A new cure strategy designed to harness the power of the immune system to achieve HIV remission in people living with HIV will begin at the University of California, San Francisco in 2020. The study was described and announced at the amfAR 2019 HIV Cure Summit held on November 21, 2019.
“This is kind of an unprecedented human clinical trial, putting together a lot of things that we think will optimally stimulate the immune system,” said Rachel Rutishauser, MD, PhD, from UCSF and Zuckerberg San Francisco General Hospital. “The main clinical outcome will be to understand the proportion of people who are getting the vaccine in the combination trial who achieve post-treatment control [of HIV].”
This small pilot study will enroll 20 people living with HIV who have been on stable, continuous antiretroviral therapy for 12 or more months.
To measure the safety of the cure strategy, the study will assess adverse events that may include lab toxicities or clinical symptoms. To measure efficacy, the study will measure the proportion of study participants who do not experience viral rebound (i.e., who have suppressed viral loads without HIV medication) 24 weeks after the treatment is administered.
The treatment involves a combination of therapies meant to boost the immune system’s CD8 T-cell response to identify and kill off latently HIV-infected cells and reduce the size of the HIV reservoir.
“The advantage of CD8 T-cells is they can recognize infected cells specifically, and they can actually kill them,” said Rutishauser.
During stages 1 – 3 of the study (lasting 24 weeks), participants will receive a “prime-boost” DNA plasmid vaccine to elicit an initial CD8 T-cell response along with a boosting agent. (This is the same vaccine being tested in a prevention vaccine study by the HIV Vaccine Trials Network.)
In stage 4 of the study, participants will receive two immunomodulatory agents: a toll-like receptor-9 (TLR9) agonist and broadly neutralizing antibodies (bNAbs). The TLR9 agonists are expected to broadly activate the immune system—by getting the virus to come out of latently-infected cells and “present” itself to the immune system, boost the response of CD8 T-cells, and also increase the effectiveness of natural killer (NK) T-cells which kill off HIV-infected cells. Broadly neutralizing antibodies will also be given during this stage to reduce the size of the HIV reservoir.
The last stage of the study includes a treatment interruption, with a final dose of broadly neutralizing antibodies being given right as treatment is stopped.
“The broadly neutralizing antibodies should control the virus on their own. But as they wear off, you give the virus a chance to sort of come out but be partially controlled by the broadly neutralizing antibodies. And our hope is that we’ve created an immune response that will then outpace the virus or sort of beat the virus as it’s coming out of latency,” said Rutishauser.
Established in 2015 with a five-year, $20 million grant, the amfAR Institute for HIV Cure Research brings together collaborative research teams with the goal of establishing a scientific basis for a cure by the end of 2020. Find out more about the road to an HIV cure in this video by amfAR.
Giaura Fenris, a transgender woman, was on the dating app Grindr looking for people to chat with and meet when a user whose profile picture was of a cute nurse messaged her. After some pleasantries, however, Fenris realized the hunky health professional wasn’t there for a hookup.
She said he asked her “a couple of questions, nothing too invasive” and then revealed he was an employee at a nearby health clinic in Brooklyn, where she lives. He then offered her a sexually transmitted infection testing appointment and help getting health insurance.
“I was like, ‘Oh, that’s great. Please sign me up right away,’” Fenris told NBC News.
Wyckoff Heights Medical Centeris thought to be the first health center in New York City — and perhaps beyond — to incorporate gay dating apps such as Grindr, Jack’d and Scruff into its sexual health efforts. The center’s method differs from the usual sexual health advertisements one can see on the apps. Staffers interact with other users with their own account like a regular user would — except they offer sexual health services. The center says the innovative approach is working: Since its launch in 2016, the program has attracted more than 300 clients to the facility.
Most of these clients are black and Hispanic gay men and trans women, groups that are disproportionately affected by HIV. Gay and bisexual men comprised 70 percent of the new HIV diagnoses in the U.S. in 2017, and of those gay and bisexual men diagnosed with HIV, 37 percent were black and 29 percent were Hispanic, according to the Centers for Disease Control and Prevention.
The program’s launch
The program was started by Anton Castellanos-Usigli, who had just finished his master’s degree in public health at Columbia University when in 2015 he was recruited by Wyckoff Heights Medical Center.
“The center hired me precisely because they wanted to increase the number of gay and bisexual Hispanic clients,” Castellanos-Usigli, who had migrated from Mexico in 2013, said. This client population, he added, “is one of the populations who needed these services the most.”
Shortly after being hired, Castellanos-Usigli recalls thinking to himself, “You are young, you’re Hispanic yourself, where do you talk to other gay guys about sex? Grindr!”
So in February 2016, he created a profile with the image of a good-looking nurse in medical clothing and started to chat with people on Grindr. After opening up with pleasantries, he shifted the conversation to offering sexual health services.
Andrew Gonzalez, a program manager at the center, said responses vary from those “who are very grateful” for getting health information and a clinic appointment through the app to those who are disappointed the cute nurse isn’t a potential date.
“Sometimes people aren’t quite ready to receive the information and pursue testing services,” Gonzalez said.
However, Gonzalez said, oftentimes those who are successfully contacted through gay dating apps go on to tell their friends about the center’s services.
“So, essentially, we’re providing these people the tools … to educate and inform other community members about services,” he said.
‘We have to treat the whole person’
Through Grindr and other gay dating apps, the center brings clients into its Status Neutral program, which aims to keep HIV-positive patients at an untransmittable viral load and protect HIV-negative patients against infection through condoms, regular testing and PrEP or preexposure prophylaxis.
Since its launch, the center has standardized the practice and tracked its results. Between 2016 to 2018, the strategy attracted 233 new clients — 67 percent of them Hispanic, 17 percent black and over half uninsured, according to Castellanos-Usigli. He said a higher-than-average percentage (5 percent) of these new clients were diagnosed with HIV, and they were connected with medical care. More than 60 percent of the 233 new clients, he added, were referred to PrEP for HIV prevention. Twenty-nine patients received personalized cognitive counseling, an evidence-based intervention to reduce risks for gay and bisexual men who have casual sex without condoms.
“A lot of times, people come in for testing, and they have greater needs than testing,” Laurel Young, the program’s interim director, said. “If we treat a person … we have to treat the whole person, not just the symptoms.”
Young said the facility’s Status Neutral program combines traditional medical care with help in navigating health insurance, employment, job access, housing and legal support. That way, she added, patients can address other factors such as poverty, immigration status or homelessness that have an impact on their health.
When Fenris, now 30, first walked into the center in February 2017, she was burdened by several issues that were negatively affecting her physical and mental health. She moved to New York the year prior to escape a living situation in another state that she said was stifling her transgender identity, and she had just had an incident with a hookup that led her to start post-exposure prophylaxis (PEP), a one-month treatment to resist HIV infection right after potential exposure. She also had a history of depression for which she had stopped taking medication, and she was about to lose her insurance.
During her first visit to Wyckoff Heights Medical Center, staffers tested Fenris for HIV, started her on HIV-prevention medication, helped her find new insurance and referred her to mental health services. The center also helped her create a plan to secure financial stability and manage her increased rent payments.
‘Cultural competency and humility’
Wyckoff Heights Medical Center serves a diverse and at-risk population, and because of this, staffers say hiring and training decisions are crucial.
“Having staff members that identify with populations we serve accompanied with cultural competency and humility trainings help best serve the population to decrease stigma,” Gonzalez said.
This was part of the reason the center hired Castellanos-Usigli back in 2015 — and Fenris last year. Fenris, a trans Latinx, was hired by the center in May 2018 as a consultant and peer educator. She works within the clinic’s Substance Abuse and Mental Health Services program and its Status Neutral program, ensuring patients are getting the care they need.
“Today, I made sure that a trans patient had a gender-affirming procedure, that they were referred to with their pronouns, that they go to their appointments and helped setting up transportation,” Fenris said recently.
Trans people in particular face barriers in health care: A 2016 studyon the barriers to transgender health care in New York found 48 percent of trans respondents “felt that the organizations that provided the care they needed were not transgender sensitive.”
Wyckoff’s commitment to being accessible, culturally sensitive and having a diverse staff representing the community it serves addresses those barriers head on.
Since Wyckoff Heights Medical Center launched its innovative program in early 2016, at least one other community health clinic has launched a similar program. CAMBA, in Brooklyn, has seen similar success using gay dating apps to reach individuals at high-risk of HIV infection: From 2017 to 2018, 65 percent of its clients linked to PrEP or PEP services were reached through apps apps like Grindr.
Castellanos-Usigli believes his data “speaks to the power that this strategy has” and he hopes to convince other agencies to adopt it.
Facebook has quietly started removing some misleading ads about HIV prevention medication, responding to a deluge of activists, health experts and government regulators who said the tech giant had created the conditions for a public-health crisis.
The ads at issue — purchased by pages affiliated with personal-injury lawyers and seen millions of times — linked drugs designed to stop the spread of HIV with severe bone and kidney damage.
LGBT advocates long have said such claims are “false,” pointing to multiple studies showing the class of medication, known as PrEP, is safe.
GLAAD reacts via press release:
“It’s gratifying to see one of Facebook’s fact-checkers backing up the overwhelming consensus of AIDS, LGBTQ, and HIV medical groups that these ads are misleading. But the question remains – why is Facebook taking money from these ambulance-chasing law firms for ads that are helping the spread of HIV?” said Peter Staley, a cofounder of the PrEP4All Collaboration.
“Removing select ads is a strong first step, but the time is now for Facebook to take action on other very similar ads which target at-risk community members with misleading and inaccurate claims about PrEP and HIV prevention,” said Sarah Kate Ellis, GLAAD President and CEO.
“Dozens of organizations have told Facebook that the safety and effectiveness of PrEP to prevent HIV transmission is unequivocal. The pervasiveness of these ads and the subsequent real world harm should be catalysts for Facebook to further review how misleading and inaccurate ads are allowed to be targeted at LGBTQ and other marginalized communities.”
Being a longtime nurse Karl Neumann of Norfolk, Va., understands just how critical it is to have a robust community blood supply available. However, as a sexually active gay man, he is banned from donating blood because of a federal law.
“It’s frustrating that there are shortages of blood, but certain people are still restricted from giving blood at a time when modern medicine can easily test for diseases.”
Karl worries confusion or resentment regarding the “blood ban” might prevent gay men from realizing that they have another opportunity to heal and save lives – by registering to be organ donors.
“I’ve worked in transplantation most of my career and there are not enough organs available for the number of people waiting for a transplant. Unfortunately, I’ve had several patients that I cared for die because the organ they needed was not donated in time.”
Currently, more than 113,000 people in the United States are waiting for a lifesaving transplant, and that staggering number is one of the reasons why Karl, who is HIV-positive, decided to donate his kidney as a living donor.
In 2013, the HIV Organ Policy Equity Act(HOPE Act) was signed into law allowing HIV-positive patients on the national transplant waiting list to receive organs from HIV-positive donors who are living or deceased. Unbeknownst to Karl, his decision would be very significant, as he would become only the second living person with HIV to donate a kidney in the U.S., and the first HIV-positive gay man to be a living donor.
“It gave me pause being one of the first people but then I realized what a great opportunity it was. We are still in the research phase of transplanting organs HIV-to-HIV, and the more procedures that have a successful outcome means more lives saved.”
Last summer, Karl traveled to Duke Health in Durham, N.C., to donate his kidney to an anonymous HIV-positive recipient. He is hopeful the recipient is regaining his or her health and enjoying an improved quality of life post-transplantation.
Karl says regardless of the myths and misconceptions that exist, everyone can register to be an organ donor regardless of gender identity or expression, choice of sexual partner or HIV status.
“Donating a kidney with HIV is normal and it can happen,” said Karl. “Being HIV-positive does not put me in danger or make me ill. I am healthy and will likely live a longer life than most people, and for that I am grateful. The least I could do was pay it forward and give life to another human being.”
As of September 2019, 160 HIV-positive organs have been donated and transplanted, including 116 kidneys from deceased donors, 2 kidneys from living donors and 42 livers from deceased donors. December is AIDS Awareness Month and Karl wants to spread awareness that HIV-positive patients can give and receive the gift of life.
For more information or to register to be an organ donor, visit BeADonor.org.
Washington Regional Transplant Community is the non-profit organ procurement organization for the metro D.C. area responsible for recovering and distributing organs and tissues used in lifesaving and life-enhancing transplants. WRTC serves approximately 5.5 million people, 44 hospitals and six transplant centers. Visit BeADonor.org for more facts and information that can help you make a legal and informed decision about donation.
When HIV first tore into America’s gay male community in the early 1980s, quotidian questions of sex, love, lust and trust transformed into weighty decisions with potential life-or-death consequences.
The decision to stop using condoms with a serious partner? Only as reliable an HIV-prevention method as your partner’s fidelity. A single instance of cheating? An indiscretion that carries the risk of an incurable and deadly disease. A random hookup? A nagging sense that, perhaps, this time was the time.
Todd Faircloth, 52, remembers those days well. In 1987, when gay men were still dying from AIDS in large numbers, Faircloth moved to New York City from North Carolina to start his big, gay life. He was just 17.
“I didn’t know anyone that lived past the age of 30, I didn’t anticipate anyone was going to live that long,” Faircloth, who now lives in Georgia with his husband, said. “It got to the point where people just assumed they all had a death sentence over their heads.”
He said he endured “hundreds” of AIDS funerals with a lot of dark humor, but still, “it was really scary to be out there.”
Amidst all the death, the human immunodeficiency virus caused understandable fear and anxiety among gay men, and Faircloth said this even influenced the relationships people entered into. “If you meet someone, you got with them, you were more likely to want to stay with them, not because you wanted to be with them, but because you’re scared to go back out,” he said.
Today, more than three decades after Faircloth moved to New York, HIV is controllable with medication and need not lead to death. In addition to condoms, first approved to stop HIV in 1987, people at risk of acquiring HIV today can take medications like Truvada to prevent the virus’ transmission, namely pre-exposure prophlyaxis (PrEP), and post-exposure prophylaxis (PEP), which are taken before and after sex, respectively, to prevent HIV transmission. And for those who already have the virus, treatment as prevention, or TasP, makes it impossible to transmit the virus in sex when taken regularly, according to the Centers for Disease Control and Prevention.
One unintended benefit of this new array of pharmaceutical prevention options, according to a new study, is a reduction in “HIV anxiety.” Anxiety about HIV transmission, which the study’s authors describe as a “common” experience of gay and bisexual men — especially those who, like Faircloth, lived through the darkest days of the AIDS epidemic — can compromise their “emotional well-being and create barriers to HIV testing.”by TaboolaSponsored StoriesTHE MOTLEY FOOL5 Stocks that Could Set You Up for Life2019 GIFT GUIDE27 Christmas Gifts That Are Selling Like Hot Cakes
Fifteen years ago, if the condom broke, I would be freaking out about it, and there really wouldn’t be anything you could do for three to six months except just passively hoping you don’t get HIV.
TIM PETLOCK THE OLD DAYS
“For many men, fear of HIV transmission led to anxiety about sex with other men, even in situations where transmission was impossible,” the authors note. Half of respondents worried about whether their sexual encounters were “safe,” and thought about HIV before sex, while a full quarter of study respondents, all of whom were HIV-negative, reported thinking about contracting HIV during sex. And the study found that taking PrEP “was independently associated with lower levels of HIV anxiety.”
The study suggests that this PrEP-associated reduction in HIV anxiety could “be promoted as part of demand creation initiatives to increase PrEP uptake,” a key goal of the U.S. government as it seeks to end the HIV epidemic by 2030.A sea change
Tim Petlock, 49, a gay man living near Dallas, said that so much has changed since he came out as gay in the early 1990s.
“Fifteen years ago, if the condom broke, I would be freaking out about it, and there really wouldn’t be anything you could do for three to six months except just passively hoping you don’t get HIV” Petlock told NBC News, referring to the monthslong window of early HIV tests.
“Now, you can go to treatment the day after to reduce the risk,” he said of post-exposure prophylaxis, or PEP. And today’s HIV tests can tell if a person is infected in about seven days. “You know that much sooner, whether you’ve got it or not, so it does kind of change the calculus of the whole thing.”
Today, Petlock takes PrEP and said that he worries much less about contracting HIV than he used to. Now he’s more focused on avoiding sexually transmitted bacterial infections, such as syphilis and chlamydia, which are on the rise in America.
“I know there’s some risk, but it’s likely not going to be life-altering,” he said.Ghosts of the epidemic
While PrEP has been shown to reduce HIV anxiety in some gay and bisexual men, the unease has by no means dissipated among this population.
“When you are bombarded your adult life with HIV and seeing death, I don’t care how much we advance biomedical technologies — that emotional reaction to the disease is still going to be the same,” Perry Halkitis, dean of the Rutgers University School of Public Health and author of “Out in Time,” told NBC News. “I unfortunately think that the way we deal with HIV in this country still to this day is very rooted in the responses from AIDS.”
It got to the point where people just assumed they all had a death sentence over their heads.
TODD FAIRCLOTH SURVIVING THE EPIDEMIC
One of the people for whom the memory of the epidemic’s darkest days is still fresh is Craig Lenti, a New York City-based media producer.
Lenti moved to Manhattan in 1996 at age 18 to attend college, one year after AIDS deaths peaked in the United States. He said he learned about homosexuality and AIDS at the same time, and during his late teenage years, AIDS was the top killer of young American men.
“They were always, for me, intrinsically linked,” Lenti said. “That was what I had in my head. That is what the media told me. And so from that point on, there really was no way of disconnecting those two concepts.”
For years, Lenti avoided taking an HIV test because of his fear that it would return positive.
To this day, Lenti said, it is hard for him to take an HIV test and to trust potential partners because of his fears from the epidemic’s early days.
“It was a foregone conclusion that I would become infected,” Lenti said of his thinking at the time. Yet despite all that worrying, he remains negative.
“I think the biggest fear that I had about HIV was not the fear of being sick. It was always the fear of dying alone,” Lenti said. “It’s just very hard for me to trust people, and I think you could argue that a lot of that stems from my fear of becoming infected, even though now there’s so many different ways to combat that.”‘I don’t think it just changes overnight’
While Lenti no longer takes Truvada for PrEP because he suffered from its rare gastrointestinal side effects, he said he counsels many of his friends to take the daily medication.
“If you can take a pill that has a 99 percent effective rate, why wouldn’t you do that?” he said.
Levi, a 19-year-old college student in Ohio, is among the nearly 1 million Americans recommended to take, but not taking, PrEP. Because he’s a man who has sex with other men and is 28 or younger, he’s considered at high risk of contracting HIV, according to the CDC risk assessment worksheet for doctors (the worksheet is based on a point system and uses a variety of risk factors).
Levi is no stranger to HIV anxiety. He recalled a recent incident after he performed oral sex where he began to worry, “Do I need to get a test?”
“I spent the night basically in a hypochondriac fit running around looking if there are any sort of symptoms I should be looking for,” he said, telling an all-too-common tale. However, he needn’t have worried, as there is “little to no risk” of acquiring HIV through oral sex, according to the CDC.
Levi, who asked not to have his full name printed because he is still on his parents’ insurance and worries they would object to PrEP, said he’s just starting to think about taking the HIV prevention pill. He said the man he is dating is HIV-negative, and even though they plan to be monogamous, he doesn’t know if he can fully trust him, because the stakes are so high.
“Is there anything that I could even ask for?” Levi wondered. “Could you show me a paper or something? And could I even believe that?”
Levi’s struggle to answer this question is as old as the virus, Halkitis said.
“You have two sets of problems: a generation that has no clue and hasn’t seen death,” he said, “and a generation that is older that is completely bombarded.”
“I think there’s a whole negotiation morphing period going on right now as we get embedded in these technologies more and more,” Halkitis continued, referring to HIV prevention medications. “I don’t think it just changes overnight.”
More than 50 LGBTQ, HIV and public health organizations have signed an open letter calling on Facebook to remove “factually inaccurate” advertisements placed by law firms that “suggest negative health effects” of HIV-prevention medication Truvada, a type of pre-exposure prophylaxis, or PrEP.
“The advertisements are targeting LGBTQ Facebook and Instagram users, and are causing significant harm to public health,” the letter states. “The law firms’ advertisements are scaring away at-risk HIV negative people from the leading drug that blocks HIV infections.”
The ads were bought by various law firms looking to use the platform’s targeted advertising capabilities to recruit gay and bisexual men for a class-action lawsuit against Gilead Sciences, the pharma giant that manufactures Truvada, a once-a-day pill that when taken regularly is 99 percent effective at preventing HIV transmission, according to the Centers for Disease Control and Prevention.
The open letter, signed by groups including ACT UP New York, amfAR and University of Chicago Medicine, claim the ads are misleading because they give the impression that PrEP may be generally harmful, when the side effects the ads warn against are primarily an issue with long-term treatment for people already living with HIV.
In a statement emailed to NBC News, a spokesperson for Facebook said the company values its “work with LGBTQ groups” and both welcomes and seeks out their input.
“While these ads do not violate our ad policies nor have they been rated false by third-party fact-checkers, we’re always examining ways to improve and help these key groups better understand how we apply our policies,” the spokesperson wrote.
‘Ambulance chasers’
The class-action lawsuit for which the law firms are trying to recruit clients was originally filed in May 2018 and claims patients who experienced certain side effects, including kidney damage and bone density loss, from Truvada could have avoided them had Gilead not intentionally delayed the release of a safer version of the drug, which it shelved in 2004.
Peter Staley, a longtime HIV activist and co-founder of PrEP4All, a coalition working to expand access and use of PrEP medications, said that he began seeing the advertisements on his own social media platforms in September and was immediately concerned.
“For the last six months, they’ve been targeting gay men on Facebook and Instagram with visuals about PrEP, the word PrEP and the blue pill, which is very iconic now for PrEP users,” Staley said. “They’re scaring the s—out of anybody who’s seeing them.”
Gay and bisexual men are likely being targeted because men who have sex with men comprise 70 percent of new HIV transmissions in the U.S. annually, according to the CDC.
Staley said the law firms that took up the case last year aren’t to blame for the misleading ads. Instead, he said, it’s the flurry of smaller “ambulance chasers” eager to get in on a potentially big payday.
“We think that they are causing hundreds of HIV infections, based on the reports that we’re getting from doctors. The clinics on the front line, they really say that these have a real impact,” he said.
‘A pretty significant chilling effect’
Demetre Daskalakis is the deputy commissioner of disease control at the New York City Department of Health and Mental Hygiene, and he also runs his own practice where he specializes in infectious diseases like HIV/AIDS. He told NBC News that he’s seen the impact of the ads first-hand, and that his colleagues across the country have, too.
“We’re all seeing and hearing the same thing, which is that this has a pretty significant chilling effect on trying to get folks on to pre-exposure prophylaxis, especially in communities that already have a baseline issue with medical trust,” Daskalakis said. “I’ve had my patients coming in to see me saying, ‘Hey, should we be switching me off of Truvada on to something else?’ It’s really frustrating.”
The U.S. is behind in the fight to prevent HIV using PrEP: Only about 18 percent of the 1.2 million Americans who might benefit from the medication actually received a prescription for it last year, according to a recent CDC report.
Staley said the reasons for this gap include the unusually high cost of the medication in the U.S. (about $2,000 for a 30-day supply), the lack of trust in the relatively new medicine and misinformation.
“Our worst nightmare is coming true, because these ads are definitely sending us back,” said Staley, who has been on the front-lines of the movement since the early days of the HIV/AIDS epidemic.
Politicians enter the controversy
Following the release of the open letter Monday, a number of lawmakers have joined the call for Facebook to remove the ads.
On Tuesday, New York Gov. Andrew Cuomo, a Democrat, issued a statement urging Facebook to remove the “deceptive” ads.
“Health officials and federal regulators have been clear that Truvada — or PrEP — is safe and effective,” it reads. “This ad campaign is putting New Yorkers in danger and jeopardizing the great strides our state has made in helping end the AIDS epidemic.”
That same day, presidential candidate Sen. Elizabeth Warren, D-Mass., took to Twitter to condemn the ads.
“Facebook is allowing entities to target misleading and false ads about HIV prevention drugs to LGBTQ+ communities and others. This can have serious public health consequences” she wrote. “Facebook needs to put the safety of its users above its own advertising profits.”
Signatories demand review of Facebook’s ad policies
GLAAD, the national LGBTQ advocacy organization that spearheaded the campaign to remove the controversial ads, is a member of Facebook’s Network of Support, a group of LGBTQ organizations that the social media giant consults on how to improve user experience. Rich Ferraro, GLAAD’s chief communications officer, said his organization initially tried to address the issue directly with Facebook but was met with resistance and an obtuse fact-checking system outsourced to third-party organizations.
“Facebook is clearly hiding behind their third party fact-checking agencies, but those agencies might not … have expertise in LGBTQ issues,” he said, adding that one of the fact-checking agencies, CheckYourFact.com, is part of The Daily Caller, an online outlet founded by right-wing pundit Ben Shapiro that has published a number of anti-LGBTQ articles and op-eds.
Ferraro said Facebook’s wide reach and targeted advertising capabilities make it even more important for the social media company to carefully vet the ads on its platform.
“This isn’t just an ad on a local news station or in a national newspaper,” he said. “The ambulance chasing law firms and the personal injury law firms behind these ads are able to target LGBTQ users and people who might be at risk for contracting HIV and who should be on PrEP.”
In addition to removing the ads, the open letter’s signatories are demanding that Facebook improve transparency with users — and the LGBTQ community in particular — around its policies for reviewing ads that contain potential misinformation. They are also asking the company to commit to a review of their current advertising policies “to prevent false or misleading public health statements from reaching users.”
Ferraro said he’s hopeful that Facebook will agree to the open letter’s demands, but he added that the fact that a public campaign was necessary at all is a troubling sign.
“This is one of the first public actions that GLAAD has taken against a social media company,” he said, noting that the organization’s work typically takes place “behind the scenes.”
“Social media is becoming home to anti-LGBTQ organizations and misinformation, and GLAAD is going to be holding them accountable in very public ways in the future,” he added.
The U.S. government will start a national HIV prevention program that will distribute free HIV pre-exposure prophylaxis medication, or PrEP, to uninsured Americans at risk of acquiring the virus, the Department of Health and Human Services announced Tuesday. Activists, however, say the plan doesn’t go far enough.
Health Secretary Alex Azar called the new “Ready, Set, PrEP” program a “historic expansion of access to HIV prevention medication” and a “major step forward” in President Donald Trump’s Ending the HIV Epidemic plan, which was announced in February and seeks to reduce HIV transmission by 90 percent by 2030.
“Thanks to Ready, Set, PrEP, thousands of Americans who are at risk for HIV will now be able to protect themselves and their communities,” Azar said in a statement.
According to a risk index devised by the CDC, men who have sex with men should be advised to start PrEP if they have multiple risk factors, such as having more than one partner per month or being between 18 and 28. One risk factor — having condomless receptive sex once in the past six months — results in an automatic PrEP recommendation, according to the guidelines.
Azar noted that just 18 percent of the 1.2 million Americans who might benefit from HIV PrEP are actually taking the medication. That low level of access is in part because of the $2,000 monthly list price of Truvada and Descovy, the two Gilead Sciences drugs approved for HIV prevention, as well as the absence of a generic alternative. A generic version of Truvada is set to be released in September 2020.
This new national program is a win for activists, like those involved in the PrEP4All Collaboration, who have for years called for a national PrEP program to end the U.S. HIV epidemic.
However, the program has one glaring loophole: Ready, Set, PrEP does not cover the blood work required for PrEP, which advocates call “a barrier to PrEP access.”
The CDC’s 2017 PrEP provider guidelines state all sexually active PrEP users should receive multiple blood tests annually in order to initiate and continue taking PrEP. These tests can easily cost hundreds of dollars per visit, and with no federal coverage for them, it remains unclear how users would pay for them. In a conference call, Azar said community health centers could provide these tests for free, though this is not an official part of the government plan.
PrEP4All Collaboration member James Krellenstein said Ready, Set, PrEP leaves much to be desired, because it is “poised to repeat the errors of Gilead’s own Medication Assistance Program, which donated free PrEP to qualified uninsured individuals, albeit on a much smaller scale.”
“Similar to the HHS program, the Medication Assistance Program did not cover lab costs or associated clinical care,” Krellenstein wrote in an email. “As a result, people who access PrEP through the Medication Association Program were found to have a statistically significant lower rate of PrEP initiation and a longer time between PrEP prescription and initiation.”
While PrEP access is weak nationwide, there are areas where it is more widely used and supported by government health care services, like New York City and San Francisco. In those municipalities, the rate of new HIV infections has declined since the introduction of PrEP and is now reaching a level where there are few HIV-positive people who are at risk of transmitting the virus and few HIV-negative people who are at risk of contracting it.
HHS launched a website — GetYourPrEP.com — and a telephone number — 855-447-8410 — to help guide potential patients to PrEP resources.
The global fight against the human immunodeficiency virus is poised to make important advances thanks to three experimental HIV vaccines that are entering the final stages of testing at sites across the globe.
While any of these three late-stage HIV vaccine trials — known as HVTN 702, Imbokodo and Mosaico — could fail, scientists say they are more hopeful than at any time since 1984, when Secretary of Health and Human Services Margaret Heckler raised hopes by predicting that there would be a test-worthy HIV vaccine within two years.
This is “perhaps one of the most optimistic moments we have been in,” said Dr. Susan Buchbinder, director of the Bridge HIV research program at the San Francisco Department of Public Health and a chair of both the Imbokodo and Mosaico trials.
“We have three vaccines currently being tested in efficacy trials,” she said, “and it takes quite a bit to actually be promising enough in the earlier stages stages of trials to move you forward into an efficacy study.”
HVTN 702
The oldest ongoing HIV vaccine trial, known as HVTN 702, is based on a prior vaccine candidate, RV144, that was effective, but not effective enough. In 2009, the RV144 clinical trial released findings showing that the vaccine lowered the rate of HIV infections by about 30 percent. To this day, RV144 remains the only HIV vaccine that have ever demonstrated any efficacy against the virus.
While RV144, at 30 percent effective, did not suffice for global distribution, it pointed the way forward for vaccine researchers, who adapted RV144’s successes to create HVTN 702. Buchbinder said even a partially effective vaccine would be “a tremendous breakthrough,” and “would really have the power to change the trajectory of the epidemic.”
Dr. Anthony Fauci, director of NIAID and a longtime advocate for a vaccine that is at least 50 percent effective, said he feels “even more strongly now” that a partially effective vaccine would be worth deploying. He said that is because prevention strategies like pre-exposure prophylaxis (PrEP) and treatment as prevention (TasP) “are being so successfully used, even in the absence of a vaccine, that if one or more of these vaccines look good, have a 50-60 percent efficacy, I think that’s going to be the game changer for turning the epidemic around.”
HVTN 702 completed enrollment this summer, and clinical results are expected in late 2020 or early 2021.
Imbokodo and Mosaico
Imbokodo, the second trial, began in five southern African nations in 2017 and completed enrollment of 2,600 women this summer. In southern African nations, heterosexual women are at extremely high risk of HIV infection.
“It’s almost unbelievable, but it’s true, women between the ages of 18 and 25 — the prevalence of infection is well over 50 percent,” Fauci said. “If ever you wanted to get a population that, if the vaccine works, you’re going to know pretty quickly, then you want to go in women.”
Unlike HVTN 702, Imbokodo uses “mosaic” immunogens, which are “vaccine components designed to induce immune responses against a wide variety of global HIV strains,” according to the National Institutes of Health.
“The presumption is that a mosaic is going to give you broader coverage,” Fauci said.
In November, the third vaccine trial, Mosaico, marked its informal start after the first study participant received an injection. Mosaico is based on Imbokodo’s unique mosaic immunogen approach.
Imbokodo and Mosaico are largely identical and consist of six injections, with slightly different vaccine formulations administered during the final two clinic visits.
In addition, while Imbokodo is only being tested in African women, Mosaico will recruit 3,800 gay men and transgender people for its clinical trials at 57 sites in the United States, Latin America and Europe. For any HIV vaccine, Fauci said there’s a need to prove it works in different at-risk populations.
Imbokodo completed enrollment of study participants this summer, marking the formal end of the recruitment process. Results from Imbokodo are expected in 2021, and results from Mosaico are expected in 2023.
Challenges ahead
Fauci noted that there has been a rapid pace of vaccine-related developments in recent years, with these three vaccine trials starting in 2016, 2017 and 2019.
“In all of these trials, intermittently the data and safety monitoring board takes a look at the data, and either says the data are so bad you have got to stop, or the data are so overwhelmingly good that you have got to stop,” Fauci said. So far, after several reviews of the data in HVTN 702 and Imbokodo, “there’s nothing there to say stop the study,” which happened in 2007 when a Merck vaccine trial was shut down after the monitoring board determined that it had no impact on prevention.
“None of these vaccines is a particularly simple regimen,” Buchbinder said, “so it’s going to require quite a bit of effort to deploy.”
“They require multiple injections, and so each one would require a minimum of four different doses in its current configuration,” Buchbinder said. But an effective vaccine could be a “stepping off point” to potentially create a simpler and more effective vaccine in the future.
And if these vaccine trials all fail, public health officials say enough tools currently exist to stop the spread of HIV — if only people would, or could, use them.
PrEP, the daily pill that prevents HIV infection, is safe and effective, but not enough people are using it to slow HIV transmission and end the epidemic. And successful treatment of people living with HIV results in an undetectable viral load that they cannot transmit the virus via sexual activity, known as “treatment as prevention” or TasP.
“It goes exactly to what I have been saying for years and years — if you implement the tools that you have, you will definitely see an impact on the dynamics of the epidemic,” Fauci said. “I have been talking about this for well over a decade. If you implement, the incidence is going to go down. It happened dramatically in San Francisco, and it is happening right now in New York.”
World AIDS Day provides us the opportunity to support those living with HIV, unite in the fight to end the HIV/AIDS epidemic, and mourn those we’ve lost. Today, we’re thinking about all the progress we’ve made, and the work still before us.
This president is no ally of people living with HIV, who are disproportionately LGBTQ and people of color. His administration has proposed cutting global HIV-prevention programs and attacked health care services that people living with HIV rely on, including the Affordable Care Act, Medicaid, and Planned Parenthood.
Just last month, we saw firsthand just how uninformed and callous the Trump orbit can be through Donald Trump Jr.’s despicable attack on people living with HIV.
Democrats are committed to ending the stigma and the epidemic. This year, House Democrats passed bills to lower prescription drug costs and protect access to the health care that those living with HIV deserve.
And Democrats fought to pass the Americans with Disabilities Act and to ensure it protects against discrimination based on HIV/AIDS status or perceived status, and of caregivers of people living with this disease. We stand in solidarity with those living with HIV and AIDS in America and around the world.
The Bill and Melinda Gates Foundation has teamed up with the National Institute of Health (NIH) to develop revolutionary gene-based cures for HIV and sickle cell anaemia.
They are now giving an additional $100 million which, combined with the NIH’s investment, will amount to at least $200 million over the next four years – a huge boost to researchers fighting the diseases.
It’s particularly vital as scientists recently announced they have discovered a new strain of HIV for the first time in nearly two decades.
Dramatic advances in genetics over the last ten years have made effective gene-based treatments a reality, including new treatments for blindness and certain types of leukaemia.
However, the high cost of these breakthroughs makes them largely inaccessible to much of the world – particularly for those in the resource-poor countries hit hardest by HIV.
But Bill and Melinda Gates and the NIH have vowed that the cures funded by their investment will be affordable and available for all.
The idea is to focus “on access, scalability, and affordability … to make sure everybody, everywhere has the opportunity to be cured, not just those in high-income countries,” NIH Director Francis Collins said in a statement. “We aim to go big or go home.”
They hope to bring safe, effective and durable gene-based cures to clinical trials in the United States and sub-Saharan Africa within the next seven to 10 years.
Anthony S Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, agreed that it was an “ambitious” step.
“[We are] harnessing the most cutting-edge scientific tools and NIH’s sizeable global HIV research infrastructure to one day deliver a cure and end the global HIV pandemic,” he said.
“We are taking into account those with the greatest need at the foundation of this effort, to ensure that, if realised, this exceptional public health achievement will be made accessible to all.”