ROCKVILLE, Md. – Since 1996, Carl W. Dieffenbach, who holds a Ph.D. in biophysics from John Hopkins University, has served as director of the Division of AIDS at the National Institute of Allergies and Infectious Diseases, which is an arm of the U.S. National Institutes of Health or NIH.
In a June 10 interview with the Washington Blade, Dieffenbach gave an update on the extensive, ongoing research into the development of an HIV/AIDS vaccine that he has helped to coordinate for many years, including current human trials for a prospective AIDS vaccine taking place in the U.S., South America, and Africa.
One thing he feels passionate about is a development not widely reported in the media reports about the successful development of the COVID-19 vaccine. According to Dieffenbach, the extensive research into an AIDS vaccine in recent and past years, while not yet successful in yielding an effective AIDS vaccine, helped lay the groundwork for the rapid development of the different versions of a COVID vaccine.
“Because my division runs the largest clinical trials program in the word, we jumped in with both feet to help with coronavirus disease for both vaccines and drugs and things like that,” he said. “And the platforms that were used – the way they are making the coronavirus vaccines – the RNA vaccines with Moderna – were first piloted by NIH and Moderna to try to make an HIV vaccine,” Dieffenbach says.
“So, in many ways, the work for the past 25 years that we’ve done in HIV vaccines sped the development of coronavirus vaccines,” he told the Blade. “And now it’s time to take what we’ve learned from coronavirus and take it back to HIV and start afresh or continue with what we have and build upon from what we have learned.”
Dieffenbach says one reason the development of a COVID vaccine came about before an AIDS vaccine, despite more than 20 years of AIDS vaccine research, is that the HIV virus is far more complex than the coronavirus, especially its ability to infect and remain embedded in the infected person for life.
“Back in 2007 we had the first hint that an AIDS vaccine might be possible with a study called RV144,” Dieffenbach says. “We spent 10 years trying to replicate that, and we just completed that study – a study called HVTN702. And it showed no efficacy,” he said, meaning it did not work.
“So that was a big disappointment to us,” he says “But in the meantime, we had pushed forward with the J&J [Johnson and Johnson pharmaceutical company] vaccine and are pretty far along. We’ll see what happens. We should know in the next several months whether the N26 version of an AIDS vaccine, and HIV vaccine works or not,” he says. “We’re very close to an answer.”
Washington Blade: Where do things stand in the development of an HIV/AIDS vaccine in light of Dr. Fauci’s statement a few weeks ago that the development of a COVID-19 vaccine could provide a boost to developing an AIDS vaccine?
Carl Dieffenbach: Sure. So, maybe I can start by introducing myself to you as a way of putting this into a context.
So, I’m the director of the Division of AIDS, which is the largest funder of HIV research in the world. And I report directly to Dr. Fauci. So, I’m responsible for all AIDS, all the time. And that is my passion and purpose in life. Part of that is working toward a safe, effective, and durable HIV vaccine, which has been one of the two most challenging questions left in science today. The other is a cure. They are connected in some ways.
So, with that as background, when coronavirus disease came along – because my division runs the largest clinical trials program in the world – we jumped in with both feet to help with coronavirus disease for both vaccines and drugs and things like that. And the platforms that were used – the way they are making the coronavirus vaccines – the RNA vaccines with Moderna were first piloted by NIH and Moderna to try to make an HIV vaccine. So, we’ve being working on that platform with Moderna for several years.
The leadership at Pfizer used to be part of a group at Penn, where we were also working with them. The J&J vaccine – we currently have in two Phase III clinical trials for HIV, one in sub-Saharan Africa, specifically in young women and the other one in the Americas in men who have sex with men and transgender individuals. Both of those Phase IIIs are moving along. The women’s study is fully enrolled. The men’s study was hit hard by COVID, but we worked through and will be fully enrolled by September.
One other vaccine just to talk about is the Oxford vaccine, the AstraZeneca vaccine. That is also using a platform at Oxford University, which has been used for HIV. So, in many ways, the work for the past 25 years that we’ve done in HIV vaccines sped the development of coronavirus vaccines. And now it’s time to take what we’ve learned from coronavirus and take it back to HIV and start afresh or continue with what we have and build upon from where we have learned.
Blade: That’s very interesting. But can we assume, then, from the clinical trials that have taken place for an HIV vaccine that they did not succeed in providing the immunity needed for an effective vaccine?
Dieffenbach: So, that’s exactly the problem we have. Back in 2007 we had the first hint that an AIDS vaccine might be possible with a study called RV144. We spent 10 years trying to replicate that, and we just completed that study – a study called HVTN702. And it showed no efficacy. So, that was a big disappointment to us. But in the meantime, we had pushed forward with the J&J vaccine and are pretty far along. We’ll see what happens. We should know in the next several months whether the N26 version of an AIDS vaccine, and HIV vaccine works or not. We’re very close to an answer.
Blade: So, the human trials are ongoing.
Dieffenbach: Oh, again – the study in young women in sub-Sahara Africa is fully enrolled. The men’s study will be fully enrolled in September. So, we have fought through the coronavirus epidemic to maintain, to nurse these trials along to make sure with the $100 million or so we’ve invested, that we didn’t want them to go down the drain literally because we lost too many people for follow-up. So, this was a herculean effort that has gone on all the time trying to do the vaccine studies for coronavirus disease, which we were also incredibly successful in.
Blade: Can we assume all of the people participating in the studies were HIV negative?
Dieffenbach: Yes, they’re HIV negative. They are people who are at risk. And also, in South America, for example, the major countries we’re in are Peru and Brazil. And they’ve had a strong research culture with us, going back more than a decade. For example, both of those countries played big roles in our studies of pre-exposure prophylaxis. A study called I-PREX that demonstrated that in men who have sex with men that [a PrEP drug] works well to prevent HIV acquisition in seronegative men who have sex with men.
So, we’ve been there. This is a really good setup for the countries, for the citizens that are in those countries that want to avail themselves to the research that has benefited everybody.
Blade: Among those who are participating in these ongoing AIDS vaccine trials, can we assume they cannot be taking the PrEP anti-retroviral drugs that have been shown to be highly effective in preventing HIV infection?
Dieffenbach: So, what we’ve done is we – everything is by conversation. So, when somebody who is interested in the study comes in, we talk to them. What is your chief interest in being in this study? And a lot of people want to be in the study because then they can access PrEP. They want to make it easier to get a hold of pre-exposure prophylaxis. They feel that is the best way that they can protect themselves.
So, in that situation, what we do is we take those people and link them to PrEP services where they can easily get PrEP in their community. So, first it’s taking care of those people. Then there are people who really have no interest in PrEP. And we actually counsel them every time they come in for a study. Are you sure you don’t want to access PrEP? And those are the people we then say, if you’re not interested in PrEP, what do you think about participating in a vaccine trial?
Because they’re the ones who have the most freedom of thought. They don’t have an opinion about the vaccine or about PrEP. So, those are the people we’ve been focusing on and enrolling. So, we’ve been very careful to make sure that if people wanted PrEP they not only have access, but they didn’t feel like somehow having to trade something in order to get it. The freedom to join a study should be a free choice. And it shouldn’t be a coercive thing to get PrEP. So, we just took that off the table and said if you’re truly interested in PrEP we can get you PrEP and make sure that was available.
Blade: So, in that case, if they choose PrEP they would not be in the vaccine trial?
Dieffenbach: You know, it’s interesting that you ask it in that way. Because you have relationships with your community, many of the investigators have reported that people will say, you know I tried PrEP and it wasn’t for me. It made me gaseous. It upset my stomach. I wasn’t myself. I tried it. I couldn’t make it work for me. I want to stop PrEP. Am I still eligible for the [vaccine] study? And the answer is of course. Many people are very happy on PrEP and they come in for visits occasionally and say this is working for me and just have the relationship with the doctors there, so it works. So, again, it’s about maintaining contact with your communities.
Blade: Can you tell a little about what happens next after people become part of an HIV vaccine trial. Do you have to keep in touch with these people, and do they have to get an HIV test periodically?
Dieffenbach: Exactly. So, the vaccine consists of a series of injections. It’s a mixture of vector systems that delivers a series of encoded HIV genes that are specifically designed to induce very broad immunity. There’s a whole computer-based process to design those components of the vaccine to make sure that it has sequence similarities with all the different versions of HIV circulating in the globe. And then at the end there is a protein boost. And we carry this out.
So, about every three to four months people come in. They get a shot. They fill out questionnaires. They give a blood sample. And they’re tested for HIV and are given a boost or a placebo. And they stay in touch with the clinic. They come in and out of the clinic. And the retention is quite high in these situations because people really like having the attention of the clinic available to them. It’s part of the community.
Blade: So, they go to a clinic for all of this?
Dieffenbach: It’s a research clinic. It’s not like a state-run health clinic. It’s a research clinic. Clinic is just a term for where people are seen.
Blade: Are any of these AIDS vaccine trials that are going on taking place in the United States?
Dieffenbach: Yes. So, the study is called Mosaico. And it’s HVTN706. And we have sites throughout the United States as well as South America. But that study is limited to men who have sex with men – the one in the United States.
Blade: Is it broader than just men who have sex with men in other countries?
Dieffenbach: No, so we decided to really focus on specific at-risk populations. So, in the Americas we chose to focus on men who have sex with men and transgender individuals. And sub-Saharan Africa we focused on young women because that is the target of the study population. So, 705 is all women in sub-Saharan Africa. And in the Americas in North and South America it is all men who have sex with men and transgender individuals.
Blade: Can we assume that the researchers that are doing these studies have a sensitivity of LGBTQ people? Is there still an issue where people worry about being outed as being gay or transgender?
Dieffenbach: So, many of the sites that we work with have been part of our system for over 20 years. And so, they are trusted members of the LGBTQ community within their cities and states. And ‘states’ is a literal term where it’s a state in Colombia or Peru or Brazil. And so, it is part of the fabric of the gay community in these places. Just like in San Francisco the San Francisco health clinic and the DCF clinics are part and parcel of everything the community does there.
And so, the lead physician in San Francisco is Susan Buchbinder. She has been a leader in health in this population for over 25 years or actually closer to 30 years at this point. We’re all getting old. Do you know that? So, we have been at this a very long time. And really have tried to build structures that are durable and therefore are reliable to the community. And that’s where we go back to the same groups time after time.
Blade: Have the locations of the vaccine testing sites been released publicly?
Dieffenbach: Yes, all of that is publicly available on clinicaltrials.gov. If you go into clinicaltrials.gov and search HVTN705 or HVTN706 you will get a version of the protocol, all the times it’s been modified, where we are – the protocol. All of that is public knowledge and available to you. HVTN705 is the women’s study. HVTN706 is the men’s study.
Blade: Is there a timeframe for when these latest vaccine studies might be completed?
Dieffenbach: I think within the next several months. We will get an answer out of the women’s study and then the men’s study is probably a year away. We were slowed a little bit because of COVID. We actually had to pause enrollment for several months. But we’re back on track.
Blade: Isn’t there a parallel research effort for an HIV/AIDS cure?
Dieffenbach: Yes, we have a very large program in cure research. It is a lot earlier in the discovery process and so it’s still very ‘researchy.’ And we have a very large program called the Martin Delany Collaboratories for Cure Research. Martin Delany was an activist who really pushed NIH in so many wonderful ways to really take the need for a cure seriously. His argument was a cure is the next logical step after effective anti-retroviral therapy. You cannot stop with one pill once a day. You’ve got to keep going. And he was pretty persistent. And unfortunately, he died several years go and we just thought the best way to honor him, and his memory was to name a program after him.
Editor’s note: Next week, in the second and final installment of his interview with the Blade, Dr. Dieffenbach discusses the progress in research and studies into an HIV/AIDS cure and explains from a scientific standpoint why an HIV vaccine is taking longer to develop than a COVID vaccine.
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Maxine Waters criticizes House GOP over proposed cuts to HIV/AIDS programs
Calif. Democrat spoke at U.S. Conference on HIV/AIDS in D.C.
WASHINGTON — U.S. Rep. Maxine Waters (D-Calif.) on Wednesday sharply criticized House Republicans over their proposed cuts to HIV/AIDS prevention programs.
The California Democrat who represents the state’s 43rd Congressional District in a speech she delivered at the U.S. Conference on HIV/AIDS noted the House Appropriations Committee’s Fiscal Year 2024 Labor, Health, Human Services, Education and Related Agencies Appropriations Bill would cut $767 million from domestic HIV/AIDS programs.
Waters said the bill would cut funds to fight HIV/AIDS among underrepresented groups by 53 percent and “completely eliminates” funding for “Minority AIDS Initiative activities within the Substance Abuse and Mental Health Services Administration.” Waters also noted the appropriations measure “eliminates funding” for the Centers for Disease Control and Prevention’s Ending the HIV Epidemic Initiative, the Ryan White HIV/AIDS Program and community health centers.
“The cuts to the Minority AIDS Initiative will exacerbate racial disparities and the elimination of the (Ending the) HIV Epidemic Initiative,” said Waters.
Waters also criticized House Republicans for “refusing to authorize” the President’s Emergency Plan for AIDS Relief.” The California Democrat said ending PEPFAR “would endanger the lives of millions of people around the world who are living with HIV and endanger the lives of millions more who are at risk.”
“Moreover, it would compromise United States leadership on global health issues,” added Waters. “These programs used to have widespread support. It’s shameful that House Republicans are now trying to eliminate them. We cannot allow these cuts to pass. We cannot compromise. We will not give up.”
U.S. Reps. Jim Jordan (R-Ohio) and Marjorie Taylor Greene (R-Ga.) are among those who Waters criticized by name in her speech.
“I will speak truth to power. I want to use words that they will understand. Hell no! We won’t go! We are not going to give up,” said Waters. “That’s the people’s money. You can’t decide who you’re going to spend it on and not who you’re going to spend it on.”
More than 3,000 people are expected to attend the National Minority AIDS Council-organized conference that will end on Saturday. This year’s theme is “A Love Letter to Black Women.”
“We need a love letter to Black women,” said Waters. “We need it not only from this conference. We need it from our families often times. We need it from our communities. We need it from the churches that we give so much attention to and give our resources to and don’t really get it back. We need a love letter coming from all over this country for what we have suffered, for what we have endured, for the way that we have been denied and for the way that we have been ostracized.”
Waters in her speech specifically praised former Massachusetts Congressman Barney Frank and the late U.S. Sen. Ted Kennedy (D-Mass.) for their work in support of LGBTQ+ rights and efforts to combat HIV/AIDS. Waters also thanked Jewel Thais-Williams, who opened Catch One, a bar and restaurant on Pico Boulevard in Los Angeles that became a refuge for people with HIV/AIDS.
“They had nowhere to gather, nowhere to go, nowhere to be recognized as people who needed support,” said Waters.
B. Kaye Hayes, deputy assistant secretary for infectious disease in the Office of the Assistant Secretary for Health who is also the executive director of the Presidential Advisory Council on HIV/AIDS, is among those who are expected to speak at the conference. Mark S. King, an HIV/AIDS activist and blogger who published “My Fabulous Disease: Chronicles of a Gay Survivor” on Sept. 1, is scheduled to talk on Thursday.
Cal Benn contributed to this story.
American Red Cross ends ban on blood donations by gay men
Many healthy individuals who previously could not give will now be able to support their community through the gift of blood donation
WASHINGTON – The American Red Cross announced a historic change in the organization’s policies regarding blood donations by gay and bisexual men. Under this new donor screening process, all donors answer the same eligibility questions regardless of gender or sexual orientation and will be assessed for blood donation based on individual risk factors, not on sexual orientation.
This change by the Red Cross falls within the U.S. Food and Drug Administration finalized guidelines for blood donation issued this past May that will use a uniform individualized risk assessment questionnaire for respondents regardless of their sexual orientation, sex, or gender.
In a statement the Red Cross noted:
“This change means many healthy individuals who previously could not give will now be able to support their community through the gift of blood donation.
Andrew Goldstein, a cancer researcher from Los Angeles, was a regular blood donor in his younger years before the FDA’s previous policies made him ineligible to donate as a gay man. His desire to influence change compelled him to register as a participant in the FDA funded ADVANCE Study in 2021, which sought to gather data to evaluate the possibility of moving to an individual donor assessment. He is proud he was able to be part of the study that led to this change and is excited to finally be able to give blood again.
“There’s so much in the world that you can’t help with, and you sometimes have to see people going through difficult times, but something like giving blood feels like something so small that you can do, and it means a lot to me that I’ll be able to do that again,” said Andrew. Now, Andrew and many others are able to share their good health with patients in need of lifesaving transfusions.”
The FDA’s new protocols issued in May note that prospective donors who have had a new sexual partner, or more than one sexual partner in the past three months, and anal sex in the past three months, would be ineligible.
So would those who are “taking medications to treat or prevent HIV infection (e.g., antiretroviral therapy (ART), pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP),” because these drugs can delay the detection of HIV.
Blood donation rules have changed to be more inclusive! All donors will answer the same eligibility questions regardless of gender or sexual orientation, and more people can give lifesaving blood with the Red Cross while keeping the blood supply safe.— American Red Cross (@RedCross) August 7, 2023
We’ve worked for years… pic.twitter.com/htnLg3AHOm
Elton John AIDS Foundation launches ambitious new initiative
Throughout Pride Month, Sir Elton John and the co-chairs of The Rocket Fund are challenging supporters to let their #InnerElton out
NEW YORK – The Rocket Fund is the Elton John AIDS Foundation’s latest transformative $125 million campaign to redouble the fight against AIDS everywhere. Growing levels of stigmatization, marginalization, and poverty have led to high rates of HIV and low access to healthcare globally.
“For years, HIV/AIDS has caused enormous pain across the world, but I pray that soon this epidemic will be a thing of the past” said Sir Elton John. “More than 30 years after I launched the Elton John AIDS Foundation, my passion for reaching everyone, everywhere with education and compassionate care is still as strong as ever. The Rocket Fund will turbo-charge our mission and reach those most at risk from this terrible disease. Now is the time. This epidemic has gone on too long. We must all act together to see AIDS defeated in our lifetimes.”
Money from the fund will go towards supporting access to HIV prevention and treatment services, including providing access to HIV tests, antiretroviral therapies, and Pre-Exposure Prophylaxis (PrEP), according to the press release. Donatella Versace, one of the Rocket Fund’s co-chairs — alongside Furnish, Tani Austin, and David Geffen — has also pledged to match donations to the fund up to $300,000 during the month of June.
Throughout Pride Month, Sir Elton John and the co-chairs of The Rocket Fund are challenging supporters to let their #InnerElton out. Letting your #InnerElton out is about proudly expressing your authentic self, showing love for others and taking compassionate action. Supporters are encouraged to join the movement by posting photos of themselves on social media wearing their own take on Elton’s signature looks – or whatever makes them feel their true self – with the hashtag #InnerElton. Many notables are joining to let their #InnerElton out, including Dolly Parton, Michaela Jaé Rodriguez, JoJo Siwa, Heidi Klum, Smokey Robinson and more. Learn more here. The Let Your Inner Elton Out campaign was created by advertising agency Invisible Man and produced in partnership with global communications agency BCW.
The Foundation launched this critical initiative on June 5, the day in 1981 when the Centers for Disease Control released its first report on what would become the AIDS epidemic. This inaugural Rocket Day commemorates the early days of the fight against HIV/AIDS, while committing to accelerate progress towards ending AIDS for all.
“The end of the HIV/AIDS epidemic is within sight, and The Rocket Fund is the push we need to finally cross the horizon,” said David Furnish, Chairman of the Elton John AIDS Foundation. “To end AIDS, we must make targeted investments that can level the playing field, by tackling the inequalities and stigma that prevent people from accessing the care they desperately need. By joining The Rocket Fund and our mission, you can help transform the future for millions of people globally.”
“As we’ve learned through the global fight to stop COVID-19, epidemics do not recognize state borders, economic or cultural differences. If left unchecked, they only worsen with devastating impacts on the most vulnerable,” said Anne Aslett, Chief Executive Officer of the Elton John AIDS Foundation. “It is critical that we meet this moment to connect vulnerable people with the care and resources they need to live vibrant, healthy lives and we welcome all who want to see an end to this disease to join us.”
New data shows HIV infections dropped- mostly among whites
Significant decline in new HIV infections, but impact of prevention efforts far less substantial for Black and Hispanic-Latino populations
ATLANTA – Data published Tuesday. by the Centers for Disease Control and Prevention shows a significant decline in new HIV infections, but suggests the impact of prevention efforts was far less substantial for Black and Latino populations.
From 2017 to 2021, as rates of HIV testing, treatment, and the use of pre-exposure prophylaxis (PrEP) medication rose, new cases dropped by 12 percent overall and by as much as 34 percent among gay and bisexual males aged 13 to 24.
The numbers show a “move in the right direction,” CDC Director Rochelle Walensky said in a press release.
However, when broken down by race, the CDC found new infections were down by 27 percent and 36 percent, respectively, among Black and Hispanic-Latino populations, compared with 45 percent of whites.
Similarly, by 2021 about one third of those who are considered eligible were taking PrEP for HIV prevention, but the CDC noted this number includes “relatively few Black people or Hispanic/Latino people” despite the significant increase in prescriptions up from just 13 percent in 2017.
“Longstanding factors, such as systemic inequities, social and economic marginalization and residential segregation,” Walensky noted, continue to act as barriers “between highly effective HIV treatment and prevention and people who could benefit from them.”
She added, “Efforts must be accelerated and strengthened for progress to reach all groups faster and equitably.”
Robyn Neblett Fanfair, acting director of the CDC’s Division of HIV Prevention, said that “At least three people in the U.S. get HIV every hour—at a time when we have more effective prevention and treatment options than ever before.”
“These tools must reach deep into communities and be delivered faster to expand progress from some groups to all groups,” she said.
The HIV+Hepatitis Policy Institute issued a press release following the CDC’s announcement of the new data, noting both the encouraging progress and need for improvement.
“It appears that our investments in HIV prevention are providing some positive results, but the persistent high number of new diagnoses and the low usage of PrEP among the communities most impacted by HIV point to the need for increased resources, particularly for a national PrEP program,” said the group’s executive director, Carl Schmid.
President Joe Biden’s FY24 budget requested $237 million for a national PrEP program along with $850 million to support the U.S. Department of Health and Human Services’ “Ending the HIV Epidemic in the U.S.” initiative.
President’s Emergency Plan for AIDS Relief marks year 20
Achievements PEPFAR have been remarkable, well-documented by outside evaluators, and hugely applauded throughout the advocacy community
WASHINGTON – The President’s Emergency Plan for AIDS Relief (PEPFAR) marks its twenty year anniversary today, marking the largest commitment by any nation to address a single disease in the world.
The initiative which was personally led and launched by former President George W. Bush in 2003, its funding has totaled more than $110 billion to date, including funding for the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund), to which the U.S. government is the largest donor.
PEPFAR is credited with saving millions of lives and helping to change the trajectory of the global HIV epidemic. The White House today released a statement by President Joe Biden marking the 20th Anniversary:
Twenty years ago today, President George W. Bush declared that preventing and treating HIV/AIDS was a foreign policy priority of the United States. At a time when nearly 30 million people were HIV positive, but very few were receiving life-saving medicines, the President’s Emergency Plan for AIDS Relief (PEPFAR) transformed the global AIDS response and laid a marker for America’s commitment to countries that were impacted the hardest by the AIDS epidemic. Helping lead the bipartisan effort in Congress to authorize PEPFAR is among my proudest achievements from my time in the Senate. To this day, PEPFAR remains a powerful example of America’s unmatched ability to drive progress and make life better for people around the world.
Since 2003, PEPFAR has saved more than 25 million lives and dramatically improved health outcomes in more than 55 partner countries. AIDS-related deaths have declined by 68 percent since their peak in 2004, and new HIV infections are down 42 percent. PEPFAR investments have ensured that 5.5 million babies have been born HIV-free. And two decades of investment in partner nations’ health systems played a critical role in countries’ ability to respond to other health crises such as COVID-19, Mpox, and Ebola.
Today, PEPFAR continues to support 20.1 million people around the world with HIV/AIDS treatment, and my Administration is committed to continuing to lead the global HIV/AIDS response. We will build on our decades of progress to reach the Sustainable Development Goal of ending AIDS by 2030, work to eliminate the stigma and inequities that keep people from accessing care, and keep the voices of people living with HIV/AIDS at the center of our response. I look forward to working with Congress on PEPFAR’s reauthorization this year.
PEPFAR is overseen by the U.S. Global AIDS Coordinator, who is appointed by the President, confirmed by the Senate, and reports directly to the Secretary of State, as established through PEPFAR’s authorizing legislation.
PEPFAR’s original authorization established new structures and authorities, consolidating all U.S. bilateral and multilateral activities and funding for global HIV/AIDS. Several U.S. agencies, host country governments, and other organizations are involved in implementation.
Dr. John Nkengasong, the current coordinator was sworn in on June 13, 2022, and holds the rank of Ambassador leading the Office of the Global AIDS Coordinator (OGAC) at the U.S. Department of State.
Twenty years ago this month, President George W. Bush announced #PEPFAR during his State of the Union address. Since then, the U.S. government has invested $100B+ in the global HIV/AIDS response through PEPFAR, saving 25M lives & bringing us closer to #EndAIDS2030. #PEPFAR20 pic.twitter.com/SMAOHWPZ03— PEPFAR (@PEPFAR) January 11, 2023
Nobel Prize winning scientist Harold Varmus, who served as Director of the National Institutes of Health (NIH) from 1993 to 1999 and currently the Lewis Thomas University Professor of Medicine at Weill Cornell Medicine in New York City, wrote in an article honoring World Aids Day 2013:
[…] “the PEPFAR story must begin with George W. Bush and his wife, Laura, and their interests in AIDS, Africa, and what Bush termed “compassionate conservatism.” According to his 2010 memoir, Decision Points, the two of them developed a serious interest in improving the fate of the people of Africa after reading Alex Haley’s Roots and visiting The Gambia in 1990.3 In 1998, while pondering a run for the U.S. presidency, he discussed Africa with Condoleezza Rice, his future secretary of state; she said that, if elected, working more closely with countries on that continent should be a significant part of his foreign policy. She also told him that HIV/AIDS was a central problem in Africa but that the United States was spending only $500 million per year on global AIDS, with the money spread across six federal agencies, without a clear strategy for curbing the epidemic.”
Key Facts (As provided by Kaiser Health & Family Foundation)
- Although the U.S. has been involved in efforts to address the global AIDS crisis since the mid-1980s, the creation of the President’s Emergency Plan for AIDS Relief (PEPFAR) in 2003 marked a significant increase in funding and attention to the epidemic.
- PEPFAR is the largest commitment by any nation to address a single disease in the world; to date, its funding has totaled more than $110 billion, including funding for the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund), to which the U.S. government is the largest donor. PEPFAR is credited with saving millions of lives and helping to change the trajectory of the global HIV epidemic.
- U.S. funding for PEPFAR grew from $2.2 billion in FY 2004 to $7.0 billion in FY 2022; FY 2022 funding includes $5.4 billion provided for bilateral HIV efforts and $1.6 billion for multilateral efforts ($50 million for UNAIDS and $1.56 billion for the Global Fund).
- As the COVID-19 pandemic continues to have profound effects across the world, PEPFAR has acted to respond to COVID-19 in countries that receive support in order to minimize HIV service disruptions and leverage the program’s capabilities to address COVID-19 more broadly.
- Looking ahead, PEPFAR faces several issues and challenges, including how best to: address the short- and long-term impacts of COVID-19 on PEPFAR and the HIV response; accelerate progress toward epidemic control in the context of flat funding; support and strengthen community-led responses and the sustainability of HIV programs; define its role in global health security and broader health systems strengthening efforts; and continue to coordinate with other key players in the HIV ecosystem, including the Global Fund.
Key Activities and Results (As provided by Kaiser Health & Family Foundation)
PEPFAR activities focus on expanding access to HIV prevention, treatment, and care interventions. These include provision of antiretroviral treatment, pre-exposure prophylaxis, voluntary male circumcision, condoms, and other commodities related to HIV services. In addition, PEPFAR has launched specific initiatives in key strategic areas. For example, in 2015, PEPFAR launched DREAMS, a public-private partnership that aims to reduce HIV infections in adolescent girls and young women.
The latest results reported by PEPFAR indicate that it has:
- supported testing services for 63.4 million people in FY 2021;
- prevented 2.8 million babies from being born with HIV, who would have otherwise been infected;
- provided care for more than 7.1 million orphans and vulnerable children (OVC);
- supported training for nearly 300,000 new health care workers; and
- supported antiretroviral treatment for 18.96 million people.
- In the 15 countries implementing the DREAMS initiative, new diagnoses among adolescent girls and young women have declined with most DREAMS areas (96%) experiencing declines greater than 25% and nearly two-thirds with declines greater than 40%.
The achievements of the PEPFAR program have been remarkable, well-documented by outside evaluators, and hugely applauded throughout the advocacy community and the developing world. In general, milestones have been met, the program has been enlarged (for instance, to include some research on implementation of medical assistance), the roster of PEPFAR countries has grown and spending plans have not been exceeded.
FDA eases blood donation restrictions for gay & bisexual men
The FDA’s proposal would lift the mandatory three-month deferral period for some men who have sex with men
SILVER SPRING, Md. – The U.S. Food and Drug Administration (FDA) introduced a proposed change to its blood donation guidelines on Friday that would ease restrictions for gay and bisexual men.
The FDA notes the proposal, news of which was first reported in November, would bring U.S. policies in alignment with those in place in countries like the U.K. and Canada. The agency is expected to formally adopt the new guidelines after a public comment period.
The move follows criticism from LGBTQ groups and organizations like the American Medical Association (AMA) who have long argued the current policy is homophobic and based on an outdated understanding of the risks associated with blood donation by men who have sex with men.
As the AMA wrote of the current policy: “a man who has protected sex with another man in the three months prior to a blood donation cannot be a donor, but a man or woman who has unprotected sex with multiple partners of the opposite sex over the same time period remains eligible.”
The FDA’s proposal would lift the mandatory three-month deferral period for some men who have sex with men and instead use a “gender-inclusive, individual risk-based questions relevant to HIV risk.”
Potential donors would be asked for information about their sexual history over the past three months. Respondents who indicate they have had sex with one or more new sexual partners would then be asked whether they have had anal sex during this period. Those who answer “yes” would be deferred from blood donation.
Axios noted that as of this morning, about 20 percent of the country’s community blood centers have a one-day supply or less, while the FDA’s broadened eligibility criteria would increase the annual blood supply by two to four percent, citing data from America’s Blood Centers’ daily tracker and the Williams Institute.
U.S. Sen. Tammy Baldwin (D-Wis.) issued a statement celebrating the FDA’s proposal. “As I have long advocated for, this blood donation policy takes a step forward and is better rooted in the most up-to-date science with a focus on individual risk factors, not outdated stigmas that effectively ban gay and bisexual men,” she said.
Baldwin has repeatedly urged the agency to revisit its blood donation policy over the years, including by corralling support from other members of Congress to cosign letters to the FDA in 2014 and 2016, raising the issue again in 2020 as the COVID-19 pandemic exacerbated shortages in the blood supply.
The Congressional LGBTQ+ Equality Caucus also acknowledged the move in a statement by its chair, Rep. Mark Pocan (D-Wis.): “I am glad the FDA is finally moving toward an individual risk-based assessment model, but recognize, based on existing reporting, that many LGBTQI+ people may still be barred from donating,” he said. “I look forward to taking a closer look at the proposed guidelines once they are published and working with the FDA to ensure that any unnecessary barriers are removed.”
Several LGBTQ groups also issued statements celebrating the FDA’s new guidance.
“These changes are 40-plus years in the making, and are a tremendous leap forward toward elevating science over stigma,” said GLAAD President Sarah Kate Ellis. “GLAAD and leading medical experts have long been advocating for guidelines that see and treat LGBTQ people the same as any other person, including as potential donors who want to help others.”
“This new policy removes a decades-long barrier for many in our community – and there is more to do to ensure gay, bisexual and transgender people are no longer unfairly stigmatized when they try to donate blood,” Human Rights Campaign President Kelley Robinson said. “The assessment criteria have flaws, focusing excessively, for instance, on the number of partners a potential donor has instead of just on new partners,” she added.
Carl Schmid, executive director of the HIV+ Hepatitis Policy Institute, said: “While this long-overdue change is being made based on the science and the facts, which have been clear for years, it is the result of the leadership of the Biden administration that continues to tear down discriminatory government policies.”
Experimental HIV vaccine failure, deemed safe but ineffective
“We remain steadfast in our commitment to advancing innovation in HIV & hope the data from Mosaico will provide insights for future efforts”
BETHESDA, Md. – A clinical trial of an investigational HIV vaccine regimen, being conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID) by Janssen Pharmaceutical Companies and global partners of parent company Johnson & Johnson dubbed “Mosaico,” was discontinued.
In an announcement made Wednesday, NIAID said the HIV vaccine regimen tested among men who have sex with men (MSM) and transgender people was safe but did not provide protection against HIV acquisition, an independent data and safety monitoring board had determined.
A spokesperson for Johnson & Johnson noted in light of the board’s determination, the Mosaico clinical trial will be discontinued. Participant notifications and further analyses of the data are underway. Throughout the trial, study investigators have ensured that any individuals who contracted HIV received prompt HIV treatment and care.
Both Johnson & Johnson and NIAID stressed that no safety issues with the vaccine regimen were identified.
“We are disappointed with this outcome and stand in solidarity with the people and communities vulnerable to and affected by HIV,” said Penny Heaton, M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC. “Though there have been significant advances in prevention since the beginning of the global epidemic, 1.5 million people acquired HIV in 2021 alone, underscoring the high unmet need for new options and why we have long worked to tackle this global health challenge. We remain steadfast in our commitment to advancing innovation in HIV, and we hope the data from Mosaico will provide insights for future efforts to develop a safe and effective vaccine. We are grateful to our Mosaico partners and the study investigators, staff and participants.”
Janssen Vaccines & Prevention sponsored the Mosaico study with funding support from NIAID, part of the National Institutes of Health. The trial was conducted by the NIAID-funded HIV Vaccine Clinical Trials Network, based at the Fred Hutchinson Cancer Research Center in Seattle. The U.S. Army Medical Research and Development Command provided additional study support.
The Phase 3 Mosaico Study:
Mosaico, a Phase 3 study of Janssen’s investigational HIV vaccine regimen, began in 2019, and completed vaccinations in October 2022. The study included approximately 3,900 cisgender men and transgender people who have sex with cisgender men and/or transgender people, who represent groups and populations vulnerable to HIV, at over 50 trial sites in Argentina, Brazil, Italy, Mexico, Peru, Poland, Puerto Rico, Spain and the United States.
The study evaluated an investigational vaccine regimen containing a mosaic-based adenovirus serotype 26 vector (Ad26.Mos4.HIV) administered during four vaccination visits over one year. A mix of soluble proteins (Clade C/Mosaic gp140, adjuvanted with aluminum phosphate) was also administered at visits three and four.
The Mosaico DSMB analysis, based on the data available to date, indicated that the regimen does not protect against HIV and the study is not expected to meet its primary endpoint. No safety issues with the vaccine regimen were identified. In light of this, the study will be discontinued, and further analyses are underway.
Patti LaBelle, Gladys Knight dazzle World AIDS Day concert
“As millions remain affected by HIV/AIDS, World AIDS Day provides an opportunity to honor those we’ve lost and those living with HIV/AIDS”
WASHINGTON – The AIDS Healthcare Foundation (AHF) hosted its 2022 World AIDS Day Concert on Wednesday, Nov. 30, in the concert hall of The John F. Kennedy Center for the Performing Arts in the nation’s capital.
Renowned multi-Grammy Award-winning vocalists Patti LaBelle and Gladys Knight delivered show-stopping performances to the packed crowd, which included supporters, dignitaries such as: Harold Phillips, Director of the White House Office of National AIDS Policy; White House Senior Advisor for Public Engagement, Mayor Keisha Lance Bottoms, Congresswoman Sheila Jackson Lee, and New Orleans Mayor, Mayor LaToya Cantrell, and more, in a night of hope and celebration.
AIDS Healthcare Foundation (AHF), is the world’s largest HIV/AIDS care provider, currently operating in 45 countries. The concert is held every year to commemorate World AIDS Day, observed internationally each year on Dec. 1. This year also marked the global organization’s 35th anniversary.
At the event, longtime humanitarian and AIDS advocate, Princess Diana was honored, posthumously, with AHF’s Lifetime Achievement Award. Under its “Keep the Promise!” banner, AHF also acknowledged progress made in the global fight against HIV and AIDS and continues to raise awareness about “The Other Pandemic” as a reminder of the significant work still to be done on HIV/AIDS, as well as remembering the lives that have been lost over the years.
Michael Weinstein, President of AHF, said, “As millions remain affected by HIV/AIDS around the globe, World AIDS Day annually provides an opportunity to honor those we’ve lost and those living with HIV/AIDS today, as well as reminding leaders and the community of the work that still remains to address this epidemic. From providing compassionate AIDS hospice care in those darkest early days to growing to become the largest global AIDS organization today, now providing lifesaving care and treatment to more than 1.7 million people around the globe, we also celebrate the tireless work of all those who help make today’s AHF possible: our staff, Board, affiliate organizations and affinity groups, friends, family and elected officials and community partners across the globe, but most of all, our clients and patients—with our annual 2022 World AIDS Day event. It was a momentous night to host our World AIDS Day concert at The Kennedy Center for the first time, and welcome back the legendary Patti LaBelle, and have another great American icon, Gladys Knight join us, while also being able to honor the legacy and humanitarian work of the late Princess Diana.”
Cleve Jones, activist & founder of AIDS Memorial Quilt honored
National AIDS Memorial hosted observances at the 10-acre Memorial Grove and displaying Quilt in nearly 100 communities throughout the U.S.
SAN FRANCISCO – The National AIDS Memorial marked World AIDS Day with a national observance at the 10-acre National AIDS Memorial Grove in San Francisco, honoring AIDS activist and founder of the AIDS Memorial Quilt Cleve Jones with its Lifetime of Commitment Award.
The two days of events brought together leaders on the front lines of the epidemic for powerful conversations and events focused on “Changing the Pattern for a Future without AIDS,” referencing a major initiative of the Memorial that is bringing the Quilt to the South to address the growing crisis of rising HIV rates amount communities of color and marginalized populations.
Jones, who founded the Quilt thirty-five years ago, was recognized for his visionary leadership, activism, and powerful voice in the fight for health and social justice. He remains an inspirational force for change and action today, standing up without hesitation and using his voice for those who are often overshadowed and not heard.
U.S. House Speaker, Rep. Nancy Pelosi (D-Cailf.) praised Jones in a special video tribute, saying, “Cleve, you are a force of nature – unshakable in the face of adversity, overflowing with a passion for serving others.”
“When the AIDS crisis tightened its grip on San Francisco – when pain and despair grew rampant – you kept hope alive,” she continued. “You were a shining light in the dark, building community out of grief and spurring action out of anguish. From the halls of power to union halls and picket lines, you have never relented in your mission: empowering the oppressed, tearing down injustice and honoring the dignity and beauty of every person.”
Presenting the award to Jones was former San Francisco mayor and mentor Art Agnos to an audience of more than 600 people from the community who gathered on the eve of World AIDS Day for a gala to support the Memorial’s programs.
“I’m honored to receive this award, but more importantly I’m so pleased that the Quilt now has a permanent home with the National AIDS Memorial and that it is continuing its mission of activism and justice. One thing I’ve learned is that through hope one finds courage and through courage we find love. Love is at the core of what we do and that is what this Quilt represents,” Jones told the audience gathered.
The National AIDS Memorial worked with local partners from across the country to display hundreds of Quilt sections featuring more than 3,500 individual panels in nearly 100 communities on World AIDS Day.
The largest Quilt display ever in Alabama is taking place in Montgomery and surrounding areas as part of the memorial’s Change the Pattern initiative. The program, funded through a $2.4 million grant from Gilead Sciences, is organizing quilting workshops, displays and educational programming with Southern AIDS Coalition throughout the Southern U.S.
“On this World AIDS Day, it is inspiring to know that thousands of Quilt panels are on display in communities across the country, touching hearts and minds through the stories represented in the fabric,” said Gilead Sciences Chairman and CEO Daniel O’Day. “The Quilt’s purpose remains as strong and important today, as it was thirty-five years ago, when the vision of Cleve Jones sparked a powerful movement to advance health and social justice.”
The National AIDS Memorial’s World AIDS Day Observance panelists highlighted the importance of the work being done around the country, the interconnectivity of issues to reach zero, and the importance of education and outreach to at-risk populations during three powerful conversations available for viewing online on the memorial’s website and include: Reflections with Cleve Jones and 35 years of the Quilt; The State of the Epidemic Today with Leaders on the Frontlines; and Young Leaders Making an Impact.
“As our community comes together this World AIDS Day, it’s hard not to look around and see who’s missing – our friends, lovers, and family we’ve lost over four decades of this horrific, cruel disease,” said National AIDS Memorial CEO John Cunningham. “It always brings tears, and we carry so many emotions, particularly as we think of what could have been. But for me, as a man living with HIV/AIDS, I shift to a brighter space, choosing to look around me, thinking about so many of us still here, living and thriving. Survivors, who have so much to be thankful for, but also a heavy burden to share our own stories and journey, so history never repeats itself.”
He continued, “Today, people are still dying and there should have been a cure long ago. We are angry because bigotry, hate, and stigma persist today in society. And we carry shame, because communities of color and marginalized populations continue to be disproportionately impacted by HIV and discrimination, and it shouldn’t be this way. It’s time to change the pattern.”
Translatinx network helps a resilient community ‘Live Its Truth’
“We’re trying to push ourselves to the next level through community empowerment and leadership development”
NEW YORK – When Cristina Herrera was 15 years old, she traveled alone from Southern California to the Bronx in pursuit of new life experiences. A native of El Salvador, Cristina thought as a teenager that she was different, but she was unsure about which terminology fully captured her identity.
“I knew that I wasn’t gay,” explains Cristina. “But I couldn’t put into words as to who I was.”
It was only through connecting with the trans Latinx community in New York that Cristina found herself – and came out as transgender.
When Cristina began her gender transition in the mid-1980s, she says there were barely any employment opportunities for a transgender person. To survive, many immigrant trans women in Cristina’s circle engaged in sex work and became more susceptible to contracting HIV. Policing and arrests of sex workers also put their immigration statuses in peril, and stigma exposed them to violence. It was during this time that Cristina became set on improving the lives of trans Latinx people.
“My community was already informally supporting one another,” she says. “But I wanted to make sure that other people would never have to go through some of the difficult issues I experienced.”
Determined to fulfill this promise, Cristina put herself through college and landed a job at a nonprofit supporting the LGBTQ+ community. She absorbed as much as she could at the organization, but she started to want a bigger influence on how to serve the community that helped find her identity.
“In 2005, I began dreaming about starting a trans-led, immigrant-led organization,” she says. “My dream came true two years later when I started the nonprofit.”
Today, as the founder and CEO of the advocacy nonprofit Translatinx Network, she serves trans Latinx people in New York City and beyond. The organization, which for the past three years has been a Gilead TRANScend Community Impact Fund grantee, connects people to legal aid, HIV prevention and support groups, and immigration assistance.
In the years since its creation, Cristina and her colleagues have led the charge in providing support and connections for trans Latinx people as they build their communities in the United States.
“Many people in our community went from being in the shadows to becoming documented and getting their green cards or work permits,” she says. “We were showing our community that we don’t have to be stuck – that there’s more to life.”
Cristina is now looking for ways to replicate the success of the organization by gathering information and its outcomes and continuing to expand its services. “We want to stay on the front lines and keep our community healthy and protected,” she says. “We’re trying to push ourselves to the next level through community empowerment and leadership development.”
And Cristina is proud that through her organization’s success, she’s able to serve a population that has historically been left out or forgotten.
“I love any opportunity where I can be there for others,” she says. “I want all of us to be able to live our truth while at the same time fulfill our life goals.”
The preceding article was previously published by Stories@GILEAD © 2022 Gilead Sciences, Inc. and is republished with permission.
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