Caitlyn Fitzpatrick

 on March 8, 2017, examines hepatitis C (HCV) testing rates among individuals born between 1945 and 1965, often referred to as “baby boomers.”

In 2013, the US Preventive Services Task Force (USPSTF) advised all baby boomers to be tested for HCV. Although testing prevalence increased by 2015, the rate is still lower than officials would like it to be.

There are approximately 3.5 million people infected with HCV in the United States. Of these, 80% are baby boomers. Unfortunately, most individuals living with HCV are not aware of their infection status, and so the USPSTF recommendation is meant to increase HCV diagnosis in those populations. In addition, increased diagnosis would lower the risk of HCV infections developing into serious liver disease, such as cirrhosis or hepatocellular carcinoma.

While there was some progress in HCV diagnosis rates, study authors Ahmedin Jemal, DVM, PhD, and Stacey A. Fedewa, PhD, of Surveillance and Health Services Research of the American Cancer Society in Atlanta, Georgia, found that it was minimal.  

The study cohort included 23,967 baby boomers, on whom data was collected between 2013 and 2015 form the National Interview Survey. Of these, only 21,827 study participants had complete records, including self-reported HCV blood testing.

Although small, there was a statistically significant increase in HCV testing two years after the USPSTF recommendation was implemented—12.3% to 13.8% (P = 0.013). Nevertheless, only 10.5 million of the 76.2 million baby boomers in the United States in 2015 were tested.  

“Reasons for the overall slow uptake of testing may include barriers to preventive care; unapparent symptoms; lack of awareness of the need to be tested among patients, who may not be fully covered by insurers; and lack of physician awareness of the USPSTF recommendations,” the researchers detailed.  

The study found that men were more likely to be tested than women (prevalence ratio (PR): 1.25, 95% confidence ratio: 1.08, 1.44). In addition, those who had lived with individuals known to have HCV infections were also more likely to get tested than those who did not share that experience (PR: 2.44, 95% CI: 2.01, 2.96).

Furthermore, those with just a high school diploma or less education had a lower testing rate than those who were college graduates (PR: 0.63, 95% CI: 0.48, 0.82 vs. PR: 0.58, 95% CI: 0.48, 0.72).  

Additionally, insurance type appeared to play an important role in predicting whether or not a baby boomer had been tested for HCV. Higher screening was found in those with Medicare plus Medicaid (PR: 1.83, 95% CI: 1.32, 2.53), just Medicaid (PR: 1.35, 95% CI: 1.04, 1.76), and military insurance (PR: 1.62, 95% CI: 1.16, 2.26), relative to privately insured adults. The researchers explained that the higher testing rate in people with military insurance could be credited to the ongoing efforts of the Veterans Health Administration, since 

The team noted that their findings showed a substantially lower rate of HCV diagnoses than those of other studies. In one study, 90% of patients at a safety net clinic had been tested for HCV. In another study conducted at a New York community hospital, screening increased from 47% to 88%. The lower testing results in the recent study could be due to underreporting of testing. Furthermore, this study was population-based while the others were institution-based.  

Despite the increase in HCV-testing following the USPSTF recommendation, there seems to be an overwhelming need to get baby boomers into doctors’ offices.  

“These findings underscore the need for increased awareness for hepatitis C testing among healthcare providers and baby boomers and other innovative strategies such as state-mandated hepatitis C testing,” the researchers concluded.  

The USPSTF recommendation follows that of the Centers for Disease Control and Prevention which urges baby boomers to get tested. As a cause of several liver complications, it is important to work towards not only diagnosing HCV infection, but curing it as well. A recent 

 out of Egypt hopes to eradicate HCV infection from around the world by offering low-cost treatment to the programs’ participants; this is in alignment with the World Health Organization’s goal of eradicating HCV by 2030.

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When the US Preventive Services Task Force (USPSTF) recommended that all baby boomers undergo a one-time hepatitis C screening in 2013, testing prevalence increased. However, the rate is still lower than officials would like to see.

HCV Testing Remains Low Among High-Risk Population

At the Conference on Retroviruses and Opportunistic Infections (CROI 2017) in Seattle, Washington, researchers from MedStar Health Research Institute in Maryland presented new data on hepatitis C virus (HCV)-positive non-baby boomers.

It’s widely acknowledged that those individuals belonging to the 

 age group (those born between 1946 and 1964) are at higher risk of acquiring HCV infection. According to the Centers for Disease Control and Prevention (CDC), these individuals are five times more likely to be infected with HCV. However, other at-risk populations may not be getting adequately tested for the virus.

Baby boomers are at a higher risk for HCV, but the reason why isn’t completely understood. Some researchers say that HCV transmission was highest from the 1960s to 1980s; others attribute it more to the fact that this group was exposed to infected medical equipment before sufficient transmission precautions were put into place. This is why the CDC recommends that all people in this population get tested for HCV, even if they don’t have any other risk factors. Beyond baby boomers, those who have ever injected drugs and those who received a blood transfusion or organ donation before 1992 are also advised to get tested.

The study presented at CROI2017 examined 329 non-baby boomers tested between July 1, 2015 and June 30, 2016. The case-control analysis did not match controls for age, sex, or race—although clinical studies typically do&mdash;because the researchers wanted to observe potential differences.

Of the study participants, 80 (1.7%) were HCV antibody positive (Ab+) or indeterminate, compared to the 249 HCV antibody negative (Ab-) controls.

Baseline characteristics for the 329 participants differed based on whether they were Ab+ or Ab-: respectively, the results showed that about 55.8% and 45% were female, 48.2% and 36.3% were African American, and 69.1% and 46.3% held private insurance. The average age differed depending on whether or not the participants were in the “baby boomer” age group—around 36 years and 75 years between the two antibody groups.

Risk factors that could contribute to HCV infections were documented among the participants. For the Ab+ and Ab- groups, participants had opiate prescriptions (40% and 20.1%), elevated liver function tests (17.5% and 14.5%), drug use (35% and 1.6%), high sexual behavior (6.3% and 16.9%), renal disease (2.5% and 2%), sexually transmitted infections (10% and 10%), and HIV (5% and 2.8%). One participant had a blood transfusion (Ab+), two had cirrhosis (Ab+), and three had alcohol abuse (two Ab+, one Ab-).

About 50% of those participants in the age clusters of 46 to 50 and 71 to 75 tested positive.

The researchers explained, “There was a significant interaction for age and opiate prescription use with those over 40 with an opiate prescribed 11x more likely to be hepatitis C Ab+.” Participants were also more likely to be HCV Ab+ if they had drug use, Medicaid (over private insurance), and were Caucasian (over any other race).

Previous research has found that drug use is a strong indicator of HCV-positive status, and this recent study backs that up. However, the researchers found that more non-baby boomers with HCV are Caucasian than African American—which is the opposite among baby boomers.

A total of 18 HCV Ab+ (23%) and 123 HCV Ab- (49%) participants did not have any risk factors indicated in the study.

The authors concluded, “Testing non-[baby boomer] patients only on the basis of risk factors has the potential to miss a significant number of hepatitis C Ab+ patients.”

In a study presented at CROI 2017 in Seattle, Washington, researchers from MedStar Health Research Institute presented new data on HCV infection in non-baby boomer populations.

HCV Screening Should Not Just Focus on At-Risk Populations

Hepatitis C (HCV) and HIV remain prevalent infections in the United States partially because many individuals are unaware that they are infected. Indeed, this is the reason behind many recent social media campaigns encouraging individuals to #KnowYourStatus or be #HepAware.

To learn even more about how many individuals are unaware of their status, Lucia V. Torian, PhD, of the New York City Department of Health and Mental Hygiene, and colleagues studied individuals who presented to a busy NYC emergency room (ER) to discover how many were unaware of their status. The findings of their study were recently presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2017) in Seattle, Washington.

Dr. Torian and her team gathered data from remnant serum of patients who visited the Bronx ER between March 8, 2015 and May 8, 2015. Blood was drawn from 63% of ER presenters, which was unusually high, according to the researchers. (The researchers noted that the study was blinded. Participants did not give consent in order to avoid patients’ bias due to perceived risk. In addition, all patient identifiers were permanently removed from the database.)

After drawing the blood, “the first consecutive 5,004 specimens appearing to have sufficient remnant serum to complete the two- or three-step testing algorithm for HIV or HCV were selected and transferred to the laboratory,” Dr. Torian and her team explained.

HIV diagnoses were screened using the fourth generation combination Antigen-Antibody immunoassay (Architect HIV Ag/Ab Combo) and confirmed with the second generation rapid HIV-1/HIV-2 differentiation assay (BioRad Multispot HIV-1/HIV-2 Rapid Test).

The Vitros Anti-HCV Immunodiagnostic Test screened for HCV with a reactive result being signal-to-cutoff ratio of >1.0. Infection was confirmed with the HCV RNA Polymerase Chain Reaction (PCR), with a positive result being >15 copies of HCV RNA/mL.

Out of the 4,990 completed tests for HIV, 308 patients were repeatedly reactive on screening. Two hundred and forty-eight patients were reactive with supplemental testing and two patients had antibody-negative/RNA positive acute HIV infections—bringing the total to 250 HIV-positive ER visitors (5%). The researchers found that only 12 of the 250 individuals who tested positive were undiagnosed (seven males, five females). Seven of the undiagnosed patients were ages 40 to 59. The researchers found anti-HCV antibody in 372 of 4,989 participants (7.5%) with completed results. The confirmatory test showed HCV RNA positive in 196 individuals&mdash;38 of which (19.2%) of which were undiagnosed.

The researchers also found a substantial number of coinfections in the cohort of patients. Of HIV-positive individuals, 32% had anti-HCV antibody; 21% of those who were anti-HCV positive had HIV. In addition, 16% of those with HIV were HCV RNA positive; 19% of HCV RNA positive also had HIV.

According to the researchers, the prevalence of HIV and the number of undiagnosed cases were actually the lowest in the history of serosurveys conducted in NYC ERs. The prevalence of HCV and the number of undiagnosed cases, however, were higher in this serosurvey than what officials estimated city-wide. Those individuals from the baby boomer generation (those born between 1945 and 1965) had the highest HCV prevalence in the study. According to the Centers for Disease Control and Prevention (

), “national prevalence data show that people born during these years are five times more likely than other adults to be infected.” The researchers found that individuals aged 40 to 59 years and 70 to 89 years also had high rates of HCV.

Although this study shows the number of undiagnosed patients on a localized scale, the CDC estimates that on a larger scale, 13% of individuals infected with HIV and 50% of individuals infected with HCV are not aware of their positive status.

Research presented at the recent Conference on Retroviruses and Opportunistic Infections shows that more individuals are aware of their HIV and hepatitis C (HCV) status, but more work is still needed.

HIV and HCV Status Awareness Rates Improving in NYC

Researchers from Johns Hopkins School of Medicine and the National Institute of Allergy and Infectious Diseases used various assay algorithms in the aims of better understanding the pre-seroconversion window in patients with acute hepatitis C (HCV) infection.

Pre-seroconversion window is the amount of time when a patient is virologically positive but IgG antibody (Ab) negative, this depends on the testing method used. The research team’s findings were presented at the Conference on Retroviruses and Opportunistic Infections (

Individuals tend to develop acute HCV between 2 weeks to 6 months after viremia. 

 does not always lead to chronic HCV; however, since acute infection is mostly asymptomatic and rarely diagnosed, many individuals go on to develop chronic HCV. In those who do present with symptoms, acute HCV can cause jaundice, dark urine, white stool, nausea, and upper abdomen pain for anywhere between 2 and 12 weeks.

The researchers pulled data from studies on commercially available HCV seroconversion panels. They evaluated primary viral infection and subsequent IgG Ab seroconversion. Laboratory results were gathered from 82 repeat donors, making up 754 visits. Thirty-nine of them were excluded—23 were HCV RNA positive at baseline, 12 remained HCV negative during the study period, and four whose interval to estimate the initial infection date more than 30 days.

The 43 donors who remained had acute HCV infection with a median of four days in between clinic visits.

Date of detectable infection was estimated using HCV RNA positivity (nucleic acid testing (NAT) by any assay) and Murex HCV Ag/Ab Combo Assay. Date of detectable seroconversion was estimated using the Architect Anti-HCV Assay, Ortho HCV Version 3.0 ELISA, and Murex 4.0 ELISA.

“The average time spent in the RNA +/Ab- stage prior to positivity by the Murex HCV Ag/Ab Combo assay was estimated to be 18 days and 25 days from the binomial regression models fitted with logit-cubic link function and log-log link function, respectively,” the researchers explained.

The team estimated the mean duration of recent infection (MDRI) prior to seroconversion with six different testing algorithms. The results showed that MDRI point estimates with the NAT (considered the gold standard) ranged from 29 to 41 days. The Murex HCV Ag/Ab Combo assay showed 25 to 45 days.

The Architect Anti-HCV assay and Murex 4.0 ELISA had equivalent MDRI point estimates and 95% confidence intervals—40 to 45 days&mdash;for patients tested with all assays, except Ortho. NAT and Murex HCV Ag/Ab Combo assay also had similar MDRI estimates.

“Our estimates regarding the pre-seroconversion window period of acute HCV infection are in agreement with the published literature (~45 days), including previous estimates calculated among people who inject drugs,” the team confirmed.

The assays had fairly consisted of MDRI point estimates. The Ag/Ab assay may be a more cost-effective option than NAT for the HCV seronegative populations. Confidence intervals were also similar, but more investigation is needed due to some inconsistency, the researchers said.

Although up to 80% of acute HCV infections develop into chronic cases, concentrating on the short-term infections is important in order to reach the World Health Organization’s goal of 90% reduction in HCV cases by 2030.

Researchers presented their findings on pre-seroconversion window in patients with acute HCV infection at the Conference on Retrovirus and Opportunistic Infections in Seattle, Washington.

Examining the Pre-Seroconversion Window in Patients with Acute Hepatitis C

, researchers from the United Kingdom investigated the overall risk of developing hepatocellular carcinoma based on the different causes of cirrhosis.

Fibrosis, or the development of scar tissue, occurs as a result of the body trying to repair injured tissues. Likewise, liver fibrosis occurs after the body tries to restore the liver after it is injured due to infection. 

 develops when a patient’s liver becomes excessively scarred due to hepatitis, chronic alcoholism, or other liver conditions. As more scar tissues form on the liver, it becomes increasingly difficult for the liver to function properly. Unfortunately, damage to the liver as a result of cirrhosis is irreversible; however, if caught and treated early, additional damage to the liver may be preventable.

Cirrhosis has long been thought to be a major risk factor for hepatocellular carcinoma (HCC), the most common form of liver cancer. Cirrhosis also limits cancer treatments. But a new study has found that cancer incidence in patients with cirrhosis is lower than originally believed—at most, about 4%. Noting that there is little research that actually supports the cirrhosis-cancer link, researchers from The University of Nottingham set out to identify the cumulative incidence of HCC in individuals with cirrhosis.

Joe West, PhD, and colleagues gathered data on 3,107 patients with cirrhosis from the UK’s General Practice Research Database (1987 to 2006); HCC diagnoses were collected from linked national cancer registries (1971 to 2006). Using a Cox proportional hazards regression model, the researchers were able to estimate hazard ratios and predict 10-year cumulative incidence of HCC.

Just over half of the patients were male and between the ages of 18 and 65. The study subjects had various etiologies leading to cirrhosis, with the highest being alcohol at 56% (1,743 patients), followed by cryptogenic at 21% (647 patients), chronic viral hepatitis at 12% (374 patients), and autoimmune or metabolic disease at 11% (342 patients).

A total of 51 patients developed HCC within a decade (1.2% of patients with alcoholic cirrhosis and 1.1% of those with cirrhosis of unknown cause).

“This very low incidence of HCC occurrence in people with cirrhosis caused by alcohol or of unknown origin suggests that surveillance for HCC among these groups is likely to benefit patients little,” Dr. West, professor epidemiology at the university’s School of Medicine, said in a 

Study results showed that, “the adjusted relative risk of HCC was increased two-fold to three-fold among people with viral and autoimmune/metabolic etiologies, compared to those with alcohol-associated cirrhosis,” the authors wrote in the study.

Further findings indicated that 1.1% of patients with cryptogenic, 3.2% with autoimmune or metabolic disease, and 4% with chronic viral hepatitis developed HCC within 10 years.

Looking at the overall population—making up 12,977 person years&mdash;the HCC rate was 3.9 per 1,000 person years (0.4% annually).

“As surveillance incurs substantial cost, it is therefore unlikely to represent value for money for the NHS,” West concluded. “There may well be other ways of spending this money that would benefit patients far more.”

A new study finds that cancer incidence in individuals with cirrhosis is lower than originally believed&mdash;at most, about 4%.

Cirrhosis Found Less Likely to Cause Liver Cancer Than Previously Thought

A group of researchers recently published a study in 

Journal of the American Medical Association 

), examining conflicts of interest (COIs) among committee members who set hepatitis C (HCV) and cholesterol management guidelines. They found that there, in fact, were COIs among committee members setting HCV management guidelines.

Akilah Jefferson, MD, MSc, and Steven Pearson, MD, MSc, set out to see if the Institute of Medicine’s (IOM) standards for managing conflicts were met in the final September 2015 print version of the HCV guideline. Clinical HCV guidelines describe protocols on testing, management, treatment, and additional aspects of the disease. They are meant to be evidence-based and free from bias. The IOM is one division of the National Academies of Sciences, Engineering, and Medicine, which is made up of private, nonprofit institutions. In their 

, the physicians analyzed whether the guidelines met IOM COI standards based on the 

Clinical Practice Guidelines We Can Trust

In order for an individual to qualify to be a guideline committee member or a chair or co-chair, she or he must meet the following IOM standards: 1) the guideline committee chair or co-chair must not have any commercial COIs; 2) among committee members, less than 50% of the individuals are permitted to have any commercial COIs.

Jefferson and Pearson examined disclosure statements to determine if guidelines were adhering to those standards. They used evidence from the 2014 American Association for the Study of Liver Diseases and Infectious Diseases Society of America HCV management guidelines.

“Little is known regarding whether IOM standards for managing COI have been met in development of recent important clinical guidelines,” the team wrote in 

There was a total of 29 committee members involved in deciding the HCV guidelines. Of those:

62% of members (18) disclosed industry-sponsored research

34% of members (10) served on advisory boards

17% of members (5) served on data safety monitoring boards

10% of members (3) reported other honoraria 

67% of co-chairs (4) had commercial COI and had additional COI in other publications which were not revealed in the disclosures 

The researchers also discovered that another co-chair had a commercial COI.

The HCV guideline met all nine of the IOM guideline for development and evidence standards. However, it did not fully meet standards for commercial COI management. It was common for committee member disclosures to be inconsistent in guidelines disclosures and contemporaneous articles.

“Adoption of consistent COI frameworks across specialty societies may help ensure that clinical guidelines are developed in a transparent and trustworthy manner,” the physicians concluded.

A group of researchers recently published a study in JAMA, examining conflicts of interest (COIs) among committee members who set hepatitis C (HCV) and cholesterol management guidelines. They found that there, in fact, were COIs among committee members setting HCV management guidelines.
 

Caitlyn Fitzpatrick

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