Hepatitis C is an infection of the liver caused by the blood-borne, Hepatitis C Virus (HCV) (Centers for Disease Control and Prevention (CDC), 2019a). According to the CDC (2019), the majority of Hepatitis C infections are caused by sharing needles or syringes with an individual who has Hepatitis C infection. Due to the main mode of Hepatitis C transmission, prevention of Hepatitis C is particularly important for individuals who are injection drug users (CDC, 2019a). However, Hepatitis C can also be spread by sexual contact (although rarely), blood donations, tattooing, and birth to a mother with HCV infection (CDC, 2019a). Furthermore, it is valuable to consider cultural practices that ultimately could lead to HCV infection, such as acupuncture and ritualistic sacrifices (Ghany, Strader, Thomas, & Seef, 2009). Almost 2.5 million people in the United States currently have Hepatitis C, with approximately 44,000 cases of acute Hepatitis C occurring in 2017 (CDC, 2019a). In the same year, more than 17,000 deaths had occurred due to chronic Hepatitis C infection (CDC, 2019a). The prevalence of Hepatitis C is particularly concerning in Asia, with 83 million people infected and in Africa, with 28 million people infected in 2010 (Lavanchy, 2011). The unpredictable consequences of a chronic Hepatitis C infection have potential lethal effects, which has encouraged scientists to find more effective treatments and creation of a vaccination, as well as public health professionals to educate individuals about the transmission and symptoms of Hepatitis C (CDC, 2019b).
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In terms of symptomatology, individuals with Hepatitis C may notice a high temperature, clay colored stool and dark urine, vomiting and nausea, jaundice (the yellowing of the skin and/or eyes), pain in the abdominal region or joints, exhaustion, and anorexia (CDC, 2019a). Hepatitis C is particularly dangerous because it progresses very slowly in many people, leading to years, even decades, without symptoms or extremely mild symptoms and then suddenly discovering a Hepatitis C infection (CDC, 2019a). Typically, individuals with non-symptomatic Hepatitis C do not discover their infection until they donate blood or have a routine physical (CDC, 2019a). Many individuals with chronic (an infection lasting 6 months or longer), untreated Hepatitis C eventually develop illnesses such as cirrhosis and/or cancer (American Liver Foundation, 2017; CDC, 2019a). In terms of individuals who experience acute (less than 6 months) Hepatitis C, they are much more likely to experience the symptoms listed previously, which generally leads to quick treatment (American Liver Foundation, 2017; CDC, 2019a). Due to the serious health concerns associated with Hepatitis C, public health professionals recommend that certain populations, such as individuals who currently or formerly utilize injection drugs, anyone born between 1945 and 1965 (also known as the Baby boomer generation), anyone who had an organ transplant or blood transfusion prior to 1992, individuals who are on dialysis, and individuals with a human immunodeficiency virus (HIV) infection are tested for Hepatitis C (CDC, 2019a).
In order to test for Hepatitis C infection, there are multiple modalities that can be utilized. According to Ghany, Strader, Thomas, & Seef (2009), healthcare providers may use two types of testing: serum and bodily fluid testing that can identify antibodies to the Hepatitis C Virus, also known as anti-HCV or molecular assays that can detect viral nucleic acid. If the results of this test are negative, the individual does not have identifiable Hepatitis C antibodies in their body (CDC, 2013). However, if that person was exposed within the last six months, they should be tested again to make a final determination on their Hepatitis C status (CDC, 2013). A positive result means that the individual has Hepatitis C infection (CDC, 2013). Even after completing treatment and becoming cured, the Hepatitis C antibodies will remain in the person’s system (CDC, 2013). Furthermore, health care providers may use genotyping strategies to determine what kind of treatments will be most effective for that individual’s Hepatitis C infection (Ghany, Strader, Thomas, & Seef, 2009). Hepatitis C has 6 identifiable genotypes (Ghany, Strader, Thomas, & Seef, 2009).Genotype 1 is considered to be most common in the United States (Ghany, Strader, Thomas, & Seef, 2009). However, this is gradually changing as the country has more residents from different countries and areas of the world (Ghany, Strader, Thomas, & Seef, 2009).During testing, clinicians may also search for the severity and longevity of symptoms to determine the best course of treatment (Ghany, Strader, Thomas, & Seef, 2009).In addition to the blood and bodily fluids testing, many physicians will also complete biopsies of the liver to determine the damage that the individual has experienced (Ghany, Strader, Thomas, & Seef, 2009).
A biopsy of the liver may reveal cirrhosis, the scarring of the liver, or fibrosis, the growth of scar tissue that intrudes healthy tissue of the liver (American Liver Foundation, 2019; Ghany, Strader, Thomas, & Seef, 2009; National Institute of Diabetes and Digestive and Kidney Diseases, 2019). Not only does the biopsy allow physicians to determine the damage to the liver but they can also determine how far along the individual is in their liver disease and what stage of the disease they are experiencing (Ghany, Strader, Thomas, & Seef, 2009). Although biopsies of the liver are common practice for individuals with Hepatitis C, there are still risks that come with this procedure (Ghany, Strader, Thomas, & Seef, 2009). For example, the biopsy could lead to bleeding and abdominal pain, anxiety, and the potential to damage nearby organs in the body (Ghany, Strader, Thomas, & Seef, 2009). Furthermore, liver biopsies cost money to perform and this can be particularly problematic since individuals of lower socioeconomic status are more likely than higher socioeconomic status individuals to have Hepatitis C (Ghany, Strader, Thomas, & Seef, 2009; Omland, Olser, Jepsen, Krarup, Weis, Christensen, Roed, Sorensen, & Obel, 2013). Due to the potential complications and issues of this procedure, scientists are working toward creating a comprehensive blood panel that can be used to determine the stage of liver disease of those with Hepatitis C (Ghany, Strader, Thomas, & Seef, 2009). Ultrasounds have also been used as an alternative modality to determine the disease stage (Ghany, Strader, Thomas, & Seef, 2009). However, neither the blood panel or ultrasounds have been entirely successful (Ghany, Strader, Thomas, & Seef, 2009).The ultrasound of the liver to diagnose disease progression is still not approved by the drug administration and has limited success on patients with an obese body mass index (BMI) (Ghany, Strader, Thomas, & Seef, 2009).
In addition to the previously mentioned concerns about liver biopsies, it is indicated that the liver biopsies are also not entirely necessary for individuals with specific genotypes of Hepatitis C, such as 2 and 3, because these strains typically clear up with standard treatments (Ghany, Strader, Thomas, & Seef, 2009). However, clinicians should consider that there are differences in cure rates using standardized treatments among American individuals (50%) and African American individuals (30%) with Hepatitis C, which can ultimately lead to a higher likelihood of a liver biopsy for individuals who are African American (Ghany, Strader, Thomas, & Seef, 2009). Treatment options are especially important because more than half of individuals with Hepatitis C infection require medication to cure their infection (Ghany, Strader, Thomas, & Seef, 2009). Younger women and infants are more likely to recover spontaneously from an acute Hepatitis C infection than older adults (Ghany, Strader, Thomas, & Seef, 2009). Hepatitis C treatment changed when biologics such as sovaldi (sofosbuvir) and Olysio (simeprevir) were approved by the Food and Drug Administration (FDA) (Henry, 2018). Biologics are created from living structures and are designed using biotechnology (Henry, 2018).These medications are particularly important because the side effects are extremely minimal, especially when compared to previously utilized medications (Henry, 2018).
In order to gain a better understanding of these drugs, it is crucial that individuals understand how these drugs work within the body to address infection. Sovaldi, also known as sofosbuvir, works by the patient consuming the drug orally (Lomberk & Klibanov, 2015). After the medication is administered, the drug quickly converts to a metabolite known as GS-331007 (Lomberk & Klibanov, 2015). The highest concentration of the metabolite are noted between half an hour and two hours, as well as between the two and four hours after administration (Lomberk & Klibanov, 2015). According to Lomberk and Klibanov (2015), these medications are not affected by fat so patients may choose to take the medication with or without a meal. Shortly after administration, sovaldi is then metabolized in the liver and turned into active nucleoside analog triphosphate, GS-461203 (Lomberk & Klibanov, 2015). The Food and Drug Administration determined that the metabolites of Sovaldi are primarily excreted from the body through the processes of the kidneys and through urine (Gilead Sciences, 2015). It is important to note that individuals with mild kidney problems are still able to consume Sovaldi at a regular dosage (Lomberk & Klibanov, 2015). According to Henry (2018), Sovaldi has over a 90% cure rate for Hepatitis C. However, there are drawbacks to these medications.
The most notable drawback of Sovaldi and Olysio is that they are incredibly expensive, with one pill of Sovaldi costing nearly $1000 (Henry, 2018). With the price of this medication being so steep, a full twelve week treatment costs nearly $85,000 in the United States (Henry, 2018). However, the price of Sovaldi varies greatly by country, with Sovaldi only costing the equivalent of $250 for a full treatment regimen in India (Hill, Khoo, Fortunak, Simmons, & Ford, 2014). Furthermore, Olysio is also incredibly expensive for consumers, with a price tag of nearly $24,000 a month (Henry, 2018). The cost of these medications is likely unaffordable to most individuals, especially since many people with Hepatitis C are of a lower socioeconomic background (Omland, Olser, Jepsen, Krarup, Weis, Christensen, Roed, Sorensen, & Obel, 2013). The cost of these medications is also problematic because a large portion of individuals who are undergoing treatment for Hepatitis C are prescribed one of these medications, in concert with other medications (Henry, 2018). In 2014, the United States spent over $6.5 billion on Solvadi alone, with $4.5 billion of this being paid by Medicaid (Henry, 2018). According to Henry (2018), if the United States paid to treat all individuals in the U.S. living with chronic Hepatitis C infection, it would cost $310 billion dollars. As one can imagine, these costs have led to serious difficulties in access to care for many people in the U.S. (Henry, 2018).
It is not uncommon that insurance companies will deny patients coverage for these drugs or the insurance companies will wait until there is significant damage to the liver prior to approval (Henry, 2018). However, this concern is more commonly associated with patients with private insurance since individuals who have Medicare or Medicaid are more likely to be approved initially than those with private coverage (Henry, 2018). According to Henry (2018), there are various reasons that the cost of Sovaldi and Olysio are particularly high, including that it is costly to create new drugs, there are no negotiations for drug prices, and there is a market-oriented economy in the U.S. Due to the market-oriented economy in the U.S., healthcare can be very costly since there isn’t a single healthcare system (Henry, 2018).Furthermore, patients with chronic Hepatitis C may request medications like Sovaldi and Olysio because they have seen advertisements for them or know that the medication is new (Henry, 2018). However, these patients may not realize that older medications may be equally or more effective than newer medications and cost significantly less (Sai, Bastian, & Griffin, 2015). While considering the high costs of drugs such as Sovaldi and Olysio, it is also important to consider solutions to these exorbitant drug costs.
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The key in addressing the high costs of Sovaldi and Olysio is for health insurance companies to allow prior authorization of these medications by restricting access to Sovaldi and Olysio to only patients with the most severe Hepatitis C Infection (Henry, 2018). This strategy is recommended because prior research indicates that just because these medications are newer does not mean that it is the best option for treating every individual’s Hepatitis C Infection (Sai, Bastian, & Griffin, 2015). Despite this, it is recognized by public health professionals that sooner treatment leads to better outcomes in the long run, such as a lesser chance of developing liver cancer or cirrhosis (Trooskin, Reynolds, & Kostman, 2015). Other researchers also argue that this restriction is harmful in terms of public health, given that only a marginal amount of individuals with Hepatitis C Infection in the U.S. who receive a diagnosis go on to access treatment (Kohli, Shaffer, Sherman, & Kottilil, 2014; Trooskin, Reynolds, & Kostman, 2015). Additionally, many insurance companies have placed limits on Hepatitis C drug distribution to only individuals who are sober (Barua, Greenwald, Grebely, Dore, Swan, & Taylor, 2015; Trooskin, Reynolds, & Kostman, 2015). This ideology is not only stigmatizing but also implies that individuals who are injection drug users will not have the same success rates in treatment (Trooskin, Reynolds, & Kostman, 2015). A meta-analysis of over 50 studies in the United States indicates that injection drug users do, in fact, have similar treatment success rates to individuals who are not using injection drugs, debunking the myth that treatment success rates are lower (Aspinall, Corson, Doyle, Grebely, Hutchinson, Dore, Goldberg, & Hellard, 2013). Henry (2018) suggests that the United States pharmaceutical market discusses a more affordable price point for Sovaldi and Olysio. However, this strategy is particularly difficult in the United States due to the many health insurance companies available to consumers (Henry, 2018).
It is suspected that the cost of Sovaldi and Olysio will begin to diminish once newer drugs for Hepatitis C infection are created (Henry, 2018). The prices of these medications has already dropped for individuals utilizing the Veteran’s Administration (VA), Medicare, and Medicaid now that new Hepatitis C treatments like Harvoni and Viekira Pak are available (Gritsenko & Hughes, 2015; Henry, 2018). An additional option for addressing high cost treatments for Hepatitis C medication is allowing patients to receive the generic version of the drug for a much lower cost (Henry, 2018). Another concern about more affordable treatments for Hepatitis C infections is that pharmaceutical companies in the United States are able to make a patent on biologic drugs for twelve years, meaning that other companies are unable to make similar biologics until the patent period is completed (Fergusson & Williams, 2016). In addition to this, the Innovation Act was recently created and passed by the Food and Drug Administration, which charges pharmaceutical companies for the approval of new drugs (U.S. Food & Drug Administration, 2012). This is another barrier for the creation of new drugs for Hepatitis C (U.S. Food & Drug Administration, 2018).
With the understanding of treatment challenges for Hepatitis C in the United States, it is absolutely crucial that prevention strategies are considered as well. Since Hepatitis C is primarily spread through injection drug use (CDC, 2019), it is important to stop using injection drug equipment or to ensure the utilization of clean, unused needles (San Francisco Department of Public Health, 2019). Although it is rare that Hepatitis C is spread through items like razors, it is still a useful prevention step to use only your own razor, nail clippers, etc (CDC, 2019; San Francisco Department of Public Health, 2019). Additionally, individuals who are receiving tattoos, acupuncture, or piercings or participating in cultural practices where blood is drawn, should ensure that the equipment being used is, in fact, clean (San Francisco Department of Public Health, 2019). Individuals who are attempting to prevent Hepatitis C transmission should also consider using condoms during sexual activity with a partner (San Francisco Department of Public Health, 2019). Lastly, individuals working in healthcare should use normal precautions when coming into contact with blood, like wearing gloves and safely disposing of used medical instruments (San Francisco Department of Public Health, 2019).
With nearly 2.5 million people in the United States having Hepatitis C infection and even fewer of those individuals actually knowing about their infection, testing for Hepatitis C is more important than ever (CDC, 2019; Kohli, Shaffer, Sherman, & Kottilil, 2014; Trooskin, Reynolds, & Kostman, 2015). There is a compelling need for a Hepatitis C vaccination, especially since vaccinations have already been created for Hepatitis A and B (CDC, 2019b). A portion of public health efforts should be attributed to educational campaigns and accessible resources about Hepatitis C (CDC, 2019a). In addition, medical providers should encourage testing for Hepatitis C with their patients, particularly individuals who are in the baby boomer generation, use injection drugs, have HIV or another autoimmune disorder, or individuals who had a transplant or blood transfusion prior to 1992 (CDC, 2019a). Lower costs for medications and treatments, as well as clean needle exchange programs, and access to condoms for individuals with Hepatitis C could be pivotal in terms of Hepatitis C prevention (Henry, 2018; Trooskin, Reynolds, & Kostman, 2015). An infectious disease that has taken more than 17,000 lives in 2017 in the United States alone and 399,000 lives throughout the world in 2016 should be considered a major public health priority and an avenue for advocacy for providers in both the medical and mental health field (CDC, 2019a; World Health Organization, 2019).
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