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Hepatitis C News

Related terms: Hepatitis C, Chronic, Chronic Hepatitis C, Hep C

Zepatier Approved for Chronic Hepatitis C

Posted 5 days ago by Drugs.com

FRIDAY, Jan. 29, 2016 – Zepatier (a combination of elbasavir and grazoprevir) has been approved by the U.S. Food and Drug Administration to treat chronic infection with the hepatitis C virus, genotypes 1 and 4. Hepatitis C causes liver inflammation, which can lead to liver failure. Most infected people have no symptoms until the onset of liver damage, which could take several years, the FDA said in a news release. Possible symptoms include a yellowing of the eyes and skin known as jaundice, bleeding or liver cancer. Genotype 1 is among the most common forms of hepatitis C, while genotype 4 is among the rarest, the agency said. Some 3 million Americans are believed infected with a form of the virus. Zepatier, sometimes paired with another antiviral drug, ribavirin, was evaluated in 12-to-16-week clinical studies involving nearly 1,400 people. At the end of the studies, between 94 ... Read more

Related support groups: Hepatitis C, Zepatier, Elbasvir/grazoprevir

FDA Approves Zepatier (elbasvir and grazoprevir) for Chronic Hepatitis C Genotypes 1 and 4

Posted 10 days ago by Drugs.com

January 28, 2016 – The U.S. Food and Drug Administration today approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients. Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take several years. Some people with chronic HCV infection develop cirrhosis over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections or liver cancer. According to the Centers for Disease Control and Prevention, approximately 3 million Americans are infected with HCV, of which genotype 1 is the most common and genotype 4 is one of ... Read more

Related support groups: Hepatitis C, Zepatier, Elbasvir/grazoprevir

Hepatitis C Reported at 19 Dialysis Clinics: CDC

Posted 10 days ago by Drugs.com

THURSDAY, Jan. 28, 2016 – Reports of hepatitis C infections among dialysis patients in the United States are rising, largely because of poor infection control practices, health officials say. Between 2014 and 2015, the U.S. Centers for Disease Control and Prevention received reports of about 36 cases of hepatitis C infection at 19 kidney dialysis clinics in eight states. So far, investigators have determined that patient-to-patient transmission of hepatitis C occurred at nine of those clinics. Lapses in infection control procedures – such as injection safety, cleaning and disinfection, and hand hygiene – were common at these clinics, the CDC reported Wednesday. The exact means of hepatitis C transmission could not be pinpointed, but all of these deficiencies could contribute to transmission of the virus. Hepatitis C, which can cause lifelong liver disease, is spread primarily through ... Read more

Related support groups: Hepatitis C, Renal Failure, Chronic Kidney Disease, Peritoneal dialysis, Hemodialysis

Hepatitis C May Be Tied to Greater Risk for Parkinson's Disease

Posted 24 Dec 2015 by Drugs.com

WEDNESDAY, Dec. 23, 2015 – Hepatitis C is an infection that affects the liver, but people with the virus may also be at greater risk for Parkinson's disease, a new report shows. "Many factors clearly play a role in the development of Parkinson's disease, including environmental factors," study author Dr. Chia-Hung Kao, of China Medical University in Taichung, Taiwan, said in a news release from the American Academy of Neurology. "This nationwide study, using the National Health Insurance Research Database of Taiwan, suggests that hepatitis caused specifically by the hepatitis C virus may increase the risk of developing [Parkinson's] disease," Kao said. However, the association seen in the study does not prove a cause-and-effect relationship. And "more research is needed to investigate this link," Kao added. One expert in Parkinson's disease agreed that it's too soon to draw firm ... Read more

Related support groups: Hepatitis C, Parkinson's Disease, Parkinsonian Tremor, Parkinsonism

Pricey Hepatitis C Drugs Denied to Almost Half of Medicaid Patients: Study

Posted 24 Nov 2015 by Drugs.com

TUESDAY, Nov. 24, 2015 – Nearly half of Medicaid patients with chronic hepatitis C have been denied cutting-edge medications that would most likely cure their condition, due to tight controls that states have placed on coverage of the pricey drugs, a new study shows. About 46 percent of Medicaid patients in four northeastern states were denied treatment with new direct-acting antiviral (DAA) drugs, which have been shown to cure more than nine out of 10 hepatitis C patients, the researchers reported. These powerful medications include Sovaldi (sofosbuvir) and Harvoni (ledipasvir). By comparison, only 10 percent of privately insured patients and 5 percent of Medicare patients were denied treatment, said study author Dr. Vincent Lo Re III, an assistant professor of medicine and epidemiology in the division of infectious diseases at the Perelman School of Medicine at the University of ... Read more

Related support groups: Hepatitis C, Harvoni, Sovaldi

Screening Inmates for Hepatitis C Benefits General Community: Study

Posted 23 Nov 2015 by Drugs.com

MONDAY, Nov. 23, 2015 – A prison-based hepatitis C screening and treatment program could benefit the broader community, researchers suggest. Besides reducing the spread of hepatitis C after prisoners are released, "universal [hepatitis C] testing and treatment in prisons would reduce outcomes of advanced [hepatitis C] such as liver cancer, end-stage liver disease and death among prisoners," said study senior author Jagpreet Chhatwal, of Massachusetts General Hospital's Institute for Technology Assessment in Boston. "We now have highly effective treatments for [hepatitis C], so we wanted to know the impact of providing routine testing and treatment to inmates, a group in which the infection is highly prevalent," Chhatwal said in a hospital news release. More than 1 percent of the U.S. population has hepatitis C, but the virus affects more than 17 percent of prisoners, the researchers ... Read more

Related support groups: Cancer, Hepatitis C, Liver Cirrhosis, Hepatocellular Carcinoma, Liver and Pancreatic Disease, Benign Liver Tumor, Hepatic Coma, Liver Metastasis in Adenocarcinoma, Hepatic Tumor

FDA Approves New Indications for Harvoni to Include Patients with Genotypes 4, 5 and 6 HCV and Patients Co-Infected with HIV

Posted 12 Nov 2015 by Drugs.com

FOSTER CITY, Calif.--(BUSINESS WIRE)--Nov. 12, 2015-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Harvoni (ledipasvir/sofosbuvir) for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection and in patients co-infected with HIV. In addition, Harvoni plus ribavirin (RBV) for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis. Harvoni received regulatory approval for the treatment of chronic HCV genotype 1 infection in adults in the United States in October 2014. “Harvoni – the first and only single-tablet regimen for the treatment of HCV – continues to demonstrate high cure rates and a tolerable side effect profile across a range of patient populations, including those who have historically been consi ... Read more

Related support groups: Hepatitis C, Harvoni, Ledipasvir/sofosbuvir

In Rare Cases, Hepatitis C Drug Tied to Slowed Heart Rate: Study

Posted 4 Nov 2015 by Drugs.com

WEDNESDAY, Nov. 4, 2015 – One of the new, highly effective drugs for treating hepatitis C can cause a very slow and erratic heart rate in some patients, new research warns. Doctors at a Paris hospital found that three out of 415 chronic hepatitis C patients treated with the drug sofosbuvir during 2014 developed an abnormally slow heart rate, called an bradyarrhythmia. In all three cases, the patients were also receiving other hepatitis C medications, including daclatasvir, simeprevir and ribavirin, according to the report. "The potential cardiac toxicity of sofosbuvir-containing regimens suggests the need for caution with the use of such regimens," the Parisian doctors concluded in the report. They suggested that doctors review other medications and potential risk factors for an abnormal heart rate before prescribing the drug. And, they pointed out the possible need to monitor the ... Read more

Related support groups: Hepatitis C, Harvoni, Sovaldi, Bradyarrhythmia, Sofosbuvir, Ledipasvir/sofosbuvir

Illnesses, Deaths Spur FDA Warning on Hepatitis C Drugs

Posted 23 Oct 2015 by Drugs.com

FRIDAY, Oct. 23, 2015 – Reports of deaths and illnesses occurring soon after use are prompting the U.S. Food and Drug Administration to issue warnings on two drugs used to fight the hepatitis C virus. The drugs, called Viekira Pak and Technivie, appeared linked to serious liver damage in patients with advanced liver disease, the agency warned in a statement issued Thursday. Of 26 cases reported worldwide where use of the medications has been the possible or probable cause of illness, 10 patients either died or required organ transplant after liver failure, and 16 patients had some form of liver dysfunction. In most cases, liver damage occurred within one to four weeks of patients starting treatment, the FDA said. The cases occurred after the two drugs were approved by the FDA – Viekira Pak in December of 2014 and Technivie in July of 2015, the statement said. The agency believes that ... Read more

Related support groups: Hepatitis C, Liver and Pancreatic Disease, Viekira Pak, Technivie

FDA Medwatch Alert: Hepatitis C Treatments Viekira Pak and Technivie: Drug Safety Communication - Risk of Serious Liver Injury

Posted 22 Oct 2015 by Drugs.com

ISSUE: FDA is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. As a result, FDA is requiring the manufacturer to include information about serious liver injury adverse events to the Contraindications, Warnings and Precautions, Postmarketing Experience, and Hepatic Impairment sections of the Viekira Pak and Technivie drug labels. FDA review of adverse events reported to the FDA Adverse Event Reporting System (FAERS) database and to the manufacturer of these medicines, AbbVie, identified cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking these medicines. Some of these events resulted in liver transplantation or death. These serious outcomes were reported mostly in patients taking Viekira Pak who had evidence of advanced cirrhosis ... Read more

Related support groups: Hepatitis C, Viekira Pak, Dasabuvir/ombitasvir/paritaprevir/ritonavir, Ombitasvir/paritaprevir/ritonavir, Technivie

Liver Damage From Hepatitis C More Widespread Than Thought

Posted 27 Aug 2015 by Drugs.com

THURSDAY, Aug. 27, 2015 – Severe liver damage may be four times more common among Americans with the liver infection hepatitis C than previously believed, a new study suggests. Analyzing nearly 9,800 patients with hepatitis C, researchers learned that using a biopsy alone to reveal liver cirrhosis – indicating scarring in the organ – is likely to seriously underestimate its prevalence. The recent emergence of medications that can cure hepatitis C, a "silent killer" that often goes undetected until advanced disease sets in years later, adds weight to the new findings, doctors said. "We thought it would be important to provide the health care community with some estimate as to the severity of liver disease among patients with hepatitis C because it's a question that comes up very frequently: Just how sick is this community?" said study author Dr. Stuart Gordon, director of hepatology ... Read more

Related support groups: Hepatitis C, Harvoni, Cirrhosis, Liver Cirrhosis, Biliary Cirrhosis

More Hepatitis C Cases Being Seen in Urban ERs

Posted 7 Aug 2015 by Drugs.com

FRIDAY, Aug. 7, 2015 – New research reveals high rates of hepatitis C infection among intravenous drug users and baby boomers seen in urban emergency departments. And three-quarters of those who tested positive for the potentially deadly virus did not know they were infected, the researchers added. "Given skyrocketing rates of injection heroin use around the country, we expect the already high rates of hepatitis C infection to explode," said study author Dr. Douglas White, from Highland Hospital in Oakland, Calif. Hepatitis C is the most common chronic bloodborne infection in the United States, and it is a leading cause of liver failure, liver cancer and liver transplants. Researchers said the disease was found in 10 percent of the emergency department patients who were tested, and 70 percent of them had chronic infections. Only 24 percent of the patients who tested positive for ... Read more

Related support groups: Hepatitis C, Heroin

FDA Approves Daklinza (daclatasvir) for Chronic Hepatitis C Genotype 3 Infections

Posted 27 Jul 2015 by Drugs.com

July 24, 2015 – The U.S. Food and Drug Administration today approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. Daklinza is the first drug that has demonstrated safety and efficacy to treat genotype 3 HCV infections without the need for co-administration of interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection. Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take several years. Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, ... Read more

Related support groups: Hepatitis C, Sofosbuvir, Daklinza, Daclatasvir

FDA Approves Technivie (ombitasvir, paritaprevir and ritonavir) for Chronic Hepatitis C Genotype 4 Infections

Posted 26 Jul 2015 by Drugs.com

July 24, 2015 – The U.S. Food and Drug Administration today approved Technivie (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for the treatment of hepatitis C virus (HCV) genotype 4 infections in patients without scarring and poor liver function (cirrhosis). Technivie in combination with ribavirin is the first drug that has demonstrated safety and efficacy to treat genotype 4 HCV infections without the need for co-administration of interferon, an FDA-approved drug also used to treat HCV infection. “Today’s approval provides the first treatment option for patients with genotype 4 HCV infections without requiring use of interferon,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished li ... Read more

Related support groups: Hepatitis C, Ombitasvir/paritaprevir/ritonavir, Technivie

Technivie Approved for Hepatitis C

Posted 26 Jul 2015 by Drugs.com

FRIDAY, July 24, 2015 – Technivie (ombitasvir, paritaprevir and ritonavir) has been approved by the U.S. Food and Drug Administration, in tandem with ribavirin, to treat hepatitis C genotype 4 infection among people without poor liver function (cirrhosis) and without scarring. Some 2.7 million Americans have hepatitis C, and genotype 4 is among the least common genetic subtypes, the agency said. Technivie is the first drug to be sanctioned to treat genotype 4 hepatitis C infection without requiring co-use of the drug interferon, the agency said Friday in a news release. Infection with the hepatitis C virus causes liver inflammation that may lead to cirrhosis or liver failure. Most infected people don't develop symptoms until liver damage has already occurred, the FDA said. Symptoms of cirrhosis may include a yellowing of the eyes and skin called jaundice, abdominal fluid retention and ... Read more

Related support groups: Hepatitis C, Ombitasvir/paritaprevir/ritonavir, Technivie

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Harvoni, ribavirin, Sovaldi, Incivek, Pegasys, Victrelis, PegIntron, sofosbuvir, Copegus, view more... interferon alfa-2b, Ribasphere, telaprevir, Viekira Pak, Rebetol, boceprevir, Olysio, ledipasvir / sofosbuvir, Daklinza, Intron A, peginterferon alfa-2b, RibaPak, peginterferon alfa-2a, simeprevir, Technivie, elbasvir / grazoprevir, Moderiba, Zepatier, interferon alfacon-1, daclatasvir, RibaTab, dasabuvir / ombitasvir / paritaprevir / ritonavir, ombitasvir / paritaprevir / ritonavir, Infergen