Showing posts with label children treating HCV. Show all posts
Showing posts with label children treating HCV. Show all posts

Tuesday, November 13, 2018

Sofosbuvir/ledipasvir cures most young children with hepatitis C

Sofosbuvir/ledipasvir cures most young children with hepatitis C
Liz Highleyman 
Published: 13 November 2018
Almost all young children ages 3 to 6 years with chronic hepatitis C achieved sustained virological response after 12 weeks of treatment using sofosbuvir/ledipasvir oral granules, according to findings presented at the 2018 AASLD Liver Meeting in San Francisco.

The prevalence of hepatitis C virus (HCV) infection is low among children in Europe and the US, though there is concern that the rate may be rising in the US as more young women become infected as a consequence of the burgeoning opioid epidemic. In some resource-limited countries such as Egypt, HCV among children is much more common.

The advent of direct-acting antiviral agents (DAAs) has revolutionised the treatment of hepatitis C for adults. These include Gilead Science's HCV polymerase inhibitor sofosbuvir (marketed alone as Sovaldi) and NS5A inhibitor ledipasvir, which are co-formulated in a 400/90mg once-daily tablet (Harvoni). 

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Monday, November 12, 2018

Adolescents HCV Geno 1 or 4 -.Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir and With/Without Ribavirin

In Case You Missed It
Hepatol Commun. 2018 Nov; 2(11): 1311–1319.
Published online 2018 Oct 5. doi: [10.1002/hep4.1250]

Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir and With or Without Ribavirin for Adolescents With HCV Genotype 1 or 4.
Daniel H. Leung, 1 Stefan Wirth, 2 Betty B. Yao, 3 Rolando M. Viani, 3 , 13 Regino P. Gonzalez‐Peralta, 4 , 14 Maureen M. Jonas, 5 Steven J. Lobritto, 6 Michael R. Narkewicz, 7 Etienne Sokal, 8 ClĂ udia Fortuny, 9 Evelyn K. Hsu, 10 Antonio Del Valle‐Segarra, 11 Jiuhong Zha, 3 Lois Larsen, 3 Li Liu, 3 Diana L. Shuster, 3 , 15 Daniel E. Cohen, 3 and Philip Rosenthal 1

In adults, treatment of hepatitis C virus (HCV) infection with ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) with or without dasabuvir (DSV) and ±ribavirin (RBV) results in high rates of sustained virologic response (SVR). However, these regimens have not been investigated in adolescents. This ongoing, open‐label, phase 2/3 study evaluated the pharmacokinetics, safety, and efficacy of OBV/PTV/r+DSV±RBV treatment for 12 weeks in adolescents infected with HCV genotype (GT) 1 without cirrhosis (part 1) and the safety and efficacy of OBV/PTV/r±DSV±RBV treatment for 12 or 24 weeks in adolescents infected with GT1 or GT4 without cirrhosis or with compensated cirrhosis (parts 1 and 2). Patients were 12‐17 years of age and treatment naive or interferon experienced. Treatment regimens were based on HCV GT and cirrhosis status. Endpoints were SVR at posttreatment week 12 (SVR12), adverse events (AEs), and pharmacokinetic parameters. Thirty‐eight adolescents were enrolled, 66% were female patients, and 76% were White; 42%, 40%, and 18% of patients had HCV GT1a, GT1b, and GT4 infections, respectively. Median age was 15 years (range, 12‐17 years), and 1 patient had cirrhosis. The SVR12 rate was 100% (38/38; 95% confidence interval [CI], 90.8%‐100%). No treatment‐emergent grade 3 or 4 laboratory abnormalities were reported. No serious AEs occurred on treatment, and no AEs led to study drug discontinuation. The most common AEs were headache (21%), fatigue (18%), nasopharyngitis (13%), pruritus (13%), and upper respiratory tract infection (11%). Intensive pharmacokinetic results showed OBV, PTV, DSV, and ritonavir drug exposures were comparable to those seen in adults. Conclusion: Treatment with OBV/PTV/r±DSV±RBV was well tolerated and highly efficacious in adolescents with HCV GT1 or GT4 infection.

Friday, November 9, 2018

Gilead Presents Latest Data from Viral Hepatitis Research Programs at The Liver Meeting® 2018

November 09, 2018

– Data Demonstrate Sofosbuvir-Based Regimens Achieve High Cure Rates in Hepatitis C Patient Populations with Unmet Need –
– Early Data from Gilead’s Functional Hepatitis B Cure Program Suggest Activation of Immune Cells Crucial to Viral Clearance –
SAN FRANCISCO--(BUSINESS WIRE)--Nov. 9, 2018-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from studies investigating Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) in chronic hepatitis C virus (HCV) infected patients with severe renal impairment undergoing dialysis and Harvoni® (ledipasvir/sofosbuvir) in pediatric HCV patients aged three to five years, adding to the efficacy and safety profile of sofosbuvir-based regimens across diverse patient populations. These results, along with data from Gilead’s hepatitis B virus (HBV) cure development program, are being presented at The Liver Meeting® 2018 in San Francisco this week.
“Our scientific leadership has helped transform the treatment of patients with chronic hepatitis C infection and we remain committed to ensuring effective and well-tolerated treatment options for a broad range of patient populations.” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead Sciences. “For patients with chronic hepatitis B infection, we are intensifying our efforts to advance research and development toward a functional cure.”
Further Progress in the Treatment of Hepatitis C
Results from an open-label Phase 2 study demonstrated that treatment with the once-daily single-tablet regimen of Epclusa for 12 weeks in patients with genotype 1, 2, 3, 4 or 6 HCV and severe renal impairment undergoing dialysis resulted in cure rates (SVR12, or undetectable viral load 12 weeks after completion of therapy) of 95 percent (n=56/59) with only two patients experiencing virologic failure. The most common adverse events (AEs) (>10 percent) were headache, fatigue, nausea, vomiting and insomnia. No patients discontinued therapy due to an adverse event.
In another open-label Phase 2 study, children aged three to five years old with genotype 1 or 4 HCV infection received weight-based oral dosing of ledipasvir/sofosbuvir granules 33.75 mg/150 mg if < 17 kg or 45 mg/ 200 mg if ≥ 17 kg) once-daily for 12 weeks. Overall, 97 percent (n=33/34) of the patients were cured, and none experienced virologic failure. The most common AEs (>10 percent) were vomiting, cough, pyrexia, rhinorrhea and streptococcal pharyngitis. One patient discontinued treatment due to an adverse event of abnormal drug taste.
The use of Epclusa and Harvoni, including granules formulation, in the aforementioned patient populations is investigational; their safety and efficacy have not been established. The granule formulation is not approved. Epclusa and Harvoni are both indicated in the US for the treatment of chronic HCV infection in patients with no cirrhosis or compensated cirrhosis: Epclusa for adults with genotypes 1-6; and Harvoni for patients 12 years and older (or ≥35 kg) with genotypes 1, 4, 5 and 6. The US product labels for Epclusa and Harvoni each contain a Boxed Warning for the risk of hepatitis B reactivation in HCV/HBV co-infected patients. See below for US Important Safety Information.
Hepatitis B Cure Research
Gilead is presenting data on GS-9688, an investigational, oral selective toll-like receptor 8 (TLR8) agonist, one of several compounds under investigation as part of Gilead’s HBV cure program. The data support continued development of GS-9688 as a potential therapeutic approach for achieving a functional cure for patients with chronic HBV infection.
In the first-in-human, healthy volunteer safety study, GS-9688 was well-tolerated at single ascending doses up to 5mg and resulted in pharmacodynamic activity as demonstrated by the production of the systemic cytokines IL-1RA and IL-12p40 and by the activation of key relevant immune cells including natural killer (NK) cells and mucosal-associated invariant T (MAIT) cells. The most commonly reported AEs among people receiving doses up to and including 5 mg were nausea and vomiting. There were no reports of Grade 3 or higher AEs, laboratory AEs or serious adverse events (SAEs) and no discontinuations or deaths.
In a Phase 1b safety and tolerability study of GS-9688 in HBV chronically infected patients, dose-dependent activation of the cytokines IL-12p40 and IL-1RA was demonstrated with once weekly dosing for up to 4 weeks in viremic and virally-suppressed patients. There were no reports of SAEs; the most common AEs were headache and nausea. Based on these data, GS-9688 is currently being evaluated in Phase 2 studies in patients with chronic hepatitis B.
GS-9688 is an investigational agent and not approved; its safety and efficacy have not been established.
Latest Research in Hepatitis B Treatment
Presentations on Vemlidy® (tenofovir alafenamide 25mg, TAF) add further evidence to its established safety and efficacy profile in adults with chronic HBV and compensated liver disease, including longer term data on the safety of Vemlidy in virologically suppressed HBV patients. Through three years of treatment, patients originally randomized to receive TAF continued to show an improved bone and renal safety profile compared to treatment with tenofovir disoproxil fumarate 300mg (TDF) with maintained viral suppression. In a separate study in post-liver transplant patients virally suppressed on TDF-based regimens, switching to TAF maintained viral suppression in all TAF-treated patients with improvements in renal function and bone mineral density, after 48 weeks of treatment.
The use of Vemlidy in post-liver transplant patients is investigational; its safety and efficacy have not been established. Vemlidy is indicated in the US for the treatment of chronic HBV infection in adults with compensated liver disease. The US Prescribing Information for VEMLIDY contains a Boxed Warning regarding the risk of post treatment severe acute exacerbation of hepatitis B; see below for Important Safety Information.
US Important Safety Information About Epclusa and Harvoni
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with EPCLUSA or HARVONI. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals (DAAs) and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive, in patients with serologic evidence of resolved HBV, and also in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV DAAs may be increased in patients taking these other agents. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
Warnings and Precautions
Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with EPCLUSA or HARVONI due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. A fatal cardiac arrest was reported in a patient taking amiodarone who was coadministered a sofosbuvir containing regimen. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.
Risk of Reduced Therapeutic Effect Due to Use with P-gp Inducers and/or Moderate to Potent Inducers of CYP: Rifampin, St. John’s wort and carbamazepine are not recommended for use with EPCLUSA or with HARVONI. P-gp inducers may significantly decrease ledipasvir, sofosbuvir and/or velpatasvir plasma concentrations. Moderate to potent inducers of CYP2B6, CYP2C8 or CYP3A4 may significantly decrease sofosbuvir and/or velpatasvir plasma concentrations.
Adverse Reactions
The most common adverse reactions (≥10%, all grades) with EPCLUSA were headache and fatigue.
The most common adverse reactions (≥10%, all grades) with HARVONI were fatigue, headache, and asthenia.
Drug Interactions
EPCLUSA: Coadministration is not recommended with topotecan due to increased concentrations of topotecan; or with proton-pump inhibitors, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, efavirenz, and tipranavir/ritonavir due to decreased concentrations of sofosbuvir and/or velpatasvir.
HARVONI: Coadministration is not recommended with oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir due to decreased concentrations of ledipasvir and sofosbuvir; or with co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate due to increased concentrations of tenofovir; or with simeprevir due to increased concentrations of ledipasvir and simeprevir; or with rosuvastatin due to increased concentrations of rosuvastatin.
Consult the full Prescribing Information for EPCLUSA and HARVONI for more information on potentially significant drug interactions, including clinical comments.
US Important Safety Information About Vemlidy
Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
Warnings and Precautions
Risk of Development of HIV-1 Resistance in HBV/HIV-1 Coinfected Patients: Due to this risk, VEMLIDY alone should not be used for the treatment of HIV-1 infection. Safety and efficacy of VEMLIDY have not been established in HBV/HIV-1 coinfected patients. HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with VEMLIDY, and, if positive, an appropriate antiretroviral combination regimen that is recommended for HBV/HIV-1 coinfected patients should be used.
New Onset or Worsening Renal Impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical trials of VEMLIDY, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue VEMLIDY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Monitor renal function in all patients – See Dosage and Administration.
Lactic Acidosis and Severe Hepatomegaly with Steatosis: Fatal cases have been reported with the use of nucleoside analogs, including tenofovir DF. Discontinue VEMLIDY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.
Adverse Reactions
Most common adverse reactions (incidence ≥5%; all grades) were headache, abdominal pain, cough, back pain, fatigue, nausea, arthralgia, diarrhea, and dyspepsia.
Drug Interactions
Coadministration of VEMLIDY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir and the risk of adverse reactions.
Coadministration of VEMLIDY is not recommended with the following: oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John’s wort. Such coadministration is expected to decrease the concentration of tenofovir alafenamide, reducing the therapeutic effect of VEMLIDY. Drugs that strongly affect P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) activity may lead to changes in VEMLIDY absorption.
Consult the full prescribing information for VEMLIDY for more information on potentially significant drug interactions, including clinical comments.
Dosage and Administration
Dosage: Adults; 1 tablet taken once daily with food.
Renal Impairment, Screening, and Monitoring: VEMLIDY is not recommended in patients with CrCl <15 mL/min. In all patients, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein prior to initiating and during treatment, on a clinically appropriate schedule. In patients with chronic kidney disease, also assess serum phosphorus.
Hepatic Impairment: Not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment.
Testing Prior to Initiation: HIV infection.

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

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
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:

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- 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.

Reviewing the state of HCV and HBV in children

From the Journals
Reviewing the state of HCV and HBV in children
Publish date: November 6, 2018
By Mark S. Lesney ID Practitioner 
The natural histories of hepatitis B virus (HBV) and hepatitis C virus (HCV) are very different in children, compared with their progress in adults, and depends on age at time of infection, mode of acquisition, ethnicity, and genotype, according to a review in a special pediatric issue of Clinics in Liver Disease. Most children infected perinatally or vertically continue to be asymptomatic but are at uniquely higher risk of developing chronic viral hepatitis and progressing to liver cirrhosis and hepatocellular carcinoma (HCC), according to Krupa R. Mysore, MD, and Daniel H. Leung, MD, both of the Baylor College of Medicine, Houston. In addition, because the risk of progression to cancer along with such other liver damage is high in children, the reviewers stated that HCV and HBV can be classified as oncoviruses.

Monday, November 5, 2018

Listen-Pregnancy guidelines: Hepatitis C testing, preferably at the start of prenatal care.

Pregnancy guidelines around vitamin D, hepatitis C testing updated
Dr. Norman Swan, the host of Health Report, along with his guest Professor Jeremy Oats, discuss the new guidelines for hepatitis C testing for pregnant women, preferably at the start of prenatal care.

Listen here....
Monday 5 November 2018 5:52PM (view full episode)
Source: Health Report

Further Information
Med J Aust 2018; 209 (9): 409-412. || doi: 10.5694/mja18.00286
Published online: 5 November 2018
Updated clinical practice guidelines on pregnancy care

HCV Guidelines - Updated to include universal screening for pregnant women
Last update: May 24, 2018
The guidelines were developed by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America.

In The Media
Infectious Disease Advisor
Universal vs Risk-Based Screening in Pregnancy: An Expert Weighs In 
Tori Rodriguez, MA, LPC 
November 06, 2018
Infectious Disease Advisor interviewed Dr Espinosa for additional insights on the topic of universal HCV screening in pregnancy.

Infectious Disease Advisor: What are some of the issues and potential benefits pertaining to universal HCV screening for pregnant women?

Dr Espinosa: Several studies have shown that risk-based screening misses many cases of infection. Several reasons account for that — for example, the screening tools are not perfect, patients do not trust the provider or just do not want to admit risks factors, and many may just not want the risk factors to be permanently part of their medical record.

These factors are not unique to hepatitis C risk factors, as we have seen it happening with other infectious diseases such as HIV. It was not until universal screening for HIV was implemented for pregnant women that the rates of perinatal transmission dramatically decreased.

Universal screening in pregnant women will destigmatize hepatitis C and increase awareness. The United States is [in the midst of] an epidemic that should be controlled, and transmission will not decrease unless several actions are taken. We will not know the true burden of the disease if we do not increase screening. 

On This Blog
Monday, October 22, 2018
Hepatitis C Virus in Women of Childbearing Age, Pregnant Women, and Children

Monday, October 22, 2018

Hepatitis C Virus in Women of Childbearing Age, Pregnant Women, and Children

Of Interest
Recent increases in hepatitis C among women of child-bearing age have led public health advocates to call for universal HCV screening in all pregnant women, regardless of reported risk factors. Read our new fact sheet for an overview of the reasons why HCV screening should be expanded. 
View and download the fact sheet here.

The American Journal of Preventive Medicine
Am J Prev Med. 2018 Nov;55(5):633-641. doi: 10.1016/j.amepre.2018.05.029.
Hepatitis C Virus in Women of Childbearing Age, Pregnant Women, and Children.
Schillie SF1, Canary L2, Koneru A2, Nelson NP2, Tanico W3, Kaufman HW4, Hariri S2, Vellozzi CJ2.
Full-text article online:
Download PDF

This study identified trends in hepatitis C virus testing and positivity in women of childbearing age, pregnant women, and children aged less than 5 years. Among women who delivered live births in 2015, hepatitis C virus–infected women were more likely to be aged 20–29 years, white, non-Hispanic, covered by Medicaid, and living in rural areas. From 2011 to 2016, hepatitis C virus testing increased by 39% among women of childbearing age, 135% in pregnant women, and 25% among children. Hepatitis C virus positivity increased by 36% among women of childbearing age, 39% in pregnant women, and 13% among children. 

Perinatal transmission is an increasingly important mode of hepatitis C virus transmission. The authors characterized U.S. births among hepatitis C virus-infected women and evaluated trends in hepatitis C virus testing and positivity in women of childbearing age, pregnant women, and children aged less than 5years.

In 2017, National Center for Health Statistics birth certificate data (48 states and District of Columbia) were analyzed to assess the number of hepatitis C virus-infected women delivering live births in 2015, and commercial laboratory data were analyzed to assess hepatitis C virus testing and positivity among women of childbearing age, pregnant women, and children aged <5years from 2011 to 2016.

In 2015, a total of 0.38% (n=14,417) of live births were delivered by hepatitis C virus-infected women. Births delivered by hepatitis C virus-infected women, compared with births overall, occurred more often in women who were aged 20-29years (60.7% vs 50.9%); white, non-Hispanic (80.2% vs 52.8%); covered by Medicaid or other government insurance (79.2% vs 43.9%); and had rural residence (26.0% vs 14.0%). From 2011 to 2016 laboratory data, among women of childbearing age, hepatitis C virus testing increased by 39%, from 6.1% to 8.4%, and positivity increased by 36%, from 4.4% to 6.0%. Among pregnant women, hepatitis C virus testing increased by 135%, from 5.7% to 13.4%, and positivity increased by 39%, from 2.6% to 3.6%. Among children, hepatitis C virus testing increased by 25%, from 0.47% to 0.59%, and positivity increased by 13%, from 3.6% to 4.0%.

The potential for perinatal hepatitis C virus transmission exists. Expanded hepatitis C virus testing guidelines may address the burden of disease in this population.

Tuesday, October 9, 2018

Tackling the Challenges Associated With Treating Hepatitis C Infection in Pediatric Patients

Tackling the Challenges Associated With Treating Hepatitis C Infection in Pediatric Patients

Infectious Disease Advisor spoke further with Dr Espinosa to learn more about challenges and potential solutions regarding HCV infection in younger patients.

Infectious Disease Advisor: What are some of the challenges pertaining to HCV management in pediatric patients?

Children infected with hepatitis C face environmental, provider, and system-based challenges, such as underreporting. The lack of screening in pregnant women in many states makes it difficult to identify infected children, as the disease may not be symptomatic for years. In fact, Kentucky just recently passed a bill for universal screening. There is a lack of structured protocols to follow-up on those affected children so we can identify earlier, rather than later, those who will require therapy.

There is also a lack of provider education regarding proper follow-up and necessary testing. Some providers may be uncertain about identifying the correct test to use in the setting of many different options.

Tuesday, August 14, 2018

Hepatitis C virus infection in children: How do we prevent it and how do we treat it?

Hepatitis C virus infection in children: How do we prevent it and how do we treat it?
Nwaohiri A, et al. Expert Rev Anti Infect Ther. 2018.

The following article was downloaded and shared by Henry E. Chang via twitter

Full Article
Download complete article: 

Hepatitis C Virus (HCV) infection is an important contributor to the worldwide burden of liver-related morbidity and mortality. Mother-to-child transmission of HCV ranges from 6-11% in different populations globally, but accurate estimates on the burden of pediatric HCV infection are limited because screening approaches are not consistent. Areas covered: The advent of new direct-acting antiviral agents that achieve very high rates of sustained virologic response, (representing virologic cure) with short (i.e., 8 to 12 weeks) regimens has revolutionized the field of HCV treatment and led to the development of global elimination goals for HCV transmission and mortality. However, information on their safety during pregnancy and efficacy in preventing mother-to-child transmission is lacking. Currently, there are no approved treatment regimens with these antiviral agents for children younger than 12 years of age. Expert Commentary: If these agents are shown to be safe during pregnancy and effective in preventing transmission to the infant, screening of pregnant women and antenatal treatment of those infected, could pave the way for eliminating pediatric HCV infection- particularly as these drugs become less costly and more accessible. Treatment of infected children when indicated, along with universal safe health care practices, can further pediatric HCV elimination.

Continue to article.....

Wednesday, June 27, 2018

Hepatitis C virus infection in children in the era of direct-acting antiviral

World J Gastroenterol. Jun 28, 2018; 24(24): 2555-2566
Published online Jun 28, 2018. doi: 10.3748/wjg.v24.i24.2555

Hepatitis C virus infection in children in the era of direct-acting antiviral

Malgorzata Pawlowska, Malgorzata Sobolewska-Pilarczyk, Krzysztof Domagalski 

Core tip: There are more than 11 million hepatitis C virus (HCV)-infected children worldwide. Most new HCV-infected cases have occurred through vertical transmission. Currently, a new era of highly effective direct-acting antiviral agents for the treatment of HCV infection has begun for pediatric patients. The first results of clinical trials with interferon-free therapy are very promising. ESPGHAN developed a position paper for the management of chronic HCV infection in children. Non-invasive methods to measure hepatic fibrosis enable the identification of patients with significant liver fibrosis. This article summarizes the current data on epidemiology, new therapies and non-invasive methods in pediatric patients with HCV infection.

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Thursday, April 26, 2018

A pilot single arm observational study of sofosbuvir/ledipasvir (200 + 45 mg) in 6‐ to 12‐ year old children

A pilot single arm observational study of sofosbuvir/ledipasvir (200 + 45 mg) in 6‐ to 12‐ year old children
M. H. F. El‐Shabrawi N. M. Kamal H. R. El‐Khayat E. M. Kamal M. M. A. H. AbdElgawad M. Yakoot

First published: 25 April 2018

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No available data on the use of sofosbuvir/ledipasvir combination in treatment of hepatitis C virus (HCV) infection in children 6‐ to 12‐ year old.

To assess the safety and efficacy of sofosbuvir plus ledipasvir in children 6‐ to 12‐ year old with chronic HCV genotype 4 infection.

This is a pilot prospective single arm observational open‐label multicentre study. A total of 20 consecutive eligible chronic HCV infected children, aged from 6‐ to 12‐ years were included in this study and treated with a fixed sofosbuvir/ledipasvir combination in half the adult dose (200/45 mg) once daily for 12 weeks. Laboratory tests including virological markers were measured at baseline, 2, 4, 8 and 12 weeks (end of treatment [EOT]), and 12 weeks after end of treatment for sustained virological response 12 (SVR12).

The intention‐to‐treat (ITT) SVR12 rate was 19/20 (95%; 95% CI: 76.4%‐99.1%). SVR12 was not assessed in one patient who was lost to follow‐up after showing viral negativity at the EOT12. All the remaining 19 patients (100%, 95% CI: 83.18%‐100%) who completed the full protocol and follow‐up visits achieved SVR12 with normal liver, haematological, and renal function tests and no side effects or fatalities.

This pilot study demonstrated that the fixed dose sofosbuvir/ledipasvir combination could be safe and effective treatment in children 6‐ to 12‐ years with chronic hepatitis C genotype 4 infection. Our pilot results might encourage larger and multicentre studies in this age group.

Friday, March 23, 2018

A serious liver ailment is stalking Kentucky's children. But they aren't getting care

A serious liver ailment is stalking Kentucky's children. But they aren't getting care
The Courier-Journal
A Courier Journal investigation found hepatitis C has skyrocketed among Kentucky births amid the state's raging drug epidemic, but attempts to prevent, track and control the infectious, curable disease have fallen short. That means many kids don't get the care they need, risking cirrhosis and liver cancer ...

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Of Interest
Webcast lecture presented at Conference on Retroviruses and Opportunistic Infections (CROI)
March 4 to March 7, 2018
Boston MA

Link - HCV Prevention and Treatment In Children
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Monday, February 26, 2018

Podcast: What happens when a pregnant woman has hepatitis C

Host: Amber Smith

What happens when a pregnant woman has hepatitis C
Rates of hepatitis C infections are on the rise among adults in the United States, and some of those adults are pregnant women. Helene Bernstein, MD, PhD, explains how the disease can easily be diagnosed through a blood test and treated with medication. (Click here for a paper she published on this topic.) She’s an associate professor of obstetrics and gynecology and of microbiology and immunology at Upstate.

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Thursday, February 22nd, 2018
Upstate University Hospital