​CARL SCHMID , EXECUTIVE DIRECTOR, HIV+HEPATITIS POLICY INSTITUTE

This year, roughly 14,000 Americans will die from hepatitis C, an infectious disease that can be cured by a simple pill in a matter of weeks.
It's infuriating that our government hasn't done more to end this highly infectious disease that disproportionately impacts minorities and people struggling with substance use disorder. Curative drugs first hit the market in 2013. But hepatitis C cases actually rose 63 percent between 2015 and 2019, according to a new report from the Centers for Disease Control and Prevention.
In other words, an epidemic that could be wiped out is instead getting worse. As we mark World Hepatitis Day on July 28, we need the U.S government to step up and commit the resources and leadership to end hepatitis C, just like other governments are doing around the world.
Roughly 2.4 million Americans have been diagnosed with hepatitis C. The Department of Health and Human Services believes another million have contracted the virus but don't know it—and may thus be spreading it inadvertently. People with hepatitis C can go years without exhibiting symptoms, even as the virus attacks their livers. Eventually, the viral assault may lead to liver failure, cirrhosis, cancer and even death.


Not long ago, treatment was difficult. Doctors prescribed shots that caused severe side effects and cured only about half of cases.
Today, direct-acting antiviral pills are available that cure over 90 percent of cases in just eight to 12 weeks with minimal side effects. And, thanks to competition, treating hepatitis C has become cheaper. The cost of treatment fell from $899 per day in 2014 to just $201 per day in 2020, a 78 percent drop, according to the health consultancy Milliman.

TO CONTINUE READING-https://www.newsweek.com/we-can-end-hepatitis-c-why-arent-we-opinion-1613565?utm_term=Autofeed&utm_medium=Social&utm_source

By Josh Katz and Margot Sanger-KatzJuly 14, 2021 NEW YORK TIMES

As Covid raged, so did the country’s other epidemic. Drug overdose deaths rose nearly 30 percent in 2020 to a record 93,000, according to preliminary statistics released Wednesday by the Centers for Disease Control and Prevention. It’s the largest single-year increase recorded.
The deaths rose in every state but two, South Dakota and New Hampshire, with pronounced increases in the South and West.

Several grim records were set: the most drug overdose deaths in a year; the most deaths from opioid overdoses; the most overdose deaths from stimulants like methamphetamine; the most deaths from the deadly class of synthetic opioids known as fentanyls.
“It’s huge, it’s historic, it’s unheard of, unprecedented, and a real shame,” said Daniel Ciccarone, a professor of medicine at the University of California, San Francisco, who studies heroin markets. “It’s a complete shame.”
In recent years, annual drug overdose deaths had already eclipsed the peak yearly deaths from car crashes, gun violence or the AIDS epidemic.

The death toll from Covid-19 surpassed 375,000 last year, the largest American mortality event in a century, but drug deaths were experienced disproportionately among the young. In total, the 93,000 deaths cost Americans about 3.5 million years of life, according to a New York Times analysis. By comparison, coronavirus deaths in 2020 were responsible for about 5.5 million years of life.
The pandemic itself undoubtedly contributed to the surge in overdose deaths, with disruption to outreach and treatment facilities and increased social isolation. Overdose deaths reached a peak nationally in the spring of 2020, in the midst of the pandemic’s most severe period of shutdowns and economic contraction. But public health experts said there had been a pre-pandemic pattern of escalating deaths, as fentanyls became more entrenched in the nation’s drug supply, replacing heroin in many cities and finding their way into other drugs like meth.
After decades of increases, overdose deaths dipped slightly in 2018. But they resumed their upward course in 2019, and drug deaths were rising in the early months of 2020, even before Covid arrived.
Change in drug deaths from 2019Jan.+1,018Feb.+1,249March+1,363April+2,360May+3,597June+2,373July+2,371Aug.+2,078Sept.+1,621Oct.+1,229Nov.+1,122Dec.+1,304
Source: Centers for Disease Control and PreventionNote: Monthly drug deaths are based on provisional data and may not add up to the annual total.“We went into Covid with this issue,” said Regina LaBelle, the acting director of the Office of National Drug Control Policy. “Rates of overdose death were going up; they were on the upswing. Certainly, Covid didn’t help and likely exacerbated things, but we were seeing an increase before.”
On Tuesday, President Biden nominated a permanent director for the post, sometimes called the drug czar. The nominee, Dr. Rahul Gupta, a physician and the chief medical and health officer for the March of Dimes, was the former commissioner of public health in West Virginia, a state with one of the sharpest rates of increase in drug deaths last year.
José Benitez, the executive director of Prevention Point Philadelphia, said the continuing mixing of heroin and other drugs with fentanyls had driven up the overdose rate there. But he also noted the effects of the pandemic. His group, which provides services to people who use drugs, saw appointments drop by about 20 percent. Some of their funding was diverted to support Covid services.
He also said that Covid public health warnings about social distancing ran counter to the advice given to opioid users. If people are going to use drugs, they’re encouraged to use them around others, so someone can revive them if they overdose. “The messages were mixed at best,” he said.
Mr. Benitez said the last year had been hard on his staff. It was not uncommon for two clients to die every week. “I was a social worker during the AIDS era,” he said. “This is, in lots of ways, almost a repeat of that.”
The C.D.C. will provide final estimates in a few months (overdose death investigations depend on toxicology reports and other testing that take time). No region was spared from the increased death toll. In the Northeast and Midwest, where the opioid epidemic was most acute in earlier phases, deaths continued to rise. But the biggest increases were in the South and the West, regions that had been less afflicted.
Rising deaths in the West, in particular, suggest a possible new phase in the epidemic. The national rise in deaths in recent years has been attributed in part to the introduction of fentanyls, which are easier to manufacture and ship than traditional heroin. Fentanyls began regularly appearing in the East Coast’s heroin supply in the last seven years, where they were easy to mix with the most common type of heroin, also a white powder. Overdoses of fentanyls, with their high yet variable potency, tend to be more common than overdoses of traditional heroin.
In the West, where most heroin is sold as a stickier substance known as black tar, fentanyls had been less widespread. Researchers examining the drug supply there say they are seeing more fentanyls sold as counterfeit pills, or sold alone as an injectable drug. An increase in overdose deaths involving both meth and fentanyls suggests fentanyls have begun penetrating the stimulant supply, too.
“We’ve seen a westward expansion of fentanyl,” said Christopher Jones, the acting director for the National Center for Injury Prevention and Control. “That just increases the pool of people who are susceptible to overdoses.”
It appears that the pandemic may have briefly interrupted the flow of fentanyls from China into the United States. Chad Sabora, the executive director of the Missouri Network for Opiate Reform and Recovery, and a consultant to the government, said the drug supply in St. Louis was altered for more than a month. “Then, a huge influx,” he said. “People’s tolerance had gone down, and boom.”
White Americans were hit particularly hard in the early years of the opioid epidemic, but in recent years deaths have been growing fast in nonwhite populations. In 2020, overdose deaths grew faster in Black and Hispanic populations than in white ones.
The trend may reflect the growing reach of fentanyls, which are now often found mixed with stimulants like cocaine and meth. They are reaching groups that were less likely to become addicted to prescription painkillers earlier in the epidemic. The stresses of the Covid pandemic have also affected Black, Latino and Native Americans disproportionately, with the potential to affect patterns of drug use.
“The pandemic has been far more disruptive in communities of color than in white communities — the death rates, the infection rates, the unemployment rates, the food insecurity rates,” said Joshua Sharfstein, a vice dean at the Johns Hopkins Bloomberg School of Public Health. “So many consequences of the pandemic have hit communities of color harder. So it’s not out of line for overdoses to do the same.”
Politicians, public health officials and clinicians have been battling the opioid epidemic for years. In 2018, Congress passed a package of bills meant to reduce the death toll by limiting overuse of prescription drugs and improving access to drug addiction treatment. And early this year, Congress allocated an additional $1.5 billion to fight the epidemic.
The pandemic brought some changes in addiction policy that may have saved lives. Temporary changes have made it easier for people enrolled in methadone treatment to take doses home with them, instead of requiring them to visit a clinic each day. Ms. LaBelle said more people in drug treatment had stayed enrolled as a result. Regulators also made it easier for people to seek medical care through telemedicine, another policy that may be extended beyond the Covid emergency. For the first time, federal funds (from the recent stimulus bill) can be used to buy needles and syringes for exchange programs, and to purchase rapid fentanyl test strips, which can be used to check whether drugs contain fentanyl.
These new initiatives, and the substantial new funding to fight the epidemic, could help, several scholars said. But Ms. LaBelle cautioned that the improvements may come slowly. “In a year, I hope some of the regulatory revisions have been extended,” she said. “I think it’s more five to 10 years when we’ll start seeing more of the fruit of our labors.”

TO CONTINUE READING:​https://www.nytimes.com/interactive/2021/07/14/upshot/drug-overdose-deaths.html

Jul 12, 2021,04:00pm EDT
John LaMattina
Contributor Health FORBES
I cover news on drugs and R&D in the pharma industry

When the breakthrough medications to cure hepatitis C were launched back in 2014 and 2015, the companies that launched the first drugs, Gilead and AbbVie weren’t praised for this major scientific advance. Rather, they were vilified for their high list prices. The headlines heralding the first of these drugs, Sovaldi, focused on the “$1,000 pill” which referenced the dosing regimen of one pill per day for 12 weeks costing $84,000. Forget the fact that hepatitis C can cause cirrhosis of the liver, liver failure leading to the need for a transplant, and liver cancer. Forget that previous treatments were minimally effective, caused people to have flu-like symptoms for the 12 month course of therapy and cost in excess of $100,000. Forget that many of these patients end up needing a liver transplant which costs in excess of $300,000. The focus was on price as evidenced by comments made at that time by the President of America’s Health Insurance Plans: “The company in this case is asking for a blank check which, if granted, will blow up employer benefit costs….and wreak havoc on the federal debt.”

Well, the federal debt wasn’t overwhelmed by the cost of curing hepatitis C. In fact, thanks to competition resulting from multiple drugs being launched, within a year, the prices for these drugs in the U.S. dropped to less than $50,000 – cheaper than what was being paid in the U.K. and Germany whose governments negotiate prices directly with manufacturers for drugs. As a result, outrage over the cost of hepatitis C curing drugs largely evaporated. More noteworthy was that the World Health Organization began developing guidelines to eradicate hepatitis C by 2030 thanks to the availability of these drugs.

TO CONTINUE READING: https://www.forbes.com/sites/johnlamattina/2021/07/12/another-covid-19-calamity--more-deaths-due-to-hepatitis-c-infections/?sh=1b97b275644a​

Katie Mulvaney The Providence Journal ET July 7th 2021

PROVIDENCE — Gov. Daniel McKee on Wednesday signed into law a proposal to help combat the opioid overdose crisis by creating safe injection sites for people to use illegal drugs under the oversight.
The legislation, which makes Rhode Island the first to enact a statewide measure, establishes a two-year pilot program to prevent drug overdoses through the establishment of so-called “harm reduction centers,” or safe injection sites. The centers are defined as resources that provide health screening, disease prevention and recovery assistance where people may safely consume pre-obtained controlled substances. 
More:  Drug bills signal sea change in RI's approach to opioid crisis
“That’s amazing. … I’m a little taken aback,” Sen. Joshua Miller said upon learning from The Journal that McKee had signed the measure into law. Miller, D-Providence, has championed the harm-reduction legislation for several years.
Advocates have hailed the proposal as a much-needed tool as the state experienced a record 384 accidental overdose deaths in 2020 and is on track to possibly another record-breaking year.
The goal is to provide clean needles to curtail the spread of infectious diseases; test drugs; and provide a bridge to medical and substance abuse treatment.
The law signed by McKee requires the approval of a center by the city or town council in which it is proposed.  The director of the Department of Health will draft regulations governing the centers by March 1 with the advice of an advisory committee.
The funding would all come from foundations and private donors as the legislation does not earmark any public or taxpayer dollars, according to advocate Annajane Yolken. Because Rhode Island is a leader in this topic, the state is well-positioned to receive private funding for a pilot program, she said.
Miller said the next focus will be working with the health officials, the advisory committee, and Attorney General Peter F. Neronha on the regulations. 
The federal stance on the centers remains unclear. Federal prosecutors successfully blocked a so-called safehouse from being opened in Philadelphia by arguing that it would violate the U.S. Controlled Substances Act’s prohibition on “crackhouses.” A federal appeals court panel agreed, despite the American Medical Association's brief in support.
President Biden’s administration released its one-year drug policy earlier this year that focuses on racial equity and expanding access to prevention, harm reduction, treatment, and recovery services while reducing the supply of illicit substances.
TO CONTINUE READING:  ​https://www.providencejournal.com/story/news/2021/07/07/gov-mckee-signs-legislation-allowing-safe-injection-sites-into-law/7891057002/?fbclid=IwAR2uwWY6vtHVjTituzq7KOSliRRSHPg-yuW_Et9YZBkS-ijO98pRX4YWo2M

Cary James CEO, World Hepatitis Alliance

International donors can’t wait to join the fight to eliminate hepatitis. Without their support, low- and middle-income countries face the burden of expensive treatment for liver cancer.

Viral hepatitis is one of the most neglected global health crises of our time. Globally, it is the leading cause of liver cancer, and it claims over a million lives every year. However, we do have a vaccine and effective treatments against hepatitis B and a cure for hepatitis C. These tools combined with prevention and testing strategies mean we have the opportunity to eliminate viral hepatitis as a global public health threat, which will save millions of lives.

For too long hepatitis elimination efforts have been under funded, not prioritized, and poorly resourced. The COVID-19 pandemic has set the world back even further from achieving the elimination of viral hepatitis by 2030, which was a target set by the World Health Organization in 2016.

A pressing need

With a person dying every 30 seconds from a hepatitis related illness, we can’t wait to act on viral hepatitis — even while we are in the current COVID-19 crisis. The 290 million people who are unaware that they are living with viral hepatitis can’t wait for testing. People living with hepatitis can’t wait for life-saving treatments. Expectant mothers can’t wait for hepatitis screening and treatment. New-born babies can’t wait for the hepatitis B birth-dose vaccination.  And people affected by hepatitis can’t wait to end the associated stigma and discrimination. 

TO CONTINUE READING:https://www.futureofpersonalhealth.com/infectious-diseases/why-viral-hepatitis-elimination-efforts-need-immediate-support/?fbclid=IwAR0KmLmcCpIQ


Author
Cary James, CEO, World Hepatitis Alliance, us.editorial@mediaplanet.com
June 15, 2021

Overdoses have surged during the pandemic. Now, for the first time, Congress has appropriated funds specifically for programs that distribute clean syringes and other supplies meant to protect users.

By Abby Goodnough June 27, 2021 NEW YORK TIMES

GREENSBORO, N.C. — The thin young man quietly took in the room as he waited for the free supplies meant to help him avoid dying: sterile water and cookers to dissolve illicit drugs; clean syringes; alcohol wipes to prevent infection; and naloxone, a medicine that can reverse overdoses. A sign on the wall — “We stand for loving drug users just the way they are” — felt like an embrace.
It was the first day the drop-in center in a residential neighborhood here had opened its doors since the coronavirus forced them shut in the spring of 2020. “I’m so glad you all are open again,” the man, whose first name is Jordan, told a volunteer who handed him a full paper bag while heavy metal music riffed over a speaker in the background. He asked for extra naloxone for friends in his rural county, an hour away, where he said it had been scarce throughout the pandemic.
Overdose deaths rose by nearly 30 percent over the 12-month period that ended in November, to more than 90,000, according to preliminary federal data released this month — suggesting 2020 blew past recent records for such deaths. The staggering increase during the pandemic has many contributing factors, including widespread job loss and eviction; diminished access to addiction treatment and medical care; and an illegal drug supply that became even more dangerous after the country essentially shut down.
But the forced isolation for people struggling with addiction and other mental health issues may be one of the biggest. Now, with the nation reopening, the Biden administration is throwing support behind the contentious approach that the center here takes, known as harm reduction. Instead of helping drug users achieve abstinence, the chief goal is to reduce their risk of dying or acquiring infectious diseases like H.I.V. by giving them sterile equipment, tools to check their drugs for fentanyl and other lethal substances, or even just a safe space to nap.

​https://www.nytimes.com/2021/06/27/health/overdose-harm-reduction-covid.html?campaign_id=2&emc=edit_th_20210628&instance_id=34042&nl=todaysheadlines&regi_id=35

The Epclusa and Mavyret combination pills are now indicated for kids as young as age 3.
June 11, 2021 • By Liz Highleyman   hep magazine

On June 10, the Food and Drug Administration (FDA) extended its approval of Epclusa (sofosbuvir/velpatasvir) and Mavyret (glecaprevir/pibrentasvir) for the treatment of hepatitis C in children ages 3 and older. Both combination pills are effective against all genotypes of hepatitis C virus (HCV).

Hepatitis C is uncommon among children, affecting an estimated 50,000 kids in the United States and some 3 to 5 million children worldwide, but it is a growing concern due to rising hep C rates among women of childbearing age. Pregnant women can transmit HCV to their infants during gestation or delivery, and experts recommend that they should be tested for the virus during each pregnancy. Most children born with HCV will develop chronic infection, which can lead to serious liver disease.


The FDA first approved Gilead Sciences’ Epclusa for adults in 2016 and extended the indication to children ages 6 and older in 2020. Now, the 12-week treatment is approved for pediatric patients ages 3 and up without cirrhosis or with compensated cirrhosis; those with decompensated cirrhosis can take Epclusa in combination with ribavirin. The latest approval covers two strengths of an oral pellet formulation of Epclusa developed for young children who can’t swallow tablets; the recommended dosage is based on body weight.

TO CONTINUE READING: https://www.hepmag.com/article/fda-approves-two-hepatitis-treatments-younger-children

Tatyana Kushner, Catherina A. Chappell
Tatyana Kushner, MD, MSCE
Icahn School of Medicine at Mount Sinai
Tatyana.kushner@mssm.edu

Catherine A. Chappell, MD
University of Pittsburgh
chappellca@upmc.edu

This article has been accepted for publication and undergone full peer review but has not been
through the copyediting, typesetting, pagination and proofreading process, which may lead to
differences between this version and the Version of Record. Please cite this article as doi:
10.1002/HEP.31885
This article is protected by copyright. All rights reserved

We read with great interest the Special Article by Jhaveri et al. entitled “Responsible Inclusion of
Pregnant Individuals in Eradicating Hepatitis C virus.”1 This article is timely and draws attention to
pregnant women, a subpopulation that has been ignored in the study of hepatitis C (HCV) treatment.
Pregnancy is an ideal window of opportunity due to the high engagement in healthcare of
reproductive-aged women. The AASLD/ IDSA, USPSTF and CDC now all recommended universal
HCV screening during pregnancy which will lead to increased diagnosis of HCV during pregnancy.
However, the American College of Obstetrics and Gynecology (ACOG) has been hesitant to
recommend universal screening due to the lack of treatment available during pregnancy.2 Jhaveri et
al. identified only one pharmacokinetic study of sofosbuvir/ledipasvir, which demonstrated safety,
tolerability, and effectiveness of direct-acting antiviral (DAA) therapy in nine pregnant women.
Guidance from the AASLD/ IDSA suggests that “women who become pregnant while on DAA
therapy should discuss the risks versus benefits of continuing treatment with their physicians.”3 This
“guidance” puts providers in the difficult position of providing advice with minimal published data on
DAA safety in pregnancy.
We agree with Jhaveri et al. that a clinical trial of HCV treatment during pregnancy ideally should be
sponsored by the NIH, leading a public-private partnership in coordination with the FDA. However,
there is no clear funding mechanism from NIH for larger trials for HCV DAAs and no NIH network of
study sites in high HCV prevalence areas. If the NIH/FDA truly supports ethical research in pregnant
women then they should dedicate funding or require industry to include pregnant women in studies
prior to FDA approval for medications. An alternative approach would be a larger industry sponsored
study which evaluates the use of a pangenotypic DAA regimen during pregnancy. This strategy
would require the pharmaceutical company to have a commitment to the health pregnant women (an
honorable cause), yet could be in opposition to a successful business strategy particularly for
medications that are closer to the patent expiration date. A critical first step would be to compare
DAA treatment compared to the current standard of care (no treatment) on pregnancy and neonatal
outcomes to convince providers that treatment is as safe as no treatment. Additionally, a registry of
outcomes after first trimester DAA exposure, similar to the antiretroviral pregnancy registry
(http://www.apregistry.com) is needed even with a larger study to determine the effect of exposure
early in pregnancy. Pregnant women with HCV prefer to be treated during pregnancy4. Jhavari, et al.
provides a strong call to action for us in the field and our NIH, FDA and industry partners to
determine the best way to get the evidence that is desperately needed.
es
1. Jhaveri R, Yee LM, Antala S, et al. Responsible Inclusion of Pregnant Individuals in Eradicating
Hepatitis C Virus. Hepatology 2021.
2. https://www.acog.org/clinical/clinical-guidance/practiceadvisory/
articles/2020/04/screening-for-hepatitis-c-virus-infection
3. AASLD-IDSA. HCV testing and linkage to care. Recommendations for testing, managing, and
treating hepatitis C. https://www.hcvguidelines.org/unique-populations/pregnancy.
[Accessed on April 7, 2021]
4. Kushner T, Cohen J, Tien PC, et al. Evaluating Women's Preferences for Hepatitis C Treatment
During Pregnancy. Hepatol Commun 2018;2:1306-1310.

Meet the birth workers helping transgender parents bring babies into the world and break stigmas.
June 2, 2021, 1:42 PM EDT / Source: TODAY
By Rheana Murray

When Kayden Coleman was pregnant with his now 10-month-old daughter, no one held the door for him, fussed over his growing belly or made him feel special in the way that pregnant women are sometimes treated.
In a way, he feels as though he missed out on "the perks" of pregnancy, he said. In another, he's relieved no one knew the truth. As a transgender man, he felt safer that way.
"I didn't have to walk around in fear, worrying that people wanted to inflict violence on me," Coleman, who lives in Houston, told TODAY. "They thought I had a beer belly."
Coleman, who also has a 7-year-old daughter, is one of a growing number of advocates trying to educate the public — and the medical community — about what it is like to navigate pregnancy, childbirth and the postpartum experience as a trans person, and dispel stereotypes about trans people that he said even health care workers believe. Trans people already face high rates of violence, discrimination and harassment; in the world of pregnancy and childbirth, their struggles are only magnified.
The 34-year-old called both of his pregnancies "very tumultuous."
"There was a lot of trauma," he said. "Most of that came from inside the birthing world, with medical professionals. There was a lot of questioning about my identity, a lot of misgendering. Being told I shouldn't be in spaces I was seeking care from because they were considered women's spaces. I was offered an abortion a ridiculous amount of times."

TO CONTINUE READING: https://www.today.com/health/trans-parents-say-medical-system-isn-t-set-their-pregnancies-t218691

Krishen Samuel 28 May 2021  ​NAM aidsmap

Swiss men living with HIV approach the risk of re-infection with hepatitis C after cure in different ways, based on recent qualitative research by Dr Patrizia Künzler-Heule and colleagues from the Universities of Basel and Zurich. They describe three distinct groups: those who choose to avoid risks and aim not to get re-infected, those who minimise risks and chance re-infection and those who accept risks and the possibility of re-infection and repeated treatment.
The World Health Organization (WHO) has set a target to eliminate hepatitis C as a public health threat by 2030. This has been made possible by a newer form of treatment – direct acting antivirals. This treatment can cure infection and reduce the risk of liver complications. Men who have sex with men (MSM) living with HIV represent an important risk group for hepatitis C infection, with an estimated prevalence as high as 39%. While many in this group are successfully treated for hepatitis C, they frequently become re-infected later.
The studyAs part of the Swiss HCVree trial, MSM living with HIV and hepatitis C received direct-acting antivirals for hepatitis C. Men reporting sexual risk behaviour also received behavioural counselling aimed at teaching risk reduction strategies. Of those who had received counselling, a subset of 17 participants were interviewed six to 12 months later, regarding their views on the cure, the behavioural intervention, their risk behaviours and any subsequent changes. The results were published in BMC Infectious Diseases.
Glossary
reinfection
cure
antiviral
direct-acting antiviral (DAA)
anxietyThe men had a median age of 44, the majority were White (94%) and nearly half were college educated (47%). The median time since HIV diagnosis was 10.9 years, while the median time since hepatitis C diagnosis was 1.6 years. Most men had had one hepatitis C infection (76%) and had never been treated for it prior to participating in the trial (59%), while six of the men had received prior interferon treatment and one had received direct acting antivirals previously.

TO CONTINUE READING:  https://www.aidsmap.com/news/may-2021/what-happens-after-curing-hepatitis-c-avoiding-minimising-or-accepting-risks-re