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Another HIV vaccine has failed – so what happens next?
“We hope to have a vaccine ready for testing in about two years. Yet another terrible disease is about to yield to patience, persistence and outright genius.”
So said Margaret Heckler, US Secretary of Health, on the HIV epidemic in 1984.
Yet four decades and some 40 million deaths later, the world still doesn’t have a vaccine to protect against HIV.
Last week, Johnson and Johnson became the latest pharmaceutical firm to withdraw a possible contender.
The US company announced that its vaccine, the world’s only candidate to have still been in late-stage trials, was ineffective.
The study, known as Mosaico, tested the shot in 3,900 men and transgender people across North America, South America and Europe. But while analysts found it was safe, the trial was halted because the vaccine did not prevent more HIV infections than a placebo.
It is yet another blow for an important area of research that has become used to disappointment.
To date, eight HIV candidate vaccines have reached late-stage clinical trials. All have failed at the final hurdle, with just one showing signs of modest efficacy in a trial in Thailand between 2003 and 2006.
Johnson and Johnson was attempting to build upon the modest success of the Thai study, but in the end it just didn’t work.
So why is developing a vaccine for HIV proving so difficult? Afterall, scientists had a jab for Covid developed and in trials within months of the virus emerging.
‘With HIV, nobody has recovered’
Experts are still confident that one day they will produce a successful HIV vaccine, but they point to several formidable challenges that have yet to be overcome.
Perhaps most notably, there’s no “roadmap in nature” for scientists to copy or enhance.
“When we get measles, we recover from measles and there’s an immune response that our body mounts, [and we can design a vaccine] that copies that response,” said Professor Salim Abdool Karim, director of Centre for the Aids Programme of Research in South Africa.
“With HIV, nobody has recovered. There’s no immune response that is naturally occurring. Nature doesn’t have anything for us to copy.”
He added that when Sars-Cov-2 emerged, earlier research into the first Sars outbreak had already identified what component of a coronavirus should be targeted – the so-called ‘spike protein’. But this is not the case with HIV.
“Even though we have the technology to make a vaccine, we don’t know what [part of the virus] it needs to make,” Prof Karim said.
The HIV virus also lurks in chromosome CD4 cells, where it’s not easily visible to the immune system,” said Tomáš Hanke, a professor of vaccine immunology at Oxford University, who has been working on HIV vaccines for 30 years.
He added that the genetic composition of the pathogen also changes rapidly – far more quickly than Sars-Cov-2, the Covid virus. This means that by the time you have created a vaccine for fighting it, the virus may have already moved on.
And finally, said Prof Karim, there is no reliable animal model that can work as a basis for HIV virus research.
“We have got these real problems which make an HIV vaccine so, so difficult,” he said.
But optimism remains.
“[The latest setback] is disappointing, but the positive thing is that we have learned,” said Prof Hanke. “[The Johnson and Johnson vaccine] was designed several years ago, when perhaps we knew less. But the trial confirmed that some ways of using T cells and antibodies are just not working, and we have a good idea how to improve.”
Tennessee says it’s cutting federal HIV funding. Will other states follow?
Health officials in Tennessee say they will reject federal funding for groups that provide services to residents living with HIV.
Earlier this week, the Tennessee Department of Health announced it would no longer accept grant money from the Centers for Disease Control and Prevention earmarked for testing, prevention and treatment of HIV.
In an email reviewed by NBC News, the Department of Health told certain nonprofit organizations that provide these services that the state would turn down the federal funding as of June, relying only on state funds afterward. “It is in the best interest of Tennesseans for the State to assume direct financial and managerial response for these services,” the email read.
When reached for comment by NBC News, a spokesperson for the Department of Health said that “the letter speaks for itself.”
An estimated 20,000 people in Tennessee are living with HIV, though not all would be affected by the cuts. There was no further guidance on how the state planned to fund such programs on its own.
The move stunned HIV experts.
“I can’t understand why the state would give back funds targeted towards health care,” said Diane Duke, president and chief executive officer of Friends for Life, a Memphis-based group that provides services to people living with HIV. Friends for Life was among the groups that received notice from the state. “It’s outrageous,” she said.
Shelby County, where Memphis is located, is among the nation’s counties with the highest rates of HIV and AIDS. In 2020, 819 per 100,000 Shelby County residents had HIV, according to the Centers for Disease Control and Prevention.
And those were only the people who’d received an official diagnosis.
“A lot of people are walking around with HIV, and they don’t even realize it,” Duke said. Providing testing for the virus is a major part of the work Friends for Life carries out. “Once somebody has tested positive, we are able to get them into care immediately,” she said.
Greg Millett, director of public policy for the advocacy group amfAR, the Foundation for AIDS Research, called the decision “devastating.” He is concerned that Tennessee health officials are setting a dangerous precedent.
“If other states follow suit,” Millett said, “we’re going to be in trouble.”
Millet said that the CDC provides Tennessee as much as $10 million in HIV funding. It remains unclear how much of that money will be turned away.
He said he worries that the state’s directive will lead to discrimination against marginalized groups most at risk for HIV.
“The overwhelming majority of new HIV cases are among gay and bisexual men, transgender populations, heterosexual women, as well as people who inject drugs,” he said.
“We have the tools needed to end the HIV/AIDS epidemic in terms of prevention and care,” Millett said. “If Tennessee is not using those tools, not using CDC funding and not focusing on the groups most at risk for HIV, we have the possibility of an outbreak.”
The CDC provides millions of dollars each year to states for HIV testing kits, condoms and medications to prevent infection, called PrEP.
In a statement provided to NBC News on Friday, the CDC said that it was unaware that Tennessee — or any other state — planned to stop accepting the grant money.
“We have not received any official notification from the Tennessee Department of Health withdrawing from CDC’s HIV prevention funding,” the CDC said. Without such notice, the CDC will automatically continue payments to the state.
The federal agency also said that it would “certainly be concerned if the services people in Tennessee need to stay healthy were interrupted or if public health capacity to respond to HIV outbreaks and bring an end to this epidemic were hindered.”
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The Only HIV Vaccine in Advanced Trials Has Failed. What Now?
The only vaccine against HIV still being tested in late-stage clinical trials has proved ineffective, its manufacturer announced Wednesday, another disappointment in a field long beset by failure.
Dozens of HIV vaccine candidates have been tested and discarded over the past few decades. The latest defeat sets progress toward a vaccine back by three to five years, experts said. Still, other options in early-stage trials may yet turn out to provide a powerful bulwark against HIV.
The news is “disappointing, but it isn’t the end of the effort toward developing a vaccine,” Dr. Anthony Fauci, who led the National Institute of Allergy and Infectious Diseases until December, said in an interview. “There are other strategic approaches.”
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An ongoing study called PrEPVacc in Eastern and Southern Africa is evaluating a combination of experimental HIV vaccines and preventive drugs. Scientists have made headway in developing powerful antibodies that can neutralize the virus. And they are testing new vaccine technologies, including mRNA, against HIV.
Still, the loss of the latest candidate underscores the challenges of designing a vaccine for an adversary as wily as HIV. Four decades after its discovery, the virus still infects about 1.5 million people each year, and kills about 650,000.
For people in wealthier nations, HIV is not the death sentence it once was. Powerful drugs can suppress the virus in infected individuals. There are several options available to prevent infection: Oral pills and shots given every two months are already approved in the United States, for example, and a shot that would only need to be given every six months is in late-stage trials.
But these medications must be taken for the rest of the patient’s life, and are often inaccessible to those who need them the most. A vaccine would be the ideal way to thwart the virus.
“The ultimate prevention modality for any infection, particularly viral infection, is a vaccine that’s safe and effective,” Fauci said. “That’s the reason why the field is going to continue to pursue very active research in that area.”
The trial now ending, called Mosaico, began in 2019 and was led by Janssen Pharmaceuticals, part of Johnson & Johnson. It tested the vaccine in 3,900 cisgender men (those who have always identified as male) and transgender individuals who have sex with cisgender men and transgender individuals, in more than 50 sites in nine countries in North America, South America and in Europe.
The vaccine contained a mosaic of components meant to target several different subtypes of HIV present worldwide. But the immune response it provoked against the virus did not include significant amounts of the so-called neutralizing antibodies that are considered the most powerful weapons against infection.
While the trial’s failure does not spell the end of the mosaic approach, it does signal that a successful vaccine should rouse the body to produce broadly neutralizing antibodies, Fauci said.
After reviewing early data from the trial, an independent data and safety monitoring board concluded that while the vaccine was safe, it did not prevent more HIV infections than a placebo did. The board recommended that the company stop the trial and inform the participants.
The outcome did not entirely surprise experts, because a study of the same vaccine, called Imbokodo, was halted in 2021. That trial tested the vaccine in cisgender women in five sub-Saharan African countries.
The failure of the studies is particularly disappointing partly because they were funded by Johnson & Johnson, said Mitchell Warren, executive director of the HIV prevention organization AVAC.
“Not that many companies get involved in infectious disease vaccines, so to see this not getting to market is a disappointment and a setback,” Warren said.
The news should prompt policymakers and activists to think of ways to make the existing tools for preventing HIV more widely accessible, he added: “It’s not that all hope is lost, it’s that we need to redirect our resources to greatest impact.”
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Tennessee to cut funding for HIV treatment, testing, prevention
The state of Tennessee is cutting funding to HIV prevention, detection and treatment programs that are not affiliated with metro health departments as of May 31. Organizations across the state were formally notified Wednesday.
In an email obtained by The Commercial Appeal, United Way of Greater Nashville ― which administers the funds given to the Tennessee Department of Health by the Centers for Disease Control and Prevention ― told partner organizations there would be a change in the state’s HIV prevention program.
“TDH has informed United Way that CDC Prevention and (Ending the HIV Epidemic in the U.S. initiative) funding will end on May 31, 2023. TDH will utilize other state initiatives to support all HIV prevention and surveillance staff and activities in funded metro health departments and those contracts will be in place by June 1, 2023,” said Niki Easley, director of the HIV/AIDS Initiative for the United Way of Greater Nashville.
In a separate email obtained by The Commercial Appeal, state epidemiologist John Dunn told affected organizations that the federally-funded Ryan White program would not be impacted.
The USA Today Network-Tennessee reached out to the Tennessee Department of Health but did not receive an immediate response.
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According to TDH, the grant from the CDC funds: “HIV counseling, testing and referral, HIV partner counseling and referral services, HIV health education and risk reduction programs, HIV prevention for positive individuals, public information programs, a toll-free HIV/STD hotline, capacity building programs, and a quality assurance and evaluation component.”
Ashley Coffield, president and CEO of Planned Parenthood of Tennessee and North Mississippi, said the severance of HIV funding for community-organizations is likely to hit Shelby County the hardest.
“The state health department walking away from CDC funding for HIV prevention is going to impact the community-based organizations that are on the ground doing the preventive work that is necessary to end the HIV epidemic in Shelby County. It’s politics before people, and it puts people’s health and well-being at risk,” Coffield said.
Though funding will officially cease on May 31, the state health department has already scrubbed Planned Parenthood from its website as a listed free condom distributer. According to the internet archiving service the Wayback Machine, Planned Parenthood was listed as a condom distributor.
The CDC has not returned a request for comment.
According to the federal agency, Shelby County is part of the Ending the HIV Epidemic in the U.S. initiative because it is one of 50 local areas that account for more than half of all new HIV diagnoses across the country.
Preliminary CDC data show 831 new cases of HIV were diagnosed across Tennessee in 2021 and 575 new cases were diagnosed in the first nine months of 2022. AHEAD, which solely tracks HIV-related data, includes a data subset for Shelby County. According to AHEAD, Shelby County saw 232 new HIV diagnoses in 2022.
All entities that track HIV data point to an overall decline in new diagnoses since the height of the HIV and AIDS epidemic in the U.S. This is largely due to urban and rural community programming that raises awareness around transmission risks, distributes prophylactics, and provides regularly accessible testing.
How drastically the landscape of HIV prevention in Tennessee will be affected is unclear. Following the May cutoff, organizations that provided these resources will have to scramble to secure new avenues of funding.
Also on Wednesday afternoon, U.S. Rep. Steve Cohen announced a $1.2 million grant for an HIV/AIDS program that helps provide wraparound care services for people living with HIV who are uninsured or underinsured.
“Shelby County’s Ryan White HIV/AIDS program has been successful in preventing the spread of HIV/AIDS and in providing treatment to patients in need,” Cohen said. “This grant funding will help Shelby County provide care for those affected by HIV and AIDS. It will improve treatment outcomes for patients in Shelby County and ultimately save lives.”
Some of the community and healthcare organizations that will be affected include:
- AHS Alliance Healthcare Services, Memphis
- Cathedral of Praise, Memphis
- Cherokee Health Systems, statewide
- Choice Health Network, statewide
- Friends for Life, Memphis
- OutMemphis, Memphis
- Planned Parenthood of Tennessee and North Mississippi, Memphis and Knoxville
- St. Jude Children’s Research Hospital, Memphis.
Reporter Frank Gluck contributed to this report.
Corinne S Kennedy covers healthcare, economic development and real estate for The Commercial Appeal. She can be reached via email at Corinne.Kennedy@CommercialAppeal.com
Micaela Watts is a reporter for The Commercial Appeal covering issues tied to access and equity. She can be reached at micaela.watts@commercialappeal.com.
Women Experiencing Intimate Partner Violence Three Times More Likely to Contract HIV
Summary: Study reveals women who experience domestic abuse are three times more likely to contract HIV infection.
Source: McGill University
Women that experience recent intimate partner violence (IPV) are three times more likely to contract HIV, according to a new study led by McGill University researchers. In regions like Sub-Saharan Africa, women face an intersecting epidemic of intimate partner violence and HIV.
“Worldwide, more than one in four women experience intimate partner violence in their lifetime,” says McGill University Professor Mathieu Maheu-Giroux, a Canada Research Chair in Population Health Modeling.
“Sub-Saharan Africa is among one of the regions in the world with the highest prevalence of both IPV and HIV. We wanted to examine the effects of intimate partner violence on recent HIV infections and women’s access to HIV care in this region,” he says.
Their study, published in The Lancet HIV, shows considerable overlap between violence against women and the HIV epidemics in some of the highest burdened countries. Among women living with HIV, those experiencing intimate partner violence were nine percent less likely to achieve viral load suppression—the ultimate step in HIV treatment.
New calls to eliminate all forms of sexual and gender-based violence
“The 2021 UN General Assembly, attended and supported by the Government of Canada, adopted the Political Declaration on HIV and AIDS with bold new global targets for 2025. This encompasses a commitment to eliminate all forms of sexual and gender-based violence, including IPV, as a key enabler of the HIV epidemic. Improving our understanding of the relationships between IPV and HIV is essential to meet this commitment,” says Professor Maheu-Giroux.
The researchers found that physical or sexual intimate partner violence in the past year was associated with recent HIV acquisition and less frequent viral load suppression. According to the researchers, IPV could also pose barriers for women in accessing HIV care and remaining in care while living with the virus.
“Given the high burden of IPV worldwide, including in Canada, the need to stem the mutually reinforcing threats of IPV and HIV on women’s health and well-being is urgent,” says Salome Kuchukhidze, a Ph.D. candidate studying epidemiology and the lead author of the research.
About this domestic violence and HIV research news
Author: Press Office
Source: McGill University
Contact: Press Office – McGill University
Image: The image is in the public domain
Original Research: Open access.
“The effects of intimate partner violence on women’s risk of HIV acquisition and engagement in the HIV treatment and care cascade: a pooled analysis of nationally representative surveys in sub-Saharan Africa” by Salome Kuchukhidze et al. Lancet HIV
Abstract
See also
The effects of intimate partner violence on women’s risk of HIV acquisition and engagement in the HIV treatment and care cascade: a pooled analysis of nationally representative surveys in sub-Saharan Africa
Background
Achieving the 95-95-95 targets for HIV diagnosis, treatment, and viral load suppression to end the HIV epidemic hinges on eliminating structural inequalities, including intimate partner violence (IPV). Sub-Saharan Africa has among the highest prevalence of IPV and HIV worldwide. We aimed to examine the effects of IPV on recent HIV infection and women’s engagement in the HIV care cascade in sub-Saharan Africa.
Methods
We did a retrospective pooled analysis of data from nationally representative, cross-sectional surveys with information on physical or sexual IPV (or both) and HIV testing, from Jan 1, 2000, to Dec 31, 2020. Relevant surveys were identified from data catalogues and previous large-scale reviews, and included the Demographic and Health Survey, the AIDS Indicator Survey, the Population-based HIV Impact Assessment, and the South Africa National HIV Prevalence, Incidence, Behavior and Communication Survey. Individual-level data on all female respondents who were ever-partnered (currently or formerly married or cohabiting) and aged 15 years or older were included. We used Poisson regression to estimate crude and adjusted prevalence ratios (PRs) for the association between past-year experience of physical or sexual IPV (or both), as the primary exposure, and recent HIV infection (measured with recency assays), as the primary outcome. We also assessed associations of past-year IPV with self-reported HIV testing (also in the past year), and antiretroviral therapy (ART) uptake and viral load suppression at the time of surveying. Models were adjusted for participant age, age at sexual debut (HIV recency analysis), urban or rural residency, partnership status, education, and survey-level fixed effects.
Findings
57 surveys with data on self-reported HIV testing and past-year physical or sexual IPV were available from 30 countries, encompassing 280 259 ever-partnered women aged 15–64 years. 59 456 (21·2%) women had experienced physical or sexual IPV in the past year. Six surveys had information on recent HIV infection and seven had data on ART uptake and viral load suppression. The crude PR for recent HIV infection among women who had experienced past-year physical or sexual IPV, versus those who had not, was 3·51 (95% CI 1·64–7·51; n=19 179). The adjusted PR was 3·22 (1·51–6·85). Past-year physical or sexual IPV had minimal effect on self-reported HIV testing in the past year in crude analysis (PR 0·97 [0·96–0·98]; n=274 506) and adjusted analysis (adjusted PR 0·99 [0·98–1·01]). Results were inconclusive for the association of ART uptake with past-year IPV among women living with HIV (crude PR 0·90 [0·85–0·96], adjusted PR 0·96 [0·90–1·02]; n=5629). Women living with HIV who had experienced physical or sexual IPV in the past year were less likely to achieve viral load suppression than those who had not experienced past-year IPV (crude PR 0·85 [0·79–0·91], adjusted PR 0·91 [0·84–0·98], n=5627).
Interpretation
Past-year physical or sexual IPV was associated with recent HIV acquisition and less frequent viral load suppression. Preventing IPV is inherently imperative but eliminating IPV could contribute to ending the HIV epidemic.
Funding
Canadian Institutes of Health Research, the Canada Research Chairs Program, and Fonds de recherche du Québec-Santé.
Experimental HIV Vaccine Shows Promise in Early Human Trial
An experimental HIV vaccine appears to have passed its first test in humans. In a newly released study, the vaccine candidate produced the sort of immune response that scientists had been hoping for in 97% of recipients. Importantly, the vaccine also seemed to be safe and well-tolerated.
The vaccine candidate is known as eOD-GT8 60mer and was developed by researchers from the Scripps Research Institute. The Phase I trial testing eOD-GT8 60mer, first announced in 2018, was sponsored by the International AIDS Vaccine Initiative (IAVI). It’s part of a large collaboration between scientists at Scripps, the National Institutes of Health, the Fred Hutchinson Cancer Center, and other groups in the U.S. and Sweden. It involved 48 healthy participants, 36 of whom were given two doses of the vaccine eight weeks apart (these participants were divided into a low- and high-dose group).
HIV infection can be now effectively managed through lifelong antiviral therapy. But the virus has the ability to craftily change its structure once inside the body, making it hard for the immune system to recognize it for long. This means that sustained immunity to the virus, at least in most cases, has remained out of reach. But we’ve known for decades that some people can produce broadly neutralizing antibodies to the virus that can keep up with it. And scientists have been chasing after the elusive HIV vaccine capable of creating these antibodies ever since.
A new method for obtaining these antibodies, known as the germline-targeting strategy, is represented by eOD-GT8 60mer. In simple terms, the first dose of vaccine tries to prime a rare and select group of B cells into a state where they could produce these antibodies. Subsequent boosters are then supposed to reactivate these cells, eventually leading to durable and broadly neutralizing antibodies against HIV. And in the findings of this new trial, published Friday in Science, the first part of this strategy appears to be working.
The researchers found that 35 out of 36 volunteers appeared to generate the precursors to these broadly neutralizing antibodies and that this immune response only grew in strength following the second dose.
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“The hope is that if you can induce this kind of immunity in people, you can protect them from some of these viruses that we’ve had a very hard time designing vaccines for that are effective,” Timothy Schacker, the program director in HIV medicine at the University of Minnesota Medical School, who was not involved in the research, told CNN. “So this is an important step forward.”
Phase I trials are primarily designed to test the safety of an experimental treatment. And the vaccine also did have a favorable safety profile, the researchers wrote, with no severe vaccine-related adverse reactions reported. The findings are timely as well, given that yesterday was World AIDS Day.
This study is only a proof of concept, though, the authors note. It will take more research in humans to confirm the early findings seen here, and to show that broadly neutralizing antibodies can be reliably coaxed through boosters. Any truly effective vaccine would also likely have to create a broad T cell response to HIV since T cells are often a crucial aspect of our immunity to germs. But if this research does continue to pan out, then scientists may one day be able to create vaccines that not only provide lasting protection against HIV, but other evasive diseases like hepatitis C, flu, and covid-19.
Another Phase I trial of eOD-GT8 60mer is already ongoing, and other similar vaccine candidates are being tested out in early human trials as well.