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

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

Posted 4 days ago by

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 5 days ago by

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, Hepatic Coma, Benign Liver Tumor, Hepatic Tumor, Liver Metastasis in Adenocarcinoma

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

Posted 16 days ago by

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

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

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

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, Technivie, Ombitasvir/paritaprevir/ritonavir

Liver Damage From Hepatitis C More Widespread Than Thought

Posted 27 Aug 2015 by

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

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

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

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, Technivie, Ombitasvir/paritaprevir/ritonavir

Technivie Approved for Hepatitis C

Posted 26 Jul 2015 by

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, Technivie, Ombitasvir/paritaprevir/ritonavir

Most U.S. Hepatitis C Infections May Be Missed: Study

Posted 30 Jun 2015 by

TUESDAY, June 30, 2015 – New cases of hepatitis C are drastically underreported to federal officials, researchers contend in a new study. And they suggested that may be hampering public health efforts to cope with the chronic infection that can lead to cirrhosis or liver cancer. The new study found that only one out of 183 Massachusetts residents diagnosed between 2001 and 2011 with acute hepatitis C infection was reported to the U.S. Centers for Disease Control and Prevention. The rest went unreported, either because their test results didn't come back quickly enough or because the results didn't meet the strict CDC definition for hepatitis C infection, said senior study author Dr. Arthur Kim, director of the Viral Hepatitis Clinic at Massachusetts General Hospital in Boston. "We were shocked to find only one made it to the CDC, reported as an acute hepatitis C case," Kim said. "This ... Read more

Related support groups: Cancer, Hepatitis C

Experimental Drug Combo Shows Promise Against Hepatitis C

Posted 5 May 2015 by

TUESDAY, May 5, 2015 – Researchers have released yet another study finding impressive results for an experimental drug combo that aims to rid the body of infection with liver-damaging hepatitis C. In this case, a combination of three drugs in the pipeline – daclatasvir, asunaprevir and beclabuvir – effectively cleared the virus in 93 percent of patients, according to new research from Duke University in Durham, N.C. All of the patients had already developed an infection-linked scarring of the liver known as cirrhosis. None of these drugs has been approved by the U.S. Food and Drug Administration, but daclatasvir is currently under FDA review, according to a Duke news release. One U.S. expert said the drug combination could be an additional advance against hepatitis C. "This regimen is yet another all-oral treatment for the most common type of hepatitis C, which offers high cure rates ... Read more

Related support groups: Hepatitis C, Harvoni, Sovaldi, Sofosbuvir

Drug-Related HIV Outbreak Spurs Nationwide Alert

Posted 24 Apr 2015 by

FRIDAY, April 24, 2014 – With narcotic painkiller abuse now linked to 142 cases of HIV in rural Indiana, U.S. health officials are alerting other states to watch for clusters of HIV and hepatitis C among injection drug users. The Scott County epidemic is "a powerful reminder that people who inject drugs are at high risk for both HIV and hepatitis," said Dr. Jonathan Mermin, director of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. HIV, the AIDS-causing virus, "can gain ground at any time unless we remain vigilant about prevention, testing and care," he said during a Friday morning news conference. There is no indication that HIV infection among injection drug users is spreading beyond this area of Indiana, he said. "But it will be critical to examine all available data on the state and local level to assess whether HIV is increasing among injection drug ... Read more

Related support groups: Hepatitis C, HIV Infection, Toxic Reactions Incl Drug and Substance Abuse

New Specialty Medicines Drive Up Drug Spending

Posted 14 Apr 2015 by

TUESDAY, April 14, 2015 (HealthDay New) – New medicines targeting conditions like hepatitis C, cancer and multiple sclerosis helped to propel drug spending to its highest level in more than a decade, a new report finds. Medicine sales jumped 13 percent, to nearly $374 billion, in 2014 after a period of mostly low single-digit growth, according to the report released Tuesday by the IMS Institute for Healthcare Informatics in Parsippany, N.J. Last year's increase was the largest since 2001, as spending rose 17 percent to nearly $174 billion on the growth of new "blockbuster" drugs, the report said. For the report, the IMS Institute tallies U.S. drug spending across all settings – from hospitals to retail pharmacies – and outlines the forces channeling that growth. The institute received no drug company or government funding for the report. New drug innovation, higher sticker prices and ... Read more

Related support groups: Cancer, Multiple Sclerosis, Hepatitis C

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