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Simeprevir + Sofosbuvir...or... wait for Ledipasvir/Sofo combo

Any reasons to hold on a suggested Simeprevir + Sofobuvir protocol in favor of waiting for the all Giliad Sofobuvir + Ledipasvir combo treatment due out in Nov/Dec???   Gen 1a with stable liver panel and stage 2-3 fibro.   Thank you.
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Avatar universal
I am so sorry to hear that you are having kidney issues
And that the mds missed it !

Well I am 11 days till finishing Sovaldi and olysio
And UND, so maybe soon you will be also, !!

I wanted task you said you learned to read the blood tests results your self to see the kidney issues, can you please tell me how? I want to read it correctly too
Thank you
Helpful - 0
Avatar universal
there are still  ledipasvir trials i think..

don't want to wait..  and couldn't make the trial (hcv/hiv trial)
because my creatine is not in the normal range..

now they think the HCV has damaged my kidneys… anyone heard of that..? all the docs and blood tests over the years and no one saw my kidney function decline.. no one ever checked my urine…

i told them my symptoms and they shrugged? they said i was depressed and kept trying to give me anti depressants..

i was also on meds that should not be taken with kidney disease.. now i have CKD stage 3..ugh..what happened toe stage 1 and 2? they missed it and made me worse..

so will start sov/oly i hope next week.

.if i clear the hcv maybe the kidney will stop declining.. won't know till i see the nephrologist and talk about the biopsy results..next week

going to be a bust time for me but at least finally i can get answers and treatment!

all this time it was about the liver.. liver enzymes fine..VL not too bad.. nothing about the kidney.EVER.. if the doc does not tell you how does  one find out? ugh..

  i got all my records from 2008 and yep.. the decline is there.. i learned to read the blood tests and what they mean and i am so mad that they didn't follow through …

so move on to do what we can and treat the HCV and cross my fingers the kidney thing is not aggressive..

best to all of you in your treatments!
Helpful - 0
131114 tn?1380083190
yes i am 1-B
this looks to be very exciting news for 1B F1's. Treatment naive might be better, but the avg. rate of clearance is 93%. That's way better that the 20% of SOC. I hope to be staring in May if not sooner! I will try to post here a bit more- i've been very distracted with other issues and getting ready to TX.
Sure hope you start to get some energy! The other health stuff surely can cause fatigue. I will ck back in once i get my meds. We have a group on Facebook for Sovaldi that really has helped a lot. It's immediate real time interaction and i've been there al bunch!
praying for us all,
Jerialice
Helpful - 0
131114 tn?1380083190
thank you for the insight- yes i am 1-b and f-1.
i did SOC 2x and so relapsed both times. My doc was the main research doc on the COSMOS trial. i do have hours of study on that.. i did find the monograph today for Olysio and also have talked to several on our FB group. It sounds like this is the one for me. I have a pharmacy card and a script. Not sure when I'l hear from them, but I am excited! I have had this all my life and i am ready to be cleared once and for all! Sure hope we all get healed with these new meds. my doc says in 5 years, hcv will be gone!!!
yee haw.
Helpful - 0
Avatar universal
Re read my answer, yeah basically only real daily side effect is fatigue for me, others said they had more energy

I have hypothyroid and auto immune issues though, primary Bilary cirrhosis so could be that too
Helpful - 0
Avatar universal
If you are geno type IB as I am, then in the cosmos trials the cure rate was 100%, granted it was a very very small study so I only have that to go off of

I cleared at week 4, have two more weeks to go( and everything all blood work is normal)I have had hepatitis c for 43 years, and now I don't so weird to say

The only real side effect I have had was extreme fatigue ( and I believe that is from Sovaldi) and two and half months of treatment 2 nausea moments, and two mild headaches

I was tired before but am much more so on tx, I figure small price to pay for SVR =That's it!

Good luck
Helpful - 0
Avatar universal
Google cosmos study, simeprevir, janssen.  Olysio is trade name for simeprevir.  Pay attention to results for your specific condition (genotype, fibrosis, q80k mutation.....).   Uw hep site as well.  No great insight just public info.   Still jacked on forthcoming ledisprevir//sofo giliad combo option for this fall.  Its all a probability game.  Good luck.
Helpful - 0
131114 tn?1380083190
i noticed you seem to have olysio info- where can i get more sx data. I am: G1-b stage 1-
2x SOC relapse experienced

thanks! jerialice
Helpful - 0
131114 tn?1380083190
hello y'all where can i find any negatives/sx on simeprevir? i have an opp to take it with sofo and my doc is the one who did the COSMOS trial. i have heard we can't be in the sun. Any feed-forward will be helpful as I look at my choices for now. I have not been on in a while due other health issues and family needs, but it is now time to slay some dragon!
glad to back and getting more great info!
glad to hear we have a real chance now!!!
<3
Helpful - 0
Avatar universal
Great to share our travails.

jimmyM...the UW site is a treasure trove of info, thanks!!!!

The COSMOS digits are ulta-encouraging but a few simeprevir risks look to be in play... relapse, rash, and viral mutation.   I was once advised to hit the beast with shock and awe, rather than repeatedly with a pea shooter due to the risks associated with viral mutation.

Thank you biotech!  The beasts days look truely numbered.
Helpful - 0
Avatar universal
"FDA get moving" They have already put this on a fact tract  Feb submitted 2 months FDA approves fast tract 6 month if no problem will be approved within a day of October 10 2014. This is as fast as possible. Actually there is some criticism that this is two fast. The same as it took for Olysio & Sovaldi.

In general a few new drugs for other conditions on fast tract in the past few years had late confirmation of life threatening possibilities.  A few during phase 2.  Others confirmed with serious problem became apparent during phase 3 and a couple actually approved for a year or more before serious problems occurred.that resulted in a recall.  So far we have been lucky with the new HCV drugs and I hope it will stay that way in the long term..

The only other option is in the USA Access to Investigational Drugs Outside of a Clinical Trial (Expanded Access)
FDA has to approve and Companies are not required to make their drug available through expanded access, or to make more of a drug for that purpose.
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/AccesstoInvestigationalDrugs/ucm176098.htm

This seams very limited and last year a dying kid was denied a cancer drug and there was some outcry.

Europe seams further ahead with their similar "compassionate use" but an individual country appls and then may get approval. Other countries have to
ask or agree on a country by country basis.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/02/news_detail_002032.jsp&mid=WC0b01ac058004d5c1

21/02/2014
European Medicines Agency advises on compassionate use of a new combination therapy for chronic hepatitis C
Combination of ledipasvir and sofosbuvir to be used in patients in urgent need of therapy to prevent progression of liver disease


http://clinicaltrials.gov/ct2/show/NCT02097966
A Multicenter Compassionate Use Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C
Expanded access is currently available for this treatment.
Last Update April 16

Previous post with some more detailed info
http://www.medhelp.org/posts/Hepatitis-C/NEW-Daclatasvir-Sofosbuvir-w-wo-RBV-Compassionate-Use-H-Risk-Decomp-death-1yr-/show/2141305
Helpful - 0
Avatar universal
T51 you make a good case for waiting for an NS5A in your situation.  With the recent final results from COSMOS Cohort 2 showing 100% SVR12 in people with cirrhosis,

http://www.clinicaloptions.com/Hepatitis/Conference%20Coverage/London%202014/Highlights/Capsules/165.aspx

I wonder whether simeprevir might not be a better choice for those with cirrhosis.  Clearly, the PI simeprevir is not an intuitive first choice for those who are prior PI rx failures, but with these amazing responses, should someone with F4 wait another 6 mos for ledipasvir?    The numbers are small in the COSMOS Cohort 2, and that makes the decision more difficult.  But the response is dramatic and could halt progressive liver damage in a patient who is running out of reserve.

Like you say, FDA get moving!  I've already written to my senators, congressional rep, the FDA and the President's ofc of health care to get FDA moving on sofos/ledip approval.   People will decompensate and probably die while we are waiting.
Helpful - 0
Avatar universal
After more research into the ION study results I am prone to hold for ns5a (ledipasvir) over the PI Simeprevir.   Crazy exciting study results.   Come on FDA...!
Helpful - 0
Avatar universal
I can offer my non medical opinions and guesses.  The only one that can medically advice you is your HCV medical and/or treatment provider. If a treatment or choice of treatments is offered or not offered you have to make the final decision to choose if available, wait or get a second opinion.  

1. The most important thing is the expertise of your doctor especially if you are higher than F0/F1  The specific ranges between F1 and F3/F4 can be the hardest to distinguish.  Biopsy has been considered the gold standard but not perfect especially in the mid ranges. This is even more so for indirect tests. It's actually easier to diagnose F0/F1 or F4  

opinion
The more likelihood and the further above F1 you are, the greater importance of your doctor's advanced knowledge and experienced required. At F3/F4 the doctor should be a recognized expert Gastroenterologist in liver disease, cirrhosis and hepatology. At close to Class 2, Class 2 or 3  then a Hepatoligist preferably in a major transplant center is highly recommended.  In reality depending on your fibrosis stage, or relevant conditions, your insurance, doctors available and location can be a factor. Unfortunately some are unable to get the doctor they want and have to settle for less even if they put up a fight.  

2. Become as knowledge as you can about Hepatitis C and treatment.
One of the best places is this online course for medical people but any one can view and has not required Registration unless for credit.  Yes it's technical but you will get some knowledge that may help you after your doctor ask if you have any question. Then if you do you can respectfully ask appropriate ones not already answered. (can be a good way to get a gut feeling of your doctor's qualifications)
__________________________________________________
Hepatitis C Online is a free educational web site from the University of Washington.
The site is a comprehensive resource that addresses the diagnosis, monitoring, and management of hepatitis C virus infection.
http://hepatitisc.uw.edu/
Check last update of specific module core concepts or presentation selection as some may be from last year or so.  
______
There is a link there to Activity 1A. State of the Art Therapy for HCV
http://hepatitisc.uw.edu/browse/all/lectures#go/special-topics/state-art-therapy/presentation

Watch the slide lecture and complete the quiz for this lesson to claim CME/CNE credit(You must be signed in) But anyone like you or me can watch for free. What a great but technical fast paced overview of newly approved treatments, upcoming possible ones and even more in the future possibilities
_____
Hepatitis C Online has a direct link on main page to
http://www.hcvguidelines.org/    
To get the latest treatment recommendations. Be sure to go back to that site to see if there are any updates especially before doctor visits and making a treatment decision
_____________________________________________________

3. Search for and read information about trials, phase 2,3 and above. Who what and the pros vs cons. The first year after drug approval.

God we all hope and pray that these new treatments will work for all of us that need them and we won't suffer from any long term, unexpected or  change from rare to more common serious side effects or worst.

I am not suggesting nor not suggesting any treatment choice or delay in treatment. ' sorry I can not provide any advice one way or another. That is best done by an expert medical provider and/or a second expert opinion.

There are so many possible reasons why one or more recommendation are made.

A few of my personal non exclusive opinions are.
1. A patient's exact medical condition(s) including many variable factors that the doctor uses to decide which drugs and when to treat. They may have more specific knowledge either from experience or consultation with other experts that may or may not have been published, confirmed or available to the public.     .  

2. For many reasons a doctor may have to restrict and /or delay treatment by the resources available, management directive, insurance or other limiting treatment to those in the most immediate or close to immediate treatment need.  Also a doctor may decide or is able to make proscribe treatments/ off label treatments to those with less serious liver conditions.

The last time I checked hcvguidelines.org the recommendation for Simeprevir + Sofobuvir was those in immediate need of treatment and resversions for Class 2 and especially 3 (implied)  
Still waiting for COMING SOON: In Whom and When to Initiate Treatment
(my guess there isn't enough agreement and/or results to do so. Hopefully it's been done and getting read to update soon).  

The current VA guide restricts that to cirrhosis or maybe with other specific markers.    

3. Hopefully a recommendation or non recommendation isn't based on lack of expertise, incompetence, or immoral behaviour.    

Please excuse my long worded comment probably many of you know most if not all of this already.  Since this is Google indexed many visitors may not be as informed and need a little more overview  My personal opinion that may or may not be supported by verifiable medical sources.

I wish the best for anyone seeking treatment.

I sure some others can offer their own opinions and suggestions

The great thing about MedHelp Hepatitis C Community is the members who help each other when they can. They offer support and prayers that eventually everyone can get rid of this HCV "varmin" and live a longer and healthier life.    

.

  
Helpful - 0
Avatar universal
I am currently on week 5 and at week 2 my VL was 400. Prior to taking Olysio and Sovaldi I was 2.5 mil. I do labs for week 4 thurs. Praying for undetected  on to SVR.
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Avatar universal
that makes three of us except I have two failed attempts and one relapse from Incivek triple therapy 1a TT 2-3. I'm waiting best wishes for SVR
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Avatar universal
i am wondering the same thing..

1a
TT
stable liver panel and stage 2-3 fibro  also..
the ledipasvir sounds great!

Helpful - 0
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