Aa
new drugs
how is everyone getting these new drugs before they are approved? I want them! Sovaldi and Ledipasvir?
Hi all
I am also taking Sovaldi and Olysio with no other meds. Just on my dorctor prescription.
I am Genotype 1a diagnosed with cirrhosis in 2008 3 treatment null responder so I definately qualified for the off label use
Good luck to all on getting treated and getting rid of Hep C
Lynn
I am also taking Sovaldi and Olysio with no other meds. Just on my dorctor prescription.
I am Genotype 1a diagnosed with cirrhosis in 2008 3 treatment null responder so I definately qualified for the off label use
Good luck to all on getting treated and getting rid of Hep C
Lynn
Boobert is correct. Some people were chosen to be in a special trial. In my case, it was because I am also cirrhotic and I believe that Gilead (Sovaldi Co) and researchers are interested in learning the efficacy of Sovaldi/Olysio treatment on those with more advanced liver disease. Soon, this drug will be available, along with Olysio, to everyone. For now, it is recommended with other, more nasty drugs like Interferon or Riba.
Hoping for all currently undergoing treatment to reach SVR as well as those who benefit from the ongoing research and options that will soon be available to everyone. Hang in there!
Hoping for all currently undergoing treatment to reach SVR as well as those who benefit from the ongoing research and options that will soon be available to everyone. Hang in there!
Other than a clinical trial the only other way a a compassionate use approval
I hope you get treated somehow some way and achieve SVR.
If treatment is needed ASAP Sovaldi & Olyiso w/wo Riba may be the way to go in my non medical opinion. If you are Cirrhotic your best bet is to see see a hepatologist who specialises in Hepatitis C treatment.
.
http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed
Changes made on this page on March 21, 2014. Be sure to revisit this webpage before making a decision because it is updated when any recommendations are changed, added or removed.
USA
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/AccesstoInvestigationalDrugs/ucm176098.htm
A search of clinicaltrials.gov shows no Ledipasvir | Expanded Access Studies as of my reply
Regulatory Explainer: FDA's Expanded Access (Compassionate Use) Program
http://www.raps.org/focus-online/news/news-article-view/article/4786/regulatory-explainer-fdas-expanded-access-compassionate-use-program.aspx
excerpts
Why Wouldn't a Company Agree to Allow Access?
Companies and regulators alike have expressed some hesitancy about the program.
For companies, expanded access means letting products out of tightly controlled and heavily monitored environments, potentially subjecting the product to incorrect use and previously unknown adverse events, which would still need to be reported to FDA. Such incidents could potentially raise questions for regulators, thereby harming the chance of a product getting to market.
Further, some companies are concerned that expanded access programs could remove the incentive for patients to enroll in clinical trials meant to provide evidence for their drug's full approval, thereby delaying its approval and harming other patients in the process.
Cancer example
http://www.cnn.com/2014/03/10/health/cohen-josh/
Company denies drug to dying child Tue March 11, 2014
European Medicines Agency advises on compassionate use of a new combination therapy for chronic hepatitis C
The assessment report and conditions of use of the combination of ledipasvir and sofosbuvir with or without ribavirin in this setting will be published shortly on the Agency's website.
Combination of ledipasvir and sofosbuvir to be used in patients in urgent need of therapy to prevent progression of liver disease
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/02/news_detail_002032.jsp&mid=WC0b01ac058004d5c1
If someone had the money and was desperate but could travel, Don't know if traveling to a European country that has compassionate use approval for those specific drugs is an option. My guess if it was possible you would have to meet the conditions.
Patients with a life-threatening, long-lasting or seriously disabling disease with no available treatment options access to treatments that are still under development and that have not yet received a marketing authorisation
marketing authorisation. The approval to market a medicine in one, several or all European Union Member States.
Plus have to pay for all cost.
.
I hope you get treated somehow some way and achieve SVR.
If treatment is needed ASAP Sovaldi & Olyiso w/wo Riba may be the way to go in my non medical opinion. If you are Cirrhotic your best bet is to see see a hepatologist who specialises in Hepatitis C treatment.
.
http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed
Changes made on this page on March 21, 2014. Be sure to revisit this webpage before making a decision because it is updated when any recommendations are changed, added or removed.
USA
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/AccesstoInvestigationalDrugs/ucm176098.htm
A search of clinicaltrials.gov shows no Ledipasvir | Expanded Access Studies as of my reply
Regulatory Explainer: FDA's Expanded Access (Compassionate Use) Program
http://www.raps.org/focus-online/news/news-article-view/article/4786/regulatory-explainer-fdas-expanded-access-compassionate-use-program.aspx
excerpts
Why Wouldn't a Company Agree to Allow Access?
Companies and regulators alike have expressed some hesitancy about the program.
For companies, expanded access means letting products out of tightly controlled and heavily monitored environments, potentially subjecting the product to incorrect use and previously unknown adverse events, which would still need to be reported to FDA. Such incidents could potentially raise questions for regulators, thereby harming the chance of a product getting to market.
Further, some companies are concerned that expanded access programs could remove the incentive for patients to enroll in clinical trials meant to provide evidence for their drug's full approval, thereby delaying its approval and harming other patients in the process.
Cancer example
http://www.cnn.com/2014/03/10/health/cohen-josh/
Company denies drug to dying child Tue March 11, 2014
European Medicines Agency advises on compassionate use of a new combination therapy for chronic hepatitis C
The assessment report and conditions of use of the combination of ledipasvir and sofosbuvir with or without ribavirin in this setting will be published shortly on the Agency's website.
Combination of ledipasvir and sofosbuvir to be used in patients in urgent need of therapy to prevent progression of liver disease
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/02/news_detail_002032.jsp&mid=WC0b01ac058004d5c1
If someone had the money and was desperate but could travel, Don't know if traveling to a European country that has compassionate use approval for those specific drugs is an option. My guess if it was possible you would have to meet the conditions.
Patients with a life-threatening, long-lasting or seriously disabling disease with no available treatment options access to treatments that are still under development and that have not yet received a marketing authorisation
marketing authorisation. The approval to market a medicine in one, several or all European Union Member States.
Plus have to pay for all cost.
.
The only way to get that combo is in a clinical trial right now until approved at the end of this year or early 2015.
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