The UCLA–Charles R. Drew University of Medicine and Science Center for AIDS Research has received a five-year, $11 million grant from the National Institutes of Health. A priority of the award is to fund research addressing health inequities that have fueled the spread of HIV in marginalized communities.
The Center for AIDS Research will strengthen and amplify the impact of ongoing research at both UCLA and Charles R. Drew University, as well as forming new partnerships with community groups across Los Angeles and in nations that are severely affected by HIV. Its aim is to prevent new HIV infections, reduce deaths among people who are living with HIV and develop strategies for eradicating HIV.
The partnership will be directed by Dr. Judith Currier, chief of the UCLA Division of Infectious Diseases; Dr. LaShonda Spencer, professor of clinical pediatrics and internal medicine at Charles R. Drew; and Jerome Zack, chair of the UCLA Department of Microbiology, Immunology and Molecular Genetics. The Center will support investigators at UCLA’s Westwood campus and affiliated sites including the Lundquist Institute at Harbor–UCLA Medical Center and the VA Greater Los Angeles Healthcare System, as well as Drew CARES, the MLK Oasis Clinic and the PUSH Coalition, a group of organizations involved in HIV services that are located on or near the Charles R. Drew campus.
“We are thrilled to have the opportunity to leverage the resources provided by the Center for AIDS Research to expand the support for HIV/AIDS research across Los Angeles and build new partnerships among investigators at all of the partner sites and communities most impacted by HIV,” Spencer said.
The partnership will support equity in health care in part because Charles R. Drew engages a primarily minority population — 80% of its students and 71% of faculty members are from communities of color — and its scholars are committed to health equity in underserved populations through education, research and clinical service. The partnership also will promote opportunities for early-stage investigators to learn from more experienced HIV researchers, and for senior faculty to learn from younger scholars about community-engaged research, as well as increasing diversity among HIV researchers.
The center’s four primary aims will be:
Provide scientific leadership and institutional infrastructure.
Mobilize and coordinate multidisciplinary, state-of-the-art research.
Develop the next generation of basic, behavioral and clinical scientists in the field of HIV/AIDS, with a focus on promoting diversity in HIV research.
Expand community-based research with populations that are disproportionately affected by HIV in Los Angeles and beyond.
The Defense Department has officially ended a 1980s-era policy that restricted HIV-positive service members from deploying overseas and being promoted into leadership and management positions.
The updated guidance officially took effect Monday, according to a memo addressed to military leadership from the office of Defense Secretary Lloyd Austin. A judge struck down the decades-old policy in early April.
U.S. District Judge Leonie Brinkema of Eastern Virginia found that the Pentagon’s classification of HIV as a chronic condition did not reflect modern scientific understandings of the virus.
In one of two orders, Brinkema banned the Pentagon from “separating or discharging” asymptomatic HIV-positive service members with undetectable viral loads solely because they have HIV.
The two cases involved three men who sued the military for discrimination based on their HIV statuses. One of the plaintiffs, Army National Guard Sgt. Nick Harrison, who was denied a promotion because of his HIV status, called the Pentagon’s reversal a “generally positive move,” but he said it came only after advocates were forced to resort to “kicking and screaming” in the court system.
“I would like to see them go further,” he said. “At this point, the decision is just basically doing what the judge told them to do. So there’s a lot more space for them to do more.”
Kara Ingelhart, a senior attorney at Lambda Legal, which represented the plaintiffs, said the move “makes perfect sense from a science-medical stigma standpoint but also a policy standpoint.”
“The fact that the military, [which] is the largest employer in the world, not just the country, will no longer be able to treat, categorically, the service members living with HIV differently from others, it’s huge,” she said.
Since the Americans with Disabilities Act of 1990 passed, no employer other than the U.S. military has been legally permitted to discriminate against potential employees because they have HIV. But as noted in the memo Monday, the policy amendment does not change current Pentagon policy denying those with HIV from being able to enlist in the military.
According to the memo, current service members who display “laboratory evidence” of HIV infection will continue to be evaluated on a case-by-case basis, including access to “appropriate treatment” and medical evaluations of “fitness for continued service in the same manner as a Service member with other chronic or progressive illnesses.”
They will not, however, be discharged solely based on their HIV statuses. Military leaders will convene a working group to “develop proposed standards” for case-by-case evaluations, which will consider how long service members must display undetectable viral loads and be symptom-free, the memo says.
The Human Rights Campaign, the country’s largest LGBTQ advocacy group, has long called for the policy reversal, which it listed among 85 recommendations it sent to the incoming Biden administration in November 2020.
“Research has shown for years now that antiretroviral therapy is highly effective in shrinking the risk of HIV transmission to essentially zero,” David Stacy, the campaign’s government affairs director, said in a news release. “To maintain a discriminatory policy against service members living with HIV without the backing of medical evidence was unsustainable, and we’re glad to see our military leaders recognize that.”
Stacy added that the campaign will continue to “push for the same policy to be applied to those who want to enlist.”
“This week’s announcement was a good first step, but as long as some people are still being discriminated against for no good reason, there’s still work to be done,” he said.
First lady Jill Biden on Saturday announced the U.S. will provide an additional $80.9 million to the fight against HIV/AIDS in Latin America.
Biden during a visit to Casa Hogar el Buen Samaritano, a shelter for people with HIV/AIDS in Panama City, said the State Department will earmark an additional $80.9 million for President’s Emergency Plan for AIDS Relief-funded work in Latin America. A Panamanian activist with whom the Washington Blade spoke said LGBTQ people were among those who met with the first lady during her visit.
Pope Francis visited the shelter in 2019.
“I’m glad we have the opportunity to talk about how the United States and Panama can work together to combat HIV,” said the first lady.
Michael LaRosa, the first lady’s spokesperson, noted Panama will receive $12.2 million of the $80.9 million in PEPFAR funding.
“This funding, pending Congressional notification, will support expanded HIV/AIDS services and treatment,” said LaRosa.
UNAIDS statistics indicate an estimated 31,000 Panamanians were living with HIV/AIDS in 2020. The first lady’s office notes the country in 2020 had the highest number of “newly notificated cases of HIV/AIDS” in Central America.
The first lady visited Panama as part of a trip that included stops in Ecuador and Costa Rica.
The Summit of the Americas will take place next month in Los Angeles. The U.S. Agency for International Development and PEPFAR in April announced they delivered more than 18 million doses of antiretroviral drugs for Ukrainians with HIV/AIDS.
The U.S. Agency for International Development and the President’s Emergency Plan for AIDS Relief on Wednesday announced they delivered more than 18 million doses of antiretroviral drugs for Ukrainians with HIV/AIDS.
USAID Administrator Samantha Power posted a picture of the shipment on Twitter. She said it is “part of a broader U.S. effort to maintain continuity of life-saving treatments for chronic illnesses during Russia’s war.”
A USAID spokesperson told the Washington Blade that “USAID delivered the PEPFAR-funded antiretroviral drugs to a Ukrainian non-profit organization that provides health services to people living with HIV.”
“The organization is distributing the antiretroviral drugs to different regions within Ukraine based on need and logistical feasibility,” said the spokesperson.
The spokesperson did not identify the Ukrainian organization that received the drugs.
In a landmark ruling, a federal court has ordered the Defense Department to end a long-standing Pentagon policy forbidding enlisted military service members from deploying in active duty outside the continental U.S. and being commissioned as officers if they have HIV.
Supporters hailed it as overdue legal affirmation that people receiving effective antiretroviral treatment for HIV are essentially healthy and pose no risk to others.
The judgment topples one of the country’s last major pillars of HIV-related employment discrimination. Federal law has for decades barred employers from discriminating against people with HIV under the Americans with Disabilities Act of 1990. The military has stood alone as the sole U.S. employer maintaining such explicit discriminatory practices.
“This is one of the biggest rulings for people living with HIV and enshrining their protections under the Constitution in decades,” said Kara Ingelhart, a senior attorney at Lambda Legal, which along with a team of private-practice attorneys litigated the cases.
The Pentagon still bans people with HIV from enlisting in the military or from being commissioned out of military academies. The new ruling, which could affect those other prohibitions, concerns service members who are diagnosed after they enter the military.
U.S. District Judge Leonie Brinkema of Eastern Virginia ruled Wednesday in the two cases, Harrison v. Austin and Roe & Woe v. Austin, in which a trio of men sued the military for HIV-related discrimination. The Air Force tried to discharge two pseudonymous plaintiffs, while the D.C. Army National Guard denied Sgt. Nick Harrison a commission in the Judge Advocate General’s Corps, or JAG Corps, because they had HIV.
Brinkema ruled that the Pentagon’s policy qualifying HIV as a chronic condition requiring a waiver was scientifically outdated and that it unfairly treated people with the virus differently from other service members living with chronic health conditions requiring routine medication.
“This is the first decision securing the rights of people living with HIV that is rooted in the equal protection clause of the Constitution,” said Scott Schoettes, a former Lambda attorney in private practice in Chicago, who is co-counsel in the two cases.
Brinkema, who was appointed by President Bill Clinton in 1993, has ordered the Air Force to rescind the discharges of the two airmen. She further ordered the Army to rescind and reconsider its denial of Harrison’s JAG Corps application.
Under the ruling, the Pentagon can no longer use the virus as a reason to discriminate against asymptomatic HIV-positive service members whose viral loads are undetectable thanks to antiretroviral treatment. In particular, the Pentagon may not separate, discharge or deny applications for deployment from such people.
The Justice Department could appeal the ruling to the 4th U.S. Circuit Court of Appeals. In January 2020, the court upheld a preliminary injunction in the case of the two airmen, blocking the Air Force from discharging them while their case was litigated.
President Joe Biden’s 2020 campaign platform included a measure supporting the right of people with HIV to serve fully in the military. Ingelhart expressed hope that the administration will compel the Pentagon to reverse the remaining policies that discriminate based on HIV status.
The Defense Department is the world’s largest employer, with 3 million service members worldwide.
The Pentagon referred questions to the Justice Department, which declined to comment.
In defending the two cases, the military argued that service members with HIV pose a theoretical risk to others, such as on the battlefield.
After the Pentagon appealed the injunction to the 4th Circuit in 2019, a group of former military leaders filed an amicus brief supporting the plaintiffs. The brief criticized as scientifically outdated the Pentagon’s policy qualifying HIV as a chronic condition requiring a waiver and argued that the policy compromised military readiness.
Effective antiretroviral treatment for HIV has been on the market since 1996. Today, HIV is typically treated with a once-a-day pill.
Scientists have known for decades that HIV cannot be transmitted through casual contact. Extensive research led the global HIV scientific community to conclude in the late 2010s that people with undetectable viral loads thanks to HIV treatment cannot transmit the virus through sex.
According to Lambda Legal, nearly all of the approximately 2,000 members of the U.S. military living with HIV have undetectable viral loads.
Today, people treated for HIV have near-normal life expectancies.
“The military is being forced to acknowledge the current science regarding HIV: It is easily treatable; there are zero documented cases of transmission in combat; and, most importantly, it is never a reason for discrimination,” said Sarah Warbelow, the legal director of the Human Rights Campaign, who was not involved with the litigation.
Harrison, 45, an Oklahoma native who joined the military in 2000, was diagnosed with HIV in 2012 after he returned from a tour of duty in Kuwait. In May 2018, he sued the Army and the Defense Department for denying his application to become a military lawyer with the JAG Corps.
“It’s nice to see the court make a decision placing science over stigma,” Harrison said of the judge’s ruling.
In December 2018, Harrison’s legal team further sued the Air Force and the Justice Department on behalf of two airmen who received notifications discharging them from service because their HIV statuses prevented their potential deployment to the Middle East.
The policy, codified in a February 2018 memorandum and dubbed “Deploy or Get Out,” outraged the HIV community by forcing some HIV-positive service members out of the military, not previously a common practice, if they faced potential deployment.
Harrison said he keeps in touch with the two other plaintiffs, as well as a collection of fellow HIV-positive members of the military. “We’re looking forward to the opportunity to go forward with our lives and to continue to serve the military in the best way possible,” he said.
His lawyers have also sued the Navy and the Air Force on behalf of a pair of cadets who were blocked from commissioning in the military after their military academy graduations because they had HIV. The case, Deese and Doe v. Austin, which is pending in U.S. District Court for Maryland, is in the discovery phase after the court denied the Pentagon’s request for dismissal.
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.
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.
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.
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.
D.C.’s George Washington University School of Medicine and Health Sciences is one of four sites across the country in which a preliminary component of an experimental HIV vaccine is being given to volunteer participants in a study aimed at reversing years of failed attempts to develop an effective HIV vaccine by pursuing what study sponsors say is a new, promising approach.
The study, which involves 56 healthy, HIV-negative volunteer participants, is being conducted by the nonprofit scientific research organization known as IAVI and the biotechnology company Moderna, which developed one of the coronavirus vaccines now being used throughout the world.
In a Jan. 27 joint statement, IAVI and Moderna said their study is part of a Phase 1 trial designed to test newly developed experimental HIV vaccine antigens to determine if they will lead to the development of an effective HIV vaccine.
According to scientific literature, antigens are substances such as bacteria, viruses, and chemicals that induce the body to release antibodies that fight off infections. The statement by IAVI and Moderna says a vaccine technology developed by Moderna to use another component of the human body called messenger RNA or mRNA to strengthen a potential vaccine’s ability to fight off infection by HIV is also a part of this vaccine study.
“We are tremendously excited to be advancing this new direction in HIV vaccine design with Moderna’s mRNA platform,” Mark Feinberg, president and CEO of IAVI, says in the statement. “The search for an HIV vaccine has been long and challenging and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine,” he says in the statement.
The statement says that scientific teams at IAVI and the biotechnology firm Scripps Research helped to develop the HIV vaccine antigens being tested in the trials taking place at the GW School of Medicine and Health Sciences and at locations in Atlanta, Ga., Seattle, Wash., and San Antonio, Tex.
It says the trial involving the 56 volunteer participants — who are divided among the four sites — began on Jan. 27 and is being funded by the Bill & Melinda Gates Foundation.
Among those calling the IAVI-Moderna trial an important step in HIV vaccine development is Carl Dieffenbach, director of the Division of AIDS at the National Institute of Allergies and Infectious Diseases (NIAID), which is part of the U.S. National Institutes of Health.
“This is a variation of a theme,” Dieffenbach told the Washington Blade. “IAVI in collaboration with NIH did a version of this study already with a protein form of this immunogen,” Dieffenbach said. He said that study worked out well and was published in a scientific journal.
“What’s unique about this latest study is they’re using RNA to deliver the vaccine rather than a protein,” said Dieffenbach. “So, this is an important step for us in the vaccine field, that they can now compare the protein to the RNA.”
Dieffenbach said the IAVI-Moderna trial is taking place after two other recently completed HIV vaccine studies involving human trials that NIAID was involved in resulted in findings that the two experimental HIV vaccines were ineffective. He said a third HIV vaccine study NIAID is involved in that is taking place in the U.S. and South America is expected to be completed in about a year.
The ongoing study in the Americas involves men who have sex with men and transgender individuals as those participating in that vaccine trial, he said.
Dieffenbach said in addition to the vaccine studies, NIAID is monitoring at least two studies of medication aimed at curing HIV. One of the studies was conducted by HIV researcher Dr. Timothy Schacker, who serves as Vice Dean for research at the University of Minnesota Medical School.
Schacker arranged for human trials of people who are HIV positive and taking standard anti-retroviral HIV medication to be given an experimental HIV cure medication developed by the biotechnology company ImmunityBio called Anktiva, according to a Jan. 31 statement released by ImmunityBio.
The statement says the trials showed promising results in the ability of Anktiva to induce the immune system of HIV-positive patients under standard HIV treatment who participated in the study to “kill” the latent or “hidden” HIV in their body that would otherwise reactivate and cause illness if they stopped taking HIV medication.
The goal of the development of Anktiva is to “rid the body of the virus for good and eliminate the need for antiretroviral therapy,” the company’s statement says.
Dieffenbach said his office was also monitoring an HIV cure study being conducted by the Rockville, Md., based genetic engineering company called American Gene Technologies. The company is conducting a human trial for a therapeutic treatment it has developed that’s intended to enable the immune system of HIV-positive people to permanently eliminate HIV from their bodies. The company has said it was hopeful that early results of the effectiveness of the treatment would become available this year.
The number of straight people being diagnosed with HIV is higher than that of gay and bisexual men for the first time in a decade, new figures show.
Statistics released by the UK Health Security Agency show that straight people made up almost half (49 per cent) of all new HIV diagnoses in England in 2020. Gay and bisexual men accounted for 45 per cent of new diagnoses.
Experts are warning that the true number of straight people contracting HIV is likely even higher. Due to the coronavirus pandemic, there was a 33 per cent drop in heterosexuals being tested for the virus in sexual health services in 2020. That’s compared to a seven per cent drop in HIV testing for gay and bisexual men.
When population size is taken into account, gay and bisexual men are still more likely to contract HIV than their straight counterparts – but health outcomes are not the same across the board. Straight people with HIV are significantly more likely to be diagnosed late, meaning they’re more likely to pass it on through sex.
New figures released by the UK Health Security Agency show that 51 per cent of women, 55 per cent of heterosexual men and 66 per cent of those aged over 65 were diagnosed at a late stage in 2020. By comparison, just 29 per cent of gay and bisexual men were diagnosed late.
‘Massive misconceptions’ about HIV almost stopped Sue Hunter from getting tested
Sue Hunter is one of the many straight women who are living with HIV in the UK today. She was diagnosed 15 years ago after she entered into a new relationship following a divorce. Looking back, she says she almost didn’t get tested because she had “massive misconceptions” about HIV.
“I’d come out of a marriage, I started again, I was only 45 and I met a new partner. We had a lovely relationship for about a year but I decided I wanted to go my own way after the divorce and all that, so we separated but we stayed friends,” Sue tells PinkNews.
Shortly after they separated, Sue’s former partner started developing persistent chest infections. He eventually ended up being hospitalised for pneumonia, which led to him testing positive for HIV.
“Once he mentioned those three letters, I was like: ‘Why is he talking to me about something like that?’” Sue says. She had always thought that, as a straight woman, she wasn’t at risk of contracting HIV.
“He walked out the door and one of the last things he said to me was: ‘Please go for a HIV test.’ Obviously I did and I got my result, and it was positive.
“The first thing I thought was: ‘HIV doesn’t happen to women for a start, and certainly not to heterosexual women.’ I contacted the Terrence Higgins Trustand started to inform myself, and I learned that it does happen to women and it does happen to heterosexuals.”
In the months afterwards, Sue descended into shame and stigma over her diagnosis. Eventually, she came to realise that she had just been “unlucky”.
“I didn’t use protection because I thought: ‘Well I’m going through menopause and STIs happen to young people.’ Again, it’s those misconceptions.”
Sue’s family were shocked when she told them about her diagnosis – like many others, they wrongly assumed it was a virus that only affected gay and bisexual men. The stigma resulted in her keeping her status a secret from her daughter for years.
If you look at the statistics, a third of people living with HIV in the UK are women, and 52 per cent of people with the virus worldwide are women.
“I’ve had relationships since and some people have walked away from me. I remember a guy said to me once when I told him I was positive after a couple of dates: ‘I value my life too much to have a relationship with you.’”
Sue is urging other straight people who are sexually active to get tested for HIV – she says she had “no signs or symptoms” that she had contracted the virus before she got her diagnosis.