Aa
new treatment
anyone else starting treatment with the new drugs sofosbuvir/ledipasvir. i took my first pill this afternoon. i'm feeling so anxious about the whole thing and i really need support from others who are also being treated with these new trial drugs and those who have been through treatment and finished. it would help so much to hear how your doing and for me to share how i'm doing.
i've been selected to for a 8 week trail being done at NY Presbyterian Hosp.... my geno type is 1B, i'm at grade 2 stage 1/cirrhosis
i really dont know much about hep C even those i've done a lot of reading about it.
i've been selected to for a 8 week trail being done at NY Presbyterian Hosp.... my geno type is 1B, i'm at grade 2 stage 1/cirrhosis
i really dont know much about hep C even those i've done a lot of reading about it.
Hi I was really overwhelmed with your post. To much information to process at once. I don't think I could understand it all in my life time. I guess I just want to know as much as I can without boggling my mind. I am very new at all this. So please don't think I was complaining. I am glad for any feedback I can get at this point,
still waiting to wait. bluebirdbird305 p.s be well
still waiting to wait. bluebirdbird305 p.s be well
Just saying Hi and to say thanks for the feedback. As far as my husband is concerned, he going to either support me or not. In the long run I am going to do what I need to do for me. I cannot change him. I've got enough on my plate now. I hope you are doing okey. bluebird305
Boy do I have a bad memory. I think I already touched bases with you. Now I am even more confused. Should I shouldn't I. I know that is a individual choice but now I'm thinking I should wait. My present doctor just acted like he didn't care one way or the other. I know everyone keeps telling me to get a new doctor. I am trying out a new one as soon as I get the results from the tests my present doctor ordered. I hope I can find a good one that accepts Medicaid. Wow I am rambling on. Bluebird305
thank you all for straightening out all the miss info...but i posted to get some support while i'm on treatment....
Hi Dee, yes you got to SVR which is really the point, right? I'm sure it wasn't easy but you did it, congratulations! I am just 8 weeks into diagnosis and am still finding my way in all this. I am having my biopsy in 4 days. I am gen 2b so I'm fairly certain I will be waiting for the all orals which should be available by the first of the year for gen 2 and 3 from what I am hearing. My hep doc is not treating any gen 2s pending the potential approval. I am going to the Dartmouth College/Mayo Clinic facility in New Hampshire so I trust their judgement. This is why I personally attach a fair amount of significance to this date in December.
There are no trials that I can find for gen 2s so my only other option is the SOC dual treatment of Peg-Inf and Riba for 24 weeks. At this point by the time I have my biopsy results and get ready to treat the end of treatment for the 24 weeks of SOC and 12 weeks of the new treatment are not all that different. This is assuming I could start the new treatment around the first of the year. If Sofosbuvir does not get approved then I will start the SOC immediately. There are lots reasons I am motivated to wait, shorter treatment, fewer sides and better efficacy (in the trials results anyway)
I am hopeful that my biopsy comes back without major damage. All my blood work (platelets, bilarubin, albumin, INR, etc) are in normal ranges except for ALT which is now only slightly elevated since I stopped drinking.
Thanks for being here everybody, we all have the same destination, just a different path!
There are no trials that I can find for gen 2s so my only other option is the SOC dual treatment of Peg-Inf and Riba for 24 weeks. At this point by the time I have my biopsy results and get ready to treat the end of treatment for the 24 weeks of SOC and 12 weeks of the new treatment are not all that different. This is assuming I could start the new treatment around the first of the year. If Sofosbuvir does not get approved then I will start the SOC immediately. There are lots reasons I am motivated to wait, shorter treatment, fewer sides and better efficacy (in the trials results anyway)
I am hopeful that my biopsy comes back without major damage. All my blood work (platelets, bilarubin, albumin, INR, etc) are in normal ranges except for ALT which is now only slightly elevated since I stopped drinking.
Thanks for being here everybody, we all have the same destination, just a different path!
Thank you all for this great thread.
I thought that they were submitting for approval in December and that interferon free might be out next year. I have been beating myself up for not waiting to treat when they were so close to interferon free. I now see where I also got it wrong. I am glad I treated with Incivek and got to SVR
Thank you for the information
I thought that they were submitting for approval in December and that interferon free might be out next year. I have been beating myself up for not waiting to treat when they were so close to interferon free. I now see where I also got it wrong. I am glad I treated with Incivek and got to SVR
Thank you for the information
As was said "its all good", it can get very confusing with all this "mix and match", "with and without", genotypes, treatment naive or prior treatment, cirrhotic non cirrhotic, submitted not submitted that it can make ones head spin..........One thing that is for sure it can't come soon enough and we are rid of Hep C.............. Christinatas, Mydear, Klonny, and the rest, wishing you all nothing but the best.......
Drug Review Steps Simplified
Preclinical (animal) testing.
An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials.
Phase 1 studies (typically involve 20 to 80 people).
Phase 2 studies (typically involve a few dozen to about 300 people).
Phase 3 studies (typically involve several hundred to about 3,000 people).
The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet.
Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval.
After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.
If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's research on the drug's safety and effectiveness.
The FDA reviews information that goes on a drug's professional labeling (information on how to use the drug).
The FDA inspects the facilities where the drug will be manufactured as part of the approval process.
FDA reviewers will approve the application or issue a complete response letter.
Accelerated Approval
Traditional approval requires that clinical benefit be shown before approval can be granted. Accelerated approval is given to some new drugs for serious and life-threatening illnesses that lack satisfactory treatments. This allows an NDA to be approved before measures of effectiveness that would usually be required for approval are available.
Instead, less traditional measures called surrogate endpoints are used to evaluate effectiveness. These are laboratory findings or signs that may not be a direct measurement of how a patient feels, functions, or survives, but are considered likely to predict benefit. For example, a surrogate endpoint could be the lowering of HIV blood levels for short periods of time with anti-retroviral drugs.
Gleevec (imatinib mesylate), an oral treatment for patients with a life-threatening form of cancer called chronic myeloid leukemia (CML), received accelerated approval. The drug was also approved under the FDA's orphan drug program, which gives financial incentives to sponsors for manufacturing drugs that treat rare diseases. Gleevec blocks enzymes that play a role in cancer growth. The approval was based on results of three large Phase 2 studies, which showed the drug could substantially reduce the level of cancerous cells in the bone marrow and blood.
Most drugs to treat HIV have been approved under accelerated approval provisions, with the company required to continue its studies after the drug is on the market to confirm that its effects on virus levels are maintained and that it ultimately benefits the patient. Under accelerated approval rules, if studies don't confirm the initial results, the FDA can withdraw the approval.
Because premarket review can't catch all potential problems with a drug, the FDA continues to track approved drugs for adverse events through a postmarketing surveillance program.
....................
The above are exerpts from www.fda.gov The actual approval process is grueling and time consuming. If you go to the web site you can see the detailed process each drug must go through. Whether or not drugs are fastracked does not mean they will receive market approval. They could very well be sent back to the drawing board.
Preclinical (animal) testing.
An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials.
Phase 1 studies (typically involve 20 to 80 people).
Phase 2 studies (typically involve a few dozen to about 300 people).
Phase 3 studies (typically involve several hundred to about 3,000 people).
The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet.
Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval.
After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.
If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's research on the drug's safety and effectiveness.
The FDA reviews information that goes on a drug's professional labeling (information on how to use the drug).
The FDA inspects the facilities where the drug will be manufactured as part of the approval process.
FDA reviewers will approve the application or issue a complete response letter.
Accelerated Approval
Traditional approval requires that clinical benefit be shown before approval can be granted. Accelerated approval is given to some new drugs for serious and life-threatening illnesses that lack satisfactory treatments. This allows an NDA to be approved before measures of effectiveness that would usually be required for approval are available.
Instead, less traditional measures called surrogate endpoints are used to evaluate effectiveness. These are laboratory findings or signs that may not be a direct measurement of how a patient feels, functions, or survives, but are considered likely to predict benefit. For example, a surrogate endpoint could be the lowering of HIV blood levels for short periods of time with anti-retroviral drugs.
Gleevec (imatinib mesylate), an oral treatment for patients with a life-threatening form of cancer called chronic myeloid leukemia (CML), received accelerated approval. The drug was also approved under the FDA's orphan drug program, which gives financial incentives to sponsors for manufacturing drugs that treat rare diseases. Gleevec blocks enzymes that play a role in cancer growth. The approval was based on results of three large Phase 2 studies, which showed the drug could substantially reduce the level of cancerous cells in the bone marrow and blood.
Most drugs to treat HIV have been approved under accelerated approval provisions, with the company required to continue its studies after the drug is on the market to confirm that its effects on virus levels are maintained and that it ultimately benefits the patient. Under accelerated approval rules, if studies don't confirm the initial results, the FDA can withdraw the approval.
Because premarket review can't catch all potential problems with a drug, the FDA continues to track approved drugs for adverse events through a postmarketing surveillance program.
....................
The above are exerpts from www.fda.gov The actual approval process is grueling and time consuming. If you go to the web site you can see the detailed process each drug must go through. Whether or not drugs are fastracked does not mean they will receive market approval. They could very well be sent back to the drawing board.
well i apologize too for ANY misinformation i have contributed to BUT i should have clearly stated interferon-free at least 2 years but if someone had some information that I and others,deemed important i would want them to post and get responses and thats exactly what has happened here
I'm afraid I may have contributed to some of the confusion here when I posted this about a week ago. All it indicates is that a decision will be made on December 6 by the FDA on Sofosbuvir in combination with Ribavirin for genotype 2 & 3 and with Pegylated Interferon and Ribavirin for treatment naive patients with genotype 1. This is not any different than what we know about how Sofosbuvir was submitted for approval in April. This is not an application or decision for an all oral non-interferon treatment for Genotype 1. I apologize if posting this gave anyone the wrong idea. Like I said in my original post I have no idea about the accuracy of this I was just passing along something I saw while poking around. I should probably be more careful about how and what I post......
"I found this this morning. I have no idea if this is accurate or not but thought I would pass it along. It says the decision date for Sofosbuvir will be December 6 of this year. This was included in a list of other drugs pending approval in 2013
http://www.thestreet.com/story/11929167/1/2013-fda-drug-approval-calendar.html?cm_ven=GOOGLEN
Gilead Sciences
Drug/indication: Sofosbuvir, hepatitis C
Approval decision date: Dec. 6"
"I found this this morning. I have no idea if this is accurate or not but thought I would pass it along. It says the decision date for Sofosbuvir will be December 6 of this year. This was included in a list of other drugs pending approval in 2013
http://www.thestreet.com/story/11929167/1/2013-fda-drug-approval-calendar.html?cm_ven=GOOGLEN
Gilead Sciences
Drug/indication: Sofosbuvir, hepatitis C
Approval decision date: Dec. 6"
I have to agree with Can-do on this .....
When mydear asked.....
"anyone else starting treatment with the new drugs sofosbuvir/ledipasvir" .... and you responded with..."feel free to email me about how you feel or if u need any support.i am genotype 1a-waiting for this to be approved dec.6th(supposedly)"
..... I also thought that you meant that you thought the interferon free regimen for Genotype 1 that mydear is currently on would be approved on Dec. 6th.
I did not post anything at the time because I have already posted numerous times that the Interferon free regimens are not going to be available this year.
When mydear asked.....
"anyone else starting treatment with the new drugs sofosbuvir/ledipasvir" .... and you responded with..."feel free to email me about how you feel or if u need any support.i am genotype 1a-waiting for this to be approved dec.6th(supposedly)"
..... I also thought that you meant that you thought the interferon free regimen for Genotype 1 that mydear is currently on would be approved on Dec. 6th.
I did not post anything at the time because I have already posted numerous times that the Interferon free regimens are not going to be available this year.
Seems from your own post you took it that way also.
"thank you Can do man. i didn't know there was a date either. cause if it was a sure thing i would of waited until then.."
"thank you Can do man. i didn't know there was a date either. cause if it was a sure thing i would of waited until then.."
Well when you ask....."anyone else starting treatment with the new drugs sofosbuvir/ledipasvir" .... and one responds with..."feel free to email me about how you feel or if u need any support.i am genotype 1a-waiting for this to be approved dec.6th(supposedly)"
Waiting for this to be approved, how is one supposed to take it...... Geez
Waiting for this to be approved, how is one supposed to take it...... Geez
hi, christinatas, your post from earlier today is very clear to me. your dr said" NOW, my dr says interferon free is approx, 2 years for geno 1. what i am talking about is the formerly called gs7977. all is good
barry
barry
no one has posted that they are. kathhall said that she doing a treatment but never said what kind of meds
From Hectors post
"DR. says if I can hold on there are drugs coming thru for FDA approval, with high success rate, unlike inter-feron " "GENO-1"
It appears your doctor is misinformed about the new treatment that has applied for FDA approval by Gilead. For genotype 1 treatment naive patients, the treatment will be Sofosbuvir in combination with RBV and peg-IFN for patients with genotype 1, 4, 5 and 6 HCV infection. So the next new treatment to come to market in early 2014 for genotype 1 patients will have peg-interferon.
http://www.medhelp.org/posts/Hepatitis-C/hep-C--symptoms-treatment/show/1953356#post_9150512
"DR. says if I can hold on there are drugs coming thru for FDA approval, with high success rate, unlike inter-feron " "GENO-1"
It appears your doctor is misinformed about the new treatment that has applied for FDA approval by Gilead. For genotype 1 treatment naive patients, the treatment will be Sofosbuvir in combination with RBV and peg-IFN for patients with genotype 1, 4, 5 and 6 HCV infection. So the next new treatment to come to market in early 2014 for genotype 1 patients will have peg-interferon.
http://www.medhelp.org/posts/Hepatitis-C/hep-C--symptoms-treatment/show/1953356#post_9150512
Mydear......."anyone else starting treatment with the new drugs sofosbuvir/ledipasvir"
"Christinatas..."feel free to email me about how you feel or if u need any support.i am genotype 1a-waiting for this to be approved dec.6th(supposedly)"
Not the same, as the trial mydear is in is interferon free, I have done my research.
"Christinatas..."feel free to email me about how you feel or if u need any support.i am genotype 1a-waiting for this to be approved dec.6th(supposedly)"
Not the same, as the trial mydear is in is interferon free, I have done my research.
I FOUND OUT FDA APPOVALS FOR THE SOFOSBUVIR STARTS ON DEC.6TH AGAIN.FOUND THRU ANOTHER MEDHELPER THAT HAD LEFT THE WEBPAGE BUT I AM NOT TRYIN TO SEND OUT FALSE REPORTS BUT JUST WHATS BEING DOCUMENTED MAYBE IT ALL STARTS DEC.6TH ,MAYBE ITS NOT UP FOR APPROVAL BUT I DONT CARE,ITS RIGHT AROUND THE CORNER.
i found out this date from doc and i ALSO found this when i googled "sofosbuvir".BUT doc also said not to rely on specific dates so she said to make appt. for the training class she makes all of her pts. do---i had to take nurse training class for tx. available right nowin april 2013.---for late 2013-early 2014---the sofosbuvir training class---.but it is up for approval as far as what i have found out myself for dec.6th.NOW she also said the interferon-free will not be available for at least 2 years what I am talking about is the formerly called GS-7977 pill(this # is from my memory so i hope i got the # right).i hope this helps your search but i easily found this info myself.i can find it again if you want me to.i am not trying to get anybody's hopes up but this is the information my doc has given me.i did get curious and i did find this out also by myself.she's very excited and she strongly advised me to do a watch n wait approach.
i hope this helps.
i hope this helps.
i just took pill number to 2. last nite i had a hard time fallen to sleep was up until 1:30 am, i'm usually in bed by 9:00/10:00 pm... i dont know what it was but i was wide awake last night...other wise no side affect and i feel fine
thank you Can do man. i didn't know there was a date either. cause if it was a sure thing i would of waited until then..
Wishing you the best mydear...:)
Christinatas..."feel free to email me about how you feel or if u need any support.i am genotype 1a-waiting for this to be approved dec.6th(supposedly)"
I am curious to what makes you think these 2 drugs are to be approved for geno 1 on December 6th when they have not even been submitted yet for approval?
Good luck to all of you
Christinatas..."feel free to email me about how you feel or if u need any support.i am genotype 1a-waiting for this to be approved dec.6th(supposedly)"
I am curious to what makes you think these 2 drugs are to be approved for geno 1 on December 6th when they have not even been submitted yet for approval?
Good luck to all of you
i'm on 8 weeks of treatment, that's what this trial is testing to see if 8 weeks of treatment with sofosbuvir/ledipasvir is long enough to cure Hep C. without a relapse... so we are going to see how it goes. it really makes me afraid when i write it...hope some one who has been through an 8 week trial and remind SVR after 48 weeks response to this post...
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