This blog is all about current FDA approved drugs to treat the hepatitis C virus (HCV) with a focus on treating HCV according to genotype, using information extracted from peer-reviewed journals, liver meetings/conferences, and interactive learning activities.
Risk Of Developing Liver Cancer After HCV Treatment
Nine-year distribution pattern of hepatitis C virus (HCV) genotypes in Southern Italy
Arnolfo Petruzziello ,
Rocco Sabatino,
Giovanna Loquercio,
Annunziata Guzzo,
Lucia Di Capua,
Francesco Labonia,
Anna Cozzolino,
Rosa Azzaro,
Gerardo Botti
Published: February 20, 2019
https://doi.org/10.1371/journal.pone.0212033
In conclusion, the epidemiological framework of Hepatitis C infection in Southern Italy, particularly interesting for the high prevalence of this virus in the general population, seems to highlight the "returning" role of the iatrogenic transmission as risk factor for the diffusion of HCV infection. Furthermore, the small increase of genotype 3a among young people should be more investigated, with a support of a phylogenetic analysis. At support of our hypothesis, some studies report small HCV outbreaks in Europe due to breaches in standards of health and safety practices among health-care workers [56]. Indeed, an interesting case–control study highlighted some unconventional routes of diffusion of Hepatitis C infection such as digestive endoscopy, beauty treatments and professional pedicure/manicure [57]. This suggest not only a necessary evaluation of the safety practices in surgery, but the fundamental importance of not lowering the safety levels, especially among all health-care professionals.
Abstract
Introduction
It has been greatly described that different hepatitis C virus (HCV) genotypes are strictly correlated to various evolution, prognosis and response to therapy during the chronic liver disease. Aim of this study was to outline the changes in the epidemiology of Hepatitis C genotypes in Southern Italy regions from 2006 to 2014.
Material/Methods
Prevalence of HCV genotypes was analyzed in 535 HCV-RNA positive patients with chronic Hepatitis C infection, selected during the period 2012–2014, and compared with our previous data, referred to periods 2006–2008 and 2009–2011.
Results
In all the three periods analyzed, genotype 1b is predominant (51.8% in 2006–08, 48.3% in 2009–11 and 54.4% in 2012–14) while genotype 2 showed an increase in prevalence (27.9% in 2006–08, 31.7% in 2009–11 and 35.2% in 2012–14) and genotypes 3a and 1a a decrease during the same period (6.8% in 2006–08, 4.7% in 2009–11 and 3.2% in 2012–14 and 7.9% in 2006–08, 4.7% in 2009–11 and 2.6% in 2012–14, respectively). Subtype 1b seems to be equally distributed between males and females (52.7% vs 56.6%) and the prevalence in the age range 31–40 years is significantly higher in the 2012–14 period than in both previous periods (53.8% vs. 16.6% in 2009–11, p< 0.001 and 13.4% in 2006–08, p < 0.001).
Conclusions
Genotype 1b is still the most prevalent, even if shows a significantly increase in the under 40 years old population. Instead, genotype 3a seems to have a moderate increase among young people. Overall, the alarming finding is the “returning” role of the iatrogenic transmission as risk factor for the diffusion of Hepatitis C infection.
Reformulation of OxyContin to Discourage Abuse Linked to Higher Rates of Hepatitis C
Reformulation of the pain medicine OxyContin in 2010 to make it more difficult to abuse directly led to a large rise in hepatitis C infections as drug abusers switched from the prescription medication to injectable heroin, according to a new RAND Corporation study.
While hepatitis C infection rates increased broadly across the country during the years following the reformulation, researchers found that states with above-average rates of OxyContin misuse prior to the reformulation saw hepatitis C infections increase three times as fast as in other states.
Public health officials previously have blamed the shift from prescription opioids to injectable heroin as a cause of the rise in hepatitis C cases, but the new study provides the best evidence to date of a direct link between OxyContin reformulation and the infection surge. The findings are published in the February edition of the journal Health Affairs.
“These results show that efforts to deter misuse of opioids can have unintended, long-term public health consequences,” said David Powell, the study's lead author and a senior economist at RAND, a nonprofit research organization. “As we continue to develop policies to combat the opioid epidemic, we need to be careful that new approaches do not make another public health problem worse.”
The hepatitis C virus causes liver disease and is responsible for more deaths in the United States than any other infectious disease, accounting for 20,000 deaths in 2015. While the rate of new hepatitis C had remained steady for several years, the infection rate began rising at an alarming rate beginning in 2010.
Injection drug use has consistently been identified as a predominant risk factor for hepatitis C, leading experts to consider whether the opioid epidemic might be a driver of the recent rise in the infection.
Much of the early years of the opioid abuse epidemic was driven by misuse of prescription pain medicine. But one of the most abused drugs, OxyContin was reformulated in 2010, making the pill difficult to crush or dissolve, thus deterring the most-dangerous methods of abuse by injection or inhalation.
RAND researchers previously demonstrated that the reformulation of OxyContin caused some nonmedical users of the drug to switch to injectable heroin, which led to a sharp increase in heroin overdoses after 2010.
In the latest study, researchers from RAND and the Wharton School at the University of Pennsylvania examined rates of hepatitis C infections in each state from 2004 to 2015, examining differences between states based on the level of misuse of the drug before the reformulation occurred.
The analysis found that states with above-median OxyContin misuse prior to the reformulation experienced a 222 percent increase in hepatitis C infections after reformulation, while states with below-median misuse of OxyContin experienced a 75 percent increase in hepatitis C infections over the same period.
Before the reformulation, there was almost no difference in hepatitis C infections rates across the two groups of states.
“Even with recent advancements in the treatment for hepatitis C, the dramatic increase in infections represents a substantial public health concern that can have tremendous long-term costs if infected people are not identified and treated,” said Rosalie Liccardo Pacula, a study co-author, and co-director of the RAND Opioid Policy Tools and Information Center and the RAND Drug Policy Research Center.
As drug abuse policy continues to reduce access to abusable prescription opioids, researchers say the study suggests that there could be further unintended public health consequences if drug abusers switch to injected drugs.
“It is important that strategies that limit the supply of abusable prescription opioids are paired with polices to ease the harms associated with switching to illicit drugs, such as improved access to drug treatment and increased efforts to identify and treat diseases associated with injection drug use,” Pacula said.
Support for the study was provided by the National Institutes on Drug Abuse. Abby E. Alpert of the Wharton School at the University of Pennsylvania also co-authored the study.
Since 1989, the RAND Drug Policy Research Center has conducted research to help policymakers in the United States and throughout the world address issues involving alcohol, marijuana and other drugs.
Making OxyContin 'Tamper Proof' Helped Spread Hepatitis C
MONDAY, Feb. 4, 2019 (HealthDay News) -- An effort to make the opioid painkiller OxyContin harder to abuse drove addicted patients to heroin and caused a dramatic increase in hepatitis C, a new study suggests.
In a classic case of unintended consequences, Connecticut-based Purdue Pharma reformulated its powerful and popular drug OxyContin for the right reasons. It became harder to crush or dissolve, thus making it harder to snort or inject for a fast high.
In The News New evidence shows needle and syringe programmes are highly cost-effective Thu, 01/24/2019 - 14:55 Evidence from a new study shows that needle and syringe programmes providing clean injecting equipment are a highly cost-effective way of preventing hepatitis C transmission. New research led by the University of Bristol and London School of Hygiene and Topical Medicine reveals that rolling out these programmes could save millions of pounds in infection treatment costs in the UK. This is the first study to evaluate the cost-effectiveness of needle and syringe programmes in Western Europe.
The researchers used data from three cities with different levels of hepatitis C infection among people who inject drugs—Bristol (45%), Dundee (26%) and Walsall (18%). They estimated the cost-effectiveness of existing needle programmes in each city and their impact on hepatitis C transmission rates. Using mathematical models, they were able to project how hepatitis C transmission would increase if all needle and syringe programmes were stopped for the first ten years of a 50-year time period (2016-2065).
Their findings revealed that in all three cities, current needle and syringe programmes result in lower healthcare and treatment costs than if the programmes were stopped, with estimated cost-savings of £159,712 in Bristol and £2.5 million in Dundee.
Maintaining the needle and syringe programmes was also associated with a lower prevalence of hepatitis C and improvements in quality of life for people who inject drugs. Infections were projected to reduce by 8 per cent in Bristol and Walsall and 40 per cent in Dundee between 2016 and 2065 if needle and syringe programmes were maintained.
Even if hepatitis C treatment rates were to increase or treatment costs were further reduced, needle and syringe programmes would continue to save money, because of their effectiveness in preventing re-infection.
Responding to the findings of the study, Rachel Halford, CEO of The Hepatitis C Trust said: “Needle and syringe facilities are key to preventing the transmission of hepatitis C, yet we know that in many areas provision is insufficient or dropping.
While in recent years the numbers of people being treated and tested for the virus have increased, Public Health England estimates that prevalence has remained broadly stable due to new infections and re-infections. To achieve NHS England’s ambition to eliminate hepatitis C as a public health concern by 2025, we must ensure that numbers of new infections are falling.
This will require sustained investment in prevention initiatives. Now that we have clear evidence for the cost-effectiveness of needle and syringe programmes, there is no excuse for not expanding them significantly.”
In recent years, an overwhelming body of clinical evidence has firmly established the HIV Undetectable = Untransmittable (U=U) concept as scientifically sound, say officials from the National Institutes of Health. U=U means that people living with HIV who achieve and maintain an undetectable viral load—the amount of HIV in the blood—by taking and adhering to antiretroviral therapy (ART) as prescribed cannot sexually transmit the virus to others. Writing in JAMA, officials from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) review the scientific evidence underlying U=U and discuss the implications of widespread acceptance of the message.
In the new commentary, NIAID Director Anthony S. Fauci, M.D., and colleagues summarize results from large clinical trials and cohort studies validating U=U. The landmark NIH-funded HPTN 052 clinical trial showed that no linked HIV transmissions occurred among HIV serodifferent heterosexual couples when the partner living with HIV had a durably suppressed viral load. Subsequently, the PARTNER and Opposites Attract studies confirmed these findings and extended them to male-male couples.
Validation of the HIV treatment as prevention strategy and acceptance of the U=U concept as scientifically sound have numerous behavioral, social and legal implications, the NIAID officials note. U=U can help control the HIV pandemic by preventing HIV transmission, and it can reduce the stigma that many people with HIV face.
The success of U=U as an HIV prevention method depends on achieving and maintaining an undetectable viral load by taking ART daily as prescribed. Numerous factors, including lack of access to quality health care, can make ART adherence difficult. To enhance the overall success of U=U, the authors emphasize the importance of implementing programs that help patients remain in care and address the barriers to daily therapy.
ARTICLE:
RW Eisinger, CW Dieffenbach, AS Fauci. HIV viral load and transmissibility of HIV infection: undetectable equals untransmittable. Journal of the American Medical Association DOI: 10.1001/jama.2018.21167 (2019).
WHO:
NIAID Director Anthony S. Fauci, M.D., is available for comment.
NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
Draft Recommendation Statement Hepatitis B Virus Infection in Pregnant Women: Screening The USPSTF recommends screening for hepatitis B virus (HBV) infection in pregnant women at their first prenatal visit.
This opportunity for public comment expires on February 4, 2019 at 8:00 PM EST
Note: This is a Draft Recommendation Statement. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. The final Recommendation Statement will be developed after careful consideration of the feedback received and will include both the Research Plan and Evidence Review as a basis.
Media Coverage USPSTF Affirms Guidance for Hep B Screening at First Prenatal Visit
Last Updated: January 08, 2019.
The U.S. Preventive Services Task Force recommends hepatitis B virus infection screening in pregnant women at their first prenatal visit. These findings form the basis of a draft recommendation statement published online Jan. 8 by the task force.
Article: https://www.doctorslounge.com/index.php/news/pb/85739
Targeted Hepatitis C testing misses substantial number of cases in correctional setting
Researchers recommend routine testing for all incarcerated individuals upon arrival
Results from a new study led by Boston Medical Center (BMC) found routine Hepatitis C testing identified a significant number of cases that would have been missed by targeted testing among a population of individuals in Washington State prisons. Published in the American Journal of Preventive Medicine, the authors recommend routine testing in correctional facilities to best identify and treat the disease as part of the national strategy to eliminate Hepatitis C transmission.
It is estimated that 30 percent of the total Hepatitis C (HCV) infected population in the United States passes through the prison system annually, yet there is no widely accepted approach to HCV testing in correctional settings. Approximately 40 percent of state prison facilities, including Washington State, routinely test for HCV. Other facilities employ the Centers for Disease Control and Prevention (CDC) recommendation of targeted or risk-based testing, which tests individuals born between 1945 and 1965 as well as those with a history of injection drug use.
Researchers looked at data from Washington State prison HCV testing results to determine whether routine or targeted testing was most effective in identifying cases of disease. From 2012 to 2016, more than 24,000 people were tested for HCV; 20 percent of those people were infected and close to 2,000 people had chronic infections. Of those with chronic infections, nearly a quarter had at least moderate liver disease, putting them at risk for complications.
Infections were more prevalent in individuals born between 1945 and 1965, however nearly 35 percent of infections would have been missed if only targeted testing was performed. With routine testing, five individuals had to be tested to identify a case of HCV, compared to three individuals with targeted testing. This remains a small number in contrast with other infectious diseases, such as HIV, that require testing a large number of incarcerated individuals to identify a single case.
"These data build upon existing evidence supporting the implementation of routine testing for all individuals when entering a correctional facility," said Sabrina Assoumou, MD, MPH, an infectious diseases physician at BMC and lead author of the study. "Coupled with treatment, routine testing would identify and cure many cases of HCV, preventing the substantial burden of future liver disease."
One of the current barriers to routine testing is the high cost of HCV treatment. Even without treatment, those who receive a diagnosis of HCV may make lifestyle changes that can reduce transmission.
Researchers also note that it is unclear how these findings will generalize to other U.S. prison populations, and believe more research should be done to determine the effectiveness of routine HCV testing across the country.
Conference Coverage @ infohep Hepatitis C is detectable in rectal and nasal fluid
Keith Alcorn Published: 12 November 2018
High levels of hepatitis C virus (HCV) can be found in the rectal and nasal fluids of people with high hepatitis C viral loads even when blood is not present, Austrian researchers reported on Sunday at the 2018 AASLD Liver Meeting.
The findings reinforce the plausibility of HCV transmission through sharing up rolled-up bank notes or other equipment for snorting drugs.
The findings were presented by Dr David Chromy of the Medical University of Vienna on behalf of the Vienna HIV & Liver Study Group.
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...
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.
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.
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
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.
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.
Government of Canada launches call for proposals under its Harm Reduction Fund Reducing the risk of HIV, hepatitis C and other blood-borne infections
OTTAWA, May 28, 2018 /CNW/ - Sexually transmitted and blood-borne infections, including HIV and hepatitis C, are largely preventable but remain a significant public health concern in Canada. The Government of Canada is taking action to reduce transmission of these diseases, including measures to prevent the spread of HIV and hepatitis C through the sharing of drug-use equipment, such as needles and pipes.
Through its Harm Reduction Fund, the Public Health Agency of Canada is investing $30 million over five years to support community initiatives to address the risk of infection among people who share drug-use equipment.
Today, the Honourable Ginette Petitpas Taylor, Minister of Health, launched an open call for proposals to support community projects that will reduce the rate of infections of HIV and hepatitis C among people who share injection and other drug-use equipment. Successful projects will implement evidence-based, time-limited interventions such as the development of educational resources for people who use drugs, peer outreach initiatives and training for health service providers.
The open call for proposals will allow applicants to apply for up to three years of funding for time-limited projects.
Quotes "The Harm Reduction Fund will help organizations implement response activities in communities where there are high rates of infections among people who share drug-use equipment, with the goal of reducing the rates of diseases, like HIV and hepatitis C, across our country."
The Honourable Ginette Petitpas Taylor, P.C., M.P. Minister of Health
"Evidence shows that harm reduction is a vital part of a comprehensive, compassionate and collaborative public health approach to prevent the transmission of infectious diseases that result from the sharing of drug-use equipment. The Harm Reduction Fund will help Canadians who use drugs to adopt safer behaviours, and will reduce the rate of preventable diseases like HIV and hepatitis C."
Dr. Theresa Tam Chief Public Health Officer of Canada
Quick Facts Eligible activities under the Harm Reduction Fund include front-line prevention activities and capacity-building of individuals, providers and systems. Additional calls for project proposals are planned for spring 2019 and 2020. People who share drug-use equipment continue to be disproportionately represented among those acquiring HIV and hepatitis C infections in Canada. In 2014, 10.5% of new HIV infections were among people who injected drugs. 68% of people who inject drugs and who were surveyed between 2010 and 2012 indicated that they had at one point been infected with hepatitis C.
Access to Syringe Services Programs — Kentucky, North Carolina, and West Virginia, 2013–2017
Danae Bixler, MD1; Greg Corby-Lee2; Scott Proescholdbell, MPH3; Tina Ramirez4; Michael E. Kilkenny, MD5; Matt LaRocco6; Robert Childs, MPH7; Michael R. Brumage, MD4; Angela D. Settle, DNP8; Eyasu H. Teshale, MD1; Alice Asher, PhD
The Appalachian region of the United States is experiencing a large increase in hepatitis C virus (HCV) infections related to injection drug use (IDU) (1). Syringe services programs (SSPs) providing sufficient access to safe injection equipment can reduce hepatitis C transmission by 56%; combined SSPs and medication-assisted treatment can reduce transmission by 74% (2). However, access to SSPs has been limited in the United States, especially in rural areas and southern and midwestern states (3). This report describes the expansion of SSPs in Kentucky, North Carolina, and West Virginia during 2013-August 1, 2017. State-level data on the number of SSPs, client visits, and services offered were collected by each state through surveys of SSPs and aggregated in a standard format for this report. In 2013, one SSP operated in a free clinic in West Virginia, and SSPs were illegal in Kentucky and North Carolina; by August 2017, SSPs had been legalized in Kentucky and North Carolina, and 53 SSPs operated in the three states. In many cases, SSPs provide integrated services to address hepatitis and human immunodeficiency virus (HIV) infection, overdose, addiction, unintended pregnancy, neonatal abstinence syndrome, and other complications of IDU. Prioritizing development of SSPs with sufficient capacity, particularly in states with counties vulnerable to epidemics of hepatitis and HIV infection related to IDU, can expand access to care for populations at risk.
Discussion
During 2013–2017, the number of operational SSPs increased from one to approximately 50 in Kentucky, North Carolina, and West Virginia. Visits to SSPs by clients who inject drugs also increased. In Kentucky and North Carolina, this increase followed changes in laws permitting access to sterile injecting supplies; in West Virginia, SSPs were never prohibited under state law. In North Carolina, any group can start an SSP after notifying the state health department; Kentucky requires a lengthy approval process for local health departments before offering syringe services. This paper demonstrates that increasing access to SSPs is possible with community support using a variety of models if SSPs are not prohibited by law.
The increase in client visits to SSPs by persons who inject drugs represents an unprecedented opportunity to improve access to care for this highly stigmatized population. In addition to increased access to sterile needles, syringes, and injection paraphernalia (5), comprehensive syringe services programs should also improve access to medication-assisted treatment, counseling, and social support to address substance use disorder (6); naloxone and lay naloxone training to prevent fatal overdose (7); the full range of contraceptives, including long acting reversible contraceptives to prevent unintended opioid-exposed pregnancy; prenatal care and medication-assisted treatment to reduce harm from substance use disorder in pregnant women and their infants (8); vaccination; and HCV, HIV, and hepatitis B virus (HBV) screening and treatment (5). State and local health departments that are actively addressing the health effects of the opioid crisis might consider a formal evaluation process to improve service quality and access for persons who inject drugs, including those attending SSPs. Process evaluation indicators for SSPs should include number of clients, number of syringes distributed, number of syringes returned, availability of services in hours per week, summary statistics on HIV, HBV, and HCV testing, and number and type of services (e.g., patient-centered family planning services and naloxone) and referrals provided (e.g., medication assisted treatment, prenatal care, HIV, and hepatitis treatment) (9). Evaluation should also include health indicators such as rates of hepatitis, HIV, fatal and nonfatal overdose, unintended pregnancy and neonatal abstinence syndrome, and initiation and retention in drug treatment. CDC has published a framework to guide evaluation of public health programs (10), which might be useful for evaluating access to essential services at the community level for persons who inject drugs.
The findings in this report are subject to at least six limitations. First, data were self-reported from SSPs and are therefore subject to bias. Second, because some programs do not collect identifying information, the total numbers of clients served is estimated. Third, at the time of this analysis, North Carolina was in its first year of implementation, and limited data are available. Fourth, no data were obtained for SSPs operating underground (i.e., outside the legal framework). Fifth, growth of SSPs and service integration in these states is rapid, and the most recent data on SSPs should be sought through the state or local health department or harm reduction coalition. Finally, these data cannot be used to evaluate quality of service delivery and whether service delivery is adequate to meet the needs of the population.
SSPs can be implemented through a variety of models and by a variety of agencies and organizations including those in rural areas. Demand for syringe services is growing rapidly in these three states with underserved populations of persons who inject drugs, representing an opportunity to implement, evaluate, and improve access to evidence-based services known to reduce the considerable morbidity and mortality associated with injection drug use.
Featured on the blog today in honor of Hepatitis Awareness Month, is a look at three common viruses that cause hepatitis, brought to you by Centers of Disease Control and Prevention (CDC), health experts, advocates, and patient bloggers, who work hard to spread information and awareness about viral hepatitis.
Hepatitis C
Lets start with the hepatitis C virus (HCV), a virus that once caused serious damage to my liver, putting me at risk for liver-related complications. The good news is after testing; it all starts with getting tested for HCV, I went on to successfully treat the virus. The bad news is close to 50% of people who have HCV have not yet been diagnosed. Why not take this opportunity to learn more about viral hepatitis, or better yet, have a long frank discussion with "yourself" about getting tested.
Young Or Not So Young - The Risk
Today we have two different groups of people that are at risk for hepatitis C, young people who have injected drugs and well, older people. We know that the hepatitis C epidemic peaked between 1940 and 1965 due in part because of hospital transmissions caused by the practice of reusing needles. So if you are at risk for HCV, rather you are young or part of the baby boomer generation; people born between 1945 and 1965, I hope you consider getting tested for HCV.
-You were born from 1945 through 1965
-Extensive surgical procedures
-Needlestick injuries in health care settings
- Recipients of donated blood, blood products, and organs (once a common means of transmission but now rare in the United States since blood screening became available in 1992)
-People who received a blood product for clotting problems made before 1987
-Hemodialysis patients or persons who spent many years on dialysis for kidney failure
-Other possible risk behaviors: tattoos, body piercing, living and medical care in a developing country, folk medicine, intranasal cocaine
-Sexual transmission, rare; the risk of sexual transmission to an individual is probably less than 3% when a person is in a stable monogamous relationship - Unless you also have human immunodeficiency virus (HIV).
-Sharing personal care items, such as razors or toothbrushes, that may have come in contact with the blood of an infected person
-Unknown--up to 5% of patients have no identifiable risk factors
May 19th is Hepatitis Testing Day!
Are You At Risk For Viral Hepatitis?
Find out if you should get tested or vaccinated by taking a quick, online Hepatitis Risk Assessment, developed by the CDC and get a personalized report.
Hepatitis C - A Few Facts
Of every 100 people infected with hepatitis C, 75 to 85 will develop chronic disease and 10-20 will go on to develop cirrhosis over a period of 20-30 years. Early on HCV doesn't always have noticeable symptoms but overtime and with certain co-factors the virus can lead to serious liver problems, including cirrhosis (scarring of the liver) or liver cancer. Almost 80 percent of cases of hepatocellular carcinoma (HCC) are due to underlying chronic hepatitis B and C infection, and 80 to 90 percent of people with HCC have liver cirrhosis. According to the recent EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma;Vaccination against hepatitis B reduces the risk of HCC and is recommended for all new-borns and high-risk groups. In patients with chronic hepatitis, antiviral therapies leading to maintained HBV suppression in chronic hepatitis B and sustained viral response in hepatitis C are recommended, since they have been shown to prevent progression to cirrhosis and HCC development.
The American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) with the International Antiviral Society developed a living document with ever evolving guidelines to treat HCV. The guidelines break down treatment according to liver damage and HCV genotype, updated when new HCV drugs are approved, or new real world data is established.
Help - Where Do I Begin?
Talk To Someone Help‑4‑Hep is a non-profit, peer-to-peer helpline where counselors work with patients to meet the challenges of hepatitis C head-on. Callers talk one-to-one with a real person, typically someone who's had hepatitis C touch their own life. And they talk about the specifics of their particular situation. The phone call, support and information are all provided free of charge. Let us help you cut through the clutter and confusion. Call toll-free: 877‑Help‑4‑Hep (877‑435‑7443).
Begin here.......
More than 2 million Americans are chronically infected with hepatitis B virus (HBV), to learn more about HBV visit The Hepatitis B Foundation, for patients it's the best site for easy to understand information, here are a few links to get you started:
You may have questions about the hepatitis A virus (HAV) after reading about HAV outbreaks across the US; Michigan, California, Indiana, Kentucky and Utah. The outbreak began in California in 2017, this year Michigan, Utah, and Kentucky have reported outbreaks with a high number of cases. Here is a Public Service Announcement from San Diego County Health & Human Services Agency on HAV prevention.
I think I have been exposed to hepatitis A. What should I do?
If you have any questions about potential exposure to hepatitis A, call your health professional or your local or state health department. If you were recently exposed to hepatitis A virus and have not been vaccinated against hepatitis A, you might benefit from an injection of either immune globulin or hepatitis A vaccine. However, the vaccine or immune globulin are only effective if given within the first 2 weeks after exposure. A health professional can decide what is best based on your age and overall health.
What is postexposure prophylaxis (PEP)?
Postexposure prophylaxis (PEP) refers to trying to prevent or treat a disease after an exposure. For hepatitis A, postexposure prophylaxis is an injection of either immune globulin or hepatitis A vaccine. However, the vaccine or immune globulin are only effective in preventing hepatitis A if given within the first 2 weeks after exposure. Begin here.......
Blog Updates: The ABCs Of Viral Hepatitis
Swedish Medical Center
What is hepatitis C, and how does it differ from hepatitis A or B?
By 2030, the World Health Organization wants to have hepatitis C eliminated from the planet. A key to reaching that goal is to create awareness of the disease among baby boomers, who suffer from it in larger numbers compared to the rest of the population, as well as those with increased lifestyle risks. But what is hepatitis C, and what can be done to reduce its numbers? Kris Kowdley, MD, director of the Liver Care Network and Organ Care Research at Swedish Medical Center in Seattle, WA, discusses hepatitis C in detail.
HEP Blogs Go-to online source for educational and social support for people living with hepatitis. The website is devoted to combating the stigma and isolation surrounding hepatitis.
What are the Different Types of Hepatitis?
May 9, 2018 • By Connie M. Welch
Viral hepatitis is a liver infection that causes inflammation and damage. There are 5 viruses that cause viral hepatitis, Hepatitis A, B, C, D, and E. Hepatitis A and E viruses can cause acute infections (infections that last less than 6 months). Hepatitis B, C, and D viruses can cause acute and chronic (lasting longer than 6 months and typically ongoing) liver infections.
So, you are hanging out with the same crowd that you always have. They’re like your family. In many ways, they are closer to you than your own family.
The Fallout Guide for Hep C: Support Network
By Rick Nash · May 2, 2018
I am lucky after my transplant, I carry that reminder on my stomach. Because when someone hears you have a condition, they may not initially understand the reality of how that affects you. This is part two of a six-part series, view part one here.
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.
Hepatitis Awareness Month is dedicated to increasing awareness of hepatitis in the United States and to encourage high risk populations to get tested. If you’re not sure how you can get involved in the hepatitis B community this month, here are some ways you can!
The Al D. Rodriguez Liver Foundation is a 501(c)(3) non-profit organization that provides resources, education and information related to screening, the prevention of and treatment for the Hepatitis Virus and Liver Cancer.
A New York Post article about an unsafe “pizza joint manager” — who was reported to have sparked hepatitis C scare — made a few rounds on the panicked social media circuit earlier this year.
Healio features the industry’s best news reporting, dynamic multimedia, question-and-answer columns, CME and other educational activities in a variety of formats, quick reference content, blogs, and peer-reviewed journals. A quick free registration may be required.
Hepatitis Awareness Month: 10 recent reports on viral hepatitis
May 8, 2018
The Centers for Disease Control and Prevention have designated May as Hepatitis Awareness Month to raise public awareness of viral hepatitis including the most common strains: hepatitis A, hepatitis B and hepatitis C. Additionally, the CDC designated May 19th as Hepatitis Testing Day. The following recent reports, many from recent meetings including the International Liver Congress 2018, include new research data on hepatitis prevalence and outbreaks, transmission risks and treatment outcomes...
May 9, 2018
Physicians should consider administering hepatitis A vaccines to their patients with hepatitis B and those with hepatitis C, according to a…
What is the hepatitis virus? Well, the hepatitis virus invades liver cells and causes inflammation in the liver tissue. There are five known hepatitis viruses—hepatitis A, hepatitis B, hepatitis C, hepatitis D, and hepatitis E, all of which have slightly different presentations, symptoms and severity.
Do you want to know your status? If you fall under any of the above mentioned risk groups please consider getting tested.
by Pippa Wysong
Contributing Writer, MedPage Today
The prevalence of HCV infection in children and adolescents has been reported to vary from 0.05% to 0.36% in the United States and Europe, to 1.8% to 5.8% in some developing countries -- and even that might be low.
According to a review published in Hepatology Communications, the six genotypes seen in adults have been identified in children, with similar global geographic distribution as adults -- but that like adults, the younger cohort in the U.S. tend to have genotypes 1 through 3.
The paper notes that while HCV infection in younger children tends to be from vertical transmission from HCV-infected mothers, in adolescents it is increasingly linked to intravenous drug abuse. In fact, one study from the Centers for Disease Control and Prevention shows a 364% increase in HCV infection among people ages 12 to 29 living in the Appalachian region of the U.S. between the years 2006 to 2012.
Potential geographic "hotspots" for drug-injection related transmission of HIV and HCV and for initiation into injecting drug use in New York City, 2011-2015, with implications for the current opioid epidemic in the US
D. C. Des Jarlais ,
H. L. F. Cooper,
K. Arasteh,
J. Feelemyer,
C. McKnight,
Z. Ross
For HIV, the lack of potential hotspots is further validation of widespread effectiveness of efforts to reduce injecting-related HIV transmission. Injecting-related HIV transmission is likely to be a rare, random event. HCV prevention efforts should include focus on potential hotspots for transmission and on hotspots for initiation into injecting drug use. We consider application of methods for the current opioid epidemic in the US.
Published: March 29, 2018
https://doi.org/10.1371/journal.pone.0194799
Full-Text View Online Download PDF
Abstract
Objective
We identified potential geographic “hotspots” for drug-injecting transmission of HIV and hepatitis C virus (HCV) among persons who inject drugs (PWID) in New York City. The HIV epidemic among PWID is currently in an “end of the epidemic” stage, while HCV is in a continuing, high prevalence (> 50%) stage.
Methods
We recruited 910 PWID entering Mount Sinai Beth Israel substance use treatment programs from 2011–2015. Structured interviews and HIV/ HCV testing were conducted. Residential ZIP codes were used as geographic units of analysis. Potential “hotspots” for HIV and HCV transmission were defined as 1) having relatively large numbers of PWID 2) having 2 or more HIV (or HCV) seropositive PWID reporting transmission risk—passing on used syringes to others, and 3) having 2 or more HIV (or HCV) seronegative PWID reporting acquisition risk—injecting with previously used needles/syringes. Hotspots for injecting drug use initiation were defined as ZIP codes with 5 or more persons who began injecting within the previous 6 years.
Results
Among PWID, 96% injected heroin, 81% male, 34% White, 15% African-American, 47% Latinx, mean age 40 (SD = 10), 7% HIV seropositive, 62% HCV seropositive. Participants resided in 234 ZIP codes. No ZIP codes were identified as potential hotspots due to small numbers of HIV seropositive PWID reporting transmission risk. Four ZIP codes were identified as potential hotspots for HCV transmission. 12 ZIP codes identified as hotspots for injecting drug use initiation.
Abstract
The availability of effective, simple, well-tolerated oral direct-acting antiviral (DAA) hepatitis C regimens has raised optimism for hepatitis C virus (HCV) elimination at the population level. HCV reinfection in key populations such as people who inject drugs (PWID) and HIV-infected men who have sex with men (MSM) however threatens the achievement of this goal from a patient, provider and population perspective. The goal of this review was to synthesize our current understanding of estimated rates and factors associated with HCV reinfection. This review also proposes interventions to aid understanding of and reduce hepatitis C reinfection among PWID and HIV-infected MSM in the oral direct-acting antiviral era.
Full text available at: Medscape Free registration may be required
The reasons that Vietnam vets are more likely to have hepatitis C are disputed. Kaifetz blames a device called the "jet gun injector" that the military used to vaccinate service members during the Vietnam era. It generated a burst of air pressure to force the vaccine under the skin.
"It was supposed to shoot the injection through your skin cells without piercing the skin with a needle," Kaifetz explained.
Even though the gun wasn't supposed to break the skin, a lot of veterans say it made them bleed. The gun usually wasn't sterilized between each use.
This story was produced by the American Homefront Project, a public media collaboration that reports on American military life and veterans. Funding comes from the Corporation for Public Broadcasting and the Bob Woodruff Foundation.
An estimated 1% to 2.5% of pregnant women in the United States are infected with hepatitis C virus (HCV), which translates to about 4,000 new cases yearly. This also comes packaged with about a 6% risk of mother-to-infant transmission.
Worrisomely, the rates are increasing, with various studies adding to the discussion about screening for at-risk pregnant women and related to managing and treating them.
According to Raymond Chung, MD, director of Hepatology and the Liver Center at Massachusetts General Hospital in Boston and a recent co-Chair of the American Association for the Study of Liver Diseases-Infectious Diseases Society of America HCV Guidance Panel, screening with an HCV antibody assay is recommended for pregnant women with known or suspected risk factors for HCV infection.
"Confirmatory HCV RNA testing is recommended for women with a positive screening test," he told MedPage Today.
Tenofovir fails to add extra hepatitis B protection for vaccinated newborns
Last Updated: 2018-03-07
By Reuters Staff
NEW YORK (Reuters Health)
Adding tenofovir disoproxil fumarate (TDF) to an aggressive treatment strategy fails to give extra protection to newborns at risk for contracting hepatitis B virus (HBV) from their infected mothers, according to a study at 17 public hospitals in Thailand.
The drug or placebo was given to 331 infected women from 28 weeks of gestation until two months postpartum. All newborns were also given both hepatitis B immune globulin and the first dose of hepatitis B vaccine at birth, with booster vaccine doses at 1, 2, 4 and 6 months.
Wednesday, March 7, 2018 Antiviral drug not beneficial for reducing mother-to-child transmission of hepatitis B when added to existing preventatives
NIH-funded study observes no significant reduction of infection rates at age 6 months.
Tenofovir disoproxil fumarate (TDF), an antiviral drug commonly prescribed to treat hepatitis B infection, does not significantly reduce mother-to-child transmission of hepatitis B virus when taken during pregnancy and after delivery, according to a phase III clinical trial in Thailand funded by the National Institutes of Health. The study tested TDF therapy in addition to the standard preventative regimen — administration of hepatitis B vaccine and protective antibodies at birth — to explore the drug’s potential effects on mother-to-child transmission rates. The results appear in the New England Journal of Medicine.
“Limited evidence of the benefit of using antiviral drugs to prevent mother-to-child transmission of hepatitis B has led to conflicting practice recommendations around the world,” said Nahida Chakhtoura, M.D., a study team member and medical officer at NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). “Our study suggests that adding TDF to the current regimen seems to have little effect on infant infection rates when transmission rates are already low.”
Hepatitis B (link is external) virus can cause serious, long-term health problems, such as liver disease and cancer, and can spread from mother-to-child during delivery. According to the latest estimates from the World Health Organization (WHO), approximately 257 million people in 2015 were living with the virus. Countries in Asia have a high burden of hepatitis B. There is no cure, and antiviral drugs used to treat the infection usually need to be taken for life.
To prevent infection, WHO recommends that all newborns receive their first dose of hepatitis B vaccine within 24 hours of delivery. Infants born to hepatitis B-infected mothers are also given protective antibodies called hepatitis B immune globulin (HBIG). However, mother-to-child transmission can still occur in women with high levels of virus in their blood, as well as those with mutated versions of the virus.
The current study was conducted at 17 hospitals of the Ministry of Public Health in Thailand. It screened more than 2,500 women for eligibility and enrolled 331 pregnant women with hepatitis B. The women received placebo (163) or TDF (168) at intervals from 28 weeks of pregnancy to two months after delivery. All infants received standard hepatitis B preventatives given in Thailand, which include HBIG at birth and five doses of the hepatitis B vaccine by age 6 months (which differs from the three doses given in the United States). A total of 294 infants (147 in each group) were followed through age 6 months.
Three infants in the placebo group had hepatitis B infection at age 6 months, compared to zero infants in the TDF treatment group. Given the unexpectedly low transmission rate in the placebo group, the researchers concluded that the addition of TDF to current recommendations did not significantly reduce mother-to-child transmission of the virus.
“We observed no treatment-related safety concerns for the mothers or infants and no significant differences in infant growth,” said the study’s lead author Gonzague Jourdain, M.D., Ph.D., of Thailand’s Chiang Mai University, the Harvard T.H. Chan School of Public Health and France’s IRD (Institut de recherche pour le développement). “These safety data also are relevant for pregnant women receiving TDF as part of HIV treatment or HIV pre-exposure prophylaxis.”
According to the study authors, the clinical trial had enough participants to detect statistical differences if the transmission rate in the placebo group reached at least 12 percent, a rate observed in previous studies. Though the reasons are unknown, the researchers speculate that the lower transmission rate seen in the study may relate to the number of doses of hepatitis B vaccine given to infants in Thailand, lower rates of amniocentesis and Cesarean section deliveries in this study, or the lower prevalence of mutated viruses that result in higher vaccine efficacy in Thailand compared to other countries.
Funding for the study was provided under a cooperative agreement between NICHD, the U.S. Centers for Disease Control and Prevention and the IRD. Study drugs were donated by Gilead Sciences, Inc.
About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD conducts and supports research in the United States and throughout the world on fetal, infant and child development; maternal, child and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit NICHD’s website.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
Jourdain G et al., Tenofovir versus placebo to prevent hepatitis B perinatal transmission. New England Journal of Medicine DOI: 10.1056/NEJMoa170813 (2018).
