BED NOW

glen-10
LOG AT GLENIFFER

Mountain water

and children’s songs

day is done

Advertisements

Harvoni, Sovaldi, Viekira Pak, And Other Direct-Acting Antivirals Get Black-Box Warning: Risk Of Hepatitis B Virus Reactivation – Drug Injury Watch

Returning to the “FDA Drug Safety Communication: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C”, which was issued on October 4, 2016:FDA identified 24 cases of HBV reactivation reported to FDA and from the published literature in HCV/HBV co-infected patients treated with DAAs during the 31 months from November 22, 2013 to July 18, 2016. This number includes only cases submitted to FDA, so there are likely additional cases about which FDA is unaware. Of the cases reported, two patients died and one required a liver transplant. HBV reactivation was not reported as an adverse event in the clinical trials submitted for the DAA approvals because patients with HBV co-infection were excluded from the trials.

Source: Harvoni, Sovaldi, Viekira Pak, And Other Direct-Acting Antivirals Get Black-Box Warning: Risk Of Hepatitis B Virus Reactivation – Drug Injury Watch

Conflicts of Interest Abound in Hepatitis C Treatment Guidelines – Hep

A recent investigation into the Institute of Medicine (IOM) has revealed that several committee members tasked with setting official hepatitis C virus (HCV) treatment guidelines in 2015 had significant conflicts of interest involving the pharmaceutical and health care industries. The study, published in the Journal of the American Medical Association (JAMA), raises serious concerns about the ethics of the group’s official hepatitis C recommendations, ContagionLive reports. IOM is a division of the National Academy of Sciences, Engineering and Medicine, a conglomerate of private nonprofit institutions that provide expert advice to international policy makers on health care issues. The group’s 2015 HCV guidelines encompassed protocols on testing, management, treatment and additional aspects of the liver virus that were meant to be considered by doctors around the world as evidence-based and bias-free.

Source: Conflicts of Interest Abound in Hepatitis C Treatment Guidelines – Hep

FDA Adds Boxed Warning to Hepatitis C Drugs, Warns of Hepatitis B Reactivation Risk | RAPS

The US Food and Drug Administration (FDA) on Tuesday warned of serious risks for some patients who have been infected with the hepatitis B virus (HBV) and are being treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus (HCV).FDA identified 24 cases of HBV reactivation reported to FDA and from the published literature in HCV/HBV co-infected patients treated with DAAs between 22 November 2013 and 18 July 2016.Of the cases reported, two patients died and one required a liver transplant, though FDA cautions that this number includes only cases submitted to FDA, so there are likely additional cases.

Source: FDA Adds Boxed Warning to Hepatitis C Drugs, Warns of Hepatitis B Reactivation Risk | RAPS

Leaving the Legacy of Family: A Tribute to Susan Reynolds | – Cambodian Children’s Trust Cambodian Children’s Trust

Susan Reynolds20 September 1951 – 10 November 2014who found happiness in Cambodia and its childrenand wanted to repay that kindness.We would like to acknowledge and celebrate the life of Susan Reynolds, whose final act of kindness after a lifetime of giving to others was to leave a generous bequest to CCT. We would also like to give special thanks to her sister, Annie, who assisted with managing this commemoration.When it comes time to prepare a last will and testament, many people consider their families; after all – we want to make sure the loved ones we have known all our lives, and who have nurtured us, are taken care of as best we can after we are gone. But for the tens of thousands of children in Cambodia’s institutions, the life-long bond of family support has been removed. For this reason, leaving a bequest to an organisation that reunites families, and enables parents to care for their own children, is a powerful legacy to leave – it is leaving the gift of family to others. We would like to extend a heartfelt thanks to Susan and her family for this generous donation which will allow us to ensure many Cambodian children are happy, healthy and living in families while they leave poverty behind together.Susan was born in Sydney and enjoyed happy early years playing with her siblings in the lovely big garden of their old weatherboard house in Epping. They rode on the nectarine trees pretending they were horses, and argued over who should take charge of their baby sister. Their social life was weekend dinners at grandma’s house, visiting uncles and aunts on both sides of the family, and playing with their cousins. Sadly, her life was deeply affected with sickness from her earliest years with very severe asthma, yet she still enjoyed herself with books, dress-ups, and collecting small, pretty or unusual things – a bowerbird from birth. Susan endured severe clinical depression from her teenage years, which was only diagnosed much later.

Source: Leaving the Legacy of Family: A Tribute to Susan Reynolds | – Cambodian Children’s Trust Cambodian Children’s Trust

GLENIFFER ON SUNDAY

glen-60
GLENIFFER

A call from the girls and then out to Gleniffer for a swim in the Never Never creek. What a happy experience.  I think I am simply very lonely. I was able to walk quite a distance and swim. WE laughed and played and it was good. GLENIFFER is about 12 kms from my place in a Valley with creeks coming down from the Dorrigo mountain range.

I carry 95 kgs which is a LOT on my 5 foot height.

BUT TODAY it didn’t matter. I walked over the rocks and swam in the creek. Playing and laughing is very good for the spirit and the body .

This slideshow requires JavaScript.

THE HEP C TREATMENTS

12983381_10153595330706342_5405560333132329647_o
IN URUNGA ON THE LAGOON

One of the other pressures on me is to do with the Hep C. The doctors are more than keen to have me on Harvoni but I hesitate. I am always cautious when something is called Wonder Drug or a Miracle.  Even moreso nowadays where the profits to Big Pharma are so huge. In the background of each day is the awareness that I may be risking my life by refusing treatment. On the other hand is a great deal of caution. I KNOW they are bending data to suit them because just in my small world of NA I have seen adverse results and dropouts from the treament which the Hospital doesn’t acknowledge at all.

Its heatwave still and once again I am home alone. Too hot to try to go out methinks and I am developing depression and agorophobia. I have run out of fight so I have. Bed. Book. Thats it.

Nonetheless – its not easy to go through each day with a background argument going on. I thought it was too early to know what the results truly were and now I am finding articles confirming that. Here are some samples.

_____________________

There are a number of sides we have not heard about, ranging from Cardiac Arrest, Respiratory Failure, Mouth Ulcers, Tinnitus, Chest Pain, Lung Damage, etc. I know this because I secured a report from the FDA under a Freedom of Information Act request. I have attached it and hope it goes through for everyone to see. I personally have Tinnitus, Vertigo, Lung and Heart Issues. I am not the only one. The FDA has no requirement to report issues until at least 18 months after the drug goes on the market…..so bssically for another year, Gilead and the FDA have no responsibility to the public to let them know of additional dangers. I was perfectly healthy except for Hep C until I took Harvoni. If you can wait to take it until the additional information comes out, please do. I wish I had. And in response to the comment that I saw on the this site, no one quit trials, that is not true.

http://www.hepatitiscentral.com/harvoni-ledipasvir-and-sofosbuvir/warnings/

Risk of Hepatitis B Reactivation

The FDA has indicated that there is risk of the Hepatitis B virus becoming an active infection again in any patient who has a current or previous infection with Hepatitis B virus and is being treated with Harvoni, a direct-acting antiviral medicine for Hepatitis C virus. In a few cases, Hepatitis B virus reactivation in patients treated with these types of medicines resulted in serious liver problems or death. In addition to a prominent warning being required on the medication’s labeling, healthcare professionals are being directed to also screen and monitor for the Hepatitis B virus in all patients receiving this treatment.

 

Last Updated: October 2016

 

The U.S. Food and Drug Administration (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. We are adding information about serious slowing of the heart rate, known as symptomatic bradycardia, to the Harvoni and Sovaldi labels. We are 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. Patients should not stop taking any of their medicines without first talking to their health care professionals.

Harvoni and Sovaldi are used to treat chronic hepatitis C, a viral infection that can last a lifetime and lead to serious liver problems, including cirrhosis or liver cancer. These drugs reduce the amount of hepatitis C virus in the body by preventing the virus from multiplying within the body.

Our review of submitted postmarketing adverse event reports found that patients can develop a serious and life-threatening symptomatic bradycardia when either Harvoni or Sovaldi combined with another direct-acting antiviral is taken together with amiodarone. The reports included the death of one patient due to cardiac arrest and three patients requiring placement of a pacemaker to regulate their heart rhythms. The other patients recovered after discontinuing either the hepatitis C drugs or amiodarone, or both (see Data Summary). The cause of these events could not be determined. Information about this serious risk of bradycardia has been added to the Warnings and Precautions, Drug Interactions, and Postmarketing Experience sections of the drug labels for Harvoni and Sovaldi. We will continue to monitor Harvoni and Sovaldi for risks of serious symptomatic bradycardia and further investigate the reason why the use of amiodarone with these hepatitis C drugs led to the heart-related events.

Health care professionals should not prescribe either Harvoni or Sovaldi combined with another direct-acting antiviral drug with amiodarone. However, in cases where alternative treatment options are unavailable, we recommend heart monitoring in an inpatient hospital setting for the first 48 hours. Subsequently, monitoring in a doctor’s office or self-monitoring of the heart rate should be done every day through at least the first 2 weeks of treatment.

Patients taking either Harvoni or Sovaldi combined with another direct-acting antiviral drug with amiodarone should seek medical attention right away if they experience signs or symptoms of symptomatic bradycardia such as:

  • Near-fainting or fainting
  • Dizziness or light-headedness
  • Malaise
  • Weakness
  • Excessive tiredness
  • Shortness of breath
  • Chest pains
  • Confusion or memory problems

We urge health care professionals and patients to report side effects involving Harvoni, Sovaldi, or amiodarone to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

US FOOD AND DRUG ADMINSTRATION