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The waiting game-2 weeks post-ION2
Hi all,
Since I started the ION-2 trial in Boston in January, I have been following your experiences on the forum. It was comforting to read other people going through similar situations, especially those who did not have success with previous treatments.
My Hep C came from a bad blood transfusion when I was born at 25 weeks gestation. This was before blood products were tested for Hep and HIV, luckily I do not have the latter. I am 29 and do not have any liver damage or elevated levels. For a chance to knock it out, I did Pegasys interferon and ribavirin in 2006-7. I dont have to tell you the sides effects were absolute hell. It has left me with some residual anxiety issues as well, anticipating the attacks I had on the treatment. My viral load got close to undetected on the interferon and riba. but then relapsed and I stopped at about 30 weeks.
Fast forward to early 2013 when my (one of the best) liver dr let me know about ION-2 at my yearly appointment. The stars were aligned and I decided to go for the opportunity to be involved, again as a preventative measure. This has been amazing, as I have read others have experienced. Very little side effects, headache until week two, and the biggest complain was the fatigue. I was on the 24 week arm of both sofosbuvir and riba. (1000mg/day). I blame the riba. for lowering my hemoglobin and contributing to the fatigue. I will take that since I have been UNDETECTED since week 2!! My viral load was 9.5mill down to 0-25 in 2 weeks! I am really hoping this is it for us, my dr is quite positive as well.
Now I wait. Here's where I need some support. My last dose of the drugs was 7/16 and my bloods from my 7/19 appointment show I am still undetected. I have an appointment in two weeks and will most likely have the viral load results back in the last week of the month. Then, I will have an appointment in early October and early January. My team also says October is a good indicator of SVR. I lead a healthy lifestyle, with good eating habits, I sleep 7-8 hours a night, and spin and do yoga. I took the drugs exactly as prescribed (to the minute) and did not miss a dose. That's all I can do, and I am having some agita waiting until my next appointment and result.
Any words of wisdom? Experiences post-ION with SVR? Please share.
Much appreciated.
Since I started the ION-2 trial in Boston in January, I have been following your experiences on the forum. It was comforting to read other people going through similar situations, especially those who did not have success with previous treatments.
My Hep C came from a bad blood transfusion when I was born at 25 weeks gestation. This was before blood products were tested for Hep and HIV, luckily I do not have the latter. I am 29 and do not have any liver damage or elevated levels. For a chance to knock it out, I did Pegasys interferon and ribavirin in 2006-7. I dont have to tell you the sides effects were absolute hell. It has left me with some residual anxiety issues as well, anticipating the attacks I had on the treatment. My viral load got close to undetected on the interferon and riba. but then relapsed and I stopped at about 30 weeks.
Fast forward to early 2013 when my (one of the best) liver dr let me know about ION-2 at my yearly appointment. The stars were aligned and I decided to go for the opportunity to be involved, again as a preventative measure. This has been amazing, as I have read others have experienced. Very little side effects, headache until week two, and the biggest complain was the fatigue. I was on the 24 week arm of both sofosbuvir and riba. (1000mg/day). I blame the riba. for lowering my hemoglobin and contributing to the fatigue. I will take that since I have been UNDETECTED since week 2!! My viral load was 9.5mill down to 0-25 in 2 weeks! I am really hoping this is it for us, my dr is quite positive as well.
Now I wait. Here's where I need some support. My last dose of the drugs was 7/16 and my bloods from my 7/19 appointment show I am still undetected. I have an appointment in two weeks and will most likely have the viral load results back in the last week of the month. Then, I will have an appointment in early October and early January. My team also says October is a good indicator of SVR. I lead a healthy lifestyle, with good eating habits, I sleep 7-8 hours a night, and spin and do yoga. I took the drugs exactly as prescribed (to the minute) and did not miss a dose. That's all I can do, and I am having some agita waiting until my next appointment and result.
Any words of wisdom? Experiences post-ION with SVR? Please share.
Much appreciated.
Most patients relapse within the first month so that is the best indicator of SVR that we had.
The only data we have from a similar trial is from LONESTAR.
NOTE: treatment is for shorter duration then your trial.
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Trial: LONESTAR, NCT01726517, GS-US-337-0118; sofosbuvir/ledipasvir with and without ribavirin; phase II.
"Participants: n=100 (planned); aged 18 years and older; HCV infection; genotype 1; chronic; treatment naïve or experienced.
Schedule: Randomised to:
Treatment naïve participants sofosbuvir/ledipasvir, oral, 400mg/90mg once daily for 8 or 12 wks; or sofosbuvir/ledipasvir, oral, 400mg/90mg once daily, with ribavirin, 500mg or 600mg twice daily for 8 wks;
Treatment experienced participants sofosbuvir/ledipasvir, oral, 400mg/90mg once daily for 12 wks; or sofosbuvir/ledipasvir, oral, 400mg/90mg once daily, with ribavirin, 500mg or 600mg twice daily for 12 wks.
Follow-up: Active treatment period up to 12 wks; 3 yrs follow-up.
Primary outcome/s: SVR; safety and tolerability.
Secondary outcome/s: Viral resistance to study drug; viral dynamics; pharmacokinetics.
Key results: For treatment naïve participants: sofosbuvir/ledipasvir 8wks, 12wks and sofosbuvir/ledipasvir with ribavirin respectively, 95% achieved SVR8(a) , 100% achieved SVR4(b), 100% achieved SVR8; for treatment experienced participants: for sofosbuvir/ledipasvir and sofosbuvir/ledispavir with ribavirin respectively, 95% achieved SVR4, 95% achieved SVR4.
(a) Sustained virologic response 8 weeks after completing therapy.
(b) Sustained virologic response 4 weeks after completing therapy.
-------------------------------------------------------------------------------------------------
Trial: ION-2, NCT01768286, GS-US-337-0109; sofosbuvir/ledipasvir with and without ribavirin; phase III.
Sponsor: Gilead Sciences.
Design: Randomised.
Participants: n=400 (planned); aged 18 years and older; HCV infection; genotype 1; chronic; treatment experienced including patients who have previous failed NS3/4A protease inhibitor plus peginterferon/ribavirin regimen.
Schedule: Randomised to sofosbuvir/ledipasvir, oral, 400mg/90mg once daily for 12 or 24 wks; or sofusbuvir/ledipasvir, oral, 400mg/90mg once daily, with ribavirin, 500mg or 600mg twice daily for 12 or 24 wks.
Follow-up: Active treatment period up to 24 wks; 3 yrs follow-up.
Primary outcome/s: SVR; safety and tolerability.
Secondary outcome/s: Kinetics of circulating HCV RNA; viral resistance to study drug; pharmacokinetics.
Expected reporting date: Q4 2014.
-------------------------------------------------------------------------------------------
You should have very good odds for cure.
Best of luck to you!
Hector
The only data we have from a similar trial is from LONESTAR.
NOTE: treatment is for shorter duration then your trial.
---------------------------------------------------------------------------------------------
Trial: LONESTAR, NCT01726517, GS-US-337-0118; sofosbuvir/ledipasvir with and without ribavirin; phase II.
"Participants: n=100 (planned); aged 18 years and older; HCV infection; genotype 1; chronic; treatment naïve or experienced.
Schedule: Randomised to:
Treatment naïve participants sofosbuvir/ledipasvir, oral, 400mg/90mg once daily for 8 or 12 wks; or sofosbuvir/ledipasvir, oral, 400mg/90mg once daily, with ribavirin, 500mg or 600mg twice daily for 8 wks;
Treatment experienced participants sofosbuvir/ledipasvir, oral, 400mg/90mg once daily for 12 wks; or sofosbuvir/ledipasvir, oral, 400mg/90mg once daily, with ribavirin, 500mg or 600mg twice daily for 12 wks.
Follow-up: Active treatment period up to 12 wks; 3 yrs follow-up.
Primary outcome/s: SVR; safety and tolerability.
Secondary outcome/s: Viral resistance to study drug; viral dynamics; pharmacokinetics.
Key results: For treatment naïve participants: sofosbuvir/ledipasvir 8wks, 12wks and sofosbuvir/ledipasvir with ribavirin respectively, 95% achieved SVR8(a) , 100% achieved SVR4(b), 100% achieved SVR8; for treatment experienced participants: for sofosbuvir/ledipasvir and sofosbuvir/ledispavir with ribavirin respectively, 95% achieved SVR4, 95% achieved SVR4.
(a) Sustained virologic response 8 weeks after completing therapy.
(b) Sustained virologic response 4 weeks after completing therapy.
-------------------------------------------------------------------------------------------------
Trial: ION-2, NCT01768286, GS-US-337-0109; sofosbuvir/ledipasvir with and without ribavirin; phase III.
Sponsor: Gilead Sciences.
Design: Randomised.
Participants: n=400 (planned); aged 18 years and older; HCV infection; genotype 1; chronic; treatment experienced including patients who have previous failed NS3/4A protease inhibitor plus peginterferon/ribavirin regimen.
Schedule: Randomised to sofosbuvir/ledipasvir, oral, 400mg/90mg once daily for 12 or 24 wks; or sofusbuvir/ledipasvir, oral, 400mg/90mg once daily, with ribavirin, 500mg or 600mg twice daily for 12 or 24 wks.
Follow-up: Active treatment period up to 24 wks; 3 yrs follow-up.
Primary outcome/s: SVR; safety and tolerability.
Secondary outcome/s: Kinetics of circulating HCV RNA; viral resistance to study drug; pharmacokinetics.
Expected reporting date: Q4 2014.
-------------------------------------------------------------------------------------------
You should have very good odds for cure.
Best of luck to you!
Hector
I just had my 12-week-post-end-of-treatment blood draw two days ago. I was in the ION-2 12-week without ribavirin group. When the research clinic calls me within the next couple of weeks to ask me to schedule my 24-week-post blood draw, or when they call saying "there was a problem with your labs and we need to repeat your blood draw", I'll be sure to post.
My anxiety level is a lot less now than it was 6 weeks ago. I was able to convince my family physician to order me up a viral load test, good down to 2IU/ml, at 6-weeks post treatment. Those results showed that I was undetected at EOT+6. That was quite the relief for me because I didn't go undetectable until treatment week 6, I only treated for 12 weeks, I only took the SOF/LDV without RBV, and I was a 3X treatment failure, one of which included a protease inhibitor. However, because of all of that, I do still have some anxiety about this EOT+12 test.
But in your case, you, having gone undetectable at week 2 of treatment, getting 24 weeks of SOF/LDV plus RBV, I'd say are now free to go about a normal life. Don't sweat it. Relax. Enjoy your life.
My anxiety level is a lot less now than it was 6 weeks ago. I was able to convince my family physician to order me up a viral load test, good down to 2IU/ml, at 6-weeks post treatment. Those results showed that I was undetected at EOT+6. That was quite the relief for me because I didn't go undetectable until treatment week 6, I only treated for 12 weeks, I only took the SOF/LDV without RBV, and I was a 3X treatment failure, one of which included a protease inhibitor. However, because of all of that, I do still have some anxiety about this EOT+12 test.
But in your case, you, having gone undetectable at week 2 of treatment, getting 24 weeks of SOF/LDV plus RBV, I'd say are now free to go about a normal life. Don't sweat it. Relax. Enjoy your life.
I just read your post and I just wanted to comment because it is the same for me to a T...I too received a bad blood transfusion at birth being born at 30 weeks I am now 27 and have slightly elevated enzymes just now and not treated yet and am looking to get into a interferon trial as I have 2 young kids and the easier the better! I hope SVR for you and everyone else for that matter. It makes me hopeful to hear you say u still did a bit of excercise as I am on the go all day pretty much with 2 young kids. Sleep well for me lack there of hoping that will get better with baby getting older! Congrats on completing treatment! All the best
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