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More on Hepatitis C
More on Hepatitis C
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Research and Clinical Trials
More on Hepatitis C
More on Hepatitis C
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Viral hepatitis is a liver infection caused by one of five known viruses: hepatitis A, B, C, D, and E. Hepatitis C is a serious disease caused by the hepatitis C virus (HCV), which accounts for most cases of viral hepatitis in the United States. Approximately 4.1 million Americans, or 1.6 percent of the population, are infected with HCV, and of these, about 3.2 million are chronically infected. New infections have declined from about 240,000 per year in the 1980s to approximately 16,000 annually in 2009.
Chronic HCV infection increases the risk of cirrhosis (scarring and dysfunction of the liver), end-stage liver disease/liver failure, and liver cancer. Infection with HCV is the most common indication for liver transplantation. Unlike hepatitis B, there is currently no vaccine for HCV infection.
NewYork-Presbyterian Hospital is a leading center for the management and study of HCV. Patients receive the full range of care, including personalized medical therapy with the latest medications and monitoring. Our physicians have directed and participated in major studies that led to the development of the standard HCV therapies used today, as well as those evaluating investigational drugs and new treatment regimens for patients with HCV – both within and outside of the setting of liver transplantation.
We have a distinguished track record for liver transplantation and a multidisciplinary team of world-renowned leaders in the field. NewYork-Presbyterian's Center for Liver Disease and Transplantation excels in providing liver transplantation to patients with HCV and has more clinical experience caring for these patients than most hospitals. These individuals require careful monitoring and care, since the immunosuppressive drugs they take after the transplant increase the risk of recurrent HCV disease in the new liver.
Symptoms of Hepatitis C
Many individuals chronically infected with HCV do not have any symptoms, and may have normal blood tests. Others may feel like they have the flu, with fever, fatigue, nausea, lack of appetite, mild upper-right abdominal pain or discomfort, or diarrhea. Blood tests may indicate an elevation in liver enzymes. Individuals with more advanced disease may have jaundice (yellowish tint to skin and/or eyes), light-colored stools, or darker urine. Patients with cirrhosis usually experience fatigue, weakness, itching, dark urine, fluid buildup in the legs (edema) or abdomen (ascites), nausea, and little appetite. Patients with acute hepatitis may have jaundice, nausea, fatigue, and elevations in one liver enzyme, and tests sometimes show the presence of HCV antibodies.
Risk Factors for Hepatitis C
HCV is most often spread via the blood of an infected individual. Most cases of HCV are due to intravenous drug use (sharing needles with a person infected with the virus), receiving blood clotting factors produced before 1987, or receiving a blood transfusion or organ donation before 1992 (the year blood donations and transplanted organs began to be screened for HCV). The virus may also be spread to an infant born to an HCV-infected mother, through accidental needle sticks among healthcare workers, and (to a lesser extent) through sexual contact, sharing of HCV-contaminated razors, or through contaminated tattoo equipment.
There are six known variations or "genotypes" of HCV, and about 50 subtypes of the virus. Physicians test patients for each genotype to determine what type of antiviral drug therapy is most appropriate.
Diagnosis of Hepatitis C
If HCV is suspected, the liver specialists at NewYork-Presbyterian Hospital will perform a physical examination to determine whether the patient's liver or spleen is enlarged or if tenderness is present. They also use a number of blood tests to detect HCV infection, including:
- An enzyme immunoassay, or EIA, antibody test
- A recombinant immunoblot assay, or "RIBA", if the result of the EIA is positive
- A PCR test to detect the presence of viral RNA, and a second test to measure the amount of the virus in the blood
- A blood test to check platelet and white blood cell counts
- Some patients may also have a liver biopsy, which a physician performs using an ultrasound-guided thin needle inserted into the abdomen. The physician removes a very small piece of liver tissue via the needle. Our pathologists analyze the tissue to determine if the liver is damaged, and if so, to what extent.
Treatment for Hepatitis C
The standard treatment for HCV has been a combination of the antiviral drug ribavirin with pegylated interferon (a type of interferon designed to remain in the body longer). Patients with genotypes 2 and 3 usually have 24 weeks of combination therapy, while those with genotype 1 – the most common type, and one of the most challenging to manage – typically receive 48 weeks of treatment. Our physicians monitor patients with HCV regularly with blood tests and sometimes liver biopsy.
However, interferon is associated with significant side effects, such as chills, fever, headache, rapid heartbeat, and muscle and joint pain, followed by fatigue, cognitive problems, depression, irritability, and low blood count. More severe side effects, although rare, include hearing loss, lung problems, suicidal thoughts, seizures, worsening of liver disease, and acute kidney or heart failure. About 40 percent of patients require a reduction in their interferon dose because of severe side effects, and about 15 percent stop treatment, diminishing its effectiveness.
In 2011, the field of HCV care was boosted with the approval by the U.S. Food and Drug Administration of two new drugs: boceprevir and telaprevir. NewYork-Presbyterian physicians were leaders in the clinical trials that ultimately led to the approval of these drugs, which are known as "protease inhibitors." Each of these drugs, when given in combination with ribavirin and pegylated interferon, can actually cure patients of HCV infection. Our physicians also have exceptional experience in the use of these drugs – particularly telaprevir – after liver transplantation, to reduce the risk of HCV recurrence in the new liver.
Research for Hepatitis C
Because interferon is associated with side effects and must be given at a doctor's office, researchers have been seeking interferon-free regimens with only oral drugs (those taken by mouth). NewYork-Presbyterian/Weill Cornell Medical Center investigators are leading studies of highly promising targeted HCV agents, including interferon-free regimens. NewYork-Presbyterian/Columbia University Medical Center offers clinical trials assessing HCV treatment before and after liver transplantation. Patients who come to us for HCV care may have opportunities to participate in these studies.
In 2013, NewYork-Presbyterian/Columbia investigators presented groundbreaking data showing the value of combining interferon, ribavirin, and telaprevir or boceprevir – so-called "triple therapy" – to treat liver transplant recipients with recurrent HCV genotype 1. NewYork-Presbyterian/Columbia collaborates with five other centers treating patients with HCV after transplantation through the Consortium to Study Health Outcomes in HCV Liver Transplant Recipients (CRUSH-C). NewYork-Presbyterian/Columbia is enrolling patients in clinical trials assessing oral, interferon-free regimens with a variety of drug combinations in patients with HCV before and after liver transplantation. The hospital is one of very few centers providing access to these studies.
NewYork-Presbyterian/Weill Cornell physicians led or participated in late-stage clinical trials of the investigational drug sofosbuvir, which belongs to a class of drugs called "nucleotide polymerase inhibitors." In one of these studies, reported in 2013, a combination of peginterferon, ribavirin, and sofosbuvir given for only 12 weeks was effective in 89 percent of patients with HCV genotype 1. Another study demonstrated that an interferon-free regimen of sofosbuvir plus ribavirin was as effective against HCV as interferon plus ribavirin in patients with HCV genotypes 2 and 3. Sofosbuvir and ribavirin were also shown to be effective for patients who were not candidates for interferon therapy. These studies represent a new model for HCV management and have the potential to change the standard of care for this challenging viral infection.
NewYork-Presbyterian also participates in the Center for the Study of Hepatitis C, a collaborative research and treatment partnership comprised of physicians and researchers from Weill Cornell Medical College, The Rockefeller University, and NewYork-Presbyterian Hospital. The Center has a serum and tissue repository, and a database with blood and liver samples from over 1,500 patients.