question about a trial I am in sofosbuvir ledipasvir opinions much appreciated

[simon4271]

Hi I am in a 12 week trial sofosbuvir/ledipasvir . From what I have read on the internet , ion 1 ,2 , 3 and others almost everybody was undetected at week 4 using this combo .
I tested  <15 detetected at week 4 .
I have my next viral load at week 8 and was told it is unnecessary to have another test done before then as I am going in the right direction down from 3 million .
I have failed in the a past telaprevir , interferon , ribavirin and have cirrhosis , I am very concerned .
I am thinking about asking if they could extend my trial to 24 weeks when I next go in , is that possible ?, I think it is pretty unlikely as they are very strict with trial protocols .
I see that the svr rates are around 80 % in my situation but mostly in people who were undetected at week 4 , as I cannot find any data I am wondering if anyone knows
how much less chance I have now of svr as I did not clear at week 4 .  Unlike solvadi olysio where is more common to be still detected at week 4 , with sofosbuvir/ledispasvir it
is  less common from what I have read see so you can why I am concerned .
I would appreciate any opinions , thank you .

[Sarah1949]

Hi Mac, I can't imagine anyone having a problem with your sharing a link to another site. Unless they are selling something. Anyway, I'm curious about which site you're talking about.

[Dee1956]

Hi there, I think Mac has a good take on it.
You are moving in the right direction when I treated and got to UND <43 was the lowest it would go.
You are doing really well.
Take Care
Dee

[simon4271]

Thank you very much for your encouraging words I need to think good thoughts and be patient and hopefully achieve a great outcome of svr . I wish you luck my friend hopefully we will both be clear and have a less stressful Christmas . Take Care .

[mac790]

Simon4271, I am in a Phase III clinical trial, different drugs, but very close in chemical structure/method of action to yours. Merck is making the drug in my trial. I would NOT be concerned about a viral load count of 15, down from 3 million plus. 15 could very well be in the margin of error, depending upon the quality of the testing lab.Your trend is obviously dramatically positive. If I had to bet, week 8 will reveal "no detectable viral particles found", or "ND". I am on a 12 week trial of a combo of two Merck drugs in one pill, very much the same as the combo you are taking. The gold standard that four huge "Big Pharma" have drugs in the pipeline are shooting for is: A 1 pill per day, 12 week long treatment, with no Interferon or Ribavirin ("RBV"), ending with a SVR in 99% of patients, regardless of cirrhosis stage. I am Stage 5/6 cirrhotic, about as bad as you can get. My viral load dropped from 585,000+ to 396 in 7 days. Since then, the lab they send the blood samples out to has managed to bungle both week 4 and 6 viral load tests. No data. I just had week 8's viral load blood drawn today. I won't know anything until my next visit, in early October. If I am not "ND" by then, I most assuredly will not clear the virus. I missed getting the 16 week arm of the study. No amount of asking, pleading or offering animal sacrifices will get them to extend either of us to 16 weeks. We were both chosen randomly by a computer program, I had 4 possible arms: 1) 2 experimental meds for 12 weeks, 2) same for 16 weeks, 3) 2 experimental meds plus RBV for 12 weeks, and finally 4) experimental meds and RBV for 16 weeks. You and I drew the short straw, but that using my assumption that the experimental meds plus RBV  was an option for you. I'm certain you are going to be fine ,according to the literature I have read (contact me personally and I'll give you the website address showing the latest clinical trial results). I would mention it here, but got ripped for "pushing" this great informational website on another, completely different forum. (If the administrators here don't mind, I'd be glad to spell out for everyone the URL of this great, free resource). You are I are taking meds on the very cutting edge of antiviral therapy, but in the next few years, I would postulate SVRs in 100% of patients. I can envision a day when you check yourself into a hospital or clinic, they give you an infusion, watch you for a day and release you, with an SVR of ND. That is my guess where the therapy will eventually wind up. I would not worry my friend, I think you've got this beat. I would bet money on it, in fact. Please feel free to contact me, and please keep us all posted. mac790