NATIONAL INSTITUTE OF HEALTH- NEWS RELEASES

A National Institutes of Health-funded study found that people with substance use disorders (SUDs) are more susceptible to COVID-19 and its complications. The research, published today in Molecular Psychiatry, was co-authored by Nora D. Volkow, M.D., director of the National Institute on Drug Abuse (NIDA). The findings suggest that health care providers should closely monitor patients with SUDs and develop action plans to help shield them from infection and severe outcomes.
By analyzing the non-identifiable electronic health records (EHR) of millions of patients in the United States, the team of investigators revealed that while individuals with an SUD constituted 10.3% of the total study population, they represented 15.6% of the COVID-19 cases. The analysis revealed that those with a recent SUD diagnosis on record were more likely than those without to develop COVID-19, an effect that was strongest for opioid use disorder, followed by tobacco use disorder. Individuals with an SUD diagnosis were also more likely to experience worse COVID-19 outcomes (hospitalization, death), than people without an SUD.
“The lungs and cardiovascular system are often compromised in people with SUD, which may partially explain their heightened susceptibility to COVID-19,” said Dr. Volkow. “Another contributing factor is the marginalization of people with addiction, which makes it harder for them to access health care services. It is incumbent upon clinicians to meet the unique challenges of caring for this vulnerable population, just as they would any other high-risk group.”
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​TO CONTINUE READING: https://www.nih.gov/news-events/news-releases/substance-use-disorders-linked-covid-19-susceptibility

September 12, 2020

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) announced today that they have submitted an amended protocol to the U.S. Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200912005013/en/
Enrollment in the trial has been proceeding as planned and the company expects to reach its initial target of up to 30,000 participants next week. The proposed expansion would allow the companies to further increase trial population diversity, and include adolescents as young as 16 years of age and people with chronic, stable HIV (human immunodeficiency viruses), Hepatitis C, or Hepatitis B infection, as well as provide additional safety and efficacy data.
The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing. As stated previously, based on current infection rates, the companies continue to expect that a conclusive readout on efficacy is likely by the end of October.

To Continue Reading:
View source version on businesswire.com: https://www.businesswire.com/news/home/20200912005013/en/
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BY MORGAN MCKAY NEW YORK STATE
PUBLISHED 5:01 AM ET AUG. 25, 2020   SPECTRUM NEWS

Restaurants and bars are now joining a growing list of businesses that will be able to carry opioid antagonists, like Narcan, in the case of an opioid-related overdose. 
Governor Andrew Cuomo signed legislation on Monday that expands the list of establishments that are allowed to possess and administer opioid overdose reversal medication. This list will now include malls, beauty parlors, theaters, hotels, restaurants, bars and retail establishments. 
"
​We have made tremendous progress in combating addiction across New York and while we have seen a reduction in opioid deaths over the past 10 years, there is still work to be done," Cuomo said.
The bill will also give these businesses protection under the "Good Samaritan Law," so they will not be penalized for providing medical attention.

"By authorizing the use of these reversal drugs without fear of liability, this new law will also provide peace of mind to residents and business owners around the state who are inclined to help those in desperate need of help," bill sponsor Senator Pete Harckham said. 

​TO CONTINUE READING: https://spectrumlocalnews.com/nys/buffalo/ny-state-of-politics/2020/08/25/cuomo-signs-bill-to-expand-narcan-use?cid=id-app15_m-share_s-web_cmp-app_launch_august2020_c-producer_posts_po-organic

July 31, 2020 | by Samar Khurshid GOTHAMGAZETTE

With the pandemic blowing a hole in the economy and leading to a drastic drop in state tax revenue, budget officials have for months been withholding payments for state contracts to manage cash flows. Among the victims of that fiscal approach are substance use treatment providers who are being forced to cut already-limited services and consider staff layoffs and furloughs, which they say will likely lead to a sharp increase in overdoses and new disease outbreaks around the state. 
The pandemic caused a 14% drop in expected revenue for the state in the current fiscal year, roughly $13.3 billion, leading the state to reduce $4 billion in spending so far by withholding contract payments across the board and imposing freezes on new contracts, hiring, and pay raises, according to the Division of Budget. Governor Andrew Cuomo has said the state cannot meet the shortfall unless the federal government provides aid, failing which he would cut about 20%, or $8.2 billion, of funding for local governments for everything from education and social services to health care programs. 
But several nonprofit providers that contract with the state to run substance use treatment programs – including syringe exchanges, sexually-transmitted infection (STI) screenings, naloxone overdose rescue training, and more – are already feeling the crunch, having gone months without being paid by the state. The state has also cut local funding for substance use and addiction treatment programs by 31%, according to news reports, exacerbating providers’ worries about being able to provide services.
In interviews, providers and harm reduction advocates painted a dire picture. They say that the already rising rate of overdoses that they are witnessing is at risk of spiking to the same levels as 2016, when the opioid epidemic reached its peak and spurred local and state officials into action. Since official data lags behind and could be unavailable until even a year after the fact, they fear that by the time the actual numbers become apparent, it will be too late. A generational crisis could be underway.  
TO CONTINUE READING:   https://www.gothamgazette.com/state/9637-state-withholds-contract-payments-nonprofits-substance-use-treatment-providers-overdoses-disease?mc_cid=5

​Yale University News|August 7, 2020

Researchers at the Yale Liver Center found that patients with COVID-19 presented with abnormal liver tests at much higher rates than suggested by earlier studies. They also discovered that higher levels of liver enzymes — proteins released when the liver is damaged — were associated with poorer outcomes for these patients, including ICU admission, mechanical ventilation, and death.
The study appeared online onJuly 29 in Hepatology.
Previous studies in China found that approximately 15% of patients with COVID-19 had abnormal liver tests. The Yale study, which looked retrospectively at 1,827 COVID-19 patients who were hospitalized in the Yale New Haven Health system between March and April, found that the incidence of abnormal liver tests was much higher — between 41.6% and 83.4% of patients, depending on the specific test.
In all, the Yale researchers examined five liver tests, looking at factors such as elevations in aspartate aminotransferase (AST) and alanine transaminase (ALT), which indicate liver cell inflammation; an increase in bilirubin, which indicates liver dysfunction; and increased levels of alkaline phosphatase (ALP), which may indicate inflammation of bile ducts.

Although the researchers do not know why the incidence of abnormal liver tests was so much higher than in previous studies from China, senior author Dr. Joseph Lim, professor of medicine and director of the Yale Viral Hepatitis Program, said other health differences between the Chinese and U.S. populations could account for it.
“We can speculate that U.S. patients may have an increased rate of other risk factors such as alcoholic or non-alcoholic fatty liver disease,” he said.

TO CONTINUE READING: https://www.mdlinx.com/news/strong-link-found-between-abnormal-liver-tests-and-poor-covid-19-outcomes/62T02X3quARxyENd5XKdnn?utm_medium=e

Terri Wilder, M.S.W.Aug. 3, 2020- The Body Pro

​The 23rd International AIDS Conference (AIDS 2020) was held virtually for the very first time and featured discussion about the current direction and future prospects for HIV prevention, diagnosis, and treatment. It was followed by a virtual COVID-19 conference on July 10 and 11. This conference was the first abstract-driven scientific conference dedicated to the global COVID-19 pandemic. It featured 140 late-breaking studies addressing urgent questions related to COVID-19 epidemiology, prevention, treatment, and care.
During the summit, researchers gave a presentation entitled, “Sofosbuvir and Daclatasvir as a Potential Candidate for Moderate or Severe COVID-19 Treatment, Results from a Randomised Control Trial.” During the official press briefing, Andrew Hill, Ph.D., the principal investigator, reviewed promising results from the study.
Hill graduated from Oxford University and then gained his Ph.D. from the University of Amsterdam. He’s been working on clinical trials of drugs to treat HIV and hepatitis C for the past 28 years. He’s a senior visiting research fellow at Liverpool University and also works as a consultant for the World Health Organization and Unitaid. Hill spoke with Terri Wilder, M.S.W., after the COVID-19 conference.
Terri Wilder: Dr. Hill, can you start by giving me an overview of the trial, the preliminary results, and how you were involved?
Andrew Hill: There were three studies conducted in Iran at the peak of their first epidemic there in March and April 2020. I was involved with them because they had used the same drug to cure thousands of people with hepatitis C in Iran. I actually contacted them at the beginning of the epidemic and suggested they try using the hepatitis C drugs to actually treat COVID-19, as well, because there were some early studies suggesting that these drugs might be active, not just against hep C, but against the SARS-CoV-2 virus, as well.
TW: The drugs that were used, as you mentioned, were hepatitis C drugs. Can you talk a little bit about the dosage of the drugs that were given to the patients? And then also, what was the control treatment that was given?

TO CONTINUE READING:​https://www.thebodypro.com/article/can-hepatitis-c-drugs-treat-covid-19-research

By Josh Katz, Abby Goodnough and Margot Sanger-Katz July 15, 2020 NY Times- The Upshot

Drug deaths in America, which fell for the first time in 25 years in 2018, rose to record numbers in 2019 and are continuing to climb, a resurgence that is being complicated and perhaps worsened by the coronavirus pandemic.
Nearly 72,000 Americans died from drug overdoses last year, according to preliminary data released Wednesday by the Centers for Disease Control and Prevention — an increase of 5 percent from 2018. Deaths from drug overdoses remain higher than the peak yearly death totals ever recorded for car accidents, guns or AIDS, and their acceleration in recent years has pushed down overall life expectancy in the United States.

71,999 people died from drug overdoses in the U.S. in 2019
Drug overdose deaths in the U.S. reached a record last year
Source: Centers for Disease Control and Prevention

It looks as if 2020 will be even worse. Drug deaths have risen an average of 13 percent so far this year over last year, according to mortality data from local and state governments collected by The New York Times, covering 40 percent of the U.S. population. If this trend continues for the rest of the year, it will be the sharpest increase in annual drug deaths since 2016, when a class of synthetic opioids known as fentanyls first made significant inroads in the country’s illicit drug supply.

TO CONTINUE READING: https://www.nytimes.com/interactive/2020/07/15/upshot/drug-overdose-deaths.html

Researchers launch large-scale trials as early data show promise

ByAnne Gulland, GLOBAL HEALTH SECURITY CORRESPONDENT

​Two cheap and widely available hepatitis C drugs have cut death rates among patients hospitalised with coronavirus, the results of three small studies have shown.
 
The drugs - sofosbuvir and daclatasvir - were given to three groups of patients hospitalised with the virus in Iran. After 14 days of treatment 94 per cent of patients taking the drug combination were showing signs of recovery versus 70 per cent receiving standard care.
 
The death rate for the combination of drugs was five per cent, compared to 20 per cent for people on standard care.
 
“We saw significantly faster rates of clinical recovery and hospital discharge for people taking the drug combination and we also saw faster rates of survival,” said Dr Andrew Hill, senior visiting research fellow at Liverpool University and one of the researchers. 
 
The treatment works by binding to one of proteins of the virus, interfering with its ability to replicate. Laboratory studies showed that daclatasvir was the most effective of the two as it penetrates into the lungs where Covid-19 infection is often concentrated. 
 
One of these small trials was not randomised so the researchers, who presented their results at the International Aids Society Covid-19 scientific conference this week, stress that the results should be seen as preliminary.
 
“It’s early data so we do not want to get carried away,” Dr Hill added. 
 
Five randomised control trials to test the combination as both a treatment and a prophylactic have now been set up in Iran, Brazil, Egypt and South Africa and researchers hope to recruit 2,000 patients and health workers. 
 
They hope to see data by October and if the combination proves successful it could be approved for worldwide use.

TO CONTINUE READING: https://www.telegraph.co.uk/global-health/science-and-disease/cheap-widely-available-hep-c-drug-shown-reduce-death-rate-covid/
 

Ronald O. Valdiserri, Alexander Billioux, Boatemaa Ntiri-Reid, Lauren Canary
June 26, 2020 HEALTH AFFAIRS BLOG      10.1377/hblog20200624.8487510.1377/hblog20200624.84875

As our nation continues to confront the burgeoning pandemic of COVID-19, much has been written about the importance of building and sustaining a strong public health infrastructure to contain the epidemic, minimize its impact, and prepare for future waves of SARS-CoV-2 and other deadly pathogens. For those not working on the front lines, perhaps less obvious has been the pandemic’s effect on other health department programs and services. In the setting of already understaffed and underfunded state and local health departments, the deployment of personnel from their regular duties to work on COVID-19 response has resulted in other key services being reduced or suspended.
Impact Of COVID-19 Response On Other Necessary Public Health ServicesIn a a recent survey of health department sexually transmitted disease (STD) programs, more than half reported negative impacts of the COVID-19 response on the provision of recommended screening, diagnostic, and treatment services. Decreases in the availability of syringe service programs and limitations in access to pre-exposure prophylaxis (PrEP) for HIV have also been reported as a consequence of shifting resources and changing priorities in response to COVID-19. Not surprisingly, viral hepatitis prevention and control programs have also experienced this strain.
In May 2020, the National Alliance of State and Territorial AIDS Directors (NASTAD) conducted a request for information (RFI), asking the viral hepatitis and HIV prevention and care staff of health departments to provide specific details about the impact of the COVID 19 pandemic on public health capacity. The organization found that over 80% of hepatitis program, 75% of HIV prevention program, and 57% of Ryan White HIV/AIDS program staff at health departments reported being detailed to the COVID 19 response. In light of current circumstances, over 90% of the hepatitis programs responding to the RFI indicated that they anticipate reductions in viral hepatitis outreach, education, testing, and linkage to care services.
Effect On Viral Hepatitis Elimination EffortsWhile no public health leader questions the need to respond to SARS-CoV-2 with deliberate speed and appropriate action, the COVID-19 pandemic has emerged at a particularly critical time in America’s effort to eliminate hepatitis C in the United States. Consider the situation in Louisiana. In June 2019, the state announced the creation of an innovative payment model for hepatitis C treatment that would enable it to provide curative therapy for two vulnerable populations disproportionately affected by hepatitis C: persons on Medicaid and those receiving care through the state corrections system. Prior to the program’s launch, approximately 61 persons per month were started on curative treatment for hepatitis C virus (HCV) in state Medicaid and Department of Corrections programs. After a successful implementation, this figure increased dramatically to some 478 persons per month being treated.  However, due to disruptions brought on by the COVID-19 pandemic, the number of new treatment starts dropped to 155 persons in Spring 2020 (mid-March to mid-April). And given constraints in state budgets anticipated in the face of COVID-19 response, other jurisdictions may be slowed or even halted in their efforts to launch viral hepatitis elimination programs.
TO CONTINUE READING: https://www.healthaffairs.org/do/10.1377/hblog20200624.84875/full/

Maggie L. Shaw
Newsroom – Published on: June 18, 2020 AJMC

Despite the CDC’s recommendation, which has been in effect since 1998, study results show that just half of HIV-positive individuals choose to get tested for hepatitis C virus (HCV) in the 12 months following the receipt of their diagnosis.

Just half of individuals with HIV were ever tested for hepatitis C virus (HCV) in the year after receiving their HIV diagnosis, despite being at increased risk for the liver disease, report recent study results that appeared in Open Forum Infectious Diseases. Living in a rural area, too, meant this patient group was the least likely to get tested.

“Because HIV infection can accelerate the natural history of HCV infection leading to increased risk for cirrhosis, liver failure, and hepatitis C–related mortality, all individuals living with HIV should be tested for hepatitis C and linked to care where appropriate,” the study authors noted.

TO CONTINUE READING: ​https://www.ajmc.com/newsroom/having-a-high-risk-of-hcv-does-not-always-lead-to-testing-among-those-with-hiv