Showing posts with label opioid addiction. Show all posts
Showing posts with label opioid addiction. Show all posts

Wednesday, November 21, 2018

Opioid use more common in chronic liver disease than other chronic diseases

VIDEO: Opioid use more common in chronic liver disease than other chronic diseases
Healio
SAN FRANCISCO — In this exclusive video perspective from The Liver Meeting 2018, Monica Konerman, MD, director of the Michigan Medicine NAFLD Clinic, discusses results of a study that found opioid use to be twice as common among patients with chronic liver disease compared with other common chronic diseases.

See more from The Liver Meeting @ Healio

HCV epidemic continues to rise among young adults

Of Interest 
AASLD 2018 The Liver Meeting®:
“Our data demonstrate that people who inject drugs can achieve SVR at comparable rates to non-drug using populations, even if adherence is imperfect,”

We Cured Hepatitis C - Now The Work Begins: Finding Neglected Patients  
One Health System's Efforts to Eliminate Hepatitis C

Real-World Data Show Rising HCV Epidemic Among Young Adults
Cassandra Pardini, PharmD
Results from the largest real-world study analyzing hepatitis C virus (HCV) screening practices determined that, although HCV antibody (AB) screening and confirmatory RNA testing rates are improving, the HCV epidemic continues to rise among young adults.

The study included 17,149,480 patients obtained from 2 national laboratory datasets who were screened between 2013 and 2016 based on an AB test. The study authors defined an active HCV infection as having an HCV RNA+ result following a positive AB test. The study authors added, "AB screening rates, AB+ rates, RNA follow-up testing rates, and RNA+ rates were assessed descriptively by year and stratified by baby boomers 48-71 years old and young adults 18-39 years old, to reflect the evolving disease epidemiology."

Reference: Abstract
Sulkowski MS, Marx S, Manthena SR, Strezewski J, Chirikov VV. National Estimates for HCV Screening and Diagnosis Rates in the United States (2013-2016) Based on Large Real-World Dataset. Presented at AASLD The Liver Meeting 2018. Study number 1565.

Full-Text Article
First published: 6 November 2018 - In Hepatology

Thursday, November 15, 2018

Albertans are dying at alarming rates from opioid overdoses

Personal drug use should be decriminalized, addictions expert says
Sarah Rieger · CBC News · Posted: Nov 15, 2018

Doctor says removing barriers to help saves lives — but not all agree

"Personal drug use needs to be decriminalized and the possession of small amounts of substances needs not to result in people going to jail."

Virani spoke at an expert forum hosted by the Alberta Liberals in northwest Calgary Wednesday evening. The party, and the doctor, are calling on the federal government to amend the criminal code.

Sunday, November 11, 2018

Tracking addiction: New treatments appear to be working

Tracking addiction: New treatments appear to be working
By Matt Bise
It has been almost a year since Gov. Henry McMaster called opioid and heroin addiction a statewide public health emergency. The declaration of a health emergency gives public health agencies and law enforcement new powers to act and respond on a much larger scale.

In October the Kennedy Center in Berkeley County started offering a new medical option for addicts who commit to counseling, and treatment for opioid or heroin addiction has shown that it can work when it’s accessible.

Meantime as new treatments make their way into rural communities, where the crisis takes root, another health concern is surfacing from the scourge — hepatitis C...


Hepatitis C Transmission
The great majority of HCV infections are found among people with a history of drug injection, including people who have been incarcerated. HCV is easily transmitted among drug injectors by sharing syringes or other injection paraphernalia (such as cookers, filters). Hepatitis C is easier to transmit through shared injection equipment than HIV, and HCV is usually the first blood borne virus IDUs acquire. As a result, as many as 50-90% of IDUs have been infected with HCV.

Saturday, November 10, 2018

The Liver Meeting® People with Hepatitis C Who Actively Inject Illegal Drugs Have High Rates of Hepatitis C Treatment Adherence and Cure

People with Hepatitis C Who Actively Inject Illegal Drugs Have High Rates of Hepatitis C Treatment Adherence and Cure

SAN FRANCISCO – Preliminary data from a new study presented this week at The Liver Meeting® – held by the American Association for the Study of Liver Diseases – found that people who inject drugs who are infected with the hepatitis C virus have high rates of hepatitis C treatment adherence (completion of their treatment), and sustained virologic response. Based on these findings, researchers conclude these patients should be included in HCV treatment programs.

Hepatitis C virus, commonly called HCV, is a liver disease that ultimately can cause cirrhosis (scarring of the liver), liver cancer and liver failure. HCV is mainly contracted when a person comes in contact with an infected person’s blood.

People who inject drugs, such as opioids, are at high risk to acquire and transmit HCV, but many are excluded from HCV treatment programs due to concerns about their ability to follow their treatment plans. The ANCHOR Study, conducted by researchers at the Institute of Human Virology at the University of Maryland, evaluated HCV treatment in patients who have chronic HCV, opioid use disorder and ongoing injection drug use. They looked at rates of treatment adherence, treatment completion and sustained virologic response (commonly called SVR) as benchmarks. This is an ongoing study, and data will be updated in the future.

“The ANCHOR study was developed in an attempt to understand if people who inject drugs can be effectively treated with direct-acting antivirals,” explains Elana Rosenthal, MD, co-director, DC PFAP Hepatitis Clinical Research Program, University of Maryland, and the study’s co-author. “Many insurance companies impose restrictions requiring treatment of or abstinence from drugs and alcohol prior to initiation of HCV medication. We wanted to specifically evaluate treatment of the highest risk population, people with ongoing injection drug use, to evaluate if they could be cured with standard treatment using direct-acting antivirals.”

Beyond these restrictions, insurance companies often deny access to HCV treatment for people who inject drugs based on an assumption that they will not follow their treatment plans, says Dr. Rosenthal. “However, this assumption is based on stigma and not medical science. Therefore, we wanted to evaluate if people who inject drugs could have sufficient adherence to HCV treatment to achieve cure.”

Of the 100 participants enrolled in the study, 76 percent were male, 93 percent were black, and 51 percent were unstably housed. Their median age was 57 years. At the study screening, 58 percent of the participants reported they injected opioids at least daily.

Patients received HCV treatment with sofosbuvir/velpatasvir over 12 weeks. Medication was dispensed monthly in 28-pill bottles. Sixty out of 66 patients who reached week 24 of their treatment received a second bottle of medication before running out, and 58 patients received a third bottle of medication before running out. At the fourth week of HCV treatment, 62 patients had their HCV viral load checked, and 59 had a HCV viral load of less than 200 IU/mL.

Two patients received four weeks of treatment, two patients received 8 weeks of treatment, three received between 8 and 12 weeks of treatment, and 59 received 12 weeks of treatment. Of the 59 patients who completed 12 weeks of treatment, 28 finished treatment one to seven days after the anticipated end date; nine finished between eight and 14 days late; and nine patients finished more than 14 days late.

Of the 58 patients who attended an office visit at week 24 of their treatment, 52 achieved SVR (which is marked by no detectable HCV in the blood for 12 or more weeks), giving an overall cure rate of 89.7 percent. This high rate of cure was significantly associated with having an HCV viral load of less than 200 at week four, and with taking 12 weeks of treatment. The researchers also found that finishing treatment late did not impact SVR, even in those completing treatment more than 14 days late. Preliminary data from the study indicates that people who inject drugs who also have HCV and are continuing injection drug use have high rates of adherence and completion in their therapy programs and achieve SVR – even with imperfect adherence.

“Our data demonstrate that people who inject drugs can achieve SVR at comparable rates to non-drug using populations, even if adherence is imperfect,” explains Dr. Rosenthal of the study’s findings. “Therefore, there is no justification for excluding people who inject drugs from being treated. In fact, people who inject drugs should represent a unique high-priority population, because injection drug use remains the primary reason for ongoing HCV transmission in the U.S. Therefore, treatment of people who inject drugs will help prevent new cases of HCV.”

Editor’s note: This press release contains updated data that is not reflected in the published abstract but will be presented at The Liver Meeting®.

Dr. Rosenthal will present these findings at AASLD’s press conference in Room 312-314 at the George R. Moscone Convention Center in San Francisco on Saturday, Nov. 10 from 4 – 5:30 PM. The study entitled “High Svr in PWID with HCV Despite Imperfect Medication Adherence: Data from the Anchor Study,” will be presented on Monday, November 12 at 8:00 AM in Hall D. The corresponding abstract (number 0018) can be found in the journal, HEPATOLOGY (link is external).

About AASLD
AASLD is the leading organization of clinicians and researchers committed to preventing and curing liver disease. The work of our members has laid the foundation for the development of drugs used to treat patients with viral hepatitis. Access to care and support of liver disease research are at the center of AASLD’s advocacy efforts.
Press releases and additional information about AASLD are available online at www.aasld.org.

Tuesday, November 6, 2018

Over 2 Million Americans Have Hepatitis C; Affects nearly every generation

CDC Press Release
CDC Estimates Nearly 2.4 Million Americans Living with Hepatitis C
New data highlight urgent need to diagnose and cure more Americans, and to address rising infections due to U.S. opioid crisis.

Nearly 2.4 million Americans – 1 percent of the adult population – were living with hepatitis C from 2013 through 2016, according to new CDC estimates published today in the journal Hepatology.

** Link to full-text journal article provided below

Medications that cure hepatitis C offer the hope of eliminating the disease in the U.S., yet, today’s report suggests that millions are infected and have not benefited from these new treatment options. Expanded testing, treatment, and prevention services are urgently needed, especially in light of the surge in new infections linked to the opioid crisis.

Every American who has been cured of hepatitis C is living proof that ending this epidemic is possible,” said CDC Director Robert R. Redfield, M.D. “Hundreds of thousands of Americans have already been cured. In order to achieve our goal, we must commit to ensuring that everyone living with hepatitis C is tested and treated.”

To estimate total hepatitis C prevalence in the United States, researchers analyzed blood test results from the nationally representative National Health and Nutrition Examination Survey (NHANES) from 2013 through 2016. They also analyzed data from other studies of groups not surveyed in the NHANES, including active duty members of the military, and people who are incarcerated or homeless.

Opioid crisis puts new generations at risk of hepatitis C infections 
Adding to the burden of those already living with hepatitis C, separate CDC surveillance data indicate that the number of new infections each year in the United States is disturbingly high and on the rise. Acute hepatitis C cases reported to CDC more than tripled from 2010 to 2016, with most new hepatitis C infections due to increased injection drug use associated with the nation’s opioid crisis. Based on these data, CDC estimates that more than 41,000 Americans were newly infected with hepatitis C in 2016 alone.

Seeing an undiagnosable infection become a curable disease has been a public health highlight of the past 30 years. But the shadow of the opioid crisis puts our nation’s progress at risk,” said Jonathan Mermin, M.D., director of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. “Tackling hepatitis C requires diagnosing and curing people living with the virus and cutting off new infections at the source.”

Hepatitis C affects nearly every generation 
Hepatitis C now poses a serious health threat to three generations of Americans, all of whom need to be reached with prevention services, testing, and treatment:
Baby boomers (born between 1945 and 1965) account for a large portion of all chronic hepatitis C infections in the United States and currently have the highest rate of hepatitis C-related deaths. CDC recommends that all adults born between 1945 and 1965 get a one-time test for hepatitis C, but only a small fraction have done so. 

Adults under 40 have the highest rate of new infections, largely because of the opioid crisis.

Infants born to mothers with hepatitis C are a growing concern. The overall risk of an HCV-infected mother transmitting infection to her infant is approximately 4 percent to 7 percent per pregnancy. From 2011 through 2014, national laboratory data indicate that the rate of infants born to women living with hepatitis C increased by 68 percent. 

Eliminating hepatitis C requires substantial national commitment 
Even though new treatments can cure hepatitis C virus infections in as little as two to three months, far too many Americans have not been effectively treated. They may be unaware of their infection or they are unable to access medication because they lack healthcare coverage or have financial restrictions.

In addition to expanding testing and removing barriers to treatment, authors of the new report stress that intensified programs to prevent, track, and respond to new hepatitis C infections are also essential to reducing the number of infections. Prevention efforts to address new infections include support for comprehensive community-based prevention services. Such services focus on drug treatment and recovery and reducing transmission of viral hepatitis and HIV through hepatitis A and B vaccination, testing, linkage to care and treatment, and access to sterile syringes and injection equipment. 

“Until we as a nation remove the barriers to hepatitis C testing and treatment, it will continue to cost us dearly – both in terms of dollars and American lives,” said Dr. Mermin. “Every death from hepatitis C is a reminder of a promise not yet realized for far too many.” 

For more information from CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, visit www.cdc.gov/nchhstp/newsroom.

Read More From The CDC:
Hepatitis C Prevalence Estimates 2013-2016

In The Journal Hepatology
Full-Text Article
First published: 6 November 2018 - In Hepatology
Estimating Prevalence of Hepatitis C Virus Infection in the United States, 2013‐2016
Abstract
Hepatitis C virus (HCV) infection is the most commonly reported bloodborne infection in the United States, causing substantial morbidity and mortality and costing billions of dollars annually. To update the estimated HCV prevalence among all adults aged ≥18 years in the United States, we analyzed 2013‐2016 data from the National Health and Nutrition Examination Survey (NHANES) to estimate the prevalence of HCV in the noninstitutionalized civilian population and used a combination of literature reviews and population size estimation approaches to estimate the HCV prevalence and population sizes for four additional populations: incarcerated people, unsheltered homeless people, active‐duty military personnel, and nursing home residents. We estimated that during 2013‐2016 1.7% (95% confidence interval [CI], 1.4‐2.0%) of all adults in the United States, approximately 4.1 (3.4‐4.9) million persons, were HCV antibody‐positive (indicating past or current infection) and that 1.0% (95% CI, 0.8‐1.1%) of all adults, approximately 2.4 (2.0‐2.8) million persons, were HCV RNA–positive (indicating current infection). This includes 3.7 million noninstitutionalized civilian adults in the United States with HCV antibodies and 2.1 million with HCV RNA and an estimated 0.38 million HCV antibody‐positive persons and 0.25 million HCV RNA–positive persons not part of the 2013‐2016 NHANES sampling frame. Conclusion: Over 2 million people in the United States had current HCV infection during 2013‐2016; compared to past estimates based on similar methodology, HCV antibody prevalence may have increased, while RNA prevalence may have decreased, likely reflecting the combination of the opioid crisis, curative treatment for HCV infection, and mortality among the HCV‐infected population; efforts on multiple fronts are needed to combat the evolving HCV epidemic, including increasing capacity for and access to HCV testing, linkage to care, and cure.
Continue to article:
https://jumpshare.com/v/xa89GRExLqqc35sKT2DQ

Follow On Twitter
- This full-text research article was downloaded and shared today by @HenryEChang on Twitter.

In The Media
Over 2 Million Americans Have Hepatitis C; Opioids Help Drive Spread
By Amy Norton
HealthDay Reporter
TUESDAY, Nov. 6, 2018 (HealthDay News) -- More than 2 million Americans have hepatitis C -- and the opioid epidemic is a major contributor to the problem, according to a new government study.

The study, by the U.S. Centers for Disease Control and Prevention, does highlight progress against the potentially fatal liver disease. It also shows how much more work remains, CDC officials said.

Between 2013 and 2016, the agency estimated, nearly 2.4 million Americans had hepatitis C infections.

That's a small decline from previous years. And the CDC said that may indicate the effects of new therapies that have changed the face of hepatitis C treatment in the past several years.

Tuesday, October 23, 2018

Making The Opioid Use Disorder Cascade Of Care A Reality, Despite Data Limitations

“Making The Opioid Use Disorder Cascade Of Care A Reality, Despite Data Limitations, " Health Affairs Blog
October 23, 2018. 
DOI: 10.1377/hblog20181018.540807

Recent discussion on the Health Affairs Blog has described both the development of a cascade of care model and corresponding quality measures to assess addiction treatment system performance, as well as the collection of data needed to implement the cascade of care. In this follow up, we offer an approach that combines administrative data sets and provides a starting point for the nation and individual states to measure progress and barriers to success in addressing the opioid epidemic. Despite imperfect data collection and reporting systems, we are past due for an honest attempt to create baseline measures of opioid use disorder management from which to improve. We propose a method to develop baseline calculations that uses approved Healthcare Effectiveness Data and Information Set (HEDIS) measures and national survey and administrative claims data organized into a cascade of care.

Thursday, October 18, 2018

Fentanyl test strips prove useful in preventing overdoses

Fentanyl test strips prove useful in preventing overdoses
October 18, 2018
Mollie Rappe 

A Brown University study found that many young adults who tried fentanyl test strips reduced overdose risk by using less, going slower or using with someone else present.

PROVIDENCE, R.I. [Brown University] — Among more than 72,000 deaths in the U.S. last year, fentanyl — a highly potent prescription opioid often used to lace other heroin or cocaine, but hard for drug users to detect — factored into many of cases.

In the search for solutions, a team of researchers led by Brandon Marshall, an associate professor of epidemiology at Brown University’s School of Public Health, provided rapid-acting fentanyl test strips to young adults at risk of overdose in the state. New research by the team found that most of those young adults used the strips — and many who detected fentanyl reported changing their behavior to reduce overdose risk.

“We found that fentanyl test strips are an effective harm-reduction tool to prevent overdose,” Marshall said. “Harm reduction is important because everyone deserves to be able to take care of themselves and make informed decisions about their health, whether they use drugs or not. These tests strips could be a life-saving intervention for many young adults who use drugs.”

The findings were published on Thursday, Oct. 18, in the International Journal of Drug Policy.

The fentanyl test strips work like an over-the-counter pregnancy test, said Max Krieger, a research assistant in Marshall’s lab and the lead author of the study. Each single-use strip is dipped into water containing a bit of drug residue, and after a minute, either one or two red lines appear — one line means the liquid contains fentanyl, and two lines means the test did not detect the drug.


In this pilot study, the researchers provided test strips to 93 young adults who reported injecting opioids or using heroin, cocaine or prescription pills bought off the streets in the past month, and taught them how to use the strips.

Each participant received 10 strips,which cost about $1 each but aren’t commercially available. The study found that 77 percent of them used at least one test strip. Of the participants who used the strips, 12 percent used all 10 strips, and about half gave strips to friends. All participants also received overdose prevention education and a naloxone kit — commonly known by the brand name Narcan — to take home.

Half of the participants who used the strips detected fentanyl in their drug supply. Of those, 45 percent reported using smaller amounts, 42 percent proceeded more slowly when using, and 39 percent used with someone else present, who could call 911 or administer naloxone in the case of overdose. Some participants used multiple overdose-reducing strategies, and a few reported discarding fentanyl-laced drugs, Marshall said.

“Our study shows that the fentanyl test strips are effective at preventing overdoses,” Krieger said. “A majority of our participants who received a positive result changed their drug-using behavior. The harm reduction concept behind these test strips, adding a cheap but effective layer of protection against known overdose risks, is similar to other health precautions such as using condoms to prevent sexually transmitted diseases.”

Almost all of the participants (98 percent) — even those who didn’t use a single strip — said they were confident in their ability to use the strips, and 95 percent wanted to continue using them.

The study also found that participants would feel most comfortable obtaining rapid-acting fentanyl test strips at health clinics and other community-based organizations. The authors suggest that “community-based organizations that conduct overdose prevention education and outreach efforts may be ideal venues for rapid fentanyl test strip training and distribution, as these organizations also distribute other harm reduction supplies.”

Marshall cautioned that the findings might not apply to older drug users. The average age of the participants was 27.

The research team is analyzing the results from in-depth interviews with participants to learn more about their overdose risks and how they used the fentanyl test strips to avoid overdose, Marshall said. He hopes to build from this pilot study and conduct a larger efficacy trial to assess the effectiveness of the test strips in reducing overdoses in a larger population.

In addition to Krieger and Marshall, the research team included William Goedel, Dr. Josiah Rich and Traci Green of Brown; Jane Buxton and Dr. Mark Lysyshyn of the University of British Columbia; Dr. Edward Bernstein and Dr. Scott Hadland of the Grayken Center for Addiction, Boston University School of Medicine; and Susan Sherman of Johns Hopkins University’s Bloomberg School of Public
Health.

Funding from Brown’s Office of the Vice President of Research supported the pilot study.

https://news.brown.edu/articles/2018/10/fentanyl

Wednesday, October 17, 2018

UC researchers support universal screening to tackle rise in hepatitis C

Recommended Reading
At-Risk Teens and Young Adults Overlooked During Opioid Crisis Too Few Tested for Hepatitis C, Research Suggests
SAN FRANCISCO – Teens and young adults who have injected drugs are at risk for contracting hepatitis C, but most aren’t tested and therefore don’t receive life-saving treatment, according to a national study being presented at IDWeek 2018. The study of more than 250,000 at-risk youth found only one-third of those with diagnosed opioid use disorder (OUD) were tested for hepatitis C...
Read more...

UC researchers support universal screening to tackle rise in hepatitis C 
Physicians are encountering a growing number of younger patients who are testing positive for hepatitis C virus (HCV) fueled largely by the opioid crisis impacting communities around the country. That increase and more effective and tolerable drug regimens for HCV infection, means one-time universal screening of all adults for HCV is now cost effective and recommended, say physician researchers in the University of Cincinnati (UC) College of Medicine.

The researchers used a computerized Markov state transition model to estimate the impact of one-time universal screening of adults 18 years of age and older compared either with no screening at all or with the current guideline-based strategy of largely screening baby boomers—adults born between 1945 and 1965—for HCV, says Mark Eckman, MD, Posey Professor of Clinical Medicine and Director of UC Division of General Internal Medicine.

They measured effectiveness with quality-adjusted life years (QALYs)—that’s the gain of in life expectancy adjusted for the quality of life—and costs from the health system perspective in 2017 U.S. dollars, says Eckman, lead author of the study and a UC Health physician. Universal screening followed by guideline-based treatment of all those with chronic HCV infection has an incremental cost effectiveness ratio of $11,378 per quality-adjusted life year compared with birth cohort-based screening alone.

"Most health economists consider anything less than $50,000 per quality-adjusted life year to be highly cost-effective,” says Eckman.

The results of the study are available online in the scholarly journal Clinical Gastroenterology and Hepatology.

The Centers for Disease Control and Prevention (CDC) estimates 2.7 million individuals in the U.S. have chronic HCV infection with 81 percent of that group consisting of baby boomer adults. In 2011, in addition to testing individuals at high risk due to intravenous drug use or other possible exposures to HCV, the CDC recommended one-time testing for the baby boomer cohort. That recommendation was later endorsed by the U.S. Preventive Services Task Force.

But since then the face and treatment of hepatitis C has changed.

"So what happened to make it reasonable to screen a wider population for HCV?” asks Eckman. "The incidence of hepatitis C among younger drug-injecting patients is skyrocketing so we have a blip in HCV cases that’s no longer isolated to the baby boomer cohort.

"We are also now in an era of HCV treatments that are more effective than even five or six years ago. Furthermore, these new regimens are easier to tolerate, have fewer severe side effects and require a short period of treatment,” says Eckman.

"All these factors coming together are what drove the model to show that screening a broader population than just the baby boomer cohort is effective,” says Eckman.

The baby boomer generation came of age during a time of experimentation, and many individuals who may have tried injectable drugs, even once, and never thought of themselves as having a problem, may be infected with the hepatitis C virus, says Eckman. "While these silent cases have been hanging out for decades what has changed recently is the new epidemic of hepatitis C in younger patients related to drug use,” he says.

Eckman says the cost to treat HCV can range from $9,000 to $30,000 per month depending on the medications being used, and that many health insurance plans, including Medicare Part D and most Medicaid plans cover the costs of treatment. For individuals without health insurance, treatment may remain a challenge, he adds.

Eckman says the U.S. Preventive Services Task Force is currently reviewing and updating guidelines for hepatitis C and it’s possible a broadening of the current screening recommendations may occur.

"Early diagnosis and treatment of hepatitis C infection prevents development of progressive liver disease, and reduces long-term risk of cirrhosis, liver cancer and other HCV-associated health problems”, says study co-author and liver expert, Kenneth Sherman, MD, PhD, Gould Professor of Medicine and Director in the UC Division of Digestive Diseases.


John Ward, MD from the Task Force for Global Health and the Centers for Disease Control and Prevention is also a co-author of the study. Funding for the study came from the CDC Foundation along with support coming from multiple donors to the CDC Foundation’s Viral Hepatitis Action Coalition.

Sherman has grants/contracts (institutional funding) from AbbVie, Bristol-Myers Squibb, Gilead, Inovio, Intercept, MedImmune, and Merck, and serves on advisory boards for Abbott Laboratories, Gilead, MedImmune, Merck, and Inovio. Sherman also serves on safety monitoring boards for Watermark and MedPace. Eckman has grant support from Merck through the Merck Investigator Studies Program.

Thursday, October 4, 2018

At-Risk Teens and Young Adults Overlooked During Opioid Crisis Too Few Tested for Hepatitis C, Research Suggests

SAN FRANCISCO – Teens and young adults who have injected drugs are at risk for contracting hepatitis C, but most aren’t tested and therefore don’t receive life-saving treatment, according to a national study being presented at IDWeek 2018. The study of more than 250,000 at-risk youth found only one-third of those with diagnosed opioid use disorder (OUD) were tested for hepatitis C.

AT A GLANCE
Injection drug use increases the risk of contracting hepatitis C, but few teens and young adults are tested, according to a large national study presented at IDWeek.

The study of more than 250,000 youth determined only one-third of those with documented opioid use disorder were tested for hepatitis C.

Hepatitis C treatment was recently approved for teens, making it even more important that they get tested so they can be treated.

The Centers for Disease Control and Prevention seeks to eliminate HCV transmission among injection drug users. These data suggest that goal may not be attainable without substantial effort to improve testing rates.

This study is the first to look at opioid use and hepatitis C testing in at-risk youth. “We’re missing an opportunity to identify and treat young people who are at risk for this deadly infection,” said Rachel L. Epstein, MD, MA, lead author of the study and a post-graduate research fellow in the section of infectious diseases, Boston Medical Center. “Screening for OUD and other drug use, and then testing for hepatitis C in those at high risk, can help us do a better job of eliminating this serious infection, especially now that very effective hepatitis C medications are approved for teenagers.”

An infection of the liver, hepatitis C killed more than 18,000 Americans in 2016, making it the most common cause of death from a reportable infectious disease, according to the Centers for Disease Control and Prevention (CDC). It can be spread by sharing needles used to inject drugs. Health care providers may not test young people they suspect of misusing opioids because the drugs are available in pill form, which does not increase the risk of infection with hepatitis C. But studies show many youths who misuse prescription oral opioids eventually begin injecting them.

Results of the study suggest that current guidelines -- which only recommend testing those with known injected drug use or other specific risk factors – underestimate who is at risk for hepatitis C.

In 2017, the Food and Drug Administration (FDA) approved the first direct-acting hepatitis C medications for teens. These medications can cure a person with hepatitis C infection in two to three months. Without treatment, people may develop liver failure, liver cancer, or chronic liver disease (cirrhosis) many years after being infected.

For the study, researchers analyzed electronic medical records for 269,124 teens and young adults (13-21 years old) who visited one of 57 Federally Qualified Health Centers, which provide health care to diverse and underserved communities across 19 states, between 2012 and 2017. Of the 875 who had diagnosed OUD, 36 percent were tested for hepatitis C, and of those, 11 percent had been exposed to hepatitis C and 6.8 percent had evidence of chronic hepatitis C infection.

Overall, 6,812 (2.5 percent) who visited the health centers were tested for hepatitis C and of those, 122 (1.8 percent) tested positive for hepatitis C. Researchers found those most likely to be tested for hepatitis C were African American youth, those with any substance use disorder, and those 19-21 years old.

“The issue is complicated by the fact that not enough at-risk youth are screened for opioid or other drug use for a variety of reasons, including lack of time, comfort level between clinician and patient, and privacy and stigma concerns,” said Dr. Epstein. “And even when drug use is identified, there’s a belief that youth are less likely to test positive for hepatitis C, which isn’t necessarily the case as we show in our study. Clearly, this is an overlooked group that is at high risk.”

In addition to Dr. Epstein, co-authors of the study are: Jianing Wang, MSc, Kenneth Mayer, MD, Jon Puro, MPH, C. Robert Horsburgh, MD, Benjamin P. Linas, MD, MPH and Sabrina A. Assoumou, MD, MPH.

About IDWeek
IDWeek 2018TM is the annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA) and the Pediatric Infectious Diseases Society (PIDS). With the theme “Advancing Science, Improving Care,” IDWeek features the latest science and bench-to-bedside approaches in prevention, diagnosis, treatment, and epidemiology of infectious diseases, including HIV, across the lifespan. IDWeek 2018 takes place Oct. 3-7 at the Moscone Center in San Francisco. For more information, visit www.idweek.org.

Wednesday, October 3, 2018

Reported by Jules Levin - Talking About Hepatitis C: FAQs From Young Adults Who Inject Drugs

Reported by Jules Levin
Executive Director, NATAP 

7th International Symposium on Hepatitis Care in Substance Users
Cascais, Portugal
19 - 21 September 2018

*Full-Text article available for download @ NATAP

Talking About Hepatitis C: FAQs From Young Adults Who Inject Drugs
Introduction. Young adults who inject drugs and live in rural communities are at high risk for hepatitis C virus (HCV) infection. Recent changes in HCV treatment must be communicated within these communities to improve access to care and reduce HCV transmission.

Methods. Field workers in the ¡VÁLE! Hepatitis Treatment and Integrated Prevention Services study identified frequently asked questions (FAQs) posed by young-adult participants at high risk for HCV during screening and educational sessions. From 2016 to 2018, 183 young adults (44.3% women; 85.8% Latino/a) younger than 30 years who inject drugs and reside in Rio Arriba or Doña Ana counties in New Mexico were enrolled. The research team compiled deidentified questions during field enrollments.

Results. FAQs were reviewed and categorized into four major domains, including risk/prevention, screening, treatment, and reinfection. FAQs were addressed by a team of medical and public health professionals, using the most current research and recommendations.

Conclusions. These FAQs address important gaps in HCV knowledge among young adults who are at high risk for infection. The FAQs also highlight the importance of risk reduction counseling provided by frontline public health providers as well as access to safe and effective HCV treatments for young adults who inject drugs.

Continue to complete article: http://www.natap.org/2018/HCV/100118_04.htm

Recommended Reading
7th International Symposium on Hepatitis Care in Substance Users (INSHU)

INSHU: High Cure Rates in a Real world Cohort of HCV Infected Patients on Opioid Substitution Therapy (OST) Despite Alcohol and Cannabis Consumption Data from The German Hepatitis C-Registry (DHC-R) - (10/01/18)

INSHU: Treatment as prevention approach results in early and marked prevalence reduction of hepatitis C viremia among people who recently injected drugs. Results from Iceland: Treatment as Prevention (TraPHepC) - (10/01/18)

INSHU: Drug use and reinfection during and following Hepatitis C Virus treatment with Elbasvir/Grazoprevir among patients receiving Opiate Agonist Therapy: C-EDGE Co-STAR study - (10/01/18)

INSHU: New Questions About HCV From a New Generation - (10/01/18)

INSHU: C Change: Philadelphia's Plan to Eliminate Hepatitis C Among People Who Use Injection Drugs - (10/01/18)

INSHU: Building Bridges to Eliminate HCV in PWID Building Bridges to Reach People Who Inject Drugs with the Goal to Eliminate HCV - (10/01/18)

INSHU: A Screening Program for Hepatitis C among Baby Boomers in the Northeast United States reveals an Alarmingly High Prevalence of HCV among People who Inject Drugs - (10/01/18)

More Hep C Articles @ NATAP...

Friday, September 14, 2018

Hepatitis C virus prevalence and estimated incidence among new injectors during the opioid epidemic in New York City, 2000 to 2017: Protective effects of non-injecting drug use

Drug and Alcohol Dependence
Available online 12 September 2018

Don C. Des Jarlais, K. Arasteh, J. Feelemyer, C. McKnight, David M. Barnes, David C. Perlman, A. Uuskula, H.L.F. Cooper, Susan Tross
DOI: https://doi.org/10.1016/j.drugalcdep.2018.07.034
Publication stage: In Press Accepted Manuscript

Published online: September 12, 2018

Highlights
•Reverse transitioning was strongly associated with lower HCV seroprevalence.
•HCV seropositivity was inversely associated with current non-injecting heroin use.
•Injecting cocaine was associated with behavior likely to transmit HCV.
•NYC has high rates of HCV infection among persons who began injecting since 2000.

Abstract
Objective
Assess hepatitis C virus (HCV) prevalence and incidence among person who began injecting drugs during the opioid epidemic in New York City (NYC) and identify possible new directions for reducing HCV infection among persons who inject drugs.

Methods
846 persons who began injecting drugs between 2000 and 2017 were recruited from persons entering Mount Sinai Beth Israel substance use treatment programs. A structured interview was administered and HCV antibody testing conducted. Protective effects of non-injecting drug use were examined among persons who “reversed transitioned” to non-injecting drug use and persons who used non-injected heroin in addition to injecting.

Results
Participants were 79% male, 41% White, 15% African-American, 40% Latinx, with a mean age of 35. Of those who began injecting in 2000 or later, 97 persons (11%) “reverse transitioned” back to non-injecting drug use. Reverse transitioning was strongly associated with lower HCV seroprevalence (30% versus 47% among those who continued injecting, p < 0.005). Among those who continued injecting, HCV seropositivity was inversely associated with current non-injecting heroin use (AOR = 0.72, 95%CI 0.52-0.99). HCV incidence among persons continuing to inject was estimated as 13/100 person-years. HCV seropositive persons currently injecting cocaine were particularly likely to report behavior likely to transmit HCV.

Conclusions
Similar to other locations in the US, NYC is experiencing high rates of HCV infection among persons who have begun injecting since 2000. New interventions that facilitate substitution of non-injecting for injecting drug use and that reduce transmission behavior among HCV seropositives may provide additional methods for reducing HCV transmission.

Monday, September 10, 2018

HCV Newsletters & Updates: Obesity in liver disease, Nasal spray for opioid overdose and Fast-acting flu drug

HCV Newsletters & Updates
Welcome, check out the latest news, review this months collection of newsletters, and finish off by reading a handful of well written blogs focused on living well with hep B or C.

In The News
MSF and groups call for end to Gilead’s hepatitis C drug monopoly in Europe which blocks access 
--Pharmaceutical company Gilead has a patent monopoly on hepatitis C drug sofosbuvir in Europe
--The patent results in exorbitant prices, meaning people are unable to afford treatment
--MSF and other organisations are urging the European Patent Office to overturn the patent in a hearing this week.

With an award-winning newsroom, STAT gives you indispensable insights and exclusive stories on the technologies, personalities, power brokers, and political forces driving massive changes in the life science industry — and a revolution in human health.
Fast-acting flu drug shows strong potential - An experimental, fast-acting flu drug showed strong promise in two newly published trials — but it also led to some surprising and even concerning results. The drug cut the time people were sick with flu symptoms by just over a day, but didn’t make people feel better faster than Tamiflu.

Reuters
California-based Opiant earlier this year was awarded a $7.4 million grant by the U.S. National Institutes of Health’s National Institute on Drug Abuse for the development of a nasally-applied version of overdose treatment nalmefene.

Associated Press 
Doctors explore lifting barriers to living organ donation
WASHINGTON — Surgeons turned down Terra Goudge for the liver transplant that was her only shot at surviving a rare cancer. Her tumor was too advanced, they said — even though Goudge had a friend ready to donate, no matter those odds.

HepCBC 
HepCBC is a Canadian non-profit organization offering awareness with basic information about HCV and a weekly digest of news.
Read the latest issue of the highly successful Weekly Bull.

September Updates
Hepatology - Top Story From Healio 
Healio features the industry’s best news reporting, dynamic multimedia, question-and-answer columns, educational activities in a variety of formats, blogs, and peer-reviewed journals.

HCV NEXT September/October Issue - The following articles appeared in this months issue of HCV NEXT, published online over at Healio

September 7, 2018
Physicians and researchers have noted the increase in liver disease over the last couple decades, especially nonalcoholic fatty liver disease, correlates significantly…

NATAP
NATAP is a New York State non-profit corporation with 501(c)3 Federal tax-exempt status. Our mission is to educate individuals about HIV and Hepatitis treatments and to advocate on the behalf of all people living with HIV/AIDS and HCV. Our efforts in these areas are conducted on local, national, and international levels.
Global Hepatitis Summit A Few Selected Highlights 
Reported by Jules Levin, NATAP
In June the Global Hepatitis Summit took place in Toronto. Here are 3 selected talks highlighted of particular interest to me. The first talk by Andrew Hill he says we have a bleak scenario regarding the possibility of global HCV elimination. He says in many countries new HCV infections outstrip HCV cures and new diagnoses. New diagnoses are much lower in all poorer countries compared to high income countries. Screening is too low, all of which he uses to say the outlook is bleak for global HCV elimination unless we make changes.

The 2nd talk I chose to highlight was by Maria Prims from the Netherlands where she reports high HCV infection & reinfection rates among people taking PrEP to prevent HIV infection. She highlights an increasing HCV incidence among MSM. 376 started PrEP either daily or on demand and there were 12 HCV infections: 6 new infections & 6 reinfections.

The 3rd report below is on the use of a new broader type of model in India for HCV screening & care. A more comprehensive clinic model where IDUs can under 1 roof get a variety of services for IDU and HCV care. Sunil Solomon highlights how big & diverse the HCV epidemic is India, much bigger even only among IDUs compared to the entire HCV epidemic in Western Europe. 
Read it here...…

In Case You Missed It
'A long life with HIV' is now available to read online. The booklet provides information on living well with HIV as you get older, including things you can do to look after your health, health issues and preparing for the future.

Sept 4, 2018
Inovio Pharmaceuticals (NSDQ:INO) and its partner, GeneOne Life Science (KSE:011000), said today that the companies have dosed the first patient in a Phase I study designed to test a preventive vaccine against hepatitis C infection. The companies plan to recruit 24 study participants to evaluate Inovio’s GLS-6150 candidate. Participants will include people who have a sustained virologic response following treatment for Hep. C, as well as healthy controls. They are slated to receive one of two doses of vaccine, administered intra-dermally and followed by electroporation with Inovio’s Cellectra device.

Risk of Liver Cancer in Patients with NAFLD 
(Reuters Health) - People with advanced cases of nonalcoholic fatty liver disease (NAFLD) may need to be monitored for liver cancer, a large U.S. study suggests.

Vosevi Beats Hepatitis C Regardless of Drug Resistance 
In a recent study of people whose previous hep C regimen failed to cure their infection, Vosevi cured almost all of them.

Will an opt-out organ transplant law save lives?
The recent decision in England to change the organ donation law from voluntary consent (opt-in) to presumed consent (opt-out) highlighted the debate around the best approach to organ donation.

Routine oral care to treat gum disease may improve cognitive function in cirrhosis patients
Routine oral care to treat gum disease may play a role in reducing inflammation and toxins in the blood and improving cognitive function in people with liver cirrhosis.

In The Journals 
Hepatitis B Virus and Risk of Non-Hodgkin Lymphoma
Journal of Viral Hepatitis

Chronic Hepatitis C Association with Diabetes Mellitus and Cardiovascular Risk in the Era of DAA Therapy.
Most likely, DAA treatment and subsequently SVR achievement decrease cardiovascular risk. This fact is another reason for early treatment of patients, including those with a lower grade of liver fibrosis. Yet, chronic hepatitis C treatment remains inaccessible not only in developing countries but also in countries with high quality of life..

Newsletters
HCV Advocate
The HCV Advocate newsletter is a valuable resource designed to provide the hepatitis C community with monthly updates on events, clinical research, and education.
In this month’s HCV Advocate newsletter, the following noteworthy articles are available to read and educate:
-SnapShots by Alan Franciscus Risk factors, mortality, and cardiovascular outcomes in patients with type 2 diabetes—A. Rawshani, et. al.
-Incidence of hepatocellular carcinoma after direct antiviral therapy for HCV in patients with cirrhosis included in surveillance programs—P. Nahom, et. al.
-Safety and efficacy of ledipasvir‐sofosbuvir with or without ribavirin for chronic hepatitis C in children ages 6‐11—K. F. Murry, et. al
Briefly……..
-Commentary: A review of the risk of hepatitis B and C transmission through biting or spitting—H. Pintilie, et. al.
-Hepatitis C virus infection in children in the era of direct-acting antivirals—M. Pawlowska, et. al
HealthWise – A Buffet of Health Information – as the title of the article implies, Lucinda discusses the various substances that may or may not be good for your health.
Hepatitis Headlines – Three interesting news stories about hepatitis C that our readers will find interesting including heart transplants, eliminating hepatitis in the U.S. and WHO and HCV treatment guidelines.
Hep C 101 – Overview of Hepatitis C by Alan Franciscus – A new series of article for people who are new to hepatitis C or for those people who want basic information.
What’s Up – We’ve updated several of the HCV Advocate Factsheets. Use the links provided in this section to get current information on several subjects that relate to Hep C, including nutrition, alcohol, co-infection, and motherhood.
Watch our patient video about treating and curing HCV. 

The New York City Hepatitis C Task Force
The New York City Hepatitis C Task Force is a city-wide network of service providers and advocates concerned with hepatitis C and related issues. The groups come together to learn, share information and resources, network, and identify hepatitis C related needs in the community. Committees form to work on projects in order to meet needs identified by the community.
Review all news updates.

HCV Action
HCV Action brings together hepatitis C health professionals from across the patient pathway with the pharmaceutical industry and patient representatives to share expertise and good practice.
HCV Action e-update

World Hepatitis Alliance
We run global campaigns, convene high-level policy events, build capacity and pioneer global movements, ensuring people living with viral hepatitis guide every aspect of our work.
View Recent Newsletters 
World Hepatitis Alliance (WHA) presents hepVoice, a monthly magazine with updates on the latest projects, news from WHA members and key developments in the field of hepatitis.

GI & Hepatology News
Over 17,000 gastroenterologists and hepatologists rely on GI & Hepatology News every month to cover the world of medicine with breaking news, on-site medical meeting coverage, and expert perspectives both in print and online. 
Hot topics
Amy Karon MDedge News 
Modest alcohol consumption was associated with significantly less improvement in steatosis and significantly lower odds of NASH resolution.
View all updates here....

Hep-Your Guide to Hepatitis
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis. Offering unparalleled editorial excellence since 2010, Hep and HepMag.com are the go-to source for educational and social support for people living with hepatitis.
View - all issues
Read the news

Hepatitis Victoria
Hepatitis Victoria is the peak not-for-profit community organisation working across the state for people affected by or at risk of viral hepatitis.
Latest Podcast: Karen Hoyt a HEP Hero and she is unique in being our first international recipient!
Speaking from Oklahoma in the United States, Karen talks about her diagnosis with hepatitis C and how she experienced the full gamut of conditions leading to a liver transplant.



View the Latest Newsletter, or relax and listen to a short podcasts interviewing health experts and practioners on topics related to viral hepatitis - come have a listen!

British Liver Trust
The British Liver Trust is the leading UK liver disease charity for adults – we provide information and support; increase awareness of how liver disease can be prevented and promote early diagnosis; fund and champion research and campaign for better services. 
News: Less Survivable Cancer Taskforce calls for government to double the survival rate of deadliest cancers by 2029
The combined five-year survival rate for people with either liver, brain, lung, oesophageal, pancreatic or stomach cancers stands is currently just 14%. Today, six charities …
View Recent Newsletters, here.

The National Viral Hepatitis Roundtable
The National Viral Hepatitis Roundtable (NVHR) is national coalition working together to eliminate hepatitis B and C in the United States.
View all NVHR newsletters

The Hepatitis C Trust
The Hepatitis C Trust is run by patients with the goal of eliminating HCV in the United Kingdom. The Trust’s mission is to reverse the rapidly increasing death toll caused by hepatitis C in the UK until no-one dies from this preventable and treatable disease and, ultimately, it is all but eradicated in this country.

National Institutes of Health
A monthly newsletter from the National Institutes of Health, part of the U.S. Department of Health and Human Services
September Newsletter
Topics
Body Odor May Be Sign of Disease
Breathe Easier
Dealing with Bad Air Quality

Harvard Health
Lipoprotein(a) is a fatty particle in the blood that invades artery walls, causing atherosclerosis. Also known as Lp(a), the particles are similar to “bad” LDL cholesterol molecules but with an extra protein attached. High blood levels of Lp(a)—which is largely determined by genetics—may explain some unexpected, premature heart attacks. Widespread testing for Lp(a) is not recommended because both the prevalence and the definition of what constitutes a dangerously high level are not yet clear. In addition, there are no FDA-approved treatments proved to lower heart disease risk in people with high Lp(a) levels.

Inspirational Bloggers
Karen Hoyt is devoted to offering support and accurate information to people coping with the effects of hepatitis C.
I hear a lot from people seeking help for autoimmune liver disease. Trying to figure it out is hard, but most symptoms are the same as any type of liver disease. I know, we can’t lump them all into one specific area, but they are in the same region.

Lucinda K. Porter
Lucinda Porter is a nurse, speaker, advocate and patient devoted to increasing awareness about hepatitis C.
Latest blog entry: Happiness: Purging Self-Help Advice

Hep 
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis.
Latest blog entry: By Connie M. Welch
Patient Experience Living With Cirrhosis With John M., Part 2 Part 2 of Connie Welch’s interview with John M, a patient with hepatitis C and cirrhosis, who was successfully treated with Harvoni.

By Greg Jefferys -How Big Pharma Corrupts Health Services 
A look at how bribing bureaucrats and buying doctors brings about bad outcomes for public health.
Check out the talented people who blog at Hep.

We provide information, support, referral and advocacy for people affected by viral hepatitis in NSW. We also provide workforce development and education services both to prevent the transmission of viral hepatitis and to improve services for those affected by it.
Latest blog entry: Pharmacists key in harm reduction

Life Beyond Hepatitis C
Life Beyond Hep C is where faith, medical resources and patient support meet, helping Hep C patients and their families navigate through the entire journey of Hep C.
Latest blog entry: Relief from Itching with Hepatitis C and Cirrhosis

Canadian Liver Foundation 
We strive to improve prevention and the quality of life of those living with liver disease by advocating for better screening, access to treatment, and patient care.
Latest blog entry: Who Gives a Sliver of a Liver to a Stranger?

Hepatitis B Foundation 
The Hepatitis B Foundation is a national nonprofit organization dedicated to finding a cure and improving the quality of life for those affected by hepatitis B worldwide.
Latest blog entry: - Be Your Own Advocate in the Medical Room
The hepatitis B virus (HBV) can be transmitted two ways: 1) through direct contact with blood and 2) infected body fluids. Some risks for direct blood contact are obvious, such as touching an open wound to another open wound or cleaning up someone’s blood without any protective gear. However, other methods of blood transmission are harder to catch. Common activities like sharing razors, earrings, or toothbrushes are simple, innocent actions, yet they all have the potential for blood exchange.

HepatitisC.net
At HepatitisC.net we empower patients and caregivers to take control of Hepatitis C by providing a platform to learn, educate, and connect with peers and healthcare professionals.
Latest blog entry: Ask the Advocate: What Were Your First Symptoms of Hep C?
There are several common symptoms of chronic HCV, including fatigue, joint pain, muscle aches, low-grade fever, decreased appetite..

HIV and ID Observations 
An ongoing dialogue on HIV/AIDS, infectious diseases, all matters medical, and some not so medical.
Latest blog entry: Doravirine Sets a New Standard for NNRTIs — But What Role in HIV Treatment Today?

KevinMD
Kevin Pho is a practicing physician and most known for his blog KevinMD. Thousands of authors contribute to his blog: primary care doctors, surgeons, specialist physicians, nurses, medical students, policy experts. And of course, patients, who need the medical profession to hear their voices.
One of the aspects of depression that’s particularly difficult is the sleep disturbance which accompanies it and often continues after the traditional symptoms of depression have finally gotten better.

On The Radio
Presented by Dr Norman Swan
Genetic test predicts dementia risk. Warning over new genetic tests on Medicare Benefits Schedule. Colonoscopy standards to reduce unnecessary treatment, risk of complications. Scan your heart to save your life...

Healthy You
This type of observational study is useful for comparing what happens to groups of people in different situations (in this case, people over 75 who have or haven't been prescribed statins), but it can't show cause and effect. So in this case, it can't show whether living longer or having strokes or heart attacks are a direct effect of taking or not taking statins...

Osteoporosis is often called "soft bones." "Osteoporosis is thinning of the bone to the point where the bones can break," says Dr. Bart Clarke, a Mayo Clinic endocrinologist. https://youtu.be/fLS1tDriG3k Watch: The Mayo Clinic Minute Journalists: Broadcast-quality video pkg (1:00) is in the downloads. Read the script. Dr. Clark says common breaks from thinning bones occur in the spine, wrist, shoulder and hip. "Women, in general, past menopause — past the mid-50s — are at high risk for this because of the…

Thanks for stopping by!
Tina

Wednesday, August 29, 2018

FDA statement on the agency’s ongoing work to address the opioid crisis

FDA Statement 

Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis
August 29, 2018
Over the past 17 months, we’ve set out to address the opioid crisis forcefully, using all the agency’s tools and authorities. These steps have been part of a comprehensive approach that the Secretary of Health and Human Services has outlined. Our efforts at the U.S. Food and Drug Administration are part of these broader efforts and cut across three broad areas.

First, we set out to cut the rate of new addiction. We did this in part by taking new steps to rationalize the prescribing of opioids, and amounts dispensed, as a way to reduce exposure to the drugs in the medical setting.

Second, we’ve stepped up enforcement of the marketing and sale of illicit opioids. One way that we’re doing this is by targeting online sites that enable the illegal sale of these drugs and their shipment through the mail.

Finally, we’ve undertaken new efforts to support novel product innovation. This includes innovation in treatments for opioid addiction, and efforts to promote their more widespread use. And it also includes steps to advance the development of non-addictive treatments for pain. We have great concern for the millions of Americans who live with chronic pain and for whom traditional treatment options have been exhausted.

I want to take this opportunity to provide an update on some of the work we are doing across each of these three areas and some of the new efforts we’re going to pursue. To pursue these goals, and many other commitments, in the last 17 months, we’ve taken a range of new steps.

We set out to extend our risk evaluation and mitigation strategy program to cover the immediate release formulations of opioid drugs, and we’ve updated our educational content for providers to include information on non-opioid alternatives. We also, for the first time, extended this training to non-physician prescribers.

And we’ve advanced a broad effort to develop evidence-based guidelines for opioid prescribing. We want to make sure that when opioids are used, the amount dispensed comports with the clinical reasons why these drugs are being used in the first place. No more 30-day prescriptions for a tooth extraction or an appendectomy.

We’ve also taken steps to protect children from unnecessary exposure to certain opioids in some common prescription cough and cold medicines.

We committed to look closely at the risks associated with the illicit use of these drugs as a factor in how we evaluate their pre- and post-market safety. We requested the market withdrawal of one drug – Opana ER – based on a consideration of risks that were manifest only when this drug was being misused and abused. We’ll soon release new guidance outlining how we make these considerations of risks associated with illicit use a clear factor in our pre- and post-market regulatory decisions.

We also took enforcement actions, including work in collaboration with the Federal Trade Commission targeting the proliferation of products on websites that marketed unapproved treatments for pain and addiction. With additional actions that we took yesterday, we’ve brought to 70 the number of web sites that we’ve targeted this summer for marketing unapproved opioid drugs. More enforcement actions are on the way. We also formed a broad collaboration with legitimate internet sites – including leading social media platforms – to target the sale of opioids in ways that are visible to the public, and in some ways that are not apparent.

We sharply expanded our oversight of drugs being shipped illegally through international mail facilities, growing by nearly a factor of 10 the number of packages that the FDA is able to open and inspect. We have also increased our special agents doing criminal work at the ports of entry as well as cybercrime, strategic intelligence and strategic analysis units – all of whom are critical to effective enforcement. And we launched major operations with other federal partners to target these shipments and get an accurate estimate of how many opioids are coming in illegally through the mail. We’ll soon announce the findings from this operation.

We expanded new pathways for the development of safe and effective treatments for addiction, lowering the barriers to innovation for treatments that meet our gold standard. New guidance we issued will expand the range of clinical endpoints that treatments for addiction can pursue, creating more opportunities for more efficient product development. And we undertook a broad campaign to promote Medication-Assisted Treatment (MAT), and address the inappropriate stigma that’s sometimes associated with replacement therapy.

We developed new regulatory guidance to promote abuse-deterrent formulations of opioid drugs, including a new path for the development of generic versions of drugs with these features. And we’ve launched an effort to evaluate whether the nomenclature that we use to describe these drugs inappropriately promotes a view that these formulations are somehow less addictive.

We launched an innovation challenge to spur the development of medical devices and mobile applications that can ultimately serve as alternatives to oral opioids to help combat the opioid crisis and prevent and treat opioid addiction. We also held two public meetings this year focused entirely on patients – one for Opioid Use Disorder and one for Chronic Pain. And we did many of these things under the direction of a new Opioid Policy Steering Committee that I formed when I arrived at the FDA, that brings together senior leaders from our programs. That Steering Committee has helped generate and oversee some of the new ideas that drive our strategy.

We appreciate the support that Congress has given us in the pursuit of these goals, with new resources as well as the new authorities that have passed the House and that the Senate is now considering that will help us in this fight. Along the way, as we’ve embraced these challenges, we’ve learned some hard lessons. I’ve learned some hard lessons. And one sticks with me above others. It’s this.

The reason that we find ourselves with a crisis of such proportion is that as a medical profession, we’ve been one step behind its sinister advance. Collectively, we didn’t take all the steps we could, when we could, to stop the advance of this crisis. We shunned hard decisions. As a profession, providers were too liberal in our use of these drugs well past the point where there were signs of trouble, and the beginning of a crisis of addiction.

I’m committed to making sure that we don’t perpetuate these mistakes of the past. And so, when we see this crisis taking new twists and turns, we’ve acted swiftly. For example, we’ve taken steps to address what we believe may be abuse of substances that contribute to the opioid crisis, like gabapentinoids and loperamide or kratom. And we’re increasing our vigilance around the risk of addiction, and acting more quickly to warn the public when we identify harmful trends and emerging risks.

I don’t want to look back ten years from now and wish there were more policies we had pursued, or more steps we had taken, to stop the advance of this crisis. We must all be able to say we did everything we could. That we acted as aggressively as needed. And that we succeeded.

So at the FDA, we’ve done all these things, and taken many other actions, with this promise in mind. We’re going to be taking many additional steps to continue to pursue these goals. That includes additional steps to foster innovation. Part of our approach is focused on developing non-opioid, and non-addictive alternatives for the treatment of pain. We know that many Americans suffer from chronic and episodic acute pain. For these people, sometimes opioids are the only drugs that work. To address these medical needs, we’re taking new steps to foster development of treatments for pain that don’t rely on opioids and don’t have their addictive features.

First, we intend to withdraw our existing, 2014 analgesic guidance document on developing new pain drugs. That guidance typically called for a large number of studies to get a general chronic pain indication and may have been difficult to implement because it was so broad. Instead, we’ve determined that a more focused approach would streamline drug development in specific areas.

To that end, we plan to issue at least four new guidance documents in place of this 2014 analgesic guidance document. We’ll issue these guidances in a series over the next six to twelve months. These new policies will create a more efficient path for new product innovation.

The new guidance documents will recommend the study of one or two populations for innovators who wish to pursue a more limited indication for the treatment of specific kinds of pain. This will broaden the range of new drug development opportunities that are available. Our new approach should also help more novel products for the treatment of pain come to market more efficiently.

Among the forthcoming guidance documents that we plan to issue is a guidance, which will be out soon, and will address drugs that can spare the use of opioids in the treatment of acute pain. This guidance document will set forth the FDA’s current thinking on how sponsors can demonstrate a clinically meaningful reduction in the use of opioid pain medications when used for acute pain.

In addition to this guidance, we also plan to issue a guidance to outline the information that the FDA will ask drug makers to provide to help assess the benefits and risks when new opioid pain drugs are put into development. This will include an updated framework for evaluating the risks associated with intentional or illicit misuse or abuse of drugs. As I noted, we’re explicitly considering the risks associated with illicit use as a factor in how we assess risks and benefits.

In a third guidance, we’ll outline a path for developing extended-release local anesthetics, which can serve as an alternative to the systemic use of oral opioid drugs. This guidance will address the clinical pharmacology, the proper evaluation of safety and efficacy, and the types of studies that may support approval of these products.

Finally, we also plan to issue a guidance document to assist sponsors with the development of new non-opioid pain medications for chronic pain that can provide therapeutic alternatives to the use of opioids.

These are just some of the new steps we’re taking to promote innovation for alternatives to opioid drugs for those who need treatment for acute and chronic pain. And today, I outlined just some of the overall steps we’re taking to address the crisis of addiction to opioids. We have many other actions underway. This is an all-of-the-above approach. Everything is on the table.

We needed to broaden our approach as this crisis continues to evolve. The epidemic is turning from one that was largely dominated by addiction formed in the medical setting, involving prescription drugs, to one that increasingly implicates the use of illicit drugs, including highly potent fentanyls. These drugs are obtained illegally, often through purchases made on-line, and in many cases shipped through the international mail.

A recent FDA analysis of commercially available data showed steep drops in dispensing of opioid analgesics in retail outpatient settings. In the first six months of 2018, the volume of opioid analgesics dispensed was 74.1 metric tons of oral morphine equivalent, down more than 16 percent from the first half of 2017, when the volume dispensed was 88.8 metric tons. Earlier declines were there, but smaller. The volumes of opioid analgesics dispensed in the first half of 2017 and 2016 were about 10.4 percent and 3.4 percent less than comparable values 12 months earlier. These trends seem to suggest that the policy efforts that we’ve taken are working as providers, payers and patients are collectively reducing some of their use of prescription opioid analgesic drugs.



But the public health impact from these reductions in prescription opioid use could be offset by the rising availability of illicit opioids, and principally fentanyl, that’s coming into America. The growing use of fentanyl is contributing to a rise in overdose deaths. It isn’t necessarily the case that more people are suddenly switching from prescription opioids to these illicit drugs. The idea of people switching to illicit drugs isn’t new as an addiction expands, and some people have a harder time maintaining a supply of prescription drugs from doctors. Many heroin users switched from prescription drugs. What’s new is that more people are now switching to highly potent drugs that are far deadlier. That’s driven largely by the growing availability of the illicit fentanyls.

At the FDA, we’re taking steps right now to accurately estimate the flow of these illicit drugs. But our current estimates are largely based on the fentanyl seized by our colleagues and partners at Customs and Border Protection (CBP). Based off of publicly available information, seizures of fentanyl by our CBP colleagues were reported as two pounds in fiscal year 2013, rising to 440 pounds in FY16, and 1,377 pounds in FY17. CBP reported 1,640 pounds seized during the first 10 months of fiscal year 2018. During these same periods, reported heroin seizures also increased, from 4,790 pounds in 2016, to 4,878 pounds in fiscal year 2017 and an estimated 5,472 pounds in fiscal year 2018 if we were to extrapolate seizures through July to the full fiscal year.

If we assume that the seizures effected by our colleagues at CBP represent some fraction of the overall illegal flows that are being smuggled into the U.S. through different routes and despite our best efforts; then we should worry that the public health impact of a decline in prescription opioid use in the medical setting could be offset by the rise in highly potent, illicit opioids like fentanyl. The FDA has garnered a strong partner with CBP in our efforts to combat these trends, whether it be our joint scientific or operational work. Our two teams are collaborating closely on solutions to this problem. We’re taking new steps to confront this dangerous turn.

We have additional enforcement operations underway. We’re taking new steps to promote innovation in the development of alternative treatments for pain that may not be as addictive as opioids. At the same time, we’re advancing new policies to rationalize the legal use of prescription opioid drugs in the medical setting. To address this goal we are also developing an approach on the use of blister packs for opioid drugs as a way to better control prescription dispensing and reduce exposure.

And we’re actively considering other new policy options, like novel steps to better manage the use of high-dose opioid formulations. More FDA action is on the way.

I made a commitment 17 months ago, when I first joined the FDA as the agency’s Commissioner, that we’d do everything in our scope to address this crisis. I’ve made this promise a cornerstone of my efforts at the agency, and a foundation of my obligation to Americans.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.