FDA Now Requires Boxed Warning on HCV Drugs: Harvoni, Sovaldi, Daklinza and More
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The Editors at Hepatitis Central
October 5, 2016
FDA warns that the use of direct-acting antiviral medicines for Hepatitis C may lead to the reactivation of Hepatitis B.
FDA Adds Boxed Warning to Hepatitis C Drugs, Warns of Hepatitis B Reactivation Risk
By Zachary Brennan on October 4, 2016
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.
Continue reading this entire article:
http://www.raps.org/Regulatory-Focus/News/2016/10/04/25946/FDA-Adds-Boxed-Warning-to-Hepatitis-C-Drugs-Warns-of-Hepatitis-B-Reactivation-Risk/
10 Comments
I am SVR since Oct 2015 viekira….it was 84 wonderful days and 1 whole yr SVR so far so good! yoowhoooo! Was treatmt naive prior.gt1b. Glad SVR!!! May dress as Prince for Halloween!!!!
Maybe they’ll cut the price now, I could afford $50 a pill, but at $1,000.00 a pill (it costs less than $5 to make), it’s no cure at all. I only hope thru the upcoming litigation, the Greedy producers get the same kind of fairness, they’ve shown those suffering.
Go to fixhepc and get 3 months supply for $900. Can’t believe people never heard of it.
Absolutely no insurance? If it’s a matter of fighting, after being denied, I can try to help.
I felt face sensitive after my hav and hbv vaccines….I could be mistaken. At that time still had hcv. Just happy cured with 3 mos viekira prescript grant.
Before hcv tx my doc tested me for nondetectable and immune for hav and hbv.. He said he had a hbv vaccine. He said sometimes the vaccines wear off after a period of time…….. He wanted to be sure I was nondetectable and immune.
@Sharre I got a HBV vaccination 25 years ago will it wear off???
I would think yes. But you have to check with your doctor. Who knows?? Think positive!
My brother with Palletive (spelling?) Services right from ICU and PS sticks around and won’t let any surgeries be performed or any procedures except drain ascites fluids and gave him morphine. I could be paranoid. But I think after offering a pacemaker, then dialysis and turning down both “not strong enough” seems odd. But I could be wrong. (Loyola hospital).
He is in late 60s. I told him to eat watermelon (diuretic) and no salt to help with ascites. 6 mos ago he was told 3 yrs to live. This mo told 2 days to 2 wks to live after 9 days in ICU. So far it has been a whole wk and he is still here….. I told him ride a bike…..heart,,,,circulation….liver……..