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Authored by

Alan Franciscus Executive Director, Hepatitis C Support Project Editor-in-Chief, HCV Advocate Website


Understanding HCV A PAtient Pocket Guide

Authored by: Alan Franciscus

Executive Director, Hepatitis C Support Project Editor-in-Chief, HCV Advocate Web site

Editor: Liz Highleyman General Editor: C.D. Mazoff, PhD


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Table of Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 The Liver and Hepatitis . . . . . . . . . . . . . . . . . . . . . .2 HCV Transmission and Prevention . . . . . . . . . . . . . . . . 3 Hepatitis C Disease Progression . . . . . . . . . . . . . . . . . 7 Symptoms of Hepatitis C . . . . . . . . . . . . . . . . . . . . .9 Conditions Linked to Hepatitis C . . . . . . . . . . . . . . . . 12 Hepatitis C Facts . . . . . . . . . . . . . . . . . . . . . . . . 13 Diagnosing and Monitoring Hepatitis C . . . . . . . . . . . . 14 HCV Treatment Options . . . . . . . . . . . . . . . . . . . . . 18 Treatment Considerations . . . . . . . . . . . . . . . . . . . 22 Hepatitis C Management . . . . . . . . . . . . . . . . . . . . 27 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

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• Preface •

Living with hepatitis C is not easy! Whether you are newly diagnosed or have been living with hepatitis C for a long time, you have many decisions to make on a daily basis. These decisions are important because they can affect your life right now and in the future. But they also can affect many other people in your life, including loved ones, family, friends, and co-workers. The best advice that I have received—and still hold close these many years later—is to become as educated as possible about hepatitis C and to work closely with medical providers and loved ones in order to receive the best possible care and support, which everyone with hepatitis C needs and deserves. Another important piece of advice is that, as a person living with hepatitis C, I am in the driver’s seat. I am the one who will make the decisions, and I will take whatever proactive steps are needed to make sure that I live a long, healthy, and happy life. This pocket guide is designed to help you make informed choices about various aspects of living with hepatitis C. Starting with basic information about hepatitis C prevention, disease progression, and management, this booklet goes on to provide you with the tools you need to advocate for the best possible medical care and treatment. There are many strategies we as people living with hepatitis C can use to stay healthy. But some of these strategies are far from simple— avoiding or reducing alcohol consumption and cigarette smoking, eating healthy and nutritious meals, getting a moderate amount of exercise, and getting enough sleep. Taking on just one of these “lifestyle modifications” is difficult. Tackling more than one at a time may seem overwhelming. Remember that you don’t have to make any changes until you are ready, and you don’t have to do everything at once. That approach can lead to failure. This being said, many of the lifestyle changes discussed in this guide are very doable, especially if you have the resources you need. These resources can include family, loved ones, friends, co-workers, peers, and your medical providers.

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•••••••••••••••••••• The guide also discusses currently available treatment options, which can cure up to 80% of people with hepatitis C. Newer medications now being developed may increase the likelihood of curing hepatitis C in even more people and may possibly shorten the duration of treatment for some people and have fewer side effects. If you need treatment now, however, don’t wait because there is no guarantee that the newer medicines will work for everyone. Another important issue for people living with hepatitis C is the stigma associated with the disease because of the association between HCV and drug use. Here again, education is the key. Tell your story! People’s opinions can change when they are able to put a human face on a disease. Managing stigma is similar to managing other aspects of hepatitis C—namely, by seeking out support from family, friends, co-workers, and peers. Remember, you not only don’t have to go it alone, but the reality is that you shouldn’t go it alone. The goal of this pocket guide is to help you start living well with hepatitis C. I am constantly amazed, encouraged, and in awe of the many people I have met who have made such a difference in their lives and the lives of those around them. This guide is dedicated to all those individuals who are making a difference in their own lives and to those who are making a difference for people living with hepatitis C.

Alan Franciscus

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• Introduction •

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epatitis C virus, or HCV, is a blood-borne virus that was previously referred to as non-A/non-B hepatitis. HCV has six major genotypes, numbered 1–6. Genotype 1 is most common in the U.S. HCV enters the body through direct exposure to blood or contaminated body fluids. The virus attacks cells in the liver, where it multiplies (replicates). HCV causes liver inflammation, kills liver cells, and can lead to buildup of fibrous (scar) tissue in the liver which can eventually lead to cirrhosis. Acute hepatitis C refers to the first six months of infection. Up to 80% of people initially infected with HCV may become chronically infected—that is, the infection does not spontaneously clear up within the six-month period. A majority of people with chronic hepatitis C do not have symptoms and lead relatively normal lives. However, in 10%–25% of people with chronic HCV infection, the disease progresses over a period of 10–40 years, and may lead to serious liver damage including advanced fibrosis, cirrhosis (scarring), liver cancer, end-stage liver failure and possibly death or the need for a liver transplant. Today, hepatitis C is the leading reason for liver transplants in the U.S. There is currently no vaccine to prevent HCV infection. But current treatment can eradicate the virus, leading to a cure for many people (up to about 80% of those with HCV genotype 1, 2 and 3). Newer therapies that directly target various stages of the viral life-cycle, HCV protease, NS5a and polymerase inhibitors, for example, are under study. Treatment may also help slow, stop, or even reverse liver disease progression, even if complete HCV clearance does not occur.

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• The Liver and • Hepatitis

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he liver is the largest internal organ, located behind the ribcage on the right side of the abdomen. It weighs approximately three pounds in the average-sized man and is about the size of a football. The liver is responsible for some 500 vital functions. It processes virtually everything you eat, drink, breathe, or absorb through the skin. The liver converts food into energy and the building blocks for muscle tissue, hormones, clotting factors, and immune factors. It stores glucose (sugar) and many vitamins and minerals for later use. Liver cells produce bile, which helps digest food (especially fats) and absorb nutrients. The liver also detoxifies substances that are harmful to the body. Unlike other body tissues, the liver can regenerate itself; as much as three-quarters of the liver can be removed and it will regenerate within a few weeks. Hepatitis means inflammation of the liver. This may be caused by viruses, toxic chemicals or drugs, heavy alcohol consumption, or other factors. The most common types of viral hepatitis include hepatitis A virus (HAV), hepatitis B virus (HBV), and HCV. These three viruses are unrelated, other than the fact that they all affect the liver.

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• HCV Transmission • and Prevention

HCV Transmission HCV is transmitted by blood-to-blood contact. Any break in the skin or invasive procedure may allow HCV to enter the body, even if no blood is visible. One common transmission route is sharing needles and other equipment for injecting drugs (cookers, tourniquets, cottons, water, etc.) and certain non-injection drug paraphernalia (crack pipes or straws used for snorting drugs, for example). Needles used for tattooing, body piercing, and acupuncture may also spread HCV. Sharing personal items such as razors, toothbrushes, or nail files is a less likely, but possible, transmission route. Do not share (or reuse on a different person) any item that might contain or come in contact with blood.

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•••••••••••••••••••• Before 1992, when a reliable blood test to identify HCV antibodies became available, many people contracted hepatitis C through blood or blood product transfusions. Since then, the blood supply has been screened, and today the risk of HCV transmission via transfusion is very low—less than one case per 2 million units of transfused blood. However, there have been some recent cases of HCV transmission in medical facilities due to inappropriate reuse or improper cleaning of items such as endoscopy equipment. The risk of sexual transmission of HCV is not entirely clear. Only a small percentage (estimated at 1%–5%) of monogamous heterosexuals in stable long-term relationships contract hepatitis C through unprotected sexual activity, but the risk is higher for people in so-called “high risk” groups, including men who have sex with men, sex workers, people with multiple sex partners, and people with sexually transmitted diseases. In recent years, outbreaks of sexually transmitted acute HCV infection have been reported in several European, Australian and U.S. cities among HIV positive gay and bisexual men with no traditional risk factors. Healthcare workers and emergency responders are at risk for HCV infection due to needlestick accidents and unavoidable situations that may result in direct contact with blood from an infected individual. Perinatal transmission from pregnant women with HCV to their infants before or during birth occurs about 4-7% of the time. Whether or not transmission occurs may depend on the amount of HCV in the mother’s blood; women who are coinfected with HIV are more likely to transmit HCV to their babies. Some studies have shown that small amounts of HCV may be present in breast milk, but breastfeeding is considered safe. The transmission route for up to 10% of individuals with hepatitis C cannot be determined. HCV is not transmitted by casual contact such as sneezing, coughing, hugging, or sharing eating utensils and drinking glasses.

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•••••••••••••••••••• HCV Prevention In most cases, HCV transmission can be prevented by taking appropriate precautions. Do not share needles or any other drug paraphernalia. Avoid sharing razors, toothbrushes, clippers, nail files, or any other items that may come in contact with blood. Make sure that instruments used for tattooing, body piercing, acupuncture, and medical procedures are properly sterilized; most practitioners today use disposable needles. Cover all cuts and wounds with a bandage. You can reduce the risk of sexual transmission of HCV by practicing safer sex, including the use of condoms, gloves and other barriers. HCV does not seem to be transmitted in semen, but rather through “rough sex” and activities that involve contact with blood. According to the Centers for Disease Control and Prevention (CDC), people in stable, longterm monogamous relationships do not need to change their sexual practices, although partners should discuss safer sex options if either is concerned about transmission. People who are not in such a relationship can take precautions to avoid contact with blood and other body fluids during sex. Proper dental hygiene can prevent bleeding gums, another potential HCV transmission route. Notify your doctor, dentist, and other healthcare providers if you have HCV. Healthcare workers and emergency personnel should observe standard universal precautions when dealing with blood. If you are a woman with HCV, talk to your doctor if you are thinking about becoming pregnant.

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• Hepatitis C •

Disease Progression

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fter exposure to HCV, the window period before antibodies can be detected using a standard test usually lasts from 2 to 26 weeks. The initial phase of hepatitis C is called acute infection. Acute HCV infection may resolve with spontaneous viral clearance, typically within 2–12 weeks. However, up to 80% of people initially infected with HCV do not clear the virus from their bodies within six months and become chronically infected. Most people with chronic hepatitis C do not have symptoms and lead relatively normal lives. But in 10%–25% of people, the disease progresses over the course of 10–40 years. There are no tests or other methods to identify who will progress to serious disease, so it’s important that all people with chronic hepatitis C are monitored on a regular basis and receive treatment if appropriate. A liver biopsy is useful in measuring the extent of any liver damage. The findings of a liver biopsy can be used in combination with the estimated date of initial infection to make an educated guess as to the rate of HCV disease progression. Noninvasive blood tests and a new type of ultrasound machine may also be used to determine the extent of liver damage and to estimate the rate of disease progression, although these tests have not been perfected.

be should is. V C H s h lar ba ne wit Everyo ed on a regu r monito

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•••••••••••••••••••• Chronic HCV infection can lead to the development of fibrous tissue in the liver (fibrosis and at later stages, cirrhosis), fat accumulation in the liver (steatosis), liver cancer, and end-stage liver failure. In severe cases, a person may require a liver transplant. Fibrosis and cirrhosis occur when liver cells are damaged or killed and replaced with fibrous tissue. Extensive scar tissue can impair the flow of blood through the liver and cause blood to back up, leading to further loss of liver function and complications such as portal hypertension (high blood pressure in the vein that serves the liver) and an accumulation of fluid in the abdominal area, called ascites. Compensated cirrhosis means that the liver is heavily scarred but still able to perform most of its vital functions; people with compensated cirrhosis exhibit few or no symptoms, but need more careful monitoring. Decompensated cirrhosis means that the liver is so extensively scarred that it is unable to function properly leading to serious complications that can greatly affect overall health and bodily functions. People with decompensated cirrhosis often develop complications such as varices (stretched and weakened blood vessels) in the esophagus and stomach, internal bleeding, ascites (fluid accumulation in the abdominal cavity), and other potentially life-threatening conditions. They may also experience reversible mental confusion (encephalopathy) as toxins build up in the body due to impaired filtering. Liver cancer usually develops at later stages of HCV infection after a person has developed advanced fibrosis (stage 3 disease) or cirrhosis. The type of liver cancer associated with HCV is called primary hepatocellular carcinoma (HCC).

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• Symptoms of • Hepatitis C

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any people report few or no symptoms during the acute phase of HCV infection, and the disease often progresses to the chronic stage without detection. Some people with acute hepatitis C, and many more with chronic infection experience flu-like symptoms including fatigue, nausea, fever, headaches, loss of appetite, abdominal pain, and muscle or joint pain. Many have elevated liver enzyme (ALT and AST) levels. Over time—years or even decades— people with chronic hepatitis C may develop various symptoms related to fibrosis, cirrhosis, or liver cancer. Chronic HCV infection is also associated with a wide variety of related conditions.

Chronic hepatitis C just means that you have the virus in your body for longer than 6 months.

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•••••••••••••••••••• Symptoms Reported by People with HCV ACUTE HEPATITIS C • Diarrhea • Indigestion or heartburn • Headaches • Muscle or joint pain • Abdominal pain • Abdominal bloating • Jaundice

• Flu-like illness • Fatigue (mild to severe) • Fever • Night sweats • Loss of appetite (anorexia) • Nausea • Vomiting

CHRONIC HEPATITIS C • Fatigue (mild to severe) • Fever • Loss of appetite (anorexia) • Nausea • Indigestion or heartburn • Headaches

• Muscle or joint pain • Abdominal pain • Depression • Mood swings • “Brain fog”

LATE-STAGE HEPATITIS C WITH CIRRHOSIS • Frequent urination • Jaundice • Bleeding varices • Depression • Mood swings • Cognitive dysfunction • Lack of concentration • Mental confusion • Dizziness • Peripheral vision problems • Poor sleep cycles • Bleeding problems

• Fatigue (mild to severe) • Loss of appetite (anorexia) • Nausea • Vomiting • Indigestion or heartburn • Headaches • Muscle or joint pain • Abdominal pain • Abdominal bloating • Fluid retention (edema) • Abdominal fluid accumulation (ascites)

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Self-Help

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d Gettin g o rganized a nd makin g all ne cess sure you ary do cum have ents and c help you o pi es of test and your s will medical p a medica rovider m l appointm aximize e nt . Keep tra followin g ck of the tests: HCV viral load (HCV RNA) HCV geno type Results o f re cent A LT and A ST tests Re cent co mplete blo od count (CBC) Liver biop sy report Ultrasou nd and im a gin g rep orts Immunizat ion re cord s Any othe r medical re cords fo disease r other s or cond itions

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• Conditions Linked • to Hepatitis C

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number of different conditions have been associated with hepatitis C. Some of these are autoimmune conditions, in which the immune system attacks the body’s own tissues. Conditions sometimes seen in people with chronic HCV infection include cryoglobulinemia (high levels of a blood protein that settles in the kidneys, skin, and nerve endings), vasculitis (blood vessel damage), Sjögren’s syndrome (characterized by dry eyes and dry mouth), and skin conditions such as lichen planus (characterized by white lesions or bumps) and porphyria cutanea tarda (characterized by a sun-sensitive rash). Other related conditions include certain types of arthritis (joint inflammation), arthralgia (joint pain), and thyroid disease. Most of the serious conditions are associated with latestage hepatitis C, when the liver is heavily damaged and not able to function properly. However, many people with HCV never develop any of these conditions. Check with your doctor if you experience these or any other unusual symptoms.

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• Hepatitis C Facts •

• The National Institutes of Health (NIH) estimates that about 4 million Americans have hepatitis C, but many researchers believe the true number may be higher than 5 million. • Up to an estimated 12,000 Americans die annually of complications related to HCV infection—a figure that is expected to triple over the next 10 years. • HCV is the leading reason for liver transplants in the U.S. in adults. • Individuals with HCV should stop or cut down on drinking alcohol and using recreational drugs. • Individuals with HCV should be vaccinated against hepatitis A & B if not protected. • Individuals with HCV should pursue a healthy diet and exercise program to decrease the risk of fatty liver and improve overall health.

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• Diagnosing and •

Monitoring Hepatitis C

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creening for hepatitis C is not routinely done, so you may have to request a test from your doctor. This usually involves an antibody test followed by a confirmatory HCV viral load test. Once hepatitis C is diagnosed, ongoing monitoring is needed to assess disease progression and the need for treatment. It is recommended that you use the same laboratory for all of your tests, since result ranges and accuracy can vary from lab to lab. Keep copies of your lab and biopsy results for future reference. HCV ANTIBODY TESTS Antibody tests measure proteins produced by the immune system to fight specific invaders. After exposure to HCV, it may take as long as 26 weeks before antibodies can be detected using a standard test (the “window period”). HCV VIRAL LOAD TESTS Viral load tests measure the amount of HCV RNA circulating in the blood. The presence of detectable genetic viral material indicates that the virus is actively replicating. HCV viral load is expressed as International Units (IU/mL). There are three different types of viral load test: HCV RNA polymerase chain reaction (PCR), branched-chained DNA (bDNA), and transcription mediated amplication (TMA). The PCR and TMA tests can detect viral loads as low as 5 IU/mL. The bDNA assay is the least expensive, but its lower limit of detection is 615 IU/mL. Viral load tests are used to confirm active HCV infection, to predict treatment response, to measure how well medications are working against the virus and are used to tailor the length of time people with HCV genotype 1 are treated with pegylated interferon, ribavirin and an HCV protease inhibitor. While lower HCV RNA levels predict better response to treatment, an association between viral load and disease progression has not been established.

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Self-Help

Tip: Med i

cal History List your il lnesses an d surgerie the most s. re cent an d work ba Start with Try to list ckwards. only the c onditions, or surgeri diseases, es that a re import provider t ant for yo o know. ur A little co can go a lo mmon sens n g way. e Be honest —y guide you if our provider can not advise and yo people fee u are hidin g informa tion. Many l like they will be jud report th ged if the at t y However, it hey smoke, drink or take drugs is importa . nt for your to know a provider ll of these thin gs in o guide you rder to and keep you healt about you hy. Be tru r feelin gs. thful If you are that you con cerned might get le ctured, ta with a pro lk about it vider. If possible , review y our re cords o n ce a mont medi cal history an d h and th o least on ce rou ghly at a year.

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•••••••••••••••••••• HCV GENOTYPE TESTS Genotype tests are used to determine what type(s) of HCV an individual carries. This information is useful for making treatment decisions—what type of medications, what doses of medication to use and how long treatment should last. BIOCHEMICAL OR LIVER FUNCTION TESTS Various blood tests are used to assess how well the liver is working. Many of these tests measure non-specific markers of liver function. Liver enzyme tests are part of a hepatic panel (a group of clinical laboratory blood tests used to evaluate a patient with symptoms of liver disease or injury). The most common measurements of liver inflammation are alanine aminotransferase (ALT, formerly known as SGPT) and aspartate aminotransferase (AST, formerly known as SGOT). ALT and AST are enzymes released into the blood when liver cells are damaged. They are often—but not always—elevated in people with hepatitis C. Many individuals with HCV infection have mild to moderate ALT and AST elevation, which is often the first indication that they are infected. In the past, ALT levels were assumed to be a marker of HCV disease progression, but it is now known that some people with chronic hepatitis C experience serious liver disease progression with relatively normal ALT levels. This is why it is important for people with HCV to be monitored with a variety of tests, which may include a liver biopsy. Other measurements of liver inflammation include alkaline phosphatase (ALK) and gamma-glutamyl transpeptidase (GGT). Abnormal levels may indicate cirrhosis or bile duct blockage, as well as other conditions. In addition, your doctor may measure INR (international normalized ratio, formally known as PT or prothrombin time, an indication of blood clotting speed), albumin and bilirubin levels. Albumin is a blood protein produced by the liver that plays a role in maintaining normal blood volume. Bilirubin is a pigment that is often present in the blood of people with liver inflammation; high

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•••••••••••••••••••• bilirubin levels result in jaundice. Many factors, such as the use of medications and alcohol, can cause abnormal lab results. Before drawing your own conclusions about the meaning of a test result, check with a healthcare provider. LIVER BIOPSIES Liver biopsies are done to evaluate the severity of inflammation, amount of fibrosis or scarring, and general health of the liver. A biopsy may be used to help determine if treatment is needed—that is, if significant liver damage is present—and serial biopsies are used to assess disease progression over time. The most common procedure is called a percutaneous (through the skin) liver biopsy, in which the skin and muscle near the liver are numbed and a needle is quickly inserted into the liver to draw out a specimen. Many people fear this procedure, but complications are rare. If you are anxious, ask your physician for a mild tranquilizer prior to your biopsy and for pain medication afterwards. NONINVASIVE FIBROSIS TESTS In recent years researchers have developed several noninvasive methods of assessing fibrosis, in an effort to avoid the discomfort and expense of repeat biopsies. Experts have evaluated the accuracy of several combinations of biomarkers and patient characteristics, including FibroSure, APRI, Fib-4, Forns index, and FibroTest. A newer method, transient elastometry (FibroScan) uses sound waves to measure liver stiffness. Noninvasive methods are reasonably accurate in distinguishing between absent or mild fibrosis and severe fibrosis or cirrhosis, but aren’t very good at estimating intermediate stages.

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• HCV Treatment • Options

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ntil 1998, interferon alone (monotherapy) was the only approved treatment for HCV infection. Today, the new standard of care for treating HCV genotype 1 is a triple combination of pegylated interferon, ribavirin and an HCV protease inhibitor. The double combination of pegylated interferon plus ribavirin remains the standard for treating HCV genotypes 2 and 3. Research is ongoing to develop new and better therapies including more HCV protease inhibitors, polymerase inhibitors, NS5A inhibitors, antifibrotic medications and different forms of long-acting interferons. Combinations of oral drugs without interferon and/or ribavirin are also under study. In addition to pharmaceuticals, there are also several alternative and complementary therapies that are commonly used to treat HCV infection—for example, milk thistle (silymarin) and licorice root (glycyrrhizin). Herbal and other alternative therapies are discussed in a fact sheet from the Hepatitis C Support Project. MEASURING TREATMENT RESPONSE The goal of hepatitis C treatment is to reduce HCV viral load and ultimately eradicate the virus. When a person’s HCV RNA becomes undetectable after starting therapy, this is considered a virological response. Undetectable HCV RNA at treatment week 4 is known as rapid virological response (RVR). Early virological response, measured at treatment week 12, may be either complete (cEVR) if HCV RNA is undetectable, or partial (EVR) if viral load has decreased by at least 2 logs but is still detectable. Undetectable HCV RNA at both treatment week 4 and week 12 is known as an extended rapid virological response (eRVR). Undetectable viral load at the end of a course of therapy is called end-of-treatment (EOT) response. If HCV RNA remains undetectable 24 weeks after completing treatment, the person has achieved a sustained virological response (SVR), which most experts consider to be a viral cure.

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•••••••••••••••••••• APPROVED PHARMACEUTICAL THERAPIES Conventional interferon alfa, pegylated interferon alfa, ribavirin, and two HCV protease inhibitors are the only medications approved by the U.S. Food and Drug Administration (FDA) for treating hepatitis C. Interferon, given by injection, is a genetically engineered product based on natural immune system proteins found in the body. Pegylated interferon is a long-acting form of interferon that can be injected once, rather than three times, per week. It maintains a more constant level of interferon in the blood and is better able to reduce HCV replication. Ribavirin is an oral antiviral medication used in combination with interferon to treat hepatitis C. Ribavirin alone is not effective against HCV, but helps prevent relapse after stopping interferon. The HCV protease inhibitors boceprevir and telaprevir are the first directacting antiviral medications (DAAs) approved to treat chronic hepatitis C genotype 1. They are only approved for treatment of HCV genotype 1 and must be taken in combination with pegylated interferon and ribavirin. HCV protease inhibitors work by preventing the virus from replicating (making copies of itself). There are currently two different pegylated interferon/ribavirin combinations and two different HCV protease inhibitor/pegylated interferon/ ribavirin combinations approved by the FDA.

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•••••••••••••••••••• HCV Protease inhibitors: • Merck’s boceprevir (Victrelis) is an HCV protease inhibitor pill. Boceprevir is only approved to treat people with HCV genotype 1. • Vertex’s telaprevir (Incivek) is an HCV protease inhibitor pill. Telaprevir is only approved to treat people with HCV genotype 1. Pegylated interferons: • Merck’s pegylated interferon alfa-2b (PegIntron) is a powder that must be reconstituted before use; it is dosed according to a person’s body weight at 1.5 µg/kg/week. • Genentech’s pegylated interferon alfa-2a (Pegasys) is a readymade solution that is dosed at 180 µg regardless of weight. The FDA has also approved Pegasys plus ribavirin for the treatment of hepatitis C in people coinfected with HIV, and Pegasys monotherapy for the treatment of chronic hepatitis B. Pegylated interferon is administered once weekly as an injection under the skin. Ribavirin is a pill taken orally twice daily with food (breakfast and dinner). HCV protease inhibitors are pills taken 3 times daily (every 7 to 9 hours) with food; boceprevir is taken with a meal or light snack and telaprevir is taken with food (not low fat). The standard duration of treatment for chronic hepatitis C genotypes 2 and 3 is 24 weeks. The length of time that people with HCV genotype 1 are treated with a triple combination regimen depends on the specific HCV protease inhibitor, how a person responds to the drugs during treatment and whether they have been treated before. This usually ranges from 24 to 48 weeks. The goal of treatment is to obtain viral clearance or a sustained virological response, also called a viral cure. Current standard-of-care regimens produce an SVR in up to approximately 80% of people with HCV genotypes 1, 2, and 3. There has been less research, yielding mixed data, on patients with other genotypes.

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•••••••••••••••••••• Important Information about HCV Protease Inhibitors: • Your doctor or nurse will give you instructions on how to take the HCV protease inhibitor • HCV protease inhibitors are only approved for people with chronic HCV genotype 1 • HCV protease inhibitors are taken three times daily (every 7 to 9 hours) • Ribavirin and the specific HCV protease inhibitor are taken with food; check with your medical provider about the type of food taken with the HCV protease inhibitor you are using • HCV protease inhibitors are never taken alone, but always in combination with pegylated interferon and ribavirin • The dose of the HCV protease inhibitor should never be lowered • If you miss a dose of medicine your medical provider will give you instructions on when to take the next dose • Always check in with your medical provider if you have any questions about treatment INVESTIGATIONAL PHARMACEUTICAL THERAPIES HCV therapy has seen impressive advances, given that the virus was only identified in 1989. However, current approved treatment options can have many undesired side effects and do not provide a cure for everyone. Extensive research is underway to develop new and better treatments without some of the serious side effects of interferon and ribavirin. Direct acting antivirals, new forms of interferon, antifibrotic agents, and other therapies are currently under study and many of them look promising. Since HCV mutates extensively as it replicates, it can develop resistance to single antiviral drugs. Most clinical trials have focused on testing new DAAs with pegylated interferon and ribavirin. Some studies are looking at combinations of different types of DAAs, or DAAs with and without pegylated interferon and/or ribavirin.

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For the most current information about investigational pharmaceutical therapies, visit the HCV Advocate HCV Drug Pipeline web page.

• Treatment •

Considerations MEASURING TREATMENT RESPONSE People receiving interferon-based treatment should be followed on a regular basis to monitor side effects and have their HCV viral load tested periodically to make sure they are responding to therapy. PREDICTING RESPONSE TO TREATMENT Adherence to HCV therapy, or taking the prescribed drug doses for the full planned duration, is an important factor in achieving the maximum possible treatment response and preventing drug resistance. There are many other factors that influence how well someone will respond to treatment with pegylated interferon, ribavirin and a protease inhibitor. These predictors of treatment response are valuable tools in guiding the treatment decision-making process, but they should never be used to deny anyone treatment.

refer to pa ge 23 •••••••••

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•••••••••••••••••••• Predictors of Treatment Response There are a variety of host factors that improve the chances of achieving an SVR, including: • Asian or Caucasian race/ethnicity – African Americans do not respond quite as well • IL28B genotype CC • Younger age – under 40 years • Female gender • Low HCV RNA or viral load • Healthy weight • Absence of fatty liver (steatosis) • Minimal liver damage – absent or mild fibrosis, no cirrhosis • Minimal insulin resistance – no diabetes • Healthy immune system Virological response during the early weeks of treatment is an important predictor of sustained response and is used to tailor treatment duration and treatment discontinuation. RVR at week 4 and complete EVR (cEVR) at week 12 both predict successful treatment and are used to guide HCV genotype 1 treatment duration. MANAGING DRUG SIDE EFFECTS The most common side effects of interferon, ribavirin and HCV protease inhibitor therapy include mild to moderate flu-like symptoms, muscle and joint pain, nausea, headaches, fatigue, loss of

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nd cation a i d e M : Tip Self-Help History ent o be Supplem n g has t rtant i h t y r e t ev impo

os is Sin ce alm by the liver it e of anythin g r d a e s w s a e is or pro c rovider p cripti on y r s u e o r y p y n ar a t that s e a i e, su ch herbs, d you tak ripti on dru gs, f sc r type o d non-pre s or any othe worksheet an t n e le p m m le si p sup n: up a ce. Set or mati o substan e followin g inf th in clude

•Namee •Dos often taken •How lon g taken •Howsons for takin g rmation •Rea e and conta ct info •Nam the providers ber of the of ta ct num e pres cription and con e m a N • arma cy that fills th ph

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•••••••••••••••••••• appetite, dry skin, anxiety, depression, diarrhea, unusual taste sensation, itching, rash and insomnia. Some physical symptoms may be reduced with low doses of ibuprofen or acetaminophen (Tylenol). Be cautious, however, since high doses of acetaminophen can be toxic to the liver. People experiencing anxiety, irritability, or depression may be helped with mild tranquilizers or anti-depressants, and some studies suggest that they work best when started at the beginning of HCV therapy rather than waiting until symptoms emerge. Check with your doctor before taking any of these medications. The most common reason for stopping hepatitis C therapy is blood cell deficiencies, including anemia (low red blood cell count), neutropenia (low white blood cell count), and thrombocytopenia (low platelet count). These conditions can often be controlled with interferon or ribavirin dose reductions, but this may compromise effectiveness. It is important to know that HCV protease inhibitors are never dose reduced or taken without pegylated interferon and ribavirin. Another strategy is to use medications such as erythropoietin for anemia and GM-CSF (granulocyte macrophage colonystimulating factor) for neutropenia. A low platelet count may indicate cirrhosis, and care should be taken during treatment. Some people may develop thyroid dysfunction while on interferon. Thyroid function should be closely monitored prior to starting treatment and then every three months during therapy. Most people who develop thyroid dysfunction can treat it without discontinuing HCV therapy. After stopping interferon, thyroid function returns to normal for the majority of people, but a small minority may develop irreversible thyroid problems that will require continuing medication. The key to managing treatment-related side effects is to know what to expect and to treat them as soon as they occur. Report any serious side effects to your medical provider as soon as possible so they can be treated before they become severe enough to require dose reduction or treatment discontinuation. For some people, physical side ef-

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•••••••••••••••••••• fects are worse when the medications are started and diminish over time. There are many simple tips to help alleviate some of the less serious side effects of hepatitis C treatment including: • Taking pegylated interferon before bedtime and before a two-day weekend; this will allow most people to rest before returning to work since the majority of side effects usually occur within two days after injection. • Drinking plenty of fluids (without caffeine or alcohol); it is especially important to drink water or clear fruit juices (apple, cranberry, or grape) right before and right after pegylated interferon injection. • Taking an over-the counter pain reliever one hour before the injection helps relieve side effects for some, while others may find that taking a pain reliever just before or 2 to 3 hours after the injection works better. • Exercising is one of the most important components of health maintenance, and this remains true during therapy. Physical activity helps you to stay positive and focused and improves well-being. Moderation is the key to physical activity. Some good choices for exercise include stretching, walking, yoga, or any activity that you enjoy.

RELIEVIN

G SIDE E FFECTS

Regular ex ercise ma y help alle viate some side effects, s uch as fat igue, associate d with HCV therapy.

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• Hepatitis C • Management

H

epatitis C can be a difficult disease to manage. Lifestyle plays an integral part in disease management and treatment. Healthy diet, moderate exercise, and stress reduction are all critical in maintaining good health. It is important to find a doctor who is both knowledgeable about and sympathetic to people with hepatitis C. Many physicians are not fully educated about HCV infection, and you may have to educate both conventional and alternative practitioners. If you have a family doctor, you may want to quiz him or her on their knowledge about hepatitis C. If you are not comfortable with your doctor, look for a new one; ask family or friends for recommendations. Once your HCV diagnosis has been confirmed, your family doctor or general practitioner should send you to a specialist. Generally, you will be referred to a gastroenterologist (digestive disease specialist) or a hepatologist (liver disease specialist). NUTRITION Since the liver processes and detoxifies everything you eat and drink, a healthy, well-balanced diet is essential. A diet that follows the general guidelines for nutritional health based on the new USDA Food Guidance System (www.choosemyplate.gov) is generally recommended. Such a diet is low in fat and sodium, high in complex carbohydrates, and has adequate protein. A good diet is an important part of hepatitis C management, helping to maintain overall health and prevent obesity-related conditions, which have been linked to faster liver disease progression and poorer response to HCV therapy. Although severe protein-restricted diets are no longer generally recommended for people with liver disease, it is important to avoid certain foods that may have an impact on the liver’s

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•••••••••••••••••••• processing and detoxification work. Processed foods often contain chemical additives, so reduce your consumption of canned, frozen, and other preserved foods. Eating organic fruits and vegetables can help you avoid the pesticides and fertilizers used to grow non-organic produce. Read all labels to acquaint yourself with ingredients. Protein derived from poultry, fish, and vegetable sources may be most beneficial. There is no reason to restrict protein, even if you have cirrhosis. Discuss adequate protein intake with your provider if you have cirrhosis It is recommended that people with any type of liver disease should not eat raw or undercooked shellfish (even if they are already immune to hepatitis A). Many experts advise people with HCV to avoid foods high in fat, salt, or sugar. Caffeine is a chemical that must be processed by the liver, and it is advisable to consume coffee, tea and soda in moderation. A well-balanced diet should contain all of the essential vitamins and minerals you need, but talk with your doctor about whether you should take extra vitamins. It is generally recommended that people with hepatitis C take a daily multiple vitamin supplement that satisfies 100% of daily requirements, but without iron. Taking megavitamin supplements may be harmful. Many patients with cirrhosis have low levels of virtamin A, vitamin D, zinc, and magnesium. If you do not have cirrhosis, avoid taking high doses of vitamins A and D; vitamin A, in particular, can be very toxic to the liver unless taken under the supervision of a medical provider. People with hepatitis C are also generally advised not to take iron supplements unless directed to do so by a knowledgeable practitioner. Inform your medical providers about any vitamins, minerals, supplements, or herbs you are taking, and talk with them about any new products that you are considering. Do not start any unconventional diet without medical advice. In addition to talking with your regular providers, you may wish to consult a licensed nutritionist or dietitian for individual dietary recommendations.

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Self-Help Tip : C h o osin g a M Provider edi cal or Spe cia li st Ev

en if you are satis f ied wit medi cal p h your cu rovider y rrent ou sh ould followin g consider : the Does the provider se and expe rien ced a em knowled gea ble b out hep he or she atitis C ? W re fer you ill to a spe ci Does the alist? provider listen and well? co mmuni c ate Does the provider explain co medi cal t mpli cated er m questions? s and answer all of your Does the provider give you attentio his or he n? r full Do you tru st the pro make imp vider to help you ortant m edi cal de A family p ci si ons? hysi cian m ay re fer spe cialist y ou t fo you are a r evaluation and t o a liver ble to pi c reat ment kt . If family phy si cian, fri he spe cialist, ask your ends, lov workers ed and othe rs livin g w ones, cofor re fer ith hepat rals . itis C

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•••••••••••••••••••• ALCOHOL AND DRUGS Studies have shown that heavy consumption of alcohol can accelerate liver disease progression. Most experts recommend that people living with HCV and other liver conditions should avoid alcohol since there is no known safe level of use. Many drugs (whether prescription, over-the-counter, or recreational) must be processed by the liver, and people with hepatitis C should avoid recreational drugs and tobacco. Check with your doctor before taking over-the-counter or prescription medications because some can cause liver toxicity, especially in people with existing liver disease. Certain herbal remedies have also been shown to damage the liver. ENVIRONMENTAL TOXINS Everything you breathe or absorb through the skin must be filtered by the liver. Fumes from paint thinners, pesticides, and aerosol sprays can damage your liver and should be avoided whenever possible.

VACCINATIONS HEPATITIS A AND B VACCINATION People with HCV are strongly advised to get vaccinated against hepatitis A and B if they are not already immune. Severe HAV and HBV infections have been reported in people who already have HCV. The hepatitis A vaccine consists of two doses administered within a six-month period, and the hepatitis B vaccine typically requires three doses within a six-month period. Both vaccines are made from killed viruses and are considered safe and effective. There is also a combination HAV/HBV vaccine (Twinrix). Twinrix was initially approved with the same dosing schedule as the single HBV vaccines, but the FDA has also approved an accelerated dosing schedule for Twinrix of three shots within 30 days followed by a booster shot after one year.

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•••••••••••••••••••• GENERAL WELLNESS • Stress management Controlling stress is a major factor in managing hepatitis C and maintaining overall good health. Living with a chronic disease is stressful. Many people report “flare-ups” (periods of increased symptoms) following episodes of stress. Exercise, meditation, and good time management can all help reduce stress. Try to maintain a realistic picture of your health while keeping a positive attitude. Understanding the severity of your liver disease is an important part of having a realistic picture of your condition. • Managing fatigue Fatigue and low energy levels are common in people with HCV. Learn your limits and do not overextend yourself. When you plan activities, allow time in between for relaxation or naps. Remember that your health is important—learn to say “no” to friends and family who have unrealistic expectations about your energy level. • Time management Plan activities well in advance and try to make realistic work and play schedules. Use a daily planner to help with organizing and remembering activities. Consult your planner regularly when making appointments and scheduling daily tasks. Don’t forget to include restful activities. • Meditation and Prayer Meditation and prayer can be useful tools in managing and living with HCV or any chronic illness. They can reduce stress and help you maintain a healthy outlook on life. Meditation is simple and easy to learn.

Mind and bod y connection can help promote healthy hea ling.

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•••••••••••••••••••• • Exercise Moderate exercise is highly recommended for all individuals who are not in an acute or end-stage phase of hepatitis C. Exercise can help reduce stress, maintain a healthy weight, and promote overall good health and fitness. However, too much exercise can lead to disease flare-ups. If this is a concern, select low impact types of exercise such as walking and swimming. Slowly increase your workouts until you reach the desired level. Always check with a healthcare provider before starting any exercise program. SUPPORT GROUPS Many people with HCV feel isolated and find it difficult to cope with the effects of living with a chronic illness. A support group can offer a safe space to discuss the emotional issues surrounding hepatitis C. Furthermore, the information shared by peer members can be helpful in making decisions about a wide variety of issues. It is highly recommended that you join a support group while undergoing HCV treatment. Support group information can be found on the Hepatitis C Support Project website www.hcvadvocate.org or by contacting the organizations listed at the end of this booklet. THE INTERNET The Internet contains a wealth of information, both good and bad. Always check the sources of the information you find. Look for dates and references. Challenge any information you believe is in error. Be skeptical of websites that contain misleading information. Remember that not all the information you find on the Internet is correct, and if something sounds too good to be true, it probably is. Talk to your medical provider regarding any information you are unsure of or concerned about. Common sense can take you a long way! For information about recommended websites, visit the Hepatitis C Support Project website at www.hcvadvocte.org.

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rin g ip: Lowe T lp e H lf Se on Costs Pres cripti

in g up, s keeps go eep g ru d n io t k p of pres cri ps you can take to The cost e st win g: are many f the follo o e m o but there s . down. Try e samples the costs about fre ey are r e id v ro p --th your Talk with drugs when possible heaper c c ri lly e ia n ant Use ge d are subst gs. n a e iv ct as effe ame dru et, to brand n tail stores like Targ compared re rge or bulk Shop at la c. is counted Costco, et es are frequently d ppli f regularly 90-day su y supply o a d 0 3 a to compared tions. ost drugs i ca d e m e or low c nies. Two taken re f r fo y f ali mpa You may qu pharma ceuti cal co find e h rvi ces to t e s h g r fe f o throu s n rganizatio umbrella o alify: qu ssistan ce: out if you for Pres cription A ip Partnersh rx.org a p eds.com .p w w w w.needym trials in w w : s d Needy Me re are any clini cal the Find out if : your area altrials.gov ni c li .c w w w

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• Conclusion • C

hronic hepatitis C is a liver disease that can have serious consequences. It is important to remember that many people do not experience symptoms or disease progression, but there is no way to know in advance who will and who won’t. Many people who do eventually experience disease progression may remain relatively symptom-free for decades, but some develop severe disease that can result in liver failure or death. This is why it is so important that people with hepatitis C be closely monitored by knowledgeable medical providers and have access to appropriate healthcare and treatment. New direct acting antivirals (DAAs) have led to a major change in how HCV is treated, and many more drugs are currently being tested. Future therapies may work better, have fewer side effects, be easier to take and cure more people. In the meantime, lifestyle changes such as healthy diet, exercise, and stress management can help alleviate the side effects of existing therapies and may help slow disease progression. Ultimately, as a person living with hepatitis C, you have the most important role in your health maintenance. Education, support, and a good relationship with a healthcare provider will help ensure that you receive the best possible medical care.

nt orta p m i most ealth in h n ce ena maint lationship re good provider with We hope this information has helped you to understand the hepatitis C virus and how it can affect your physical and emotional health. We welcome any suggestions or ideas for improving this booklet.

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• Resources •

For more information about HCV, contact the following organizations: • American Liver Foundation 1-800-465-4837, www.liverfoundation.org • Hepatitis Education Project 206-732-0311, www.hepeducation.org • Hepatitis Foundation International 1-800-891-0707, www.hepfi.org • Hep C Connection 1-800-522-4372, www.hepc-connection.org SUGGESTED READING The Hepatitis C Help Book, by Misha Cohen, OMD, LAc, and Robert Gish, MD. St. Martin’s Press (2007). Living with Hepatitis C: A Survivor’s Guide, by Gregory T. Everson, MD, and Hedy Weinberg. Hatherleigh Press (Fifth edition 2009). 1-800-367-2550. Healing Hepatitis C, by Christopher Kennedy Lawford and Diana Sylvestre, Harper Paperbacks, 2009 PHARMACEUTICAL RESOURCES • Partnership for Prescription Coverage www.pparx.org 1-888-477-2669 • Genentech (Member of the Roche Group): 1-877-PEGASYS (1-866-422-2377) www.genentechaccesssolutions.com/portal/site/AS/

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•••••••••••••••••••• • Kadmon Pharmaceuticals: 1-800-405-8506 www.3riverspharma.com • Merck (includes Schering-Plough subsidiary): 1-866-939-HEPC (4372) www.merck-cares.com • NeedyMeds: www.needymeds.org • Vertex: 1-888-552-2494 www.vrtx.com/patients.html SAFER TATTOING • Hepatitis & Tattoos: www.hepatitistattoos.org/ HIV AND HIV/HCV COINFECTION RESOURCES • Project Inform www.projectinform.org hotline: 1-800-822-7422 • HIV and Hepatitis: www.hivandhepatitis.com • National AIDS Treatment Advocacy Project: www.natap.org 1-888-26-NATAP • Treatment Action Group (TAG) www.treatmentactiongroup.org CLINICAL TRIALS www.clinicaltrials.gov

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• Glossary •

ACUTE: the rapid-onset, short-term initial stage of a disease. Contrast with chronic. ACUTE HEPATITIS: the initial stage of viral hepatitis following infection. Acute hepatitis C refers to the first six months after initial infection. ADVERSE EVENT: an undesired reaction or side effect that occurs during treatment. ALOPECIA: hair loss. ALT (formerly SGPT): abbreviation for alanine aminotransferase. ALT is an enzyme produced inside liver cells. Elevated ALT is a sign of liver inflammation. It is frequently elevated in people with chronic HCV infection and some other liver diseases due to the breakdown of cell membranes. Serum ALT is measured using a simple blood test, and is part of the liver function test panel. ANEMIA: reduced number of red blood cells or reduced ability of blood to carry oxygen. There are several types of anemia, all with different causes. Symptoms may include fatigue, weakness, pale skin, and difficulty breathing. ANTIBODY: a protein produced by the immune system when a foreign substance enters the body. The presence of antibodies is an indicator of a past or current infection. A test for HCV antibodies (“anti-HCV”) is often the first step in diagnosing HCV infection. A positive HCV antibody test must be followed by other laboratory tests to confirm the diagnosis. ARTHRALGIA: joint pain. AST (formerly SGOT): abbreviation for aspartate aminotransferase. AST is an enzyme produced in the liver. When liver cells are damaged, AST is released. Elevated levels may indicate liver

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•••••••••••••••••••• disease, but are also seen in people with other conditions. Serum AST is part of the liver function test panel. AUTOIMMUNE RESPONSE (AUTOIMMUNITY): a condition in which a person’s immune system produces antibodies that attack the body’s own tissues. Several conditions associated with hepatitis C appear to have an autoimmune aspect. BID: taken twice a day. BIOPSY: a procedure in which a sample of cells or tissue is taken to examine in a laboratory. In people with HCV, liver biopsies (often using a long needle) are used to assess the health of the liver and the extent of fibrosis. BLOOD-BORNE: transmitted through direct blood-to-blood contact; for example, through sharing needles or through a blood transfusion. BOCEPREVIR: see Victrelis. BRAIN FOG: mental confusion, memory loss, and/or lack of alertness. Not to be confused with encephalopathy. cEVR: see complete early virological response. CHRONIC: long-term or persistent disease. Contrast with acute. CIRRHOSIS: liver damage in which normal liver cells are replaced with scar tissue. In compensated cirrhosis, the liver is damaged but can still function. In decompensated cirrhosis, liver function is severely impaired and scar tissue interferes with normal blood flow through the liver, potentially leading to bleeding varices, ascites, mental confusion, and other symptoms. COINFECTION: concurrent infection with more than one diseasecausing organism (e.g., HIV and HCV). COMPLETE EARLY VIROLOGICAL RESPONSE (cEVR): HCV RNA negative at treatment week 12.

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•••••••••••••••••••• CYTOPENIA: low levels of blood cells. EARLY VIROLOGICAL RESPONSE (EVR): 2 log10 drop in HCV RNA at treatment week 12. EDEMA: swelling caused by the accumulation of fluid in body tissues. EFFICACY: effectiveness; the ability to achieve a desired effect. ENCEPHALOPATHY: disease of the brain. Hepatic encephalopathy, associated with advanced cirrhosis, is characterized by reduced cognitive function, confusion, and memory loss. END OF TREATMENT (EOT) RESPONSE: the disappearance of detectable HCV RNA from the blood at the end of a course of treatment. ESOPHAGUS: the tube leading from the mouth to the stomach. EXTENDED EARLY VIROLOGICAL RESPONSE (eEVR): HCV RNA negative at treatment week 4 and 12. EXTRAHEPATIC: outside the liver. FDA: abbreviation for the Food and Drug Administration. This U.S. federal government agency has many functions, including approval of pharmaceutical drugs. FIBROSIS (adjective FIBROTIC): liver damage that involves the development of fibrous scar tissue. FULMINANT HEPATITIS: a severe, life-threatening form of hepatitis. GENOTYPE: genetic variation in the structure of HCV. There are six major HCV genotypes, designated by the numbers 1 through 6. There are also many subtypes, e.g., 1a, 1b, 2a, etc. In the U.S., genotype 1 is predominant (approximately 70%–75% of those infected). HCV RNA: the genetic material of the hepatitis C virus. HCV is a single-stranded ribonucleic acid (RNA) virus. Commonly referred to as HCV viral load.

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•••••••••••••••••••• HEPATIC: relating to the liver. HEPATITIS: inflammation of the liver. Hepatitis may have various causes, including viruses, toxins, and heavy alcohol consumption. HEPATOCELLULAR CARCINOMA (HCC): a type of primary liver cancer seen in some people with long-term liver damage; for example, due to chronic hepatitis C or hepatitis B. HEPATOLOGY (also HEPATOLOGIST): the medical specialty that deals with the liver; a hepatologist treats liver disease. HEPATOTOXICITY (adjective HEPATOTOXIC): toxic or poisonous to the liver. HISTOLOGICAL: refers to bodily tissue. In hepatitis C, histological response means improvement in liver tissue, either reduced inflammation or reduced fibrosis, when comparing biopsies obtained before and typically six months after HCV therapy. INCIVEK (telaprevir): an HCV protease inhibitor that is manufactured by Vertex Pharmaceuticals, Inc. Incivek is FDA approved to treat people with chronic HCV genotype 1. INTERFERON (IFN): a naturally occurring protein in the human body produced by cells of the immune system. Interferon interferes with viral replication and influences host response. Genetically engineered products based on the natural protein have been developed by several pharmaceutical companies, and are approved for the treatment of chronic HCV infection. INTERLEUKIN 28B (IL28B): a protein-coding gene. Certain variations of IL28B have been found to predict the rate of spontaneous (natural) clearance of HCV after an acute infection and significantly predict treatment response in HCV genotype 1 patients. People with IL28B CC genotype are more than two to three times as likely to spontaneously clear HCV or achieve an SVR.

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•••••••••••••••••••• JAUNDICE: yellowing of the skin and whites of the eyes due to high bilirubin levels in the blood (hyperbilirubinemia). Jaundice is often a sign of liver damage or gallbladder disease. LIVER: a large organ on the upper right side of the abdomen that plays an important role in the metabolism of sugars and fats, synthesizes several proteins, and filters toxins from the blood. LOG: a way of mesuring viral load. A 2 log10 drop from 149,000 would be 1,490 IU/ML. This is an indication that you are responding to treatment and have a greater likelihood of clearing the virus. Should you not have a 2 log10 drop the odds of clearing the virus are significantly reduced. MALAISE: a generalized feeling of illness and discomfort; a flulike feeling. MONOTHERAPY: use of a single drug for treatment. MYALGIA: muscle pain. NEUTROPENIA: an abnormally low number of neutrophils, resulting in increased susceptibility to infection. NEUTROPHIL: the most common type of immune system white blood cell. Neutrophils are phagocytes—white blood cells that engulf and destroy invading organisms such as bacteria and fungi. NONRESPONDER: in hepatitis C, a nonresponder is a person who does not experience disappearance of HCV RNA during or after treatment. NULL RESPONDER: a person who does not achieve a 2 log10 drop of HCV RNA by treatment week 12. PEGYLATED INTERFERON (brand names PEGINTRON, PEGASYS): a formulation of interferon that has a long half-life in the body and can be injected less often than conventional formulations (typically once per week). Pegylated interferon is approved for the treatment of hepatitis C.

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•••••••••••••••••••• PERCUTANEOUS: through the skin. PERINATAL TRANSMISSION (VERTICAL TRANSMISSION): transmission from a mother to a fetus or newborn. Vertical transmission may occur in utero (in the womb), intrapartum (during birth), or postpartum (e.g., via breastfeeding). PLATELET: see thrombocyte. PRIOR PARTIAL-RESPONDER: a person who has a 2 log10 drop in HCV RNA by treatment week 12, but who does not become HCV RNA negative by end of treatment. (Example 2 log10 drop: 1,000,000 to ≤ 10,000) PROTEASE: a key enzyme of a virus involved in the viral replication process. PROTEASE INHIBITOR (PI): a medicine that stops or inhibits a virus from replicating. PRURITUS (adjective PRURITIC): itchiness. QD: taken once a day. QUALITATIVE: relating to, or expressed in terms of, quality. A qualitative viral load test measures the presence of a virus. QUANTITATIVE: relating to, or expressed in terms of, quantity. A quantitative viral load test measures the amount of viral genetic material, or viral load. QUASISPECIES: individual genetic variants of HCV. Within a single HCV genotype there may be multiple quasispecies. RAPID VIROLOGICAL RESPONSE (RVR): RNA negative at treatment week 4. RELAPSE: recurrence of disease symptoms following a period of improvement. In hepatitis C, relapse can refer to an increase in viral load after it has been suppressed with antiviral treatment.

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•••••••••••••••••••• RELAPSER: a person who becomes HCV RNA negative at end of treatment, but becomes HCV detectable within 24 weeks from the end of treatment (EOT). RESPONSE TO TREATMENT: how a disease responds to drug therapy. The term can refer to a biological, histological, or virological response. RIBAVIRIN (brand names COPEGUS, REBETOL): an antiviral medication that is used in combination with interferon for treatment of chronic HCV infection. STEATOSIS: buildup of fat in the liver. SUBCUTANEOUS (SC or SQ): underneath the skin; usually refers to a drug injected under the skin. SUSTAINED RESPONDER: a person who maintains a long-term response to treatment. In hepatitis C, sustained response refers to undetectable HCV viral load and/or normal ALT that persists after treatment is completed. SUSTAINED VIROLOGICAL RESPONSE (SVR): HCV RNA negative 24 weeks after completion of treatment (CURE). TELAPREVIR: see Incivek THROMBOCYTE (PLATELET): a type of blood cell responsible for normal blood clotting. THROMBOCYTOPENIA: an abnormally low number of platelets, which may result in abnormal bleeding and bruising. THYROID: an organ at the base of the neck that produces thyroxin and other hormones involved in regulating metabolism. TID: taken three times a day. TREATMENT-NAIVE: a person who has never been treated. PLATELET: see thrombocyte.

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•••••••••••••••••••• VACCINE: a preparation administered to stimulate an immune response to protect a person from illness. A vaccine typically includes a small amount of a killed or inactivated microorganism, or genetically engineered pieces. A preventive (prophylactic) vaccine is intended to prevent initial infection. A therapeutic (treatment) vaccine is given after infection and is intended to reduce or stop disease progression. VARICES (adjective VARICEAL): an abnormally dilated or swollen vein, artery, or lymph vessel. In hepatitis C, varices usually refers to swollen blood vessels in the esophagus or stomach resulting from portal hypertension. VICTRELIS (boceprevir): an HCV protease inhibitor that is manufactured by Merck and Co. Victrelis is FDA approved to treat people with chronic HCV genotype 1. VIRAL LOAD: the amount of a virus’s genetic material (e.g., HCV RNA) that can be measured, usually in the blood. VIRAL REPLICATION: the process of a virus reproducing to make new copies of itself. VIROLOGICAL RESPONSE: reduction of viral replication due to treatment, indicated by changes in viral load. In hepatitis C, when HCV RNA becomes undetectable after starting HCV therapy, this is considered a virological response. Rapid virological response is measured at four weeks and early virological response (EVR) at 12 weeks. If HCV RNA remains undetectable six months after completing treatment, this indicates sustained virological response (SVR). VIRUS: a simple microscopic organism that invades a living host and makes copies of itself (viral replication). WINDOW PERIOD: the time between exposure to a microorganism and the production of sufficient antibodies to be detected on a test. The window period for HCV is 2 - 26 weeks.

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Acknowledgement: Portions of this guide are excerpts from a previous HCSP publication, First Steps with HCV for the Newly Diagnosed, written by Lucinda K. Porter, RN. This information is provided by the Hepatitis C Support Project. Reprint permission is granted and encouraged with credit to the Hepatitis C Support Project – www.hcvadvocate.org Š2011 Hepatitis C Support Project Supported by an unrestricted educational grant from Genentech, Inc.


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Author Alan Franciscus Executive Director, Hepatitis C Support Project Editor-in-Chief, HCV Advocate Website

Editor Liz Highleyman General Editor C.D. Mazoff, PhD Design and Production Leslie Hoex, Blue Kangaroo Design www.bluekangaroodesign.com

Contact information: The Hepatitis C Support Project PO Box 427037 San Francisco, CA 94142-7037 alanfranciscus@hcvadvocate.org Š2011 Hepatitis C Support Project

Supported by an unrestricted educational grant from Genentech, Inc.

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