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Acute HCV Underreported, Time for Routine HCV Testing in USA...
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from Jules: I have been pushing for this for years. It has been obvious that this is needed because we have estimated for many years now that 75% with HCV are undiagnosed. Instead half-measures have been implemented because everyone is so afraid that no one would pay attention to HCV so they asked for less....the CDC emphasize only Baby Boomers as where the disease HCV lives & where we should focus attention, in reality at least 20-30% with HCV are not baby boomers....in addition now we see from this publication that CDC definitions of acute HCV are a root cause for horribly underreporting acute HCV as reported in this research article in Annals. Another reflection of the ineptitude in general of our federal govt in general. On top of that is a total failure of advocacy to raise adequate attention to HCV by the Federal. In the mid-1980s AIDS activists were effective & vocal in successfully getting the Federal govt to pay attention to HIV, but this has not been the case in HCV, ... we need a complete overhaul of HCV advocacy.....advocacy has been quiet, ineffective and low-key, play along to get along has been the motto, when will we wake up, when will our community realize the need to drastically change advocacy efforts, we need new & fresh advocacy. By the way I hear anecdotal reports go upticks in new acute HCV cases among MSM in key USA cities reflecting that unprotected sex and other risky behavior although PrEP may protect against HIV retransmission nothing is being said, no education regarding that HCV risk is increased if unprotected sex increases.
Acute hepatitis C infection in HIV-negative men who have sex with men [in London].....low HCV screening rate - (06/15/15)
Where next for hepatitis B and C surveillance?....."Hepatitis C Surveillance programmes are often weak" - (06/15/15)
"Gross Underreporting of Acute to CDC....'Tip of the Iceberg'.....less than 1% of clinically diagnosed acute HCV reported to CDC.....".......The authors note that, while the reported incidence of HCV infection in the U.S. has been decreasing since the 1990s, the rate of decrease has leveled off in recent years and may now be increasing due to an expanding opioid epidemic. "The CDC is already seeing increasing numbers of acute cases of HCV from a variety of jurisdictions -- including a recent report from Kentucky, Tennessee, Virginia and West Virginia," says Kim. "How large nationally is the 'iceberg' of HCV, given the growing numbers of persons who have injected drugs? An accurate estimate of the incidence of HCV is crucial for guiding public health initiatives, setting priorities and planning for future needs." ......Arthur Kim MD, Harvard Med School says, "Clinicians may wish to follow the recommendation that persons at high risk for HCV infection -- such as those who inject drugs -- be tested on an annual basis.
"We aimed to determine the proportion of clinical cases of acute HCV infection classified as confirmed for surveillance purposes and to determine why clinical cases were not counted in national statistics......in- Two hospitals and the state correctional health care system in Massachusetts....."
"This investigation showed that fewer than 1% of clinically diagnosed acute cases of HCV infection between 2001 and 2011 in Massachusetts ultimately were reported to the CDC as confirmed acute surveillance cases of HCV infection and included in national estimates of incidence of HCV infection."
"Our analysis suggests that national incidence of HCV infection during this time frame may be greater than previously estimated. In the context of a staggering increase in opiate use (2), with estimates of new heroin injectors reaching 178 000 in 2011 (30) and related outbreaks of HCV infection in other geographic locations (8, 31-33), a reexamination of the methods for measuring the burden of incident HCV infection in the United States is necessary."
"The incidence of HCV can be likened to an iceberg, in that only a fraction of cases-the proverbial tip-is visible," said Arthur Kim, MD, of the Massachusetts General Hospital's Division of Infectious Diseases, in Boston.......The Massachusetts surveillance system collects any evidence of HCV infection, allowing us to identify trends such as the epidemic of HCV in young people who inject drugs, despite this underestimation of acute infection. But in areas of the country where only acute HCV is reportable, this has likely delayed our understanding of the scope of this epidemic," said Shauna Onofrey, MPH, of the Massachusetts Department of Public Health......."The CDC is already seeing increasing numbers of acute cases of HCV from a variety of jurisdictions, including a recent report from Kentucky, Tennessee, Virginia and West Virginia," Dr. Kim said. "How large nationally is the iceberg of HCV, given the growing numbers of persons who have injected drugs? An accurate estimate of the incidence of HCV is crucial for guiding public health initiatives, setting priorities and planning for future needs."......The researchers called for better case definitions and partnerships with health care providers to collect the necessary clinical information that would enable public health officials to better target resources to respond to this epidemic. Dr. Kim said that, in response to this study, the Massachusetts health department has already changed its reporting procedures to improve capturing the change from a negative to a positive HCV antibody status by linking past test results with recent ones. Most recently, the Council of State and Territorial Epidemiologists, the organization that determines which health conditions are nationally reportable, changed its case definitions of active and chronic HCV infection-changes that will be adopted officially by the CDC in January 2016....."Clinicians may wish to follow the recommendation that persons at high risk for HCV infection-such as those who inject drugs-be tested on an annual basis," said Dr. Kim, who is also assistant professor of medicine at Harvard Medical School, in Boston......"Overall, I would argue that we should devote more resources to surveillance, so that we can better track cases as part of a comprehensive effort to prevent HCV and HIV infection in people who inject drugs, Dr. Kim noted. "Otherwise, the costs-both personal and financial-of allowing these infections to spread and treating them in the future will be quite high."
This investigation showed that fewer than 1% of clinically diagnosed acute cases of HCV infection between 2001 and 2011 in Massachusetts ultimately were reported to the CDC as confirmed acute surveillance cases of HCV infection and included in national estimates of incidence of HCV infection. This low rate of reporting to national authorities is problematic because it is already recognized that clinical diagnoses of acute HCV infection underestimate the true burden of new infections due to the difficulty in making a diagnosis, minimal symptoms, and fragmented care of patients at highest risk. The primary reason was not lack of reporting to the MDPH because approximately 80% of cases of acute HCV infection in this cohort were reported and eligible for further case investigation by the state. This rate of reporting is high compared with the relatively low rates of capture by surveillance in other jurisdictions (15-17). Massachusetts currently has more than 95% of clinical laboratories reporting results electronically to the MDPH's surveillance system, which allows for automated triage of data and centralized case management to prompt follow-up of potential acute cases of HCV infection (7-8). Moreover, surveillance for acute infection was enhanced in 2007 by more intensive requests for information in patients aged 15 to 25 years who were likely to have been infected recently. Despite these advantages, we found a low rate of confirmed surveillance case classification of acute HCV infection, resulting in gross underreporting to the CDC.
"An estimate of incidence using a multiplication factor relies on the base number of acute cases of HCV infection, which seems to be grossly underreported. The dearth of reported surveillance cases of acute infection was discordant with a burgeoning epidemic of HCV infection among adolescents and younger adults in Massachusetts (7-8). The CDC uses a multiplication factor of 20 to account for unreported cases when estimating incidence; for each case, they estimate 3.3 symptomatic and 16.7 asymptomatic cases (6). When applied to the 115 confirmed cases of acute HCV infection in Massachusetts reported to the CDC between 2001 and 2011, this correction factor results in 2300 total new cases. This estimate is substantially lower than the 16 622 confirmed cases of past or present HCV infection reported in Massachusetts residents aged 15 to 30 years during this same period. Moreover, confirmed cases may represent a fraction of true cases among at-risk persons because several studies suggest that most infected persons are unlikely to receive medical attention at all, let alone be reported to health departments (15, 24-27)."
Underascertainment of Acute Hepatitis C Virus Infections in the U.S. Surveillance System: A Case Series and Chart Review - (07/01/15)
To assist public health agencies in improving surveillance of acute HCV infection, several recommendations can be made based on our analysis. First, we agree with the decision to add seroconversion to the CDC's surveillance case definition of acute HCV infection in late 2012 to account for incident cases without need for an illness compatible with HCV infection, a criterion that is often absent, and to remove the requirement for negative test results for hepatitis A and B virus. Successful application of seroconversion as a criterion requires regular interval testing of high-risk patients (21). More detailed risk behavior history about specific injection practices and history of onset was extremely useful in a systematic screening for HCV infection in the Massachusetts state prison system, tripling the rate of identification (10). Second, because any seroconversion represents, at a minimum, incident infection, comprehensive capture of negative test results by surveillance systems would help to identify acute cases of HCV infection. Because only annual testing of high-risk populations is recommended (22), not every case will be captured reported by use of only a 6-month period; therefore, the time frame could be made consistent with current testing guidelines. Third, peak ALT levels are incompletely captured by current systems; improved ascertainment may be achieved by capturing more ALT values by automated means or chart review or by asking providers to report peak level instead of any level, which is likely to capture levels close to the case report completion. Finally, report of any single quantitative viral titer less than 100 000 IU/mL or fluctuations in HCV RNA levels greater than 1 log raises clinical suspicion for recent acquisition of HCV infection (12, 23) and could be incorporated to trigger investigation for potential cases. These HCV RNA criteria would be particularly helpful when the peak ALT level was not obtained. Electronic laboratory reporting and integrated surveillance systems, such as MAVEN, that allow synthesis of data from several facilities may be more comprehensive than data from a single clinical entity and may reduce reliance on the clinician's return of a cumbersome, detailed form. This approach would be particularly useful to capture seroconversions; however, the level of data management may exceed the current capacity of public health agencies.
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"To ascertain the likelihood of acute HCV infection, attempts to collect additional data about symptoms and laboratory results were made through completed CRFs. However, the forms were not returned for 46 (31%) of the 149 reported cases, precluding further classification (Figure 2). In addition, ALT levels were only available for 91 (61%) cases.
When an ALT level greater than 400 U/L was used as an indicator, only 25 cases were identified as potentially acute by levels reported to MAVEN despite approximately one half of patients exceeding this threshold during their clinical course
No cases were identified as acute when only the earliest ALT level reported to MAVEN was used. If the peak ALT level from the BAHSTION records had been available to the MDPH, 48 additional cases would have potentially been reviewed for acute status; otherwise, only 6 would have been reviewed because of reported jaundice or young age at the time of reporting. Five other cases were not eligible for review because of data entry error, missing ALT level, or co-infection with other hepatitis viruses.
The MDPH evaluated cases for acute status if the CRF included an ALT result greater than 400 U/L, jaundice, or-starting in 2007-younger age (15 to 25 years). Forty-three cases met at least 1 criterion and were evaluated for reasons described in Appendix Table 2. Only 1 met the CDC confirmed acute surveillance case definition and was reported to the National Notifiable Disease Surveillance System (Figure 2). Of the cases that were not reported, 17 met the pre-2012 CDC surveillance case definition except for documentation of testing for hepatitis A and B virus infection. The remaining cases did not meet the surveillance case definition because acute symptoms, jaundice, or ALT levels greater than 400 U/L were not reported (n = 16) or tests considered confirmatory for HCV infection according to the surveillance case definition were missing at the time of review (n = 9).
Cases were rereviewed with all available data from MAVEN and BAHSTION. According to the surveillance case definition of acute HCV infection used before 2012, 33 cases would have been reported to the CDC as acute if full data were available to the MDPH. An additional 75 cases met the surveillance case definition in 2012, which no longer required negative hepatitis A and B laboratory results and accepted a documented negative anti-HCV laboratory test result followed within 6 months by a positive result regardless of clinical presentation.
We then explored additional potential criteria for defining acute HCV infection. Expanding the seroconversion window to 12 months would have added 16 confirmed acute cases and expanding to 24 months would include 7 more. After 2 patients were reclassified as chronic (based on data in MAVEN), 50 clinical cases still did not meet an expanded surveillance case definition with seroconversion extended to 24 months. Six had a negative antibody test result more than 24 months before their first positive test result and still represented incident cases based on other diagnostic criteria. Fluctuating HCV RNA titers greater than 1 log, a rare occurrence in the chronic phase of HCV infection (12), were noted in 19 cases. The remaining 23 did not meet the criteria but had recent risk history compatible with acute HCV infection, especially initiation of injection drug use in the past year with new exposures by means of shared injection equipment."
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