Category: HIV

Categories : Gender HIVTags :

OPINION: With the Right Interventions We can Help Many More Men Start and Stay on HIV Treatment

On By ModernMedia

By Shawn Malone for Spotlight

June is Men’s Health Month and while the focus is mostly on men’s attitudes about their health, it is also worth reflecting on the health sector’s attitudes toward men.

We hear many stereotypes about men and health, but how many of those are actually true?

A few years ago representatives of The Mpilo Project spoke to more than 2 000 men in KwaZulu-Natal and Mpumalanga to understand why many find it hard to engage with HIV testing and treatment. We uncovered several myths and misperceptions in the process.

One common myth is that men are stubborn and apathetic about HIV – that they aren’t listening and don’t care. While many men may indeed wear a mask of indifference, HIV leaves many of them feeling paralysed by fear and anxiety. This is why we need a health service delivery approach rooted in encouragement and reassurance, not scolding and pressure.

Another common misconception is that men are mainly just workers who need practical solutions like convenient clinic hours and quick service. The reality is that men are complex human beings who face social and emotional barriers as well as practical ones. We need solutions that address both practical and psychosocial barriers.

There is also a view that sources of support are available and that men just fail to access them, perhaps because “they don’t really want support”. In fact, many men are hungry for support but see no sources that feel safe or relatable. They experience counselling as scripted, one-directional, overly technical, and often judgmental. The key is to give men the right sources of support and to speak empathetically to their individual issues and concerns.

Finally, there is a view that healthcare providers are helping men by taking proactive approaches like provider-initiated testing and tracking-tracing. But these often leave men feeling hunted and ambushed by the health system. We need proactive approaches that leave men feeling like they still have control over their own lives and decisions and help them develop their own internal motivation to start and stay on treatment.

These and other misconceptions can lead healthcare providers to conclude that men are simply difficult if not impossible to reach. But once we understand their barriers, that picture changes dramatically.

The 11th SA AIDS Conference concluded last week and in one of the plenary sessions we had the opportunity to respond to the question: “Strategies for reaching men—are we seeing a return on investment?”

The short answer is yes!

Since 2017, the percentage of men with HIV in South Africa who know their status has increased from 78% to 94%, nearly on par with women. We can attribute that in part to approaches like HIV self-testing that have made it quick, easy, and private for men to learn their status.

We’ve also seen good progress on viral suppression, which has increased from 82% to 93%, again comparable to the rate among women – proof that men on treatment are fully capable of being adherent.

Yet only 70% of men who know they have HIV are currently on treatment – hardly any increase at all from 68% in 2017.

Given the progress we’ve seen in men testing for HIV and achieving viral suppression, the persistent gap in men on treatment suggests that something is wrong – not with men but with the HIV treatment services and support we are offering them.

The good news

The good news is that we know much more than we did a few years ago about what works. Here are three examples.

The MINA campaign aims to reach men with “the new HIV story” by featuring stories from real men living a healthy, happy life with HIV on social media, television, radio, billboards, etc. The campaign also helps men feel more welcome in the clinic, using signage and materials to send the signal to men that “this is your space too”. MINA-supported districts and facilities have seen strong growth in testing and linkage, as well as modest improvement in retention in care.

The Coach Mpilo model employs men who are thriving with HIV as coaches of men at risk of non-initiation or disengagement. Coaches provide a safe, relatable source of support and serve as living proof that HIV is not the end of the road. Piloted in 2020 and currently implemented in 18 districts, the model is achieving 97% linkage to care and 94% retention.

The B-OK bead bottles are a simple visual tool for helping people to understand the benefits of HIV treatment and viral suppression and, more importantly, to build the motivation to start and stay on treatment. Red beads are HIV; black beads are healthy cells. A mixed bottle represents most people upon diagnosis. A red bottle represents the virus multiplying uncontrolled in the absence of treatment. A black bottle with one red bead represents viral suppression achieved through treatment adherence. In an evaluation of the tool, understanding of how HIV treatment works increased from 12.5% to 92.5%.

Men are not indifferent about their health and they are not inherently poor health-seekers. If many of them are avoiding healthcare services, let’s consider that it may be because they are not getting what they need from these services.

We have seen that men do engage when we in the public health sector meet them where they are rather than where we want them to be; when we speak to their needs and priorities rather than ours; when we give them the right sources of support rather than one-size-fits-all, and when we help them build understanding and motivation rather than simply instructing.

When we invest, we see returns. Let’s keep investing in scaling what works.

*Malone is the Project Director of The Mpilo Project, PSI.

Reproduced from Spotlight under a Creative Commons 4.0 Licence.

Source: Spotlight

Categories : HIVTags :

New Southern African HIV Guidelines Released Online

On By ModernMedia
Photo by National Cancer Institute on Unsplash

The Southern African HIV Clinicians Society has just released their updated 2023 guidelines for Antiretroviral Therapy in Adults. These updates reflect the changing treatment paradigms of the current era, specifically the consolidation towards dolutegravir- and darunavir-based treatment regimens, rather than efavirenz- or lopinavir-ritonavir based ones.

They are optimised for accessibility and are available in a PDF format for download, or are viewable as an online version directly on the website. The online version is in an easily navigable form, with the menu guiding readers to the different modules.

The new guidelines also incorporate numerous other changes to ensure that they stay up-to-date and helpful to the healthcare workers who use them. Some of the key changes include:

• Recommendation to shift most patients to a dolutegravir-based regimen if possible.

• For patients requiring a protease inhibitor (PI), recommendation for darunavir as the PI of choice, and for lopinavir/ritonavir to only be considered where a PI is required to be co-administered with rifampicin-based tuberculosis treatment.

• New recommendations on the move away from routine use of zidovudine (AZT) in second-line therapy in favour of recycling tenofovir or, inpatients with renal dysfunction, abacavir.

• Advice on how to assess the increase in serum creatinine seen with dolutegravir/tenofovir fixed dose therapy.

• Guidance on the role of tenofovir alafenamide; TAF.

• Inclusion of enhanced baseline screening for tuberculosis and sexually transmitted infections.

• Expansion of the module on HIV and mental health.

While many antiretroviral therapy (ART) guidelines are available internationally, the current guidelines have been written to address issues relevant to Southern Africa. Only treatment and diagnostic options available in Southern Africa are included. These guidelines also consider affordability because of the region’s low- and middle-income countries. The guideline authors also recognise and addressed the need to bridge the gap in treatment recommendations between public and private sector programmes, as many patients transition between the two sectors for treatment.

Categories : HIVTags :

Scientists Advance Towards a Universal HIV Cure

On By ModernMedia
Photo by Sergey Mikheev on Unsplash

New research from Oregon Health & Science University is helping explain why at least five people have become HIV-free after receiving a stem cell transplant. The study’s insights may bring scientists closer to developing what they hope will become a widespread cure for HIV, hopefully without the need for costly techniques like stem cell therapy.

Published today in the journal Immunity, the OHSU-led study describes how two nonhuman primates were cured of the monkey form of HIV after receiving a stem cell transplant. It also reveals that two circumstances must co-exist for a cure to occur and documents the order in which HIV is cleared from the body – details that can inform efforts to make this cure applicable to more people.

“Five patients have already demonstrated that HIV can be cured,” said the study’s lead researcher, Jonah Sacha, PhD, OHSU professor.

“This study is helping us home in on the mechanisms involved in making that cure happen,” Sacha continued. “We hope our discoveries will help to make this cure work for anyone, and ideally through a single injection instead of a stem cell transplant.”

The first known case of HIV being cured through a stem cell transplant was reported in 2009. A man who was living with HIV was also diagnosed with acute myeloid leukemia, a type of cancer, and underwent a stem cell transplant in Berlin, Germany. Stem cell transplants, which are also called bone marrow transplants, are used to treat some forms of cancer. Known as the Berlin patient, he received donated stem cells from someone with a mutated CCR5 gene, which normally codes for a receptor on the surface of white blood cells that HIV uses to infect new cells. A CCR5 mutation makes it difficult for the virus to infect cells, and can make people resistant to HIV. Since the Berlin patient, four more people have been similarly cured.

This study was conducted with a species of nonhuman primate known as Mauritian cynomolgus macaques, which the research team previously demonstrated can successfully receive stem cell transplants. While all of the study’s eight subjects had HIV, four of them underwent a transplant with stem cells from HIV-negative donors, and the other half served as the study’s controls and went without transplants.

Of the four that received transplants, two were cured of HIV after successfully being treated for graft-versus-host disease, which is commonly associated with stem cell transplants.

Other researchers have tried to cure nonhuman primates of HIV using similar methods, but this study marks the first time that HIV-cured research animals have survived long term. Both remain alive and HIV-free today, about four years after transplantation. Sacha attributes their survival to exceptional care from Oregon National Primate Research Center veterinarians and the support of two study coauthors, OHSU clinicians who care for people who undergo stem cell transplants: Richard T. Maziarz, M.D., and Gabrielle Meyers, M.D.

“These results highlight the power of linking human clinical studies with pre-clinical macaque experiments to answer questions that would be almost impossible to do otherwise, as well as demonstrate a path forward to curing human disease,” said Maziarz, a professor of medicine in the OHSU School of Medicine and medical director of the adult blood and marrow stem cell transplant and cellular therapy programs in the OHSU Knight Cancer Institute.

The how behind the cure

Although Sacha said it was gratifying to confirm stem cell transplantation cured the nonhuman primates, he and his fellow scientists also wanted to understand how it worked. While evaluating samples from the subjects, the scientists determined there were two different, but equally important, ways they beat HIV.

First, the transplanted donor stem cells helped kill the recipients’ HIV-infected cells by recognizing them as foreign invaders and attacking them, similar to the process of graft-versus-leukaemia that can cure people of cancer.

Second, in the two subjects that were not cured, the virus managed to jump into the transplanted donor cells. A subsequent experiment verified that HIV was able to infect the donor cells while they were attacking HIV. This led the researchers to determine that stopping HIV from using the CCR5 receptor to infect donor cells is also needed for a cure to occur.

The researchers also discovered that HIV was cleared from the subjects’ bodies in a series of steps. First, the scientists saw that HIV was no longer detectable in blood circulating in their arms and legs. Next, they couldn’t find HIV in lymph nodes, or lumps of immune tissue that contain white blood cells and fight infection. Lymph nodes in the limbs were the first to be HIV-free, followed by lymph nodes in the abdomen.

The step-wise fashion by which the scientists observed HIV being cleared could help physicians as they evaluate the effectiveness of potential HIV cures. For example, clinicians could focus on analysing blood collected from both peripheral veins and lymph nodes. This knowledge may also help explain why some patients who have received transplants initially have appeared to be cured, but HIV was later detected. Sacha hypothesises that those patients may have had a small reservoir of HIV in their abdominal lymph nodes that enabled the virus to persist and spread again throughout the body.

Sacha and colleagues continue to study the two nonhuman primates cured of HIV. Next, they plan to dig deeper into their immune responses, including identifying all of the specific immune cells involved and which specific cells or molecules were targeted by the immune system.

Source: Oregon Health & Science University

Categories : HIVTags :

Khayelitsha Trial Shows Single-dose Dolutegravir May Suffice in HIV-associated Tuberculosis

On By ModernMedia
Tuberculosis bacteria. Credit: CDC

In the RADIANT-TB randomised controlled trial carried out in Khayelitsha, researchers found that tuberculosis (TB) patients with HIV taking a double dose of dolutegravir had similar viral suppression to those taking a single dose plus placebo. The findings, published in The Lancet HIV, suggest that a only once-daily dolutegravir is feasible in patients with HIV-associated tuberculosis.

WHO’s preferred first-line antiretroviral therapy (ART) regimen for adults and adolescents with HIV is dolutegravir, combined with tenofovir and lamivudine or emtricitabine. A disadvantage of dolutegravir is substantial drug–drug interaction with rifampicin, which is important as tuberculosis is the most common cause of hospitalisation and mortality among people living with HIV.

The drug–drug interaction between rifampicin and dolutegravir can be overcome by supplemental dolutegravir dosing, but is a challenge in resource-constrained settings. The researchers sought to investigate whether virological outcomes with standard-dose dolutegravir-based ART are acceptable in people with HIV on rifampicin-based antituberculosis therapy.

RADIANT-TB was a phase 2b, randomised, double-blind, non-comparative, placebo-controlled trial in Khayelitsha, Cape Town, South Africa. Participants were aged over 18 years, with plasma HIV-1 RNA >1000 copies/mL, CD4 count > 100 cells/μL, ART-naive or first-line ART interrupted, and on rifampicin-based antituberculosis therapy for less than three months. Participants were assigned (1:1) to receive either tenofovir disoproxil fumarate, lamivudine, and dolutegravir plus supplemental 50mg dolutegravir 12h later or the same drugs but with placebo in place of the supplemental dolutegravir. Participants received standard antituberculosis therapy (rifampicin, isoniazid, pyrazinamide, and ethambutol for the first two months followed by isoniazid and rifampicin for four months). The primary outcome was the proportion of participants with virological suppression (HIV-1 RNA <50 copies/mL) at week 24 analysed in the modified intention-to-treat population.

No treatment-related dolutegravir resistance emerged in the trial, and though not significant, an increase in insomnia was noted in the supplemental dolutegravir arm. In terms of future research, it is questionable whether a phase 3 trial would be needed given the significant time required for a policy change. Limitations included the study not being powered to compare efficacy.

The authors concluded, “Our findings suggest that twice-daily dolutegravir dosing might be unnecessary in people with HIV-associated tuberculosis. More evidence, from cohort studies or possibly a phase 3 trial, might be necessary to change policy on the need for a supplemental dolutegravir dose with rifampicin-based antituberculosis therapy.”

Categories : HIVTags :

Tuberculosis Weakens HIV Antibody Response in Those with HIV

On By ModernMedia
Tuberculosis bacteria. Credit: CDC

According to new research findings published in iScience, people living with HIV with a history of pulmonary tuberculosis had broader and more potent HIV antibody responses and differences in HIV sequences predicted to be antibody-resistant as compared to those without tuberculosis. The study suggests that concomitant tuberculosis disease has a significant impact on HIV immune responses and the viruses circulating in people living with HIV.

Tuberculosis infects more than 2 billion people in the world, and although tuberculosis is the most common co-infection in people living with HIV, previous studies have not examined how tuberculosis impacts HIV immune responses and virus characteristics.

This study suggest that tuberculosis may impact the efficacy of antibody based prevention and therapeutic strategies. Vaccines to elicit antibodies and antibodies are also being investigated as a means to treat and cure HIV. Higher prevalence of antibody resistant strains along with tuberculosis disease implies that these antibody-based interventions are more likely to in fail in these individuals.

“Tuberculosis is extremely common, especially in regions of the world with high levels of ongoing HIV transmission, and impacts both the immune responses and the characteristics of the circulating virus in people living with HIV so it is imperative we understand the relationship between the two,” said Manish Sagar, MD, an internist at Boston Medical Center and Professor of Medicine at Boston University Chobanian & Avedisian School of Medicine. “These studies have implications for HIV vaccines and antibody based HIV therapeutics.”

Researchers worked closely with investigators in Uganda and at the AIDS Clinical Trial Group (ACTG) to collect samples from people newly diagnosed with HIV that either did or did not have tuberculosis. From these individuals, they examined samples collected prior to and about 6 months after the start of HIV medications. Researchers compared antibodies, plasma inflammatory markers, and HIV sequences in the baseline and in treatment samples.

Tuberculosis disease is associated with higher prevalence of the some antibody-resistant HIV. High ongoing HIV transmission in areas of the world with frequent tuberculosis disease suggest that a potential vaccine that elicits broad and potent antibodies may not work because these geographic regions are more likely to have antibody resistant strains.

This has implications for HIV vaccine strategies as they aim to generate antibodies that can block the virus after exposure. Generating broad and potent HIV antibodies remains a monumentally difficult goal. Understanding the biological pathways behind the broadly potent antibody responses generated by tuberculosis could provide insight into how tuberculosis enhances HIV antibody responses. This in turn could be leveraged to develop novel strategies for eliciting broad and potent HIV antibodies.

Source: Boston Medical Center

Categories : Genetics HIVTags :

Curing HIV with a Dual Gene Editing Approach

On By ModernMedia
Source: Pixabay CC0

Gene editing therapy aimed at two targets – HIV-1 and CCR5, the co-receptor that helps the virus get into cells – can effectively eliminate HIV infection, report scientists in PNAS. This is the first to combine a dual gene-editing strategy with antiretroviral drugs to cure animals of HIV-1.

“The idea to bring together the excision of HIV-1 DNA with inactivation of CCR5 using gene-editing technology builds on observations from reported cures in human HIV patients,” said Kamel Khalili, PhD, professor at the Lewis Katz School of Medicine. “In the few instances of HIV cures in humans, the patients underwent bone marrow transplantation for leukaemia, and the donor cells that were used carried inactivating CCR5 mutations.”

Dr Khalili and Howard E. Gendelman, MD, professor at UNMC, were senior investigators on the new study from the Lewis Katz School of Medicine at Temple University and the University of Nebraska Medical Center (UNMC). The two researchers have been long-time collaborators and have strategically combined their research strengths to find a cure for HIV.

“We are true partners, and what we achieved here is really spectacular,” Dr Gendelman said. “Dr Khalili’s team generated the essential gene-editing constructs, and we then applied those constructs in our LASER-ART mouse model at Nebraska, figuring out when to administer gene-editing therapy and carrying out analyses to maximise HIV-1 excision, CCR5 inactivation, and suppression of viral growth.”

In previous work, Drs Khalili and Gendelman and their respective teams showed that HIV can be edited out from the genomes of live, humanised HIV-infected mice, leading to a cure in some animals. For that research, CRISPR gene-editing technology for targeting HIV-1 was combined with a therapeutic strategy known as long-acting slow-effective release (LASER) antiretroviral therapy (ART). LASER ART holds HIV replication at low levels for long periods of time, decreasing the frequency of ART administration.

Despite being able to eliminate HIV in LASER-ART mice, the researchers found that HIV could eventually re-emerge from tissue reservoirs and cause rebound infection. This effect is similar to rebound infection in human patients who have been taking ART but suddenly stop or experience a disruption in treatment. HIV integrates its DNA into the genome of host cells, it can lie dormant in tissue reservoirs for long periods of time, out of reach of antiretroviral drugs. As a consequence, when ART is stopped, HIV replication renews, giving rise to AIDS.

To prevent rebound infection, Dr Khalili and colleagues began work on next-generation CRISPR technology for HIV excision, developing a new, dual system aimed at permanently eliminating HIV from the animal model. “From success stories of human HIV patients who have undergone bone marrow transplantation for leukaemia and been cured of HIV, our hypothesis was that the loss of the virus’s receptor, CCR5, is important to permanently eliminating HIV infection,” he explained. They developed a simple and more practical procedure for the inactivation of CCR5 that includes an IV inoculation of the CRISPR gene editing molecule.

Experiments in humanized LASER-ART mice carried out by Dr Gendelman’s team showed that the constructs developed at Temple, when administered together, resulted in viral suppression, restoration of human T-cells, and elimination of replicating HIV-1 in 58% of infected animals. The findings support the idea that CCR5 has a key role in facilitating HIV infection.

The Temple team also anticipates soon testing the dual gene-editing strategy in non-human primates.

The new dual CRISPR gene-editing strategy holds exceptional promise for treating HIV in humans. “It is a simple and relatively inexpensive approach,” Dr Khalili noted. “The type of bone marrow transplant that has brought about cures in humans is reserved for patients who also have leukaemia. It requires multiple rounds of radiation and is not applicable in resource-limited regions, where HIV infection tends to be most common.”

Source: Temple University Health System

Categories : Cardiovascular Disease HIVTags :

Statins Trial in HIV Patients Ended Early Due to Efficacy

On By ModernMedia
Colourised scanning electron micrograph of HIV (yellow) infecting a human T9 cell (blue). Credit: NIH

A large randomised controlled trial into using statins in people with HIV and low-to-moderate cardiovascular risk was stopped early due to clear benefits, according to an update posted online in JAMA Network. Participants, who were taking 4mg pitavastatin calcium daily, saw a 35% reduction in risk with no significant difference in adverse events compared to placebo, according to the National Institutes of Health.

This recommendation came after a planned interim analysis of data from the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) study, which enrolled 7769 participants, across 12 countries across Asia, Europe, North America, South America and Africa. Participants were aged 40–75 years, had 100 cells/mm3 of blood at enrollment, and had low-to-moderate traditional cardiovascular disease risk that would not typically be considered for statin treatment. 

It was not clear if statins would have the same effect in people living with HIV and who have premature cardiovascular disease despite having low-to-moderate traditional risk. The interim analysis was compelling enough that the study’s independent Data Safety and Monitoring Board recommended at its latest regular meeting that it be halted early given adequate evidence of efficacy.

The study participants are being notified of the findings and will continue to be monitored for several months. Study results from the review are expected to be published in the coming weeks.

Categories : HIVTags :

Abbott Partnership to Bring Affordable Blood-based HIV Self-test Kits to SA

On By ModernMedia

HIV testing is essential across the continuum of care but too often unavailable, unaffordable, or inaccessible. Abbott, the global leader in diagnostics and the fight against HIV, is partnering with Population Services International (PSI) and Unitaid to make HIV self-testing (HIVST) available at an affordable and accessible price. An initial 400 000 tests will be distributed within Africa.

This vital partnership serves as an early market access vehicle to enable affordable access to high-quality self-test kits in high HIV burden settings with a dire need for access to healthcare services, while mitigating risks such as increased supply chain costs and custom fees. People who test positive will undergo confirmatory testing and will be linked to antiretroviral treatment, keeping them healthy and helping reduce further transmission to others.

“With millions of people living with HIV worldwide, many of whom who do not know their status, receiving a diagnosis is a vital first step in accessing treatment”, says Bassem Bibi, divisional vice president, for Abbott’s rapid diagnostics business for EEMEA. “This is why this partnership is so important to Abbott as it reinforces our commitment to enabling people in Africa to live healthier, fuller lives, by improving testing capabilities through high quality and affordable blood-based HIV self-tests.”

“Self-testing has shifted the paradigm for HIV testing.  The HIV Self-Testing Africa (STAR) Initiative amassed compelling evidence that HIVST can reach more people than traditional diagnostics. It offers an alternative option to people living with HIV to find out about their status and to access anti-retroviral treatment services. Self-testing is a critical entry point to HIV prevention services for those testing negative, including the delivery of Pre-Exposure Prophylaxis (PrEP). It is also useful for screening in health facilities and to keep services going during COVID-19 and any future emergencies. We require more product options to meet the growing demand,” said Dr Karin Hatzold, Director of the STAR Initiative Project and Associate Director of HIV/TB Programs at PSI. “This important partnership under the early market access vehicle will make it easier for countries to acquire products and embed them in health systems. This will ensure that self-test kits are affordable to those who want to access them.”  

The Abbott HIV self-test kits will be distributed strategically to communities with inadequate access to healthcare services and will help build capacity to meet the UNAIDS 95-95-95 targets for 2025. The 95-95-95 targets stipulate that 95% of people living with HIV know their status; 95% of people who know their status are on antiretroviral therapy; and 95% of people on treatment have suppressed viral loads.

“Self-testing has helped us reach beyond health centres and make testing easier. This is critically important for vulnerable groups who are often at higher risk of HIV but may also be hesitant to access health services for fear of stigma, discrimination, and violence,” said Dr Philippe Duneton, executive director of Unitaid. “Making quality self-testing kits widely available and affordable is vital to reaching people at risk of HIV with the opportunity to test privately and access life-saving care.”

Categories : HIV VaccinesTags :

Trial of New HIV Vaccine Ended Early due to Ineffectiveness

On By ModernMedia
HIV themed candle
Image by Sergey Mikheev on Unsplash

The investigational HIV ‘Mosaico’ vaccine regimen was safe but did not provide protection against HIV acquisition, an independent data and safety monitoring board (DSMB) has determined. Based on the DSMB’s recommendation, the study will be discontinued. This follows the failure of the similar ‘Imbokodo’ vaccine in sub-Saharan Africa.

The HPX3002/HVTN 706, or ‘Mosaico’ Phase 3 clinical trial began in 2019 and involved 3900 volunteers in Europe, North America and South America. The participants were men who have sex with men (MSM) or transgender people.

The Janssen-developed vaccine was based on ‘mosaic’ immunogens, which are vaccine components featuring elements of multiple HIV subtypes, in order to induce immune responses against a wide variety of global HIV strains. The investigational vaccine regimen consisted of four injections over a year of Ad26.Mos4.HIV, with the mosaic immunogens delivered by a common-cold virus (adenovirus serotype 26, or Ad26). The final two vaccinations were accompanied by a bivalent (two-component) HIV envelope protein formulation, combining clade C gp140 and mosaic gp140 envelope proteins, adjuvanted by aluminium phosphate to boost immune responses. All study vaccinations were completed in October 2022.

In early studies, this vaccine combination induced strong antibody and T-cell responses and protected monkeys exposed to SIV, the simian cousin of HIV. The vaccines however failed to stimulate production of broadly neutralising antibodies (bNAbs) that disable multiple HIV variants, according to aidsmap. In that study, the vaccine conferred a 25.2% effectiveness in protection, but not the 50% necessary for an effective vaccine.

In its scheduled data review, the DSMB determined there were no safety issues with the experimental vaccine regimen. However, the number of HIV infections were equivalent between the vaccine and placebo arms of the study. During the clinical trial, all participants were offered comprehensive HIV prevention tools, including pre-exposure prophylaxis, or PrEP. Study staff ensured that participants who acquired HIV during the trial were promptly referred for medical care and treatment. Participants are being notified of the findings, and further analyses of the study data are planned.

The Mosaico findings track with developments in the Phase 2b ‘Imbokodo’ (HPX2008/HVTN 705) clinical trial, which was testing a similar HIV vaccine regimen in young women in sub-Saharan Africa. A DSMB determined in 2021 that the experimental vaccine regimen in that study was also safe but ineffective in protecting against HIV acquisition.

Source: NIH/National Institute of Allergy and Infectious Diseases

Categories : HIV Obstetrics & GynaecologyTags :

Even in Low-income Countries, ARVs Stop Maternal HIV Transmission

On By ModernMedia
Pregnant with ultrasound image
Source: Pixabay

Antiretroviral drugs almost completely reduce the risk of mothers passing on HIV infection to their children, even in a low-income country with a high HIV incidence such as Tanzania, according to a new study in The Lancet HIV.

UNAIDS estimates that 11% of children born to HIV-positive mothers in Tanzania are infected with HIV, during childbirth or via breast milk. But the new study suggests this figure is actually much lower.

The researchers, from Karolinska Institutet in Sweden, examined more than 13 000 HIV-positive, pregnant women, at several health centres in one of Africa’s largest cities, Dar es Salaam, in Tanzania. The women were offered antiviral treatment through maternity care between 2015 and 2017.

Only 159 infants were infected 

The women were followed for 18 months after giving birth when most of them had stopped breastfeeding. When the researchers examined the mothers’ children, they discovered that only 159 of the more than 13 000 infants had been infected with HIV by the age of 1.5 years, translating to a risk of 1.4%, taking into account a margin of error.

The risk of infection was more than twice as high among women who sought care late in pregnancy or had advanced HIV. Conversely, the risk of infection was only 0.9% in those who had already received HIV treatment when they became pregnant. 

“HIV transmission from mother to child can in principle be stopped completely with modern antiviral drugs. But so far it has not been demonstrated in low-income countries in Africa with a high incidence of HIV infection,” says Goodluck Willey Lyatuu, physician and postdoctoral researcher, also at the Department of Global Public Health at Karolinska Institutet and first author of the study.

Early diagnostics are important 

The study is limited by challenges that may be typical in low-resource health systems, such as incomplete follow-up and missing data, and that risk factors such as stigma linked to HIV are rarely or never routinely investigated.

“But it is one of the largest cohort studies published from Africa on the risk of HIV transmission from mother to child where the baby is followed until the end of the breastfeeding period,” says says Anna Mia Ekström, clinical professor of global infectious disease epidemiology with a focus on HIV at the Department of Global Public Health at Karolinska Institutet and corresponding author of the study.

Source: Karolinksa Institutet