Jaime Rosenberg

home

authors

jaime-rosenberg

Antiretroviral therapy has turned HIV into a manageable disease that has greatly extended the lives of millions. As a result, researchers have started to study HIV through the chronic disease lens. They have compared how living with managed HIV compares with living with other managed, chronic conditions, such as diabetes and rheumatoid arthritis. They have also started to look into “successful aging” in people with HIV and how the condition (and the medications used to manage it) affect people’s quality of life. One major component of successful aging is neurocognitive capabilities and arresting their decline. Although cases of HIV-related dementia have decreased with the advent of antiretroviral. there are still subtler neurocognitive problems associated with HIS.

Results of an NIH-funded study reported in

last week shed more light on the subject of HIV as a chronic disease and, in particular, on the relationship between neurocognitive impairment and quality life. A team of researchers at the University of Nebraska used data collected during four years of the longitudinal 

study, a research project that enrolled just over 2,000 patients at six university-based clinics. After some exclusions because of missing data and confounding comorbidities, the Nebraska researchers zeroed in on a smaller group of 1,340 study participants, most (77%) of whom were male and whose average age was 43. They combed through the answers the study participants gave to

At the heart of the study is their examination of the association between neurocognitive impairment and 

(HRQoL). They combed through the answers that the patients gave to a 35-item questionnaire called the Medical Outcome HIV Health Survey and grouped them in such a way as to create a summary score for the person’s mental HrQoL and their physical one.

The results were not hugely surprising and fit with previous findings, although the CHARTER study gave the researchers access to more data on a more diverse group of people than prior studies. The takeaway finding is that neurocognitive impairment, as measured by a global deficit score, is associated with worse mental HRQoL among people living with HIV, although the analysis threw some doubt on clinical importance of the association. They also found that depression may have been a factor in the impairment-mental HRQoL association, and one of their recommendations was that people with HIV with neurocognitive impairment might benefit from concurrent management of depression.

The relationship between neurocognitive impairment and physical HRQoL was not as strong and disappeared after statistical adjustments for age and other factors.

These findings will not disrupt or reframe the current thinking about people living with HIV and the challenges they face. But they do paint a fuller picture of HIV as a chronic disease that presents the mental health and quality-of-life challenges that are common to many health conditions that are eminently treatable but not curable.

Articles

Findings add to the understanding of the challenges that people living with HIV face now that it is a more manageable, long-term condition.

HIV As a Chronic Disease: Study Shows Link Between Neurocognitive Impairment, Quality of Life

Preclinical research is putting a common, inexpensive drug used to treat diabetes in the mix for potential ways to fight HIV.

, show that metformin subdues HIV’s ability to replicate in CD4+ T cells, the immune cells that the virus infects. When HIV infects these immune cells, it boosts a key process in the cells’ production of chemical energy, resulting in viral replication. Metformin, it seems, is able to hinder this process called oxidative phosphorylation.

“These findings suggest that metformin and other drugs that reduce T cell metabolism might be useful as adjunct therapies for treating HIV,” said the study’s co-first author Haitao Guo, Ph.D., assistant professor in the University of North Carolina (UNC) Department of Genetics at the UNC School of Medicine, 

If replicated in future studies, the findings have important implications for the millions of people living with HIV, many of which display signs of residual viral replication despite treatment.

This study is the latest in a newer wave of research looking at the possibilities of making it harder for these infected cells to virally replicate, which contrasts the typical treatment approach of treating HIV.

The group of researchers of the current study analyzed CD4-cell gene expression data collected from people living with HIV in Africa and Asia. They observed that the gene-expression patterns most closely linked to poor outcomes was related to oxidative phosphorylation.

From there, the researchers discovered that treatments that suppress this process in CD4 cells can subsequently prevent HIV’s ability to replicate.

“This work shows the importance of CD4 cell metabolism in HIV, and suggests that it may be targetable, for example with repurposed drugs such as metformin, to reduce HIV viral load and restore these disease-fighting CD4 cells,” said Jenny Ting, Ph.D., assistant editor in the UNC Department of Genetics at the UNC School of Medicine, in a statement.

The publication also includes the researchers’ findings from an analysis of a previous study of patients living with HIV taking antiretroviral therapy (ART)—the cornerstone of HIV treatment. In patients who also had type 2 diabetes, likely meaning they also take drugs like metformin, HIV levels in the blood were approximately 33% lower compared with patients without diabetes after 6 months.

Notably, these patients with diabetes had higher baseline CD4 cell levels and swifter recoveries of these levels with ART.

Commonly Prescribed Diabetes Drug May Be Useful in Fight Against HIV

A year of the COVID-19 pandemic has set loose a new wave of innovation across the healthcare system, creating exciting opportunities yet novel challenges in the delivery of care. Care and treatment of people with HIVis no exception, according to a new review, which says that the rapid implementation of telemedicine has been viewed favorably by providers offering HIV care yet has conflicting results on how well it facilitates patient retention.

While some research suggests that the number of patients engaged in care has remained constant throughout the pandemic, other research points to the opposite. One clinic in particular found that between February and August 2020, the number of patients lost to follow-up — defined as those not receiving care for at least one year — increased from 34 to 59.

Prior to COVID-19, adoption of telemedicine remained suboptimal because of regulatory and reimbursement restrictions. With the arrival of the pandemic, the federal government removed certain restrictions and others followed suit. Telehealth also got a major boost when many payers started to reimburse in-person and telehealth visits at the same rates. Guidance from the government put an emphasis on telemedicine visits rather than in-person visits for routine or non-urgent care.

“The COVID-19 pandemic has revolutionized the practice of ambulatory medicine,” say lead author 

, M.D., of the University of Washington and her colleagues. “We have entered an era in which we need to build telemedicine models that empower [people living with HIV] and improve access to care. In fact, the pandemic has facilitated differentiated care delivery in the U.S.” 

Their review, titled “The Impact of COVID-19 on HIV Care Provided via Telemedicine—Past, Present, and Future,” was 

published online in late February in Current HIV/AIDS Reports.

On the one hand, telemedicine visits allow for a more tailored approach to care that can decrease travel times, expenses, and time away from work, as well as help those who fear the stigma of attending a clinic. On the other hand, patients have cited concerns over privacy, data breaches, billing, and insurance challenges.

Budak and her co-authors discuss the “digital divide” between advantaged and disadvantaged populations. Communication by telephone may serve as a safety net, they say. “Some individuals have difficulty with video visits, often due to absence of broadband connectivity, inexperience with the technical hardware or software required, or lack of a private space in which to join a visit,” they say in the article. “Many such individuals thus rely on telephone visits to stay engaged with care; as such, telephone visits have become a crucial safety net for many patients to stay connected.”

With more patients perhaps being lost to follow-up, there are also concerns over viral suppression rates dropping, giving cause to the notion that the pandemic has exacerbated gaps already prevalent in the HIV care continuum.

“Importantly, connecting to a visit via telemedicine does not supplant the wraparound services often needed to help an individual achieve virologic suppression,” write the researchers, who added that more data on virologic suppression and retention in care in the age of telemedicine are required.

While the pandemic led to an acceleration of telemedicine adoption for prescribing 

 (PrEP), a daily pill that can be taken to prevent HIV, practices have seen some negative effects on PrEP; for example, data from a Boston community health center that specializes in sexual health show a 191% increase in PrEP refill lapses between January and April 2020 and that the number of people newly starting PreP fell by 72%. 

But the tailing off of PrEP has to be put in some context, note Budak and her co-authors. While visits and prescriptions have dropped drastically, many patients have stopped taking PrEP because of the social distancing resulting from the pandemic. “Physical distancing and stay-at-home orders may have contributed, as a survey study found that of individuals who stopped PrEP voluntarily, 85% stopped due to low perceived risk,” they observed.

The rapid implementation of telehealth viewed favorably by providers involved in HIV care yet there are conflicting results on how well it facilitates patient retention.

Jury Still Out on Whether Telehealth Is a Plus or Minus for HIV Amid the COVID-19 Pandemic 

As the COVID-19 pandemic in the U.S. surpasses the one-year mark, the numbers are sobering: more than 27 million Americans infected; a death toll of over half a million.

Despite uncertainty about the pandemic’s future, appreciation of the scale and speed of healthcare innovation is warranted. Vaccines to protect against the SARS-CoV-2 virus were developed and deployed in less than a year. The FDA issued emergency use authorizations for two COVID-19 RNA vaccines at the end of 2020: the Pfizer-BioNTech vaccine and the Moderna vaccine. New drugs, such as the monoclonal antibody bamlanivimab, have joined steroids in improving treatment for patients.

But in January and most of February the pace of the distribution of the vaccines wasn’t as remarkable as that of the vaccine and treatment research. Many states had not received the number of doses they were promised. Pfizer said millions of doses of its vaccine were in storage, a situation that may change after the company and the FDA agreed the vaccine could be stored at normal freezer temperatures. As of Feb. 28, the CDC’s COVID-19 vaccine tracker showed 75.2 million doses had been administered, and Bloomberg’s tracker showed 78% of the doses supplied to the states had been administered.

President Joe Biden has vowed to speed up the rollout, bolstering the distribution plan with a $20 billion national vaccination program. He also announced the purchase of another 200 million doses of vaccines from Moderna and Pfizer-BioNTech and an increase in the number of doses being shipped to the states.

Meanwhile, the emergency use authorization for Johnson & Johnson’s vaccine means there will be three vaccines available in the U.S. The company submitted its request for an emergency use authorization (EUA) in early February, and the go-ahead from the FDA came on Feb. 27. The EUA was based on phase 3 results that showed the J&J Johnson is 66% effective at preventing moderate to severe cases of COVID-19 compared with the 95% protection against symptomatic COVID-19 seen in late-stage trials of the Pfizer-BioNTech and Moderna vaccines. 

But the J & J vaccine has the advantage of being a one-dose vaccine that could mean more coverage. Novavax, a relatively small biotech company in Gaithersburg, Maryland, is a David among the Goliaths in the race to deploy a COVID-19 vaccine. Novavax reported positive phase 3 trial results at the end of January. The company will most likely seek approval in the U.K. before the U.S.

The Oxford-AstraZeneca vaccine has had a bumpy ride. The U.K.’s equivalent of the FDA approved emergency use for the vaccine in late December based on results that showed 62% efficacy from two doses but, oddly, higher efficacy among the study volunteers who received a low dose followed by a standard one. In early February, preliminary data showed that it was effective in reducing transmission after just one dose, a result that led to consideration of whether a vaccine strategy emphasizing single doses might make sense. A few days later, however, other data showed that the vaccine was only 22% effective against the South African variant, or B.1.351, of SARS-CoV-2. As a result, South African officials halted its use in that country.

GlaxoSmithKline’s website states that it is one of the largest vaccine companies in the world, with a portfolio of more than 30 vaccines that generated about $9 billion in revenues last year. But GlaxoSmithKline is well off the pace when it comes to COVID-19 vaccines. A vaccine it was developing with Sanofi had to be redesigned when it failed to trigger immunity in older people. In February, it announced that it was building on an existing relationship with CureVac, a German biopharmaceutical company, to develop a “multivalent approach (to COVID-19 vaccines) to address multiple emerging variants in one vaccine.”

The desire for good news and progress against the pandemic may have led to a premature sigh of relief when the Pfizer-BioNTech and Moderna became available in the U.S. The emergence of variants in January and February may be another setback in the yearlong effort to stem COVID-19 infections, illness and death. Three notable variants have been detected in the U.S.:

The U.K. variant B.1.1.7, which in Britain is referred to as the Kent variant (Kent is a county east of London), spreads more easily and quickly than other variants and may be more deadly than the original strain, although that is still an open question. Some experts think the U.K. strain, which was first reported in the U.S. in December 2020, will become the dominant one circulating in the U.S. this spring.

The South Africa variant, designated B.1.351, shares some of the same mutations as B.1.1.7 but appears be more difficult to protect against. It was reported in the U.S. at the end of January.

The Brazil variant, which has the scientific label of P.1, has 17 unique mutations and was reported in the U.S. in late January.

Naturally, there’s some worry that these new variants will evade the protective effect of the current crop of vaccines — and the vaccine-lit end of the COVID-19 tunnel will darken. But variance doesn’t necessarily mean immunological evasion; some preliminary data suggest that the current crop of vaccines and vaccine candidates will do just fine against the U.K. strain. There is more concern about the South African variant — and not just with respect to the AstraZeneca-Oxford vaccine. A study of Novavax’s vaccine among 4,400 people in South Africa showed that the vaccine was just 49% effective against the South Africa variant.

A Moderna study of a small group of people who received two doses of its vaccine showed antibody levels that would likely fend off the variants, especially the U.K. one. Moderna has also developed a version of its vaccine that is tailored to produce an immune response to South African variant. A phase 1 trial was of that vaccine is scheduled to start this month.

Jaime Rosenberg is a freelance writer based in Jersey City, New Jersey.

Will emerging variants make the leading vaccines less protective? 

Jaime Rosenberg

Articles

HIV As a Chronic Disease: Study Shows Link Between Neurocognitive Impairment, Quality of Life

Commonly Prescribed Diabetes Drug May Be Useful in Fight Against HIV

Jury Still Out on Whether Telehealth Is a Plus or Minus for HIV Amid the COVID-19 Pandemic

The COVID-19 vaccine race was a sprint. Now for the hurdles