March 13, 2013
100% Cure Rate for Hep C With Sofosbuvir, Ledipasvir Combo Therapy
An all-oral combination therapy of sofosbuvir, ledipasvir and ribavirin boasts a 100 percent cure rate among people with hepatitis C virus (HCV), HIVandHeptatis.com reports. Edward Gane from Auckland Clinical Studies presented these most recent results from the Gilead Sciences–sponsored ELECTRON study at the 20th Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta.
The researchers gave the nucleotide analog polymerase inhibitor sofosbuvir (GS-7997) along with the NS5A replication complex inhibitor ledipasvir (GS-5885) to 25 people with hep C who had never taken therapy and to nine who had failed a previous therapy, all of them with genotype 1 of the virus, the most difficult to treat. Four weeks into the 12-week treatment, every treatment naive participant and all but one of the null responder group experienced a rapid virologic response (RVR). By the end of therapy, all participants had a fully suppressed viral load, and at the four- and 12-week points after therapy, 100 percent of the group maintained a sustained virologic response (SVR, considered a cure).
The therapy was generally safe and well tolerated. Serious side effects included bloody urine (36 percent, mostly in women), severe anemia (20 percent) and increased coagulation (8 percent). Common and less serious side effects included mild-to-moderate anemia (20 percent), depression (8 percent) and headache (4 percent).
A current Gilead-sponsored Phase III trial is investigating a single combination therapy pill of sofosbuvir and ledipasvir. In addition, researchers plan to test the two drugs without ribavirin.
To read the HIVandHepatitis.com story, click here.
To read the CROI abstract, click here.
Search: hepatitis C, hep C, HCV, sofosbuvir, ledipasvir, ribavirin, all-oral, Edward Gane, Auckland Clinical Studies, Gilead Sciences, ELECTRON, 20th Conference on Retroviruses and Opportunistic Infections, CROI, GS-7997, GS-5885.
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comments 1 - 7 (of 7 total)
N. Bailey, San Antonio, 2013-11-12 22:35:28
My military insurance and doctors have me on the short list as soon as this is approved. I hope I can tolerate it. We have been waiting!
Dan P, Dante Virginia, 2013-08-07 21:32:50
I am sooooo excited! I am HepC positive and am on liver transplant list...My dr just told me of this regim and wants to put me on this trial...I have had interferon before and bottomed my platelets so had to quit. Virus count went right back up...I have been fighting this for going on 12 years...Prayers answered...sad for all those folks who died waiting for this cure and even the hope that one was on the horrizon. Thank you
Ara Mouradian, Ventura, Ca., 2013-06-02 14:19:41
Hello, I've been waiting for Hep c help for 20 years. Why do I have constantly read about how others are achieving success in treating this disease?. Why can't I be the one to receive those drugs that work?, why is it always someone or somewhere else?. Why do articles about cures always leave me biting my finger nails? Articles bragging about cure rates, but with no Dr.'s names or health care facilities names.
Bless us all.
Mike Lesko, vancouver bc, 2013-05-06 00:46:29
I read about this in my local paper and was wondering how I could get on as part of this trial. I have been on a couple of test studies before they both were successful as long as I was on the study as soon as stopped my liver enzymes went back to what they were. So I am extremely interested in joining your study! Thank you Mike Lesko
asmara, weslaco texas, 2013-04-11 22:31:42
so you are just taking the ledipasvir(GS-5885) and the sofosbuvir (GS-7977), no Ribavirin? Glad to hear it is working well for you. Are you allowed to take any supplements like Milk thistle, vitamins, etc. during you trial?
Lisa, San Rafael, 2013-03-21 18:55:29
I'm in a clinical trial, taking 400mg Sofosbuvir/GS-5885 90 mg.
It's a miracle after 4 prior tries with Interferon, I cleared inside the first month...but I'm experiencing significant side-effects. Light headed, emotional, weakness. I couldn't work if I had to. My 1st try on Interferon, they told me that would be manageable and it WASN'T, I was made to feel like I was crazy. Same thing now..if it's so tolerable, why do I feel so bad? Lots of hair loss too! This Rx is much better though...
hepcflorida, Saint Petersburg, 2013-03-15 14:17:01
comments 1 - 7 (of 7 total)
When will this new therapy be available?
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