The American Journal of Gastroenterology
The American Journal of Gastroenterology, September 14, 2015
Insights From the National Health and Nutrition Examination Hepatitis C Follow-Up Study
Ivo Ditah MD; MPhil; Badr Al Bawardy MD; Humberto C. Gonzalez MD; Behnam Saberi MD; Callistus Ditah; Patrick S. Kamath MD; Michael Charlton MD
Am J Gastroenterol. 2015;110(8):1126-1133.
This analysis of the NHANES HCV follow-up data has produced findings with significant public health and policy implications. First, as of 2010, about 3.2 million individuals in the United States have chronic HCV infection. About half of those infected were unaware of their status. Four-fifths of people who screen HCV positive and could be contacted on follow-up pursued downstream care. Regrettably, a significant proportion of HCV-positive individuals remain difficult to reach. The main barrier to seeking downstream HCV care was lack of health insurance. Knowledge about HCV infection did not influence care behavior following a positive test result.
The screening recommendations proposed by CDC and USPSTF represent an important step toward the control of HCV infection in the United States. However, screening for HCV infection is cost effective,[15,19] provided that the health-care system has sufficient capacity to deliver appropriate downstream care to the screen-detected individuals.[20] If accompanied by appropriate treatment, the HCV screening can reduce the risk for hepatocellular carcinoma by 70% and for all-cause mortality by 50%.[21,22] It is important to recognize that screening for a disease in asymptomatic individuals is not without consequences, including discrimination, family conflict, stigmatization, insurance denial/higher costs, and psychological distress.[23] To fully realize its intended benefits, screening programs must serve as a path to effective treatment to mitigate harms associated with identifying asymptomatic HCV subjects.
The therapeutic landscape of HCV infection is rapidly changing.[24] Interferon-free, all-oral, highly effective, and well-tolerated therapy for HCV is now becoming a reality. Previously, many patients diagnosed with HCV infection forwent treatment because of contraindications and concerns regarding medication side effects. While many of these obstacles have now become less of a problem with the new drugs, cost remains a major concern. In the first several months of treatment with the new agents, United Health reported expenditures multiple times what it had expected.[25] HCV infection has many attributes that make eradication possible; it is curable, transmission can be controlled and there is no non-human reservoir. Although optimism for possible eradication is justifiable, the high cost of treatment is a cause for caution, as only people with access to therapy stand to benefit from the new antiviral agents.
The main goal of this study was to identify barriers to downstream care in screen-positive HCV individuals. It is ethically not acceptable to offer screening unless treatment is guaranteed or measures can be taken to reduce the risk of transmission. Now that universal cure of patients with HCV seems plausible, a coordinated effort that links patients to treatment should be a high priority and should be inherent to any screening program for HCV infection. In this national sample, we found that having health insurance or not was the only factor that determined whether an individual pursued downstream care or not following a positive result. It is interesting to note that while non-Hispanic blacks, people who are less educated, and those who inject drugs are among those who bear the highest burden of hepatitis C in the general population,[26] these factors did not influence subsequent HCV-related care behavior.
The 2010 Patient Protection and Affordable Care Act (ACA) signaled a transformation of the US health-care system and is well timed if its objective of increasing insurance coverage is met. Given that minorities will comprise an estimated 48% of the 32 million expected newly insured individuals,[27] the ACA provides a window of opportunity to address disparities in HCV management.[28] The ACA is also expected to foster the exchange of information among providers, and hence timely identification and treatment of infected individuals. Although it has been projected that many low-income families may be ineligible for federal insurance subsidies and may remain uninsured under the ACA,[29] the implementation of the ACA has, overall, increased access to comprehensive care (http://www.hhs.gov/healthcare/facts/index.html).
Regrettably, a significant proportion of the HCV-positive individuals could not be reached. These individuals were more likely not to have a usual source of care, health insurance, and to be injecting drugs. Traditionally, individuals with these characteristics bear a disproportionate burden of HCV infection in the general population.[30,31] We can only speculate that most of these individuals who could not be contacted probably took no further action on the positive result based on their demographics. The significant proportion of individuals with chronic HCV detected for the first time during emergency room visits supports the presumption that many HCV patients do not have access to routine care. It also raises one potential strategy for identifying subjects with HCV infection.[32,33] Fortunately, treatment of enough individuals, including even modest numbers in the difficult-to-reach individuals could eliminate transmission once the HCV reservoir drops below what is necessary to sustain the epidemic, even if risk practices themselves cannot be controlled.[34,35]
These results should be interpreted bearing in mind the following. The results from NHANES data are only applicable to the non-institutionalized civilian population of the United States. It does not include some high-risk groups such as the homeless or incarcerated. It is worth noting that while there is advocacy for treating HCV in correctional facilities, none exist for homeless individuals.[36,37] The exact impact of the new direct acting anti-viral agents on decisions or motivation to pursue HCV treatment cannot be accurately determined at this point given that these drugs have only been recently available and continue to evolve. However, it is clear that these new agents are even more expensive and cost is likely to remain a concern for access.[25] The proportion of HCV-positive individuals who pursued downstream care in this study is certainly an overestimate given the demographic profile of the individuals who could not be reached (more likely not to have a usual source of care, health insurance, and to be injecting drugs). The inability to contact a good proportion of patients who tested positive for HCV highlights the need for community outreach programs targeting HCV as outlined in the ACA.[27] Other factors that can limit access to care, apart from lack of insurance include competing health priorities such as mental health issues, comorbidities, apathy about one's health, and lack of social support.[38] Unfortunately, we were not able to evaluate the impact of these factors in the current study. It is important to keep in mind that this study was not designed to evaluate provider decision following a positive test result but rather on the action of an asymptomatic individual who screens positive for HCV.
In conclusion, four-fifths of individuals who screened positive for HCV and could be contacted in follow-up pursued downstream care. The main barrier to not seeking downstream care was lack of health insurance. Lack of health insurance may attenuate the theoretical benefits of identifying individuals with asymptomatic HCV infection.
Medscape
Ivo Ditah MD; MPhil; Badr Al Bawardy MD; Humberto C. Gonzalez MD; Behnam Saberi MD; Callistus Ditah; Patrick S. Kamath MD; Michael Charlton MD
Am J Gastroenterol. 2015;110(8):1126-1133.
Discussion Only
This analysis of the NHANES HCV follow-up data has produced findings with significant public health and policy implications. First, as of 2010, about 3.2 million individuals in the United States have chronic HCV infection. About half of those infected were unaware of their status. Four-fifths of people who screen HCV positive and could be contacted on follow-up pursued downstream care. Regrettably, a significant proportion of HCV-positive individuals remain difficult to reach. The main barrier to seeking downstream HCV care was lack of health insurance. Knowledge about HCV infection did not influence care behavior following a positive test result.
The screening recommendations proposed by CDC and USPSTF represent an important step toward the control of HCV infection in the United States. However, screening for HCV infection is cost effective,[15,19] provided that the health-care system has sufficient capacity to deliver appropriate downstream care to the screen-detected individuals.[20] If accompanied by appropriate treatment, the HCV screening can reduce the risk for hepatocellular carcinoma by 70% and for all-cause mortality by 50%.[21,22] It is important to recognize that screening for a disease in asymptomatic individuals is not without consequences, including discrimination, family conflict, stigmatization, insurance denial/higher costs, and psychological distress.[23] To fully realize its intended benefits, screening programs must serve as a path to effective treatment to mitigate harms associated with identifying asymptomatic HCV subjects.
The therapeutic landscape of HCV infection is rapidly changing.[24] Interferon-free, all-oral, highly effective, and well-tolerated therapy for HCV is now becoming a reality. Previously, many patients diagnosed with HCV infection forwent treatment because of contraindications and concerns regarding medication side effects. While many of these obstacles have now become less of a problem with the new drugs, cost remains a major concern. In the first several months of treatment with the new agents, United Health reported expenditures multiple times what it had expected.[25] HCV infection has many attributes that make eradication possible; it is curable, transmission can be controlled and there is no non-human reservoir. Although optimism for possible eradication is justifiable, the high cost of treatment is a cause for caution, as only people with access to therapy stand to benefit from the new antiviral agents.
The main goal of this study was to identify barriers to downstream care in screen-positive HCV individuals. It is ethically not acceptable to offer screening unless treatment is guaranteed or measures can be taken to reduce the risk of transmission. Now that universal cure of patients with HCV seems plausible, a coordinated effort that links patients to treatment should be a high priority and should be inherent to any screening program for HCV infection. In this national sample, we found that having health insurance or not was the only factor that determined whether an individual pursued downstream care or not following a positive result. It is interesting to note that while non-Hispanic blacks, people who are less educated, and those who inject drugs are among those who bear the highest burden of hepatitis C in the general population,[26] these factors did not influence subsequent HCV-related care behavior.
The 2010 Patient Protection and Affordable Care Act (ACA) signaled a transformation of the US health-care system and is well timed if its objective of increasing insurance coverage is met. Given that minorities will comprise an estimated 48% of the 32 million expected newly insured individuals,[27] the ACA provides a window of opportunity to address disparities in HCV management.[28] The ACA is also expected to foster the exchange of information among providers, and hence timely identification and treatment of infected individuals. Although it has been projected that many low-income families may be ineligible for federal insurance subsidies and may remain uninsured under the ACA,[29] the implementation of the ACA has, overall, increased access to comprehensive care (http://www.hhs.gov/healthcare/facts/index.html).
Regrettably, a significant proportion of the HCV-positive individuals could not be reached. These individuals were more likely not to have a usual source of care, health insurance, and to be injecting drugs. Traditionally, individuals with these characteristics bear a disproportionate burden of HCV infection in the general population.[30,31] We can only speculate that most of these individuals who could not be contacted probably took no further action on the positive result based on their demographics. The significant proportion of individuals with chronic HCV detected for the first time during emergency room visits supports the presumption that many HCV patients do not have access to routine care. It also raises one potential strategy for identifying subjects with HCV infection.[32,33] Fortunately, treatment of enough individuals, including even modest numbers in the difficult-to-reach individuals could eliminate transmission once the HCV reservoir drops below what is necessary to sustain the epidemic, even if risk practices themselves cannot be controlled.[34,35]
These results should be interpreted bearing in mind the following. The results from NHANES data are only applicable to the non-institutionalized civilian population of the United States. It does not include some high-risk groups such as the homeless or incarcerated. It is worth noting that while there is advocacy for treating HCV in correctional facilities, none exist for homeless individuals.[36,37] The exact impact of the new direct acting anti-viral agents on decisions or motivation to pursue HCV treatment cannot be accurately determined at this point given that these drugs have only been recently available and continue to evolve. However, it is clear that these new agents are even more expensive and cost is likely to remain a concern for access.[25] The proportion of HCV-positive individuals who pursued downstream care in this study is certainly an overestimate given the demographic profile of the individuals who could not be reached (more likely not to have a usual source of care, health insurance, and to be injecting drugs). The inability to contact a good proportion of patients who tested positive for HCV highlights the need for community outreach programs targeting HCV as outlined in the ACA.[27] Other factors that can limit access to care, apart from lack of insurance include competing health priorities such as mental health issues, comorbidities, apathy about one's health, and lack of social support.[38] Unfortunately, we were not able to evaluate the impact of these factors in the current study. It is important to keep in mind that this study was not designed to evaluate provider decision following a positive test result but rather on the action of an asymptomatic individual who screens positive for HCV.
In conclusion, four-fifths of individuals who screened positive for HCV and could be contacted in follow-up pursued downstream care. The main barrier to not seeking downstream care was lack of health insurance. Lack of health insurance may attenuate the theoretical benefits of identifying individuals with asymptomatic HCV infection.
Medscape
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