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Prediction factors for relapse after treatment with Sovaldi
Six factors were independently associated with relapse: high baseline viral load, cirrhosis, IL28B non-CC, weight over 75kg (165 lbs), prior treatment, and male sex.
SVR12 rates were 100% for people with zero or one negative predictive factor, above 99% for those with two factors and 94% for those with three factors. After this, efficacy dropped off, falling to 88% for those with four negative factors, 68% for those with five factors and 57% for those with six factors.
Cure rates were 90% or higher for all genotype groups with zero to three negative predictive factors. For those with four or more factors, the effect was most pronounced among people with HCV genotypes 1 or 3.
"Sofosbuvir-based regimens were highly effective, even in patients with a combination of multiple negative factors," the researchers concluded. "SVR12 rates were comparatively lower in patients with five or six of the negative predictors."
Read full story at http://www.aidsmap.com/Sofosbuvir-works-well-despite-multiple-negative-predictive-factors/page/2848419/
SVR12 rates were 100% for people with zero or one negative predictive factor, above 99% for those with two factors and 94% for those with three factors. After this, efficacy dropped off, falling to 88% for those with four negative factors, 68% for those with five factors and 57% for those with six factors.
Cure rates were 90% or higher for all genotype groups with zero to three negative predictive factors. For those with four or more factors, the effect was most pronounced among people with HCV genotypes 1 or 3.
"Sofosbuvir-based regimens were highly effective, even in patients with a combination of multiple negative factors," the researchers concluded. "SVR12 rates were comparatively lower in patients with five or six of the negative predictors."
Read full story at http://www.aidsmap.com/Sofosbuvir-works-well-despite-multiple-negative-predictive-factors/page/2848419/
Very interesting, I am sure this will alter though as they start to study non interfereon treatments
Because the Cc,CT TT thing I thought only pertained to interferon
And I believe there is even a ribavarin resistance too, can't remember where I read that
Just like all disease treatments it maybe be modified to the indivual so specific response and genetic markers
Because the Cc,CT TT thing I thought only pertained to interferon
And I believe there is even a ribavarin resistance too, can't remember where I read that
Just like all disease treatments it maybe be modified to the indivual so specific response and genetic markers
You are right referring to the type of weight a person carries. Alot of the studies refer to BMI. In Body Mass Index, there are huge degrees of muscle
vs fat. The more fat (visceral ) you carry, the less able the body is to absorb the meds.
Good Luck with your results.
..Kim..
vs fat. The more fat (visceral ) you carry, the less able the body is to absorb the meds.
Good Luck with your results.
..Kim..
I have read that estrogen has a protective effect against liver damage from chronic hepatitis C infection, but I don't recall where I read that. So, a post-menopausal woman would no longer have that protection. I also read somewhere that post-menopausal women have lowered response rates to treatment and accelerated disease progression.
I have a few negative factors, too: high baseline viral load at 8.7 million, older age at 59, and post-menopausal.
Thanks, daroga, for adding to the information pool.
Wishing you the best!
I have a few negative factors, too: high baseline viral load at 8.7 million, older age at 59, and post-menopausal.
Thanks, daroga, for adding to the information pool.
Wishing you the best!
Thanks so much for this article, makes me feel a bit better. I guess I just have one risk factor (or 2) (I'm so foggy headed, Wednesday will be my last day of the pills) high viral load as it was 3,000,000. Dunno, is that high? Otherwise I have low liver damage, 1b, treatment naive, I'm a woman, but I am 60. Roll the dice, hope we all SVR...Hector thanks, youre always such a big help.
I have a long time history of multiple treatment w/o ever clearing or going undetected. Risk factor - #1 I have no idea with my IL28B is because it was only done one time in a clinical trial and they never gave me the results to it. When I was unblinded and asked for the results, they mysteriously lost them, couldn't find the record anywhere. I asked my doctor on this treatment if I need that test done and he said it wasn't necessary since it was an expensive test and since I had already decided that I wanted to do this that it really wouldn't change what we were going to do with regards to treatment. Also, since I wasn't going to be using the Olyssio or any other protease inhibitor, that was another reason why it was decided to just skip this test. So, I could have another risk factor with the allele type, just don't know. Not overweight at all, by any imagination. No cirrhosis. I don't know if my starting viral load is considered high or not? It was 2165111 IU/ML or 6.34 log IU/ML . I wonder if a past exposure to a protease inhibitor without viral clearance is considered a risk factor? Even though I'm not using a Protease Inhibitor on this treatment? Susan400
Thanks you are right of course. I have been mostly calm and confident during treatment and for the last 12 weeks post treatment. Now that it is the moment of truth I have to admit to being anxious and distracted.
K55, You have a 94% chance of SVR according to the above research! Them are some great odds. It's normal to feel anxious - we all do, but you are going to SVR! Believe!
Good luck on Wednesday.
Good luck on Wednesday.
I wonder if the weight issue is about fat or just weight? I am 6' 220# but very fit and muscular. I ride my bike 225 miles a week and exercised 4 days a week (backcountry skiing) while on treatment. I finished 12 weeks of Sovaldi/Ribavirin on April 22 and get my 12 week EOT blood work done the day after tomorrow, July 16. I am a bit nervous about this! Genotype 2, treatment naive, viral load low, 145,000 at baseline. My three negative factors would be sex, weight and non-CC (I am CT).
Interesting....I would say I have 3. Probably cirrhotic by now last biopsy was G2/S3, IL28B is CT, and relapsed prior tx of 3x w/ Vic. When I relapsed I had a very low VL of around 40,000. Now it's probably 4M. Hopefully something will work the 2nd time around.
Thanks for posting this
Thanks for posting this
Thanks for the information and article site. I think forearmed is forewarned. I have the weight factor- which is one that I can change. Since starting the Sol/Riba I have lost 3 or 4 lbs, ust because I am eating a big brreakfast and supper prior to taking my meds, a sensible lunch, because I am not really hungry, but know I need to eat and drinking from 120 - 150 oz water a day and with all that who has room for snacks? Also have cut out yhe candy,an easy choice now that I know my liver needs all the help I can give it. Now, I will see if I can't do other things to increase that weight loss - truly I don't need these extra lbs and maybe I can improve my chances of SVR. Again, thanks
Soon after a person viral load returns after relapsing the viral load will increase again to a steady level. Sometimes it may be higher than the initial level when treatment was started. Either was the actual viral load number has no impact on the progression of the cirrhosis.
A low viral load is considered < 800,000 IU/ml.
So whether your viral load was 2,000,000 or 7,000,000 it would make no difference as far as outcome with Sovaldi + peg-interferon and ribavirin or Sovaldi with ribavirin treatments. How much this may apply to Sovaldi + Olysio treatment is not known.
All of these host factors can't be changed. (Viral genotype, Viral load, Sex, Age, Race/ethnicity, Liver damage, coinfection with HIV ) So it is the choice of treatment that reduces or overcomes these factors is what is important. Soon we will have new treatment options to choose from that will better reduce or eliminate particular factors for better outcomes for certain infected groups of people. We already have some of this with different treatments for different genotypes and people with advanced liver disease.
It is good news that your MELD score is very low, indicating your liver's synthetic function is still quite good which should allow you the time to wait for more effective treatments coming later this year and early next year. Remember many of us cirrhotics have treated with much higher MELD scores safely.
Hang in there. Better treatments are coming soon.
Hector
A low viral load is considered < 800,000 IU/ml.
So whether your viral load was 2,000,000 or 7,000,000 it would make no difference as far as outcome with Sovaldi + peg-interferon and ribavirin or Sovaldi with ribavirin treatments. How much this may apply to Sovaldi + Olysio treatment is not known.
All of these host factors can't be changed. (Viral genotype, Viral load, Sex, Age, Race/ethnicity, Liver damage, coinfection with HIV ) So it is the choice of treatment that reduces or overcomes these factors is what is important. Soon we will have new treatment options to choose from that will better reduce or eliminate particular factors for better outcomes for certain infected groups of people. We already have some of this with different treatments for different genotypes and people with advanced liver disease.
It is good news that your MELD score is very low, indicating your liver's synthetic function is still quite good which should allow you the time to wait for more effective treatments coming later this year and early next year. Remember many of us cirrhotics have treated with much higher MELD scores safely.
Hang in there. Better treatments are coming soon.
Hector
Even though those who relapsed were able to get a "vacation" from the Hep C during treatment, won't one's viral load continue to increase now that their treatment is ended?
I keep hearing that viral load count is not so important but it is listed as one of the 6 factors predicting relapse in the article that Sue shared
I started treatment with a viral load of about 7 million
When I was first diagnosed with cirrhosis, it was only 2 million and my liver function tests have improved significantly - even before treatment - by quitting drinking Any alcohol, giving up meat and eating lots of organic fruits and veggies
MELD went from 12 last October and has stayed at 8 for the last 6 months
I keep hearing that viral load count is not so important but it is listed as one of the 6 factors predicting relapse in the article that Sue shared
I started treatment with a viral load of about 7 million
When I was first diagnosed with cirrhosis, it was only 2 million and my liver function tests have improved significantly - even before treatment - by quitting drinking Any alcohol, giving up meat and eating lots of organic fruits and veggies
MELD went from 12 last October and has stayed at 8 for the last 6 months
Great article, and it really makes sense. I had 1 risk factor being cirrhotic, and fortunately did clear. I wonder if you treat more then 2Xs, does your chance for SVR stay the same as a prior treater or do your odds decrease?
This might explain alot as to why some people relapse, and others don't.
It appears that unfortunately there is only 1 factor that we can change to increase our odds, and that would be weight.
Fascinating information and thanks for sharing.
...Kim..
This might explain alot as to why some people relapse, and others don't.
It appears that unfortunately there is only 1 factor that we can change to increase our odds, and that would be weight.
Fascinating information and thanks for sharing.
...Kim..
Thanks for posting this. Hopefully people will realize that is these "host factors" listed in the article that are predictive of SVR unlike older interferon based treatments were the viral response during treatment was one of the most predictive factors.
All people that treat with Sovaldi based treatments experience the same viral response. There become undetectable within about a month of starting treatment, remain so through treatment and only fail treatment by relapsing after stopping the treatment.
NOTE: These results are based on those who treated with Sovaldi + peg-interferon and ribavirin or Sovaldi +ribavirin. It doesn't apply to other treatments although the idea is similar. As the report says "Notably, this analysis is specific to sofosbuvir, an HCV polymerase inhibitor. Other trials indicate that the negative predictive factors which remain relevant may differ among the various DAAs."
In Linda's case we already know that Sovaldi + Olysio in cirrhotics in the COSMOS cohort 2 trial had a SVR rate of 86%. Which is constant with what has always been known about cirrhosis...people with cirrhosis are the hardest to treat patients and they have always had and continue to have the lowest SRV rates of any subgroup of patients. In the study using Sovaldi with either peg-INF & ribavirin or with ribavirin alone it shows that cirrhotics had " more than 4-fold higher risk" of relapse than those without cirrhosis.
Cheers
Hector
All people that treat with Sovaldi based treatments experience the same viral response. There become undetectable within about a month of starting treatment, remain so through treatment and only fail treatment by relapsing after stopping the treatment.
NOTE: These results are based on those who treated with Sovaldi + peg-interferon and ribavirin or Sovaldi +ribavirin. It doesn't apply to other treatments although the idea is similar. As the report says "Notably, this analysis is specific to sofosbuvir, an HCV polymerase inhibitor. Other trials indicate that the negative predictive factors which remain relevant may differ among the various DAAs."
In Linda's case we already know that Sovaldi + Olysio in cirrhotics in the COSMOS cohort 2 trial had a SVR rate of 86%. Which is constant with what has always been known about cirrhosis...people with cirrhosis are the hardest to treat patients and they have always had and continue to have the lowest SRV rates of any subgroup of patients. In the study using Sovaldi with either peg-INF & ribavirin or with ribavirin alone it shows that cirrhotics had " more than 4-fold higher risk" of relapse than those without cirrhosis.
Cheers
Hector
This gives me hope of attaining SVR12. My ribavirin was reduced in the middle of my Tx, so am hoping it won't adversly affect my outcome. Thanks Sue.
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I read something the other day that was new to me. It was in the danish guidelines. They mentioned all the negative predictive factors that was associated with a lower response rate to interferon based treatments and among them were a low alt which I never heard of before. Could it be that a low alt means less inflammation which is good when not on treatment but also show a less strong immune system that don't respond good to interferon?