Health
Research into AIDS cure advancing but remains in ‘very early days’
HIV treatment and prevention getting ‘better and better’
Editor’s note: This is part two of our interview with Carl Dieffenbach, director of the Division of AIDS at the National Institute of Allergies and Infectious Diseases. Click here to read part one.
Unlike the coronavirus, the AIDS virus’s ability to permanently infect the human body has made it more difficult to develop an AIDS vaccine, and research into a cure for HIV/AIDS is continuing to advance but remains in its “very early days,” according to Carl W. Dieffenbach, who has served for the past 25 years as director of the National Institutes of Health’s Division of AIDS.
But in an interview with the Washington Blade, Dieffenbach, who holds a doctorate degree in biophysics, said the already highly effective antiretroviral drug treatment for HIV is continuing to advance to a point where the current one pill per day regimen may soon be replaced by a single injection that will make HIV undetectable in the body and untransmitable for six months and possibly a full year.
He said the single injection advance would be applicable for both people who are HIV positive as well as for those who are HIV negative and are taking the current one pill per day prevention medication known as PrEP.
“One of the things I am most happy with is the whole U equals U movement – that undetectable equals untransmitable,” Dieffenbach said in referring to the current antiviral medication that makes HIV undetectable in the human body and prevents the virus from being transmitted to another person through sexual relations.
“That really is a rallying cry for people living with HIV that you can become fully suppressed and live knowing that there is no virus in your body as long as you take your pill, and you are free to love,” he told the Blade. “And that’s a wonderful thing.”
Although he didn’t say so directly, Dieffenbach made it clear that he and other government and private industry researchers working on an AIDS vaccine and an HIV/AIDS cure know that people with HIV can live a full and productive life as the push for a vaccine and cure continues.
Dieffenbach said a dramatic difference in the genetic makeup between the coronavirus and the AIDS virus is the reason why an AIDS vaccine has yet to be developed after more than 20 years of vaccine research while a COVID-19 vaccine was developed in a little more than a year.
“Once a person becomes HIV positive, that individual is HIV positive for life,” he said. “There is no going back. There is no spontaneous cure.” By contrast, Dieffenbach points out that with coronavirus, just five percent of those who become infected become seriously ill and are at risk of dying. He said between 35 percent and 40 percent of those infected with coronavirus are asymptomatic and often are unaware that they were infected.
“So, the human immune system by and large does a pretty good job of fighting off the coronavirus,” he said. That, among other factors, has made it possible to develop an effective COVID vaccine sooner than an AIDS vaccine, according to Dieffenbach.
Washington Blade: Where do things stand now in the progress of developing a cure for HIV and AIDS?
Carl Dieffenbach: So, let’s talk a moment about what we are doing in the space of trying to achieve a cure for HIV. Clearly, this is one of the two major research programs or research goals remaining in HIV – an effective and durable vaccine and then a cure that allows people to not take an antiretroviral [drug] and still live the ‘U’ equals ‘U’ [undetectable equals untransmitable] life.
What we want is a cure that really allows people to be free of HIV. And that can be achieved in two ways. You could see the HIV be eliminated or eradicated from the body. You would call that a sterilizing cure. And the other would be more of an immunological or other means of control that would suppress the virus similar to the way the antiretrovirals do, but it’s using the natural immunity, the induced immunity that the human body is capable of generating.
Up until recently there hadn’t been examples of an individual that had achieved that kind of cure. Just recently there was one reported. The big program we have in cure research is called the Martin Delany Collaboratories for Cure Research. And Marty was one of the lead activists in the very early days of HIV through the ‘90s. And he really pushed NIH very, very hard to not forget about a cure and to really focus on the best possible anti-virals.
He was just a strong leader and a really wonderful person who just pushed constantly the way you would hope the activist community would continue to try to drive improvements, even when things were going well. So, we felt it was a great way to honor Marty to name the program after him. This program has been around for a little over a decade and it gets more sophisticated and better every cycle.
And the two methods I mentioned – the ability to eliminate the virus completely and establish an immunologic or some other means of control – are major themes of these programs. It’s still in the very early days. There are limited clinical trials ongoing, but they’re very exploratory. There are maybe hints of things coming in the next couple of years. But it remains in the very early days. In some ways it’s similar to where we are with vaccines where we’ve had a little bit of success but nothing really that we then can say this is the vaccine for the future.
So, these two types of research – a vaccine and cure – remain our top research priorities. And we will continue at this until we have HIV vaccines and the abilities to cure, because we cannot really control and eliminate the epidemic without either of those two strategies.
Blade: Can you talk a little about the human trials that are going on now for a possible HIV cure being conducted by the Rockville-based company American Gene Technologies?
Dieffenbach: That’s right. One approach for achieving a cure are these gene-based strategies. There is a company that has a strategy for a gene-based treatment that they have been working on for a number of years. And that has been moving forward. And the proof will be in the pudding when we have a sufficient number of people in a way that are truly evaluated.
There are also strategies that look at ways of using what amounts to scissors, molecular scissors that can go in and chop out the virus. So, there are a number of strategies that people are using or considering for this idea of elimination of the reservoir, including the gene therapy method that we were just discussing.
Blade: The company conducting the gene therapy trials has said the treatment they hope will lead to a cure requires taking blood from someone, altering the genetic makeup of certain cells, and re-infusing the blood back into their body. Is that something that would be practical for treating a large number of people?
Dieffenbach: So, all of these gene therapy strategies are in the very experimental stage. They have to do something called ex-vivo transduction. That’s fancy words for saying what you just said. You take cells out of the human body, alter them by adding the new therapeutic and incorporate it into the cell, and re-infuse those cells back into the human body. So, first you start with one cell type like fully differentiated lymphocytes and then you move on.
The ultimate goal will be to get it so you can take a shot, where the shot would go in with the gene therapy and basically go into cells and immunize the cells in such a way that they provide protection from HIV infection as well as elimination of existing copies of HIV. So, we’re many steps away from that.
Blade: Some people may be asking why a COVID vaccine has been developed in just over a year since the worldwide COVID outbreak, but an HIV vaccine has not yet been developed after 20 or more years of research. Is there something different with the coronavirus as opposed to the HIV virus that might explain why we haven’t had an HIV vaccine at this time?
Dieffenbach: I think this is a really important point. And I want to talk about two different activities. One is the differences between the viruses themselves. With coronavirus, five percent of people who become infected with coronavirus actually get sick and get into a hospital and have near death experiences. Thirty-five to 40 percent of people who get infected with coronavirus are actually never aware that they were infected.
So, the human immune system by and large does a pretty good job of fighting off the coronavirus. But it is incredibly infectious. It is spread by aerosol. With HIV, it is transmitted sexually. It’s transmitted through blood and other bodily fluids. Once a person becomes HIV positive, that individual is HIV positive for life. There is no going back. There’s no spontaneous cure. We’ve had 70 million people around the world acquire HIV. By last count, there may be one person in all the years that may have spontaneously cleared their HIV infection. That took 12 years of that person’s life.
It is a rarity. So, from that perspective the type of immunity that you need to induce by a vaccine is so fundamentally different for coronavirus and for HIV. So, that’s the first step.
The second thing is why were we so successful with the coronavirus vaccine? It wasn’t dumb luck. Going back to the earliest SARS outbreak and through MERS and through other respiratory viruses the research team here at NIH has been looking at ways of building the better mouse trap, building a better immunogen. Take a part of the virus and make it the best it could be in terms of presenting or showing itself to the human immune system so that you get an incredibly robust quality response. And that was the work that was done at the VRC, the [NIH] Vaccine Research Center.
So, when that group first published their work on what we call this stabilized spike we offered that technology to all the vaccine manufacturers. And Moderna, Pfizer, and J&J all chose to use this modified version. AstraZeneca and Oxford chose different paths. The Chinese and the Russians chose a different path. And I think the quality of the vaccine and the effectiveness of the vaccine shows in part because of the genetic engineering that we have done to make it the best immunogenetic it can be.
So, it was a two-fold thing. We built a better vaccine to tackle a disease that really natural immunity can work well on. That’s one of the reasons why our vaccines – the Moderna, the Pfizer, and the J&J are still quite active against all these variants. It’s because their immune response was so robust. So, it was probably six to ten years of work that led us to that exact moment when SARS-CV2 came along that we know what to do with this. We were able to design a vaccine based on all that previous work within a very short period of time and start clinical trials within 60 days of identifying the coronavirus sequence. It wasn’t magic. It was hard work.
That’s a great story. There are so many unsung heroes in this. And it’s a great thing to be part of that we – NIH – could make it so it wasn’t just a proprietary thing for us. But we were able to give the world a way of making the best vaccine possible and to allow the companies to pick it up and run with it. So, again, at the end of the day the vaccines that I think we’ll come back to rely upon were made with this construct that was developed here through years of research.
Blade: Is there anything I did not ask you that is relevant to the HIV research?
Dieffenbach: Well, just to close the loop, so now that we learned all those lessons from the coronavirus vaccine, we’re going back to HIV vaccines and applying some of the rules and technologies and things that we’ve learned. Now we’re going back and looking at that more carefully and trying different things. And thinking about how we can build a better HIV vaccine based on what we know for a coronavirus vaccine.
So, we’re trying to complete the cycle. We started with HIV. We developed the platforms, applied it to coronavirus. And now we’re trying to close the loop.
Blade: You’ve been saying that these clinical trials for an AIDS vaccine have been going on for a while. Do you recall when the first AIDS vaccine trial started?
Dieffenbach: The very first trial for an AIDS vaccine was done in the ‘90s. And it didn’t work. It was a single protein. It induced antibodies. But the antibody did not react with the intact viruses. So, it failed. And that was the AIDS vax experience.
Blade: Do you remember when in the ‘90s that was?
Dieffenbach: The papers were finally published in 2003. So, the studies started in the late 90s and were completed in the early 2000s.
Blade: So, it appears that happened around the time the effective anti-retroviral drugs became available?
Dieffenbach: The highly active anti-retroviral therapy first made its debut in 1995. And that was a combination of AZT, 3TC, and either Crixivan, the protease inhibitor, or a different protease inhibitor from either La Roche or Abbott. And those drugs were quite effective in preventing the virus and helping people. But they all had tremendous side-effects as you will remember. And we then got better and better and better therapies where we are now at one pill once a day.
That is my background in this. I came from the drug side working with the companies back in the early ‘90s to bring those along. And I grew up in this field and then graduated to director of AIDS and then continued on to therapy and cure and vaccines ever since. I’ve been director since 2007.
District of Columbia
Trans activists arrested outside HHS headquarters in D.C.
Protesters demonstrated directive against gender-affirming care
Authorities on Tuesday arrested 24 activists outside the U.S. Department of Health and Human Services headquarters in D.C.
The Gender Liberation Movement, a national organization that uses direct action, media engagement, and policy advocacy to defend bodily autonomy and self-determination, organized the protest in which more than 50 activists participated. Organizers said the action was a response to changes in federal policy mandated by Executive Order 14187, titled “Protecting Children from Chemical and Surgical Mutilation.”
The order directs federal agencies and programs to work toward “significantly limiting youth access to gender-affirming care nationwide,” according to KFF, a nonpartisan, nonprofit organization that provides independent, fact-based information on national health issues. The executive order also includes claims about gender-affirming care and transgender youth that critics have described as misinformation.
Members of ACT UP NY and ACT UP Pittsburgh also participated in the demonstration, which took place on the final day of the public comment period for proposed federal rules that would restrict access to gender-affirming care.
Demonstrators blocked the building’s main entrance, holding a banner reading “HANDS OFF OUR ‘MONES,” while chanting, “HHS—RFK—TRANS YOUTH ARE NO DEBATE” and “NO HATE—NO FEAR—TRANS YOUTH ARE WELCOME HERE.”
“We want trans youth and their loving families to know that we see them, we cherish them, and we won’t let these attacks go on without a fight,” said GLM co-founder Raquel Willis. “We also want all Americans to understand that Trump, RFK, and their HHS won’t stop at trying to block care for trans youth — they’re coming for trans adults, for those who need treatment from insulin to SSRIs, and all those already failed by a broken health insurance system.”
“It is shameful and intentional that this administration is pitting communities against one another by weaponizing Medicaid funding to strip care from trans youth. This has nothing to do with protecting health and everything to do with political distraction,” added GLM co-founder Eliel Cruz. “They are targeting young people to deflect from their failure to deliver for working families across the country. Instead of restricting care, we should be expanding it. Healthcare is a human right, and it must be accessible to every person — without cost or exception.”

Despite HHS’s efforts to restrict gender-affirming care for trans youth, major medical associations — including the American Medical Association, the American Academy of Pediatrics, and the Endocrine Society — continue to regard such care as evidence-based treatment. Gender-affirming care can include psychotherapy, social support, and, when clinically appropriate, puberty blockers and hormone therapy.
The protest comes amid broader shifts in access to care nationwide.
NYU Langone Health recently announced it will stop providing transition-related medical care to minors and will no longer accept new patients into its Transgender Youth Health Program following President Donald Trump’s January 2025 executive order targeting trans healthcare.
Health
CMS moves to expand HIV-positive organ transplants
HIV/AIDS activists welcome potential development
The Centers for Medicare and Medicaid Services is pushing forward a proposed rule that would make it not only easier for people with HIV in need to get organ transplants from HIV-positive donors, but also make it a priority where there was often a barrier.
The Washington Blade sat down with people familiar with this topic — from former heads of the Centers for Disease Control and Prevention, to HIV activists and to the first HIV-positive person to donate an organ — about what this proposed change could mean.
HIV is a virus that attacks the body’s immune system, particularly targeting the body’s T-cells, which makes it harder to fight off infection and disease. If left untreated, HIV can become AIDS. Without treatment, AIDS can lead to death within a few months or years. The virus is spread through direct contact with bodily fluids — often through sex, unclean needles, or from mother to baby during pregnancy.
According to HIV.gov, a website managed by the U.S. Department of Health and Human Services, approximately 1.2 million people in the U.S. were living with HIV in 2022. Of those 1.2 million, 13 percent don’t know they have it.
The virus disproportionately impacts men who have sex with men and people of color.
The CDC’s statistics show men are most affected, making up almost 80 percent of diagnoses, with gay and bisexual men accounting for the majority. Racial disparities also are present — Black people make up 38 percent of diagnoses. The World Health Organization estimates that around 44.1 million people have died from AIDS-related illnesses globally as of 2024.
Since the virus was first detected 45 years ago, scientists have been working on ways to treat and prevent its spread. In 1987, the first breakthrough in fighting HIV came as the U.S. approved the first HIV medication, AZT — marking the beginning of antiretroviral therapy. This medicine — and later descendants of it, like today’s widely prescribed Biktarvy — stop the HIV virus from reproducing and allow the body to keep its T-cells.
Then in 2012, another big step toward minimizing the scope of the potentially fatal disease came as the CDC approved the first HIV prevention medication, Truvada, more commonly known as PrEP. As of 2024, nearly 600,000 people in the U.S. are using PrEP, according to AIDSVu, which uses data from Gilead Sciences (manufacturers of Truvada and Biktarvy) and is compiled by researchers at the Rollins School of Public Health at Emory University.
The following year, in 2013, the HIV Organ Policy Equity (HOPE) Act was signed into law, enabling the use of organs from HIV-positive donors for transplants into HIV-positive recipients, overturning a 1988 ban.
There are an estimated 123,000 people waiting for organ transplants in the U.S. The number of HIV-positive people on that list is estimated to be smaller, harder to precisely quantify, but they are still in dire need.
A study from the New England Journal of Medicine, published in 2024, analyzed the outcomes of 198 kidney transplantations to people with HIV at 26 medical centers across the U.S. from 2018 to 2021.
Results from the study showed that for kidney transplants performed using organs from 99 donors with HIV and 99 without HIV, one-year survival rates for HIV-positive recipients were nearly identical (94 percent and 95 percent, respectively). Three-year survival rates were also similar (85 percent and 87 percent). Organ rejection rates were also numerically on par after three years (21 percent and 24 percent). Other measures for surgical outcomes, including the number of side effects that occurred, were also roughly the same for both groups.
This shows that, overall, HIV-positive-to-HIV-positive transplants are nearly identical in outcome to transplants between HIV-negative donors and recipients.
Where we are now
Now in 2026, CMS is pushing past the clinical trial testing phase it has been in, making HIV-positive-to-HIV-positive organ transplants more widespread and more accessible.
Adrian Shanker, the former deputy assistant secretary for health policy and senior advisor on LGBTQ health equity at HHS, explained to the Blade that the HOPE Act was a step in the right direction, but this policy change from CMS will expand the ability to help HIV-positive patients in need.
“The original HOPE Act asked for scientific research,” Shanker explained. “There were 10 years of clinical trials. The Biden administration promulgated a rule that removed clinical trial requirements for kidney and liver transplants between people living with HIV. This proposed rule is further implementation on the CMS side with the organ procurement organizations to ensure they’re carrying out the stated intent of the HOPE Act law. It’s building on consensus that has existed through multiple administrations.”
The proposed change would go into effect on July 1, and, according to Shanker, would help everyone in need of an organ — not just HIV-positive people.
“People living with HIV, their ability to receive organs from other people living with HIV in a more streamlined way means that the overall organ waitlist is sped up as well,” he added. “So it benefits everyone on the waitlist.”
Shanker, who was also a member of the Presidential Advisory Council on HIV/AIDS, spoke about how this is a rare moment of bipartisanship.
“There’s no secret that the Trump administration has been quite adversarial to LGBTQI plus health, and to the health of people living with HIV/HIV prevention resources as well … From destabilizing PEPFAR to shutting down one of the primary implementation partners, which is USAID, to firing almost the entire staff of the Office of Infectious Disease and HIV Policy at HHS … But what this is is a glimmer of hope that we can have bipartisan solutions that improve quality of life for people living with HIV.”
Harold Phillips, the CEO of NMAC, a national HIV/AIDS organization that pushes policy education and public engagement to end the HIV epidemic, and an HIV-positive American, sees this as a huge gain for the HIV-positive community.
“For a number of years, we were excluded from that pool of potential donors,” Phillips said. “Many people living with HIV were excluded from being able to get organ transplants. So this opens up that door. This is a positive step forward that will help save lives.”
That “open door,” Phillips said, does more than just provide life-saving organs to people in the most need. It provides a sense of being able to support their community.
“I remember when I was no longer able to check that box on my driver’s license,” Phillips recalled during his interview with the Blade. “I remember what that meant — that my organs might not be able to save a life. The potential that now they could is really exciting for me.”
“To think about people living with HIV donating their organs to other people living with HIV and helping extend their health and well-being — that’s an exciting moment in our history. It reinforces that HIV is not a death sentence anymore.”
Human Rights Campaign Senior Public Policy Advocate Matt Rose also sat down with the Blade to explain the realities of HIV-positive people in the U.S. right now who are looking for a transplant.
“If you’re HIV positive and on the waitlist for an organ right now, your chance of getting one is slim to nil,” Rose said. “This at least gives you a real shot.”
He went on to explain that while the HOPE Act started to move in the right direction, it hasn’t done enough for HIV-positive people in dire need.
“This bill [HOPE] was supposed to fix that — and it never really has. But every administration, we keep chipping away at the next hurdle,” he said. “This latest move will drastically expand the ability for someone who is HIV positive to donate an organ.”
That slow chipping away, in addition to the non-stop trials being done to prove the efficacy and ability for HIV-positive people’s bodies to accept organ donation, is part of the broader push to normalize this practice and remove outdated restrictions.
Shanker elaborated, explaining all that time was necessary to figure out the efficacy of HIV-positive-to-HIV-positive organ transplants but now that the data has been collected — its time to expand the availability.
“There were over a decade of clinical trials between the original HOPE Act law being signed by President Obama and our rule being promulgated at the end of the Biden administration. It was to allow those clinical trials to run their course,” Shanker said.
Nina Martinez is the first HIV-positive person to donate an organ to another person with HIV.
She explained that the stigma and lack of understanding from the general public is another hurdle that those working to improve the quality of life for people living with HIV have to deal with.
“People don’t generally understand that treatment works,” Martinez said, who became the first person to undergo HIV-positive organ donation in 2019. “When you have access to antiretroviral therapy, it lowers the virus in your bloodstream to levels so low that lab tests can’t detect it. Clinically, that correlates to good health and an inability to transmit HIV sexually. I was healthy enough to pass the same evaluation as any other living donor without HIV.”
She continued explaining:
“Just by having a diagnosis of HIV, they’re labeling donors as medically complex, and that’s not accurate. Every donor with HIV has to pass the same evaluation as donors without HIV,” she said. “If someone passes that evaluation and still isn’t allowed to donate, that’s discrimination. If a patient is willing to accept that organ and you block it because of preconceived notions, you’re denying someone care based on disability. That runs counter to basic fairness.”
When asked about her decision to become a donor and what message she hopes it sends, Martinez emphasized that the choice should remain personal.
“I didn’t undertake this endeavor to say that people with HIV should donate. This is a community that’s been through a lot and has contributed to science — we have served. But for people who wanted a way to leave a legacy, and that is what I wanted, they should be supported in that. There shouldn’t be arcane scientific perceptions and myths getting in the way of that.”
National Donor Day, which raises awareness of organ donation, is on Feb. 14. To become an organ donor, visit registerme.org.
Health
CVS Health agrees to cover new HIV prevention drug
‘Groundbreaking’ PrEP medication taken by injection once every six months
CVS Health, the nation’s second largest pharmacy benefit manager company that plays a key role in deciding which drugs are covered by health insurance policies, has belatedly agreed to cover the new highly acclaimed HIV prevention drug yeztugo.
The U.S. Food and Drug Administration approved the use of yeztugo as an HIV prevention or “PrEP” medication in June 2025 as the first such drug to be taken by injection just once every six months. AIDS activists hailed the drug as a major breakthrough in the longstanding effort to end the HIV epidemic.
“We are pleased that CVS Health has finally decided to cover this groundbreaking new PrEP mediation,” said Carl Schmid, executive director of the HIV+ Hepatitis Policy Institute.
“Four months ago, 63 HIV organizations joined us in sending a letter to CVS’s president urging them to reconsider their refusal to cover Yeztugo and reminding them of their legal obligation to cover PrEP and describe the important benefits the drug would bring to preventing HIV in the U.S.,” Schmid said in a statement.
He noted that CVS Health now joins other leading pharmacy benefit manager companies and insurers in covering yeztugo. Gilead Sciences, the pharmaceutical company that developed and manufactures yeztugo, has said 85 percent of all people with health insurance in the U.S. now have coverage for the drug, according to Schmid.
“However, coverage does not automatically translate into access and usage,” Schmid said in his statement. “Too many people are being forced to pay copays while other payers, including employers, are failing to cover all forms of PrEP,” he said.
According to Schmid, the HIV+ Hepatitis Policy Institute is joining other HIV advocacy organizations in urging federal and state government officials to engage in “aggressive enforcement of PrEP insurance coverage requirements and sustained funding of state, local, and community HIV prevention programs.”
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