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

FDA Warns of Cardiac Effect When Heart Drug Mixed With Hepatitis C Meds

Posted 5 days ago by Drugs.com

WEDNESDAY, March 25, 2015 – A potentially life-threatening slowing of the heart can occur when the common heart drug amiodarone is taken with new hepatitis C medications, the U.S. Food and Drug Administration warns. The dangerous slowing of the heart – called symptomatic bradycardia – can occur when amiodarone is taken with the hepatitis C drugs Harvoni (ledipasvir/sofosbuvir) or Sovaldi (sofosbuvir) and combined with another direct-acting antiviral for the treatment of hepatitis C. Harvoni and Sovaldi are two new medicines recently approved by the FDA to help rid the body of hepatitis C infection. If left untreated, hepatitis C infection can damage the liver and raise the odds of liver failure and liver cancer. Amiodarone is commonly used to treat heartbeat irregularities, the FDA noted in a news release. Information about the risk of the drugs used in combination is being added to ... Read more

Related support groups: Hepatitis C, Amiodarone, Harvoni, Sovaldi, Bradyarrhythmia, Cordarone, Pacerone, Sofosbuvir, Nexterone, Cordarone IV

FDA Medwatch Alert: Hepatitis C Treatments Containing Sofosbuvir in Combination With Another Direct Acting Antiviral Drug: Drug Safety Communication - Serious Slowing of Heart Rate When Used With Antiarrhythmic Drug Amiodarone

Posted 6 days ago by Drugs.com

[Posted 03/24/2015] ISSUE: FDA is warning that serious slowing of the heart rate can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) taken in combination with another direct acting antiviral for the treatment of hepatitis C infection. FDA is adding information about serious slowing of the heart rate, known as symptomatic bradycardia, to the Harvoni and Sovaldi labels. FDA is recommending that health care professionals should not prescribe either Harvoni or Sovaldi combined with another direct acting antiviral, such as the investigational drug daclatasvir or Olysio (simeprevir), with amiodarone. FDA review of submitted postmarketing adverse event reports found that patients can develop a serious and life-threatening symptomatic bradycardia when either Harvoni or Sovaldi ... Read more

Related support groups: Hepatitis C, Amiodarone, Harvoni, Sovaldi, Cordarone, Pacerone, Sofosbuvir, Olysio, Simeprevir, Ledipasvir/sofosbuvir, Cordarone IV, Nexterone

Hepatitis C Drugs Will 'Strain Budgets' at Current Prices: Study

Posted 14 days ago by Drugs.com

MONDAY, March 16, 2015 – New hepatitis C drugs promise cure rates above 90 percent, but could prove to be budget-busters for public and private health insurers, a new analysis finds. Recently approved drugs for chronic hepatitis C have been heralded as a breakthrough that could make the liver disease "rare" in the United States. But with prices topping $1,000 per pill, government and private insurers are balking – often putting limits on which patients qualify for coverage. Now two new studies in the March 16 Annals of Internal Medicine conclude that for individual patients, treatment with the pricey pills is "cost-effective." That's a calculation that takes into account the years of better health and quality of life people will likely enjoy. The bad news? One study estimates that state governments and insurers will have to dig up an extra $65 billion over five years to get the drugs ... Read more

Related support groups: Hepatitis C, Harvoni, Sovaldi, Sofosbuvir, Chronic Active Hepatitis, Infectious Hepatitis

Hepatitis C Infections in Hospitals Show Need for Tight Infection Control Practices

Posted 27 Feb 2015 by Drugs.com

FRIDAY, Feb. 27, 2015 – Two cases of hepatitis C infection that occurred during routine surgeries highlight the need for hospitals to tighten infection control to prevent more transmissions, officials said Friday. In one case, two New Jersey patients (one of them had hepatitis C) received an injection of the anesthetic propofol from the same medication cart. In the other instance, two Wisconsin patients (one of them had hepatitis C) received kidneys that had been prepared for transplantation on the same machine, according to an article in the Feb. 27 issue of Morbidity and Mortality Weekly Report, a publication of the U.S. Centers for Disease Control and Prevention. The source of the infection in the Wisconsin case was not pinpointed, said Gwen Borlaug, coordinator of the HAI Prevention Program at the Wisconsin Division of Public Health, but "we identified breaches in infection control ... Read more

Related support groups: Hepatitis C

Many With Hepatitis C Missing Out on Treatment, Study Finds

Posted 11 Jan 2015 by Drugs.com

SUNDAY, Jan. 11, 2015 – Many hepatitis C patients get "lost" in the U.S. health care system, a new study suggests. Researchers looked at data from about 13,600 people in Philadelphia who tested positive for hepatitis C virus between January 2010 and December 2013. During that time, just 27 percent of the patients were in care and 15 percent had been treated or were receiving treatment, the study authors found. The study was recently published in the journal Hepatology. "Our findings show that many [hepatitis C] patients are lost at each stage of the health care continuum from screening to disease confirmation to care and treatment," Kendra Viner, of the Philadelphia Department of Public Health, said in a journal news release. "The fact that so few patients with [hepatitis C virus] are making it to treatment underscores the need to build awareness among at-risk groups of the importance ... Read more

Related support groups: Hepatitis C

Antiviral Combination Approved for Hepatitis C

Posted 23 Dec 2014 by Drugs.com

MONDAY, Dec. 22, 2014 – Viekira Pak, a combination of four antiviral drugs – ombitasvir, paritaprevir, ritonavir and dasabuvir – has been approved by the U.S. Food and Drug Administration to treat hepatitis C infection, including a major complication, cirrhosis of the liver. Some 3.2 million Americans are infected with the viral disease, which can lead to complications including reduced liver function, liver failure or liver cancer, the FDA said in a news release. Most infected people have no symptoms before onset of liver damage. Without proper treatment, 15 percent to 30 percent will develop advanced liver disease known as cirrhosis, the agency said. The combination pack's safety and effectiveness were evaluated in clinical studies involving more than 2,300 people with chronic hepatitis C, with and without cirrhosis. The most common side effects included fatigue, itching, weakness, ... Read more

Related support groups: Hepatitis C

Antiviral Combination Approved for Hepatitis C

Posted 23 Dec 2014 by Drugs.com

MONDAY, Dec. 22, 2014 – Viekira Pak, a combination of four antiviral drugs – ombitasvir, paritaprevir, ritonavir and dasabuvir – has been approved by the U.S. Food and Drug Administration to treat hepatitis C infection, including a major complication, cirrhosis of the liver. Some 3.2 million Americans are infected with the viral disease, which can lead to complications including reduced liver function, liver failure or liver cancer, the FDA said in a news release. Most infected people have no symptoms before onset of liver damage. Without proper treatment, 15 percent to 30 percent will develop advanced liver disease known as cirrhosis, the agency said. The combination pack's safety and effectiveness were evaluated in clinical studies involving more than 2,300 people with chronic hepatitis C, with and without cirrhosis. The most common side effects included fatigue, itching, weakness, ... Read more

Related support groups: Hepatitis C

FDA Approves Viekira Pak (ombitasvir/paritaprevir/ritonavir with dasabuvir) to Treat Hepatitis C

Posted 19 Dec 2014 by Drugs.com

December 19, 2014 – The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis. Hepatitis C is a viral disease that causes inflammation of the liver that can lead to reduced liver function, liver failure or liver cancer. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15-30 percent of these people will go on to develop cirrhosis. Viekira Pak contains three new drugs—ombitasvir, paritaprevir and dasabuvir—that work together to inhibit the ... Read more

Related support groups: Hepatitis C, Ritonavir

Drug Regimen Cures Hepatitis C in Most Liver Transplant Patients in Study

Posted 16 Nov 2014 by Drugs.com

FRIDAY, Nov. 14, 2014 – A new drug regimen is producing high cure rates in small groups of liver transplant patients with hepatitis C, researchers report. The study's results are a "landmark achievement," said study first author Dr. Paul Kwo, professor of medicine at the Indiana University School of Medicine, in a university news release. "Recurrent hepatitis C post-liver transplantation has historically been difficult to treat, and we have considered post-liver transplant patients a special population in need of new treatment strategies," Kwo said. "What this study showed is that this special population is no longer special. We can treat them as successfully as if they haven't had a liver transplant with drugs that are well tolerated and without risk of rejection," he explained. Kwo said liver transplantation in the United States is mainly the result of cirrhosis – liver scarring – ... Read more

Related support groups: Hepatitis C

FDA Approves Olysio (simeprevir) in Combination with Sofosbuvir for Genotype 1 Chronic Hepatitis C Infection

Posted 5 Nov 2014 by Drugs.com

TITUSVILLE, N.J., Nov. 5, 2014 /PRNewswire/ – Janssen Therapeutics, Division of Janssen Products, LP (Janssen) announced the U.S. Food and Drug Administration (FDA) has approved Olysio (simeprevir), a hepatitis C virus (HCV) NS3/4A protease inhibitor, in combination with sofosbuvir as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C (CHC) infection in adult patients as part of a combination antiviral treatment regimen. Sofosbuvir is an HCV nucleotide analog NS5B polymerase inhibitor developed by Gilead Sciences, Inc. HCV is a blood-born infectious disease of the liver that affects an estimated 3.2 million people in the U.S.[1] Approximately 75 to 85 percent of people who become infected with HCV develop chronic infection.[2] Most persons with CHC infection are asymptomatic, which means they do not show symptoms of the disease.[3] When ... Read more

Related support groups: Hepatitis C, Sovaldi, Sofosbuvir, Olysio, Simeprevir

Vaccine for Hepatitis C Inches Closer to Reality

Posted 5 Nov 2014 by Drugs.com

WEDNESDAY, Nov. 5, 2014 – An initial study suggests that a potential vaccine against hepatitis C, a liver disease that affects at least 130 million people worldwide, is safe in people. The newly released findings are good news, said study co-author Dr. Ellie Barnes, a professor of hepatology and experimental medicine at the University of Oxford in England. The results indicate the vaccine can safely boost the immune system in a way that "targets multiple parts of the hepatitis C virus," she said. "We hope it will have the capacity to prevent people from being infected, and that's something we really need." An estimated 1 percent of U.S. residents have chronic hepatitis C, which is usually transmitted through infected blood. In many people, the disease leads to scarring of the liver – cirrhosis – or liver cancer. A powerful new drug called Sovaldi is expected to improve treatment of ... Read more

Related support groups: Hepatitis C, Vaccination and Prophlaxis

Pricey Hepatitis Drug a Good Bet in U.S. Prisons, Study Says

Posted 20 Oct 2014 by Drugs.com

MONDAY, Oct. 20, 2014 – Using an expensive drug to treat prison inmates with hepatitis C is more cost-effective than another treatment option, according to a new study. More than 500,000 prison inmates in the United States have hepatitis C, which causes liver damage. It's spread by contact with infected blood. The drug Sovaldi (sofosbuvir) costs more than $7,000 a week for 12 weeks of treatment. Some states are concerned about the price and want to limit its use in prisons. However, "it looks like the additional benefits of sofosbuvir are sufficiently large even in this high-risk population to justify its increased cost," study senior author Jeremy Goldhaber-Fiebert, an assistant professor of medicine at the Stanford School of Medicine, said in a university news release. Until a few years ago, hepatitis C patients were treated over 48 weeks with two drugs, pegylated interferon and ... Read more

Related support groups: Hepatitis C, Sovaldi, Sofosbuvir

FDA Approves Harvoni (ledipasvir and sofosbuvir) for Hepatitis C

Posted 14 Oct 2014 by Drugs.com

October 10, 2014 – The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection. Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection. Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir. “With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Dr ... Read more

Related support groups: Hepatitis C, Sofosbuvir

Hepatitis C Could Become Rare Disease in 20 Years: Study

Posted 4 Aug 2014 by Drugs.com

MONDAY, Aug. 4, 2014 – The once tough-to-treat liver infection hepatitis C could become a rare disease in the United States in the next two decades, a new study estimates. Hepatitis C, a viral infection that harms the liver, is usually passed through infected blood. For most people, the infection becomes chronic and it can eventually lead to scarring of the liver (cirrhosis) or liver cancer. U.S. health officials estimate that over 3 million Americans currently have chronic hepatitis C – most of whom don't know it because the infection usually causes no symptoms. But with recent treatment advances, hepatitis C could become rare by 2036, researchers report in the Aug. 5 issue of the Annals of Internal Medicine. "Rare" refers to a disease that affects one in 1,500 people at most, said senior researcher Jagpreet Chhatwal, who conducted the study while at the University of Pittsburgh ... Read more

Related support groups: Hepatitis C, Sovaldi, Sofosbuvir

HIV Meds May Also Help Control Hepatitis C, Study Finds

Posted 23 Jul 2014 by Drugs.com

WEDNESDAY, July 23, 2014 – For patients infected with both HIV and hepatitis C, HIV antiretroviral therapy may help control both viruses, a small study suggests. Researchers said doctors could use their findings to improve treatment strategies for people with the two diseases. "The findings suggest that HIV suppression with antiretroviral medications plays an important role in the management of individuals with [hepatitis C] and HIV infection," said study leader Dr. Kenneth Sherman, a professor of medicine at the University of Cincinnati College of Medicine. "It supports the concept that in those with HCV/HIV infection, early and uninterrupted HIV therapy is a critical part of preventing liver disease." The researchers conducted the study to address concerns that treating patients who have HIV – the AIDS-causing virus – and hepatitis C with HIV antiretroviral therapy would damage the ... Read more

Related support groups: Hepatitis C, HIV Infection

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