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Research into AIDS cure advancing but remains in ‘very early days’

HIV treatment and prevention getting ‘better and better’

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Carl W. Dieffenbach, Ph.D.

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.

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Roe leak stokes fears that LGBTQ rights are now at heightened risk

Legal experts diverse on degree of threat to marriage

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Legal experts diverge on the degree Samuel Alito's opinion would threaten same-sex marriage.

Fears that same-sex marriage and other LGBTQ rights could be on the chopping block are at a new high after a leaked draft opinion from the U.S. Supreme Court that would explicitly overturn precedent in Roe. v. Wade, although the degree of perceived danger differs among legal observers.

Although language in the leaked draft by U.S. Associate Justice Samuel Alito, which was published late Monday by Politico and confirmed as “authentic” by the Supreme Court, specifically distances the potential ruling from Obergefell v. Hodges, the general reasoning against finding unenumerated rights in the U.S. Constitution could apply to challenges to the landmark 2015 marriage decision.

Karen Loewy, senior counsel for the LGBTQ group Lambda Legal, told the Washington Blade if the draft decision were to become final it would “have no good implications” for either the Obergefell or Lawrence decisions.

“The analysis that Justice Alito has laid out really calls into question the sort of underlying liberty and dignity jurisprudence that really was the underpinning of cases like Lawrence and Obergefell,” Loewy said. “It requires a really cramped vision of what is constitutionally protected, that is tied to histories of oppression that are really, really concerning.”

Alito obliterates long-standing precedent, as defined in the 1973 Roe. v. Wade decision and subsequently affirmed in the 1992 decision in the Planned Parenthood v. Casey, finding a woman’s right to have an abortion is protected under the 14th Amendment.

“We hold that Roe and Casey must be overruled,” Alito writes. “The Constitution makes no references to abortion, and no such right is implicitly protected by any constitutional provision, including the one on which the defenders of Roe and Casey now chiefly rely — the Due Process Clause of the 14th Amendment.”

Alito makes clear for the Supreme Court to find any unenumerated rights under the 14th Amendment, the right must be “deeply rooted in this Nation’s history and tradition” and “implicit in the concept of ordered liberty.”

Such an analysis would directly impact LGBTQ rights found under the 14th Amendment. In fact, three separate times over the course of the draft opinion, Alito compares the right to abortion to rights for LGBTQ people as defined by the U.S. Supreme Court.

Those references, however, aren’t to threaten those decisions, but to bolster the case for overturning precedent as established by Roe and limit the impact of the draft opinion.

“Roe’s defenders characterize the abortion right as similar to the rights recognized in past decisions involving matters such as intimate sexual relations, contraception, and marriage,” Alito writes, “but abortion is fundamentally different, as both Roe and Casey acknowledged, because it destroys what those decisions called ‘fetal life’ and what the law now before us describes as an ‘un-born human being.'”

In another instance, Alito includes Obergefell and Lawrence among a multitude of cases in a multi-page footnote giving examples of where the Supreme Court has decided to overturn precedent, which the draft opinion would do for Roe v. Wade. Another time, Alito rejects arguments from the U.S. solicitor general that abortion and marriage are connected, asserting “our decision concerns the constitutional right to abortion and no other right.”

Loewy, however, said the fundamental nature of the draft opinion, despite Alito’s rejection that abortion is comparable to LGBTQ rights, undermines that analysis no matter how many times he articulates it.

“The third time is where he offers a fig leaf saying, ‘This analysis is just about abortion rights. It’s not about anything else,’ and so suggests that it would leave untouched a case like Obergefell, when the analysis that he has offered in this opinion clearly leads to the opposite result,” Loewy said.

Indeed, the sweeping nature of Alito’s reasoning against finding unenumerated rights under the Constitution has led some observers to believe the draft was written by Alito alone and without the input of the other eight justices, which could mean the final decision would be a consensus different from the opinion that was leaked. (Upon publishing the leaked opinion, however, Politico did report the Supreme Court has five justices who will vote in favor of overturning Roe, which means without question such a ruling has a majority.)

Not all observers see the opinion in the same way and are interpreting Alito’s references to Obergefell and Lawrence as less threatening.

Dale Carpenter, a conservative law professor at Southern Methodist University who’s written about LGBTQ rights, downplayed the idea the draft opinion against Roe would be a prelude to overturning Obergefell based on Alito’s words denying the connection.

“The opinion tries to make it clear that it does not affect other unenumerated rights, like Lawrence and Obergefell and other fundamental rights cases, like contraceptive cases and other marriage cases,” Carpenter said. “So that’s comforting, I think, to LGBT rights advocates. Second, it says that there’s a fundamental distinction between those other cases and the abortion cases in that the abortion cases involve fetal life or potential life. And so, that I think, is a ground for setting a difference between them.”

Carpenter, however, conceded the mode of analysis in the opinion overturning Roe “is not very friendly to unenumerated rights like marriage and sexual intimacy,” so while Obergefell and Lawrence may face no immediate threat “there might be a longer term concern about decisions like those.”

A follow-up ruling from the Supreme Court rolling back the right for same-sex couples to marry would be consistent with a 2020 dissent from Alito and U.S. Associate Justice Clarence Thomas essentially declaring war on the Obergefell decision, urging justices to revisit the case to make greater accommodations for religious objections.

Jim Obergefell, the lead plaintiff in the marriage equality case and now a candidate for a seat in the Ohio state legislature, said in a statement after the leak of the draft Alito opinion he was fearful that the same forces seeking to overturn precedent for abortion rights would go after LGBTQ rights next.

“It’s also concerning that some members of the extreme court are eager to turn their attention to overturning marriage equality,” Obergefell said. “The sad part is in both these cases, five or six people will determine the law of the land and go against the vast majority of Ohioans and Americans who overwhelmingly support a woman’s right to make her own health decisions and a couple’s right to be married.”

The Supreme Court, of course, couldn’t willy nilly reverse the Obergefell decision, which would require some case or controversy to wind its way through the judicial system before justices could revisit the ruling. Mostly likely, such a hypothetical case would be a state passing a law banning same-sex marriage or simply declaring it would no longer allow same-sex couples to wed in defiance of the Obergefell decision.

No state, however, is engaged in a serious effort to challenge marriage rights for same-sex couples. The last such challenge was in 2020 and from the solicitor general of Indiana, who was seeking to challenge the decision on the basis of birth certificates for the children of women in same-sex marriages. Even the current 6-3 conservative majority on the court declined to hear the case.

Additionally, as polls demonstrate, the nation is in a different place with abortion rights compared to the right for same-sex couples to marry. A recent Fox News poll found six in 10 registered voters still think the U.S. Supreme Court should uphold Roe v. Wade, but more than half of those responders favored banning abortions after 15 weeks. Comparatively, a Gallup poll in September 2021 found support for marriage equality is at a record high of 70 percent and, for the first time, a majority of Republicans back same-sex marriage.

A question also remains about what the draft opinion means for decisions on LGBTQ rights that have yet to come before the Supreme Court but may come at a later time, such as a legal challenge to the “Don’t Say Gay” measure recently signed into law by Florida Gov. Ron DeSantis.

Carpenter said he doesn’t think the observers can glean anything about a potential ruling on the “Don’t Say Gay” law based on the fact the legal challenge would be different than challenges to abortion or same-sex marriage.

“That kind of challenge would more than likely be brought under the First Amendment,” Carpenter said. “And I don’t see the First Amendment being affected by the Dobbs decision. I suppose that someone might want to bring an Equal Protection challenge to the ‘Don’t Say Gay’ law in Florida, but it just doesn’t seem like it would have an immediate impact on even that kind of claim.”

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HRC names Chase Brexton ‘Leader in LGBTQ Healthcare Equality’

Perfect HEI score for Baltimore provider

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Chase Brexton Health (Washington Blade file photo by Michael Key)

The Human Rights Campaign has again awarded the title of “Leader in LGBTQ Healthcare Equality” to Chase Brexton Health Care in Baltimore. 

The designation was reported in the recently released 2022 edition of the Healthcare Equality Index (HEI). Chase Brexton was one of only two Maryland healthcare providers, and 496 nationwide, to earn the honor.

To be named a Leader in LGBTQ+ Healthcare Equality, Chase Brexton achieved a perfect score of 100 points across strict criteria implemented by the Healthcare Equality Index. The categories measured included staff training and benefits, patient services and engagement, and responsible citizenship.

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AIDS Healthcare Foundation opens first Healthcare Center in Virginia

Clients at AHF’s Falls Church Healthcare Center will receive care from Danbi Martinez, a provider with 19 years of HIV and primary care experience.

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Dr. Danbi Martinez (Photo courtesy of Aids Healthcare Foundation).

The AIDS Healthcare Foundation (AHF) just opened a new Healthcare Center in Falls Church, Virginia—the organization’s very first Healthcare Center in the state. AHF’s mission is to eradicate HIV/AIDS and to provide cutting-edge medicine and advocacy regardless of ability to pay.

As of 2019, there were 23,691 people living with HIV in Virginia, and 56.4% of those people were black Americans. AHF is rooted in providing needed services to the most vulnerable demographics. With every AHF Healthcare Center, AHF Wellness Center, and AHF Pharmacy that caters to underserved communities, AHF hopes to close the gap on HIV/AIDS disproportionately affecting a single community. 

In 2019, the Commonwealth of Virginia also saw 822 new HIV diagnoses. This further highlights the need for the free-to-low-cost HIV services and linkage to care that AHF offers. For instance, AHF is now the largest provider of PrEP (Pre-exposure Prophylaxis), an HIV prevention medication in the U.S. 

In Virginia, The prEP-to-need ratio (PNR) went from 0.30 in 2012 to 4.37 in 2019. The lower the number is, the larger the need is for HIV prevention. And although the PNR has steadily increased, among females in Virginia, the PNR was far lower at 1.48. o

AHF’s new Falls Church Healthcare Center is another step in the right direction in providing at-risk populations with HIV prevention medication, getting them tested for HIV regularly, and getting them linked to care within 72 hours of a positive test result.

Clients at AHF’s Falls Church Healthcare Center will receive care from Danbi Martinez, a provider with 19 years of HIV and primary care experience. The location offers free STI and HIV testing, linkage to care, and access to a specialty pharmacy. Operating hours are Monday, Tuesday, Thursday, and Friday from 8:30 am to 5:00 pm, as well as, Wednesday from 10:00 am to 6:30 pm. 

To welcome Danbi Martinez to the AHF family, and to celebrate their first Healthcare Center in Virginia, AHF is hosting a grand opening event and reception on March 10th, 12 pm at 2946 Sleepy Hollow Road Suite 4B Falls Church VA 22044. Please call (703) 962-1528 for further information on the event or services offered.

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