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Albert Einstein College of Medicine researchers receive $5 million NIH grant to study HIV and HPV cancers in Africa

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IMAGE: Kathryn Anastos, M.D.
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Credit: Albert Einstein College of Medicine

November 13, 2020–(BRONX, NY)–A team of scientists from Albert Einstein College of Medicine has received a five-year, $4.9 million grant from the National Institutes of Health (NIH) to establish a research center to investigate HIV- and human papillomavirus (HPV)-related cancers in Africa.

The HIV-Associated HPV-related Malignancies Research Center will build on Einstein-led efforts that have already improved research, clinical, and laboratory capacity in Rwanda. More than 200,000 people in Rwanda have HIV, and women have a higher burden of the disease, according to the Centers for Disease Control and Prevention. Additionally, cervical cancer, which is caused by HPV and which women with HIV are at greater risk of developing, is one of the two most common malignancies among Rwandan women. HPV is also linked to the development of anal, penile, and head and neck cancers.

The grant will enable Einstein researchers and their partners to expand the Rwandan programs and launch similar initiatives in the Democratic Republic of the Congo (DRC). These efforts will help improve health outcomes for millions of Africans living with HIV whose incidence of diseases, including cancer, is increasing as they live longer due to effective HIV therapies.

“We aim to develop a cadre of Rwandan and DRC scientific leaders and build the necessary physical and administrative infrastructure to launch and sustain this project,” said Kathryn Anastos, M.D., lead investigator on the grant and a member of the Albert Einstein Cancer Center, which has supported previous work in Rwanda, including efforts to bring Rwandans to the United States to train.

“Our new NIH-funded center in Africa will serve as a national and regional resource hub for research, training, and career development for those studying the epidemiology, pathogenesis, prevention, and treatment of HPV-associated malignancies in people living with HIV,” added Dr. Anastos, who is professor of medicine, of epidemiology & population health, and of obstetrics & gynecology and women’s health at Einstein and an internist at Montefiore Health System.

Dr. Anastos is recognized internationally for her clinical and investigative work in HIV-infected women, and she has long been involved in leading complex multi-faceted research projects in the United States and Rwanda. Other principal investigators on the grant are Adebola Adedimeji, Ph.D., M.B.A., research associate professor of epidemiology & population heath, and Marcel Yotebieng, M.D., Ph.D., M.P.H., associate professor of medicine, both from Einstein, and Leon Mutesa, M.D., Ph.D., professor of human genetics and director of the Center for Human Genetics at the College of Medicine and Health Sciences-University of Rwanda. The Einstein team includes more than a dozen other faculty members from a range of departments and specialties, including several from the Albert Einstein Cancer Center. They will partner with three African institutions: University of Rwanda, Rwanda Military Hospital, and Université Protestante au Congo.

The grant will support two research projects. One is the first population-based assessment of the effectiveness of HPV vaccination in women living with HIV. The study also will compare the HPV

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Acute HIV Cases Turn Up in COVID Screening

Patients newly infected with HIV are being diagnosed in greater numbers because they are showing up at hospitals with symptoms similar to infection with SARS-CoV-2, researchers reported at the 2020 virtual IDWeek conference.

While routine screening in the emergency room often finds undiagnosed cases of HIV, acute infections – when viral loads are high and transmission is heightened among these newly-infected individuals – occur less often, said David Pitrak, MD, of the University of Chicago.

But during the first 8 months of the COVID-19 pandemic, his institution found new cases of acute HIV infection at an annualized rate of 14.4 per year, Pitrak said in his oral presentation. In contrast, the annual rate during the previous 4 years was 6.8 (incidence ratio 2.14, 95% CI 1.01-4.54).

Pitrak said the first case of COVID-19 was diagnosed on Jan. 24, and from that point until August 17, nine acute HIV infections were diagnosed (along with 26 other non-acute cases). All the acute HIV cases were diagnosed in the emergency department, as were most of the others.

Pitrak said all the newly diagnosed acute cases entered treatment.

Robert Glatter, MD, of Lenox Hill Hospital/Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New York City, commented, “We advocate screening for any patient who requests to be tested, regardless of exposure history or risk factors. It’s a practical public health approach that encourages patients to know their status.”

“Since the pandemic began, I have not been seeing a significant increase in the number of patients who test positive for HIV,” he told MedPage Today. “That said, I have taken care of a few patients in the emergency room with newly diagnosed COVID-19 who incidentally tested positive for HIV. An HIV test is part of the diagnostic and lab evaluation when we evaluate patients at high risk for COVID-19, or who are found to be positive for COVID-19. It is vital to know their HIV status in the setting of such a viral illness.”

Glatter noted that “one of the most common first symptoms in a patient with acute HIV infection is fever. This may also be accompanied by fatigue, muscle aches, chills, and a sore throat.”

“While some patients with COVID-19 may also present with fever or in a similar fashion, up to 40% of patients with COVID-19 may also be asymptomatic. Some patients with COVID-19 may only have loss of taste or smell or have minor fatigue, chest pain, headache, a dry cough, or a low grade fever.”

“The spectrum of COVID-19 presentation can also include neurological symptoms including dizziness, numbness, or tingling — as well as stroke or stroke-like symptoms,” Glatter said.

Pitrak suggested that the upsurge in acute HIV cases discovered in his hospital might be due to several reasons:

  • Patients experiencing acute HIV infection symptoms may seek emergency medical treatment because of concern over possible COVID-19 infection.
  • Acute HIV infections could occur from changes in behavior precipitated by the pandemic.
  • Acute infection could also stem from disruptions in the
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How Trump success in ending Obamacare will kill Fauci plan to conquer HIV

In his State of the Union address in February 2019, Donald Trump vowed to end the HIV epidemic by 2030.

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Related: ‘Rick Scott had us on lockdown’: how Florida said no to $70m for HIV crisis

But if Trump has his way and the supreme court strikes down the Affordable Care Act (ACA), the resulting seismic disruption to the healthcare system would end that dream.

Democrats have expressed grave concern that if Amy Coney Barrett is seated on the supreme court, the conservative jurist could cast a decisive vote to destroy the ACA in the California v Texas case scheduled for oral argument starting 10 November. The Senate judiciary committee will vote on Barrett’s nomination on Thursday. A full Senate vote is expected on Monday.

The brainchild of Dr Anthony Fauci and other top brass at the Department of Health and Human Services, the ambitious Ending the HIV Epidemic: A Plan for America has received for its debut year $267m in new federal spending, largely targeted at HIV transmission hotspots across the US.



a person holding a sign: Amy Coney Barrett listens during a confirmation hearing. Photograph: Anna Moneymaker/AP


© Provided by The Guardian
Amy Coney Barrett listens during a confirmation hearing. Photograph: Anna Moneymaker/AP

The central aim of the Trump-backed plan is to improve access to antiretrovirals, given that successfully treating HIV with such medications eliminates transmission risk. For HIV-negative people, the plan promotes greater use of PrEP – a daily antiretroviral tablet that cuts the risk of HIV by more than 99% among gay and bisexual men, who are its predominant users and account for seven in 10 new infections.

Given antiretrovirals’ enormous cost, the ACA and its broadening of insurance access serves as backbone to the HIV plan, which seeks a 90% reduction by 2030 to the otherwise slowly declining or stagnant national HIV transmission rate of about 37,000 new cases annually.

“The plan is dead in the water if the ACA goes down,” said Amy Killelea, senior director of health systems and policy at Nastad, an HIV public policy non-profit.

“President Trump’s healthcare agenda, in particular his plan to get the supreme court to rule against families’ healthcare, does more to end access to HIV care than it does to end HIV,” said the Washington state senator Patty Murray.

‘Heartbreaking and morally indefensible’

Kaiser found that between 2012 and 2018, the proportion of the non-elderly HIV population lacking insurance declined from about 18% to 11%. This shift was mainly driven by the expansion of Medicaid in the states that opted under the ACA to open the program to all residents with incomes below 138% of the federal poverty level.

About 60% of non-elderly people receiving care for HIV fall into that lowest of income brackets. Forty per cent of people with HIV receive Medicaid, compared with 15% of the general population.

“Striking down the ACA would lead many people with HIV to lose insurance coverage,” said Jennifer Kates, director of global health and HIV policy at the Kaiser Family Foundation.

Not following the science to address HIV or Covid-19 primarily

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EMA Recommends First Long-Acting Injectable HIV Treatment

The first long-acting injectable treatments for HIV were recommended for marketing approval on October 16 by the European Medicines Agency (EMA).

A combination injection of two new antiretroviral (ARV) medicines, rilpivirine (Rekambys) and cabotegravir (Vocabria) was recommended by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

Instead of daily pills, patients would receive intramuscular injections monthly or bimonthly.

The combination injection is meant as maintenance therapy for adults with undetectable HIV levels (viral load <50 copies/mL) with their current ARV treatment and for those in whom the virus has not developed resistance to nonnucleoside reverse transcriptase inhibitors and integrase strand transfer inhibitors, according to the EMA.

According to a press release, the most common side effects are injection site reactions, headache, fever, nausea, fatigue, abnormal lack of energy, myalgia, and dizziness.

The CHMP opinion will now be sent to the European Commission for decision on a European Union–wide marketing authorization. Once granted, price and reimbursement decisions will be made for each country.

The standard treatment for HIV is a combination of ARVs from at least two classes that must be taken daily to suppress viral replication, increase number of CD4 cells, and stop disease progression.

“For some HIV-infected people treated with a stable and effective daily combination of ARV medicines, the availability of a long-acting ARV that reduces the dosing frequency presents a significant improvement by increasing overall satisfaction with treatment and reducing the burden associated with daily pill taking,” the EMA noted.

The two drugs work together to block the ability of the virus to replicate, the EMA explained in the press release. The long-acting injectable regimen does not cure HIV but helps reduce the amount of the virus and keep it at a low level.

The CHMP opinion was based on three phase 3 randomized, open-label, multicenter clinical trials with HIV-infected, treatment-naive or successfully treated adults. The studies demonstrated the safety and efficacy of the combination injection regimen when administered every 4 or 8 weeks.

More efficacy and safety data will be collected through a prospective cohort study and a 5-year study to assess real-world use. Postmarketing safety reports will publicize the results.

The World Health Organization reports that 38 million people were living with HIV worldwide in 2019. During the past 30 years, more 2.3 million people with HIV have been reported in the WHO European Region.

The US Food and Drug Administration declined to approve the injectable combination in December.

According to ABC News, the FDA was concerned about the manufacturing process, not the efficacy or safety of the combination.

Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick.

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