullivan, offered a fictional account of real struggles around HIV criminalization. The Q&A panel afterward provided an honest and emotional discussion with Hon. Senator Dallas Harris of Nevada, Diana Oliva from Gilead Sciences, Inc, playwright Lee Raines, and Chair of The Elizabeth Taylor AIDS Foundation’s Council of Justice Leaders Robert Suttle.
GLAAD:What made you want to tell this story?
LEE RAINES: I embraced this project because combining my experience as an activist and as a playwright felt like the perfect fit. UNJUST was a real passion project. The Elizabeth Taylor AIDS Foundation has come up with a very compelling way to present information about the topic of HIV criminalization and to humanize it.
GLAAD: What surprised you most as you were writing the script?
LEE RAINES: I didn’t realize how easily the words would flow. The team came up with a great setting and characters in an initial brainstorming session on zoom. But the more I thought about the characters and their situation, and the more research I did, the more passionate I became. By the time I sat down to write, my blood was up, and the play came gushing out. Which was fortunate – we were on a tight deadline.
GLAAD: What’s the one thing you want people to take away from the play?
LEE RAINES: I want people to feel emotionally connected to the issue of HIV stigma and modernization. There’s a tendency to shut down our emotions when we hear the words “HIV decriminalization.” But there is a terrible human cost.
GLAAD: Why did The Elizabeth Taylor AIDS Foundation launch the “HIV Is Not a Crime” initiative, and what are the goals?
CATHY BROWN, Executive Director of The Elizabeth Taylor AIDS Foundation: The Elizabeth Taylor AIDS Foundation launched the HIV Is Not A Crime campaign in collaboration with Gilead Sciences, Inc in 2020. This campaign reveals the long-outdated laws in many states criminalizing HIV. Our goal is to find a path to modernize or repeal these laws and support those living with HIV. This will allow them to lead their lives without fear. The HIV Is Not A Crime initiative has joined national and grassroots partners to modernize HIV criminal laws across the country. We collaborate with the Health Not Prisons Collective and various other state and national organizations. We have also made it a priority to feature the lived experiences of and voices of individuals living with HIV at the forefront of our work through the Council of Justice Leaders and True (Not) Crime series. Currently, we have been focusing on changing Florida, Georgia, Illinois, Missouri, Nevada, New Jersey, Ohio, Virginia, and Tennessee.
GLAAD: Tell us more about the power storytelling has on the ability to convey a message and change the narrative?
CATHY BROWN: The storytelling and impact of both the moderated panel and the play were palpable on Monday evening. The audience in the room was audibly reacting to what they heard about the need to modernize HIV laws. You don’t get to listen to the same emotional reactions over Zoom. Nothing is more powerful than seeing and hearing individuals tell their stories in person with a live audience. Through the HIV Is Not a Crime campaign, ETAF has dedicated resources, time, and unwavering support to the state coalitions working to modernize HIV laws around the country. UNJUST touched on this aspect of the work and folded in the weight of stigma, disclosure, family impact, and health equity into the program.
GLAAD: What surprised you most about the production of UNJUST?
CATHY BROWN: I was most surprised by the real opportunities for collaboration that this event and the community that attended have presented to the organization. To hear statistics around the number of persons living with HIV currently on mainstream television – 0 – is unnerving. The more we share people’s real stories with the entertainment industry, the more we will shift public perception of the virus’ impact. We hope to roll out this production, or a similar one, to states around the country that have activists and coalitions working to modernize laws.
Watch the latest True (Not) Crime video from The Elizabeth Taylor AIDS Foundation here, featuring Andre Leaphart’s story with narration from Annaleigh Ashford. Andre was a counselor and minister until he lost everything at the age of 40, as a result of being criminalized for his HIV status. He had never been charged for anything in his life until this point. Today, Andre shares his story to help others avoid his unfair experiences with the criminal justice system and HIV stigma, and has dedicated his advocacy work to improving the lives of people living with HIV.
The Food and Drug Administration has approved the first long-acting injectable medication for use as pre-exposure prevention, or PrEP, against HIV, the agency announced Monday.
Apretude, the new drug, is an injectable given every two months as an alternative to HIV prevention pills, like Truvada and Descovy, which have been shown to reduce the risk of HIV by 99 percent when taken daily.
Two FDA trials analyzing the safety and efficacy of the novel drug found that Apretude was more likely to reduce HIV than the daily oral medications — by 69 percent for cisgender men and transgender women who have sex with men and by 90 percent for cisgender women. Apretude’s superior efficacy was apparently driven by the greater ease with which study participants adhered to the every-other-month regimen compared with taking a pill every day.
“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” Dr. Debra Birnkrant, the director of antivirals division at the FDA’s Center for Drug Evaluation and Research, said in a statement. “This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option.”
While gains have been made in PrEP use over the past several years, only 25 percent of the 1.2 million people for whom PrEP is recommended were prescribed the treatment last year, according to the Centers for Disease Control and Prevention. The CDC estimates that as of 2019, there were approximately 285,000 people using PrEP, the vast majority of them gay and bisexual men.
The hope is that the newly approved, long-acting injectable — made by ViiV Healthcare, which is majority owned by GlaxoSmithKline — will make adherence easier, help increase PrEP usage and drive down the national HIV rate.
“People who are vulnerable to acquiring HIV, especially those in Black and Latinx communities who are disproportionately impacted in the US, may want options beyond daily oral pills,” Deborah Waterhouse, ViiV Healthcare’s CEO, said in a statement, adding that “Apretude was studied in one of the most diverse and comprehensive HIV prevention trial programs to date, which also included some of the largest numbers of transgender women and Black men who have sex with men ever enrolled in an HIV prevention trial.”
Men who have sex with men accounted for 66 percent of all new HIV diagnoses in the U.S. in 2019, according to the CDC. When the numbers are broken down by race, Black Americans accounted for the highest percentage, representing 42 percent of all new diagnoses that year.
In July, the federal government announced that almost all insurers must cover the two approved forms of PrEP pills, Truvada and Descovy, as well as the lab tests and clinic visits required to maintain such prescriptions — and to do so with no cost sharing. As it stands, insurers will not be required to cover all costs for the new injectable version of PrEP, which has a list price of $3,700 per dose and is slated to begin shipping to wholesalers and specialty distributors in the U.S. in early 2022.
Kenyon Farrow, the managing director of PrEP4All, an advocacy group that fights to increase access to HIV prevention and treatment, said his organization is “definitely happy to see the FDA approval of another option for people who want to use PrEP.”
However, he said he fears that the “implementation of this option will likely take years to make it real for most people.”
“Due to COVID, public health systems are already overburdened and much of the workforce needed to implement this large scale are leaving the field due to burnout,” he said in an email. “Because it will need to be administered in clinical settings, it won’t be treated as a pharmacy benefit by payers, but instead as a clinical benefit, which will take time to implement the proper coding for billing, as well as education and training for nurses who will likely bear the brunt of the work to implement.”
Since 2001, at least 97 people have been arrested under Virginia laws that criminalize people living with HIV, hepatitis B, and syphilis, according to a new report by the Williams Institute at UCLA School of Law. HIV-related crimes are disproportionately enforced on the basis of race and sex, with Black men being the most likely to be arrested and convicted.
Using data obtained from the Criminal Justice Information Services Division of the Virginia Department of State, researchers found that charges were filed in over 70 percent of HIV-related arrests in Virginia and more than half of them resulted in a guilty outcome, resulting in sentences averaging 2.1 years.
HIV criminalization is a term used to describe laws that either criminalize otherwise legal conduct or increase the penalties for illegal conduct based upon a person’s HIV-positive status. More than two-thirds of U.S. states and territories have enacted HIV criminal laws.
Until this year, Virginia’s HIV criminalization statute contained a felony provision — which prohibited people living with HIV, Hepatitis B, or syphilis from engaging in sexual activity of any kind with the intent to transmit the infection — and a misdemeanor charge for engaging in sexual activity without disclosing a positive status.
“In reality, people have been charged with felony crimes under Virginia’s HIV criminal laws simply for not disclosing their status,” said lead author Nathan Cisneros, HIV Criminalization Analyst at the Williams Institute. “For two decades, Virginia law has singled out people living with HIV for criminal prosecution without requiring actual transmission or even the possibility of transmission. Moreover, the law ignored whether the person living with HIV is in treatment and virally suppressed, and therefore cannot transmit HIV.”
KEY FINDINGS
At least 97 people in Virginia have been arrested for HIV-related criminal offenses since 2001.
Black people account for 20 percent of Virginia’s population, but 58 percent of the state’s people living with HIV, and 68 percent of all those arrested for HIV-related offenses.
Men comprise 75 percent of people living with HIV in Virginia, but 87 percent of people arrested for HIV-related offenses.
Black men are 40 percent of people living with HIV in Virginia, but 59 percent of all people arrested for HIV-related offenses.
Nearly one-fifth (18 percent) of those arrested for HIV-related crimes had no other criminal history.
Charges were filed in over 70 percent of HIV-related arrests in Virginia. And over half (54 percent) of all charges filed resulted in a guilty outcome.
Guilty outcomes resulted in an average sentence of 2.1 years.
Incarcerating people for HIV-related offenses has cost Virginia at least $3.2 million.
Virginia is one of four states, including Missouri, Illinois, and Nevada, to modernize its HIV criminal laws in 2021. Virginia’s new law only criminalizes actual, intentional transmission, which remains a felony, and it removes HIV-specific language. Virginia also revised its donation law to align with the federal HIV Organ Policy Equity Act.
People changing their patterns of sexual behaviour because of COVID has led to a staggering drop in new HIV diagnoses, according to UK government data.
On World AIDS Day 2021 (1 December), the UK Health Security Agency (UKHSA) released data about HIV testing, new diagnoses and the ability to access HIV services in 2020.
This new data revealed that the total number of new HIV diagnoses in England dropped by 33 per cent. According to the data, there were 2,630 new diagnoses in 2020 compared to 3,950 in 2019.
Among gay, bisexual and other men who have sex with men, the number of new HIV diagnoses made in England decreased by 41 per cent from 1,500 in 2019 to 890 in 2020. The UKHSA reported 1,010 people who probably acquired HIV through heterosexual contact were diagnosed with HIV in England in 2020, a 23 per cent decrease from 1,320 in 2019.
The government agency attributed the drop in new diagnoses to COVID-19changing patterns of sexual behaviour, testing and access to sexual health and HIV services.
Dr Valerie Delpech, head of HIV surveillance at UKHSA, said that the decline in HIV diagnoses is “encouraging”. But Dr Delpech warned that the data should be “considered in the context” of the pandemic which “saw prolonged and unprecedented public health restrictions, coupled with intense pressure on health services resulting in a decline in HIV testing overall”.
“It is now crucial that we continue to ramp up testing and start people on treatment at the earliest possible opportunity,” she added. “We must address inequalities and find creative ways to achieve a reduction in transmission across all populations.”
Deborah Gold, chief executive of National AIDS Trust, described the continued decreases in HIV transmissions – driven by regular testing, access to PrEP and increases in those diagnosed having access to HIV treatment – “rays of light in the UK’s response to HIV”.
But Gold said the pandemic has had a “catastrophic impact” on testing and treatment services in the UK, and “we now need an urgent plan for their recovery”.
“HIV testing must increase markedly, and the HIV prevention drug PrEP must reach all communities,” Gold said. “The government has committed to report annually on progress towards 2030, it is vital these reports identify what progress is being made in all population groups in the UK.”
According to the UKHSA data, there had also been a big decrease in HIV testing as the number of people tested at sexual health services decreased by 30 per cent from 1,320,510 in 2019 to 927,760 in 2020.
There was a seven per cent decrease (from 157,710 in 2019 to 146,900 in 2020) in the number of gay, bisexual and other men who have sex with men having an HIV test at sexual health services.
In contrast, the number of heterosexual people tested fell by 33 per cent from 1,142,950 in 2019 to 760,260 in 2020.
Debbie Laycock, head of policy at Terrence Higgins Trust (THT), told PinkNews that the charity welcomed the fall in diagnoses in gay and bisexual men, but she said “we need to see this same level of progress across the board”.
“There has been a steep decline in HIV testing among heterosexual men and women compared to previous years – this drop is a concern given that heterosexual men and women accounted for the majority of diagnosis, and rates of late diagnosis were highest in this group,” Laycock said.
In 2020, almost half (42 per cent or 640 out of the 1,540) of people first diagnosed in England were diagnosed late, an increase from 40 per cent in 2019. The UKHSA reported rates of late diagnosis were highest for heterosexual men and women at 55 per cent and 51 per cent respectively, compared with 29 per cent in gay and bisexual men.
Laycock told PinkNews that COVID-19 has had a “significant impact” on HIV services and testing, and she said there needed to be urgent action from the government to ensure the pandemic doesn’t “hinder efforts to end new cases of HIV by 2030”.
She added that testing the provision of PrEP – Pre-exposure Prophylaxis, a medicine taken to prevent getting HIV – “must be expanded to ensure that progress is felt in all communities” because “progress that isn’t felt by everyone isn’t progress at all”.
The data comes as the UK government unveiled its HIV Action Plan, which sets out how England can end new HIV transmission by 2030. The government pledged to invest £20 million to expand opt-out testing in emergency departments in areas that have the highest prevalence of HIV in England.
The plan aims to reach an 80 per cent reduction in transmissions by 2025 as well as a commitment to reach zero new transmissions by 2030.
But the government acknowledged such goals can only be met if people are diagnosed early and provided with antiretroviral treatment to reduce the viral load in a person’s bloodstream to an undetectable level.
Ian Green, chief executive at THT, welcomed the government’s plan. He said the £20 million investment for opt-out testing “keeps alive” the government’s commitment to end transmission by 2030.
But he cautioned there is “still so much more to do to make it a reality”.
“To really get on track, we need to see opt-out testing scaled up across the country to ensure equitable progress in more areas, alongside training for those involved,” Green explained.
He continued: “Ramping up HIV testing isn’t just about numbers – it’s about addressing the inequalities that continue to exacerbate the HIV epidemic and ensure we see progress across all groups, including those traditionally most impacted by HIV.
“That’s why we strongly welcome the action plan’s signal of intent to ensure free HIV test kits to do at home are available across the country – this needs to be available all year round and accessible to all who could benefit.”
As Covid-19 brought nearly every corner of the Earth to a halt early last year, researchers around the world scrambled to develop a vaccine to fend off the deadly respiratory coronavirus. And just several months later — in a process that normally takes years — several vaccines were ready for worldwide distribution.
In comparison, about 40 years since the earliest reports of what became known as AIDS, scientists are still scratching their heads to develop a vaccine against the virus that causes the life-threatening disease — HIV.
But as the anniversary of the first Covid-19 vaccine shots approaches, experts say the brisk development of the lifesaving and highly effective coronavirus vaccines may have brought researchers closer to cracking the code to develop an HIV vaccine.
“There’s a lot of new energy and buzz among scientists looking at how quickly some of the Covid science got done,” said Rowena Johnston, the vice president and director of research at amfAR, an international nonprofit AIDS research group. “I think there’s been a lot of soul-searching about how the scientific enterprise can be improved so that we can better serve the people we’re trying to help.”
Before the coronavirus vaccines, the most rapidly developed vaccine ever created — from sampling to deployment — was for the mumps in the 1960s. The process took about four years.
The federal government has conducted five large-scale Phase 3 HIV vaccine trials, all of which have failed. Its third Phase 3 trial was notable for increasing the likelihood of HIV infection among those who were vaccinated.
Scientists largely blame HIV’s unrelenting evolution inside the body.
“The scale of mutations that HIV produces are beyond anything that’s even in the same realm of what coronavirus does,” Johnston said. “If you mapped out a genetic tree of all the different variants of HIV inside the body of one person, it’s about as equivalent of all the genetic variations of all the influenza virus of all people around the world during one year.”
Therefore, HIV is always one step ahead of the antibody response that failed vaccines trigger in the body, said Dr. Ronald Desrosiers, a professor at the University of Miami’s Miller School of Medicine, who was one of the first scientists to study SIV — the monkey disease from which HIV is thought to have originated.
“The antibodies that’s present in a person can neutralize the virus that was present three months ago, but it can’t neutralize the virus that’s replicating at the current time,” Desrosiers said. “It would be predicted to make development of a vaccine very, very difficult, and those predictions have come true.”
But however elusive an HIV vaccine may be, scientists — including Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases and the chief medical adviser to the president — say it is “likely” that one could develop from the pioneering technology used to make coronavirus vaccines.
Two of the coronavirus vaccines, those made by the pharmaceutical companies Pfizer-BioNTech and Moderna, were the first vaccines ever to successfully trigger immune responses using messenger RNA, or mRNA, a genetic material that our cells read to make proteins. The mRNA coronavirus vaccines have proven to be more effective at fending off the virus than the Johnson & Johnson vaccine, which resembles more traditional influenza vaccines and does not use mRNA.
Moderna announced in August that it would soon launch a Phase 1 clinical trial for two new mRNA-based HIV vaccines, giving scientists fresh hope.
“If it were just another way to deliver the vaccine ingredients, I would say it would probably have no chance of succeeding where others have failed,” Johnston said.
However, what has piqued Johnston’s interest is that the mRNA coronavirus vaccine is delivered in the body through its lipid nanoparticles. Johnston said the lipid nanoparticles not only help deliver the drug but also act as an adjuvant, a substance that helps strengthen a drug’s effect. And in this case, the adjuvant stimulation effect is working at “a greater extent than any conventional vaccine,” she said.
“When I learned that, it really did give me some hope that finally we have a really, truly a new concept to test in HIV,” she said. “So let’s put our optimistic hats on and hope that this might be the thing that gets us over the finish line.”
Aside from the scientific advancements it sparked, some experts say, the coronavirus pandemic may also indirectly help the HIV vaccine effort by generating more interest in science.
“The world has now increased its scientific literacy. I think the opportunity to build on that in HIV and make people more vaccine-aware and engage in vaccine research and introduction has grown exponentially,” said Mitchell Warren, the executive director of AVAC, a nonprofit organization promoting global HIV treatment.
But others worry that the enthusiasm to stave off the coronavirus pandemic may have come at a cost to HIV research.
When the pandemic pummeled the globe last year, many of the world’s leading HIV researchers shifted gears to the coronavirus. For instance, Johnson & Johnson tapped Dr. Dan Barouch of Harvard Medical School, who has studied HIV for over 15 years, to help develop its coronavirus vaccine.
Overall, scientists who did not pursue Covid-19-related research initiated 36 percent fewer new projects last year compared to 2019, according to a study by Northwestern University that was published in October.
“Sometimes people chase the exciting new thing, they follow the dollars. But we need to get people back to HIV, or there will be a price,” said the director of the Infectious Diseases Initiative at Georgetown University, Jeffrey S. Crowley, a former director of the White House Office of National AIDS Policy.
Regardless of whether the coronavirus will lead to scientific improvements or setbacks, some scientists say defeating HIV will rely more heavily on commonsense global health practices.
“Any pandemic is a day away, and we sort of learned that initially with HIV, but this pandemic has brought that home in an extremely strong way,” said Dr. Kenneth Mayer, a Harvard Medical School professor who is the medical research director of Fenway Health. “What happens in one part of the world doesn’t stay in that part of the world.”
