ALTOONA - Imagine being diagnosed with a deadly disease that can be cured, but you can't get the treatment. More than 100 patients in our region and millions across the country, with Hepatitis C face that frightening situation. Treatments that can reverse the virus cost about $1,000 a pill.
A tattoo changed a Bedford County man's life. Mike Miller got it done a few years ago by a friend and last August he found out he'd also gotten the hepatitis C virus. He's tired, he has abdominal pain and his joints ache. He says, "there are just days that I don't feel like getting out of bed."
Fortunately, tests show Mike is still in the early stages of Hep. C. His blood doesn't show a high number of infected cells and he doesn't have cirrhosis of the liver. So, he doesn't qualify for treatment that could keep the disease from progressing.
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Monday, March 23, 2015
India: Dr Reddy's to launch Hepatitis C drug in India
NEW DELHI: Dr Reddy's Laboratories today entered into an agreement with Hetero to distribute and market generic version of US-firm Gilead Sciences' Hepatitis C drug under the brand 'Resof' in India.
"The company has entered into an agreement with Hetero, under which Dr Reddy's has been licensed to distribute and market Sofosbuvir 400 mg tablets indicated in treatment of chronic Hepatitis C under the brand 'Resof' in India," the Hyderabad-based drug major said in a BSE filing.
"The company has entered into an agreement with Hetero, under which Dr Reddy's has been licensed to distribute and market Sofosbuvir 400 mg tablets indicated in treatment of chronic Hepatitis C under the brand 'Resof' in India," the Hyderabad-based drug major said in a BSE filing.
Hepatitis C clinic in Charlotte fights for survival
CHARLOTTE COUNTY, FL - A free Hepatitis C Clinic in Charlotte County is struggling to keep its doors open and asking the county for help. Clinic leaders say the number of cases are growing and they desperately need $50,000 to save lives.
Since 2008, Charlotte County's free Hepatitis C clinic at the Virginia B Anderson Volunteer Community Clinic has been treating patients.
Co- founders Dr. Mark Asperilla and Dr. David Klein started it after treating residents at their HIV clinic. They were surprised by what they found.
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Since 2008, Charlotte County's free Hepatitis C clinic at the Virginia B Anderson Volunteer Community Clinic has been treating patients.
Co- founders Dr. Mark Asperilla and Dr. David Klein started it after treating residents at their HIV clinic. They were surprised by what they found.
Read more...
Weekly Special Topic: HCV & Women
HCV & Women
Our HCV and Women Series has been updated and condensed to better provide the latest information to help inform our audience.
Saturday, March 21, 2015
FDA Hepatitis Update - Important safety information: Harvoni , and Sovaldi
IMPORTANT DRUG WARNING
Subject: Serious and Life-Threatening Cases of Symptomatic Bradycardia as well as One Case of Fatal Cardiac Arrest Reported with Coadministration of Amiodarone With Either Harvoni® (ledipasvir and sofosbuvir fixed-dose combination) or With Sovaldi® (sofosbuvir) in Combination with Another Direct Acting Antiviral.
On March 20, 2015, FDA approved changes to the Harvoni (ledipasvir/sofosbuvir fixed dose combination) and Sovaldi (sofosbuvir) labels to update the WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, and DRUG INTERATIONS sections of the labeling and the patient package insert with information on post-marketing cases of symptomatic bradycardia when co-administered with amiodarone. Additionally, Gilead Sciences has issued a Dear Healthcare Provider letter (below):
Dear Health Care Provider,
The purpose of this letter is to inform you of new important safety information for Harvoni and Sovaldi.
· Sovaldi is indicated for the treatment of chronic hepatitis C infection as a component of a combination antiviral treatment regimen.
Serious Risk of Symptomatic Bradycardia With Co-Use of Amiodarone with Either Harvoni or With Sovaldi in Combination with Another Direct Acting Antiviral (DAA)
· Postmarketing casesof symptomatic bradycardia, as well as one fatal cardiac arrest and cases requiring pacemaker insertion, have been reported in patients taking amiodarone and Harvoni, or amiodarone and Sovaldi in combination with another DAA.
· Bradycardia was observed within hours to days of starting Harvoni, or Sovaldi in combination with another DAA, but cases have been observed up to 2 weeks after initiating HCV treatment.
· Risk factors for the development of symptomatic bradycardia in patients receiving amiodarone may include coadministration of a beta blocker, or those with underlying cardiac comorbidities and/or advanced liver disease.
· Similar cases have not been reported in patients receiving Sovaldi with ribavirin or with pegylated interferon and ribavirin.
Warning and Precaution
Coadministration of amiodarone with either Harvoni or with Sovaldi in combination with another DAA is not recommended.
Further Information
Ninecases of symptomatic bradycardia have been reported during postmarketing in patients receiving amiodarone with either Harvoni, or Sovaldi in combination with another DAA (daclatasvir, an investigational DAA, or Olysio (simeprevir)). Seven patients were also receiving a beta blocker.
· Sixcases occurred within the first 24 hours and the remaining 3cases occurred within the first 2-12 days following HCV treatment initiation.
· In 3cases, rechallenge with HCV treatment in the setting of continued amiodarone therapy resulted in recurrence of symptomatic bradycardia.
· Inone case discontinuation of amiodarone followed by rechallengeof HCV treatment after 8 weeks did not result in recurrent bradycardia.
· Three of the 9 cases were in patients receiving Harvoni, 5 cases were in patients receiving Sovaldi plus an investigational agent (daclatasvir) and 1 case was in a patient receiving Sovaldi with Olysio (simeprevir).
The mechanism of the potential interaction between amiodarone and Harvoni, or Sovaldi in combination with another DAA is unknown.
Because the number of patients taking amiodarone who have been exposed to Harvoni or Sovaldi in combination with another DAA is unknown, it is not possible to estimate the incidence of occurrence of these events.
For patients taking amiodarone who have no other alternative, viable treatment options and who will be co-administered Harvoni, or Sovaldi in combination with another DAA:
· Cardiac monitoring in an in-patient setting for the first 48 hours of coadministration is recommended, after which outpatient or self-monitoring of the heart rate should occur on a daily basis through at least the first 2 weeks of treatment.
Patients who are taking Harvoni or Sovaldi in combination with another DAA who need to start amiodarone therapy due to no other alternative, viable treatment options should undergo similar cardiac monitoring as outlined above.
Due to amiodarone’s long half-life, patients discontinuing amiodarone just prior to starting Harvoni or Sovaldi in combination with a DAA should also undergo similar cardiac monitoring as outlined above.
Tell your patients if they develop signs or symptoms that might suggest symptomatic bradycardia they should seek medical evaluation immediately. Symptoms may include:
· Near-fainting or fainting | · Excessive tiredness |
· Dizziness or lightheadedness | · Shortness of breath |
· Malaise | · Chest pains |
· Weakness | · Confusion or memory problems |
Patients should not stop taking any of their medicines without talking to their healthcare provider.
This information is based on currently available data and recommendationsmay change. Additionally, the product labeling will be updated.
Please report all adverse events, following or coincident with the use of Harvoni or Sovaldi, to Gilead Global Drug Safety at 1-800-GILEAD-5, option 3; or to FDA's MedWatch program by telephone at 1-800-332-1088; by fax at 1-800-332-0178; via www.FDA.gov/medwatch; or by mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20857 (use postage-paid FDA Form 3500).
Please refer to the accompanying full prescribing information and approved patient information for a complete description of the risk profile for Harvoni or Sovaldi.
Contact Gilead Medical Information at 1-800-GILEAD-5, option 2 if you have additional questions.
Friday, March 20, 2015
HIV, Hepatitis C infections up in Marion Co.
INDIANAPOLIS - New infections of HIV and Hepatitis C increased dramatically from 2013 to 2014 among Marion County's young adult population, RTV6 has learned.
According to Marion County Health Department data, new Hepatitis C infections among people ages 20-24 increased by 120 percent between 2013 and 2014 – the latest year data was available for. Hepatitis C infections increased by 100 percent among people ages 25 to 34.
New HIV infections also increased 51 percent during that time frame in the 20-24 age group, and 32 percent among people 25-34.
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According to Marion County Health Department data, new Hepatitis C infections among people ages 20-24 increased by 120 percent between 2013 and 2014 – the latest year data was available for. Hepatitis C infections increased by 100 percent among people ages 25 to 34.
New HIV infections also increased 51 percent during that time frame in the 20-24 age group, and 32 percent among people 25-34.
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Pharma accused of restricting access to hep C drug in poor countries
New drugs for hepatitis C are a major breakthrough but hugely expensive in rich countries. Pharma giant Gilead will allow cheap copies to be made for poor countries - but only for patients with proof of identification and citizenship and the drug supplies will be closely tracked
The battle over access to the new hepatitis C drug, Gilead’s sofosbuvir (and similar drugs coming along behind) is hotting up. There is angst even in the richest countries over the $1000 a pill price tag. It now looks as though Gilead is going to extraordinary lengths to ensure that cheaper versions, which it is permitting generic companies to make for poor countries, do not arrive in affluent world pharmacies.
Gilead has agreed to grant voluntary licences to eleven Indian generic companies, which means the drug will be sold at a reduced price in low-income countries. But Médecins Sans Frontières, the volunteer doctors who are treating hepatitis C infection in some of the poorest regions, say the company has imposed unacceptable conditions.
Gilead stipulates that patients will only get the drug if they can provide identification, proof of citizenship and residency, which MSF says will penalise refugees and marginalised communities. The drug supplies will be closely tracked through codes on the bottles. Gilead, even though it will not be the manufacturer, will have access to that information. If they need more, patients will have to return an empty bottle.
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