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.
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.."
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