Forum Replies Created
-
AuthorPosts
-
Yes, CJ and I have spoken and a plan is in place involving blood tests and Zofran and lots of sips of fluid.
Young J’s tummy is soft which is reassuring that it’s not appendicitis or other serious worries.
YMMV
Sofosbuvir cost almost exactly $375 million to develop including exit from Phase 3 trials.
This is clearly documented, via a bit of forensic accounting, on our blog:
http://fixhepc.com/blog/item/25-the-real-development-cost-of-sofosbuvir.html
YMMV
Yes, we have samples on the way for testing.
YMMV
My first patient on generic APIs is now past SVR12. His method was simple – weigh on a teaspoon, swallow with water. Capsules are a convenience mechanism, as are tablets. Don’t over think it.
If you want to use filler for volume based filling of multiple capsules simultaneously use lactose from the baby section of the chemist and grind the API and lactose together in a mortar and pestle to equalise particle size and ensure a uniform mix.
YMMV
Yes Twinvir is made with Chinese sourced APIs and the Form II type of Sofosbuvir (as in Gilead’s commercial product). We have tested it and found it to be a good generic copy. If you read the certifications here:
http://fixhepc.com/forum/testing-services/339-testing-provisions-patient-safety.html
You will find that Twinvir is noted to be a match.
YMMV
The Twinvir was part of some samples we had for RVR testing so we decided to pop young J on the RVR group and start before the routine meds arrived. One week bloods showed complete normalisation of LFTs and viral load will be to hand mid this week.
YMMV
Yes, it is ok to have a flu shot.
YMMV
http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(15)00424-7/abstract
We need to change the dynamics of our market economy that incentivises giving precious antibiotics to animals to facilitate high density factory farming. The end result is that stuff you could use to save people in the future is being used to improve profits now.
You, me, and our children are on track to really regret this short sightedness….
YMMV
You are probably getting anaemic and your altitude is pointing that out sooner than you would notice at sea level.
At 1200 m there is only 87% as much oxygen as at sea level.
Please get some bloods done – particularly your Hb
YMMV
12 weeks
Sofosbuvir+Daclatasvir
or
Sofosbuvir+Ledipasvir
No Ribavirin. No Interferon.
>95% cure rate
YMMV
The image is Sofosbuvir. The certifications and spectra for all of Sof + Dac + Led are down the bottom of the page. Here they are directly:
Australian NMI NATA Certification Sofosbuvir
Australian NMI NATA Certification Ledipasvir
Australian NMI NATA Certification Daclatasvir
If you happen to be a laboratory looking for real NMR data in multiple solvents, 1H, 13C, 2D, here it all is in one place:
YMMV
[video]https://www.youtube.com/watch?v=m57gzA2JCcM[/video]
Speaking of Arlo this is kind of appropriate for this site.
YMMV
So if you read the study http://www.healio.com/hepatology/hepatitis-c/news/online/%7B223dc0cb-9261-4e9c-a7d5-42ed1b96d88e%7D/astral-2-sovaldivelpatasvir-bests-standard-therapy-in-hcv-genotype-2
There were 134 patients in the sofosbuvir/velpatasvir….
First consider margin of error https://www.surveymonkey.com/mp/margin-of-error-calculator/
If you use a conservative 1,000,000 for the population size, a 95% confidence interval and 134 sample you will see the margin of error is 9%
So this could quite possibly represent a 90% real cure rate.
99% is interesting because 1 patient cure either way at this study size make big differences
133/134 = 99.2% (rounds to 99%)
132/134 = 98.507% (rounds to 99%)
131/134 = 97.76% (rounds to 98%)There were 134 patients in the sofosbuvir/velpatasvir arm and 132 in the sofosbuvir/ribavirin arm. One patient in the velpatasvir arm stopped treatment due to an adverse event on day 1 and one patient in the ribavirin arm was lost to follow-up after week 10.
There were two deaths in the velpatasvir group, but neither was determined to be related to the study regimen.
Here is better data reported in the mainstream literature:
http://www.ncbi.nlm.nih.gov/pubmed/26569658
Results Of the 267 patients who received treatment, 78% had HCV genotype 1, 4% genotype 2, 15% genotype 3, 3% genotype 4, and less than 1% genotype 6; no patients had genotype 5. Overall rates of sustained virologic response were:
- 83% (95% confidence interval [CI], 74 to 90) among patients who received 12 weeks of sofosbuvir-velpatasvir,
- 94% (95% CI, 87 to 9 among those who received 12 weeks of sofosbuvir-velpatasvir plus ribavirin, and
- 86% (95% CI, 77 to 92) among those who received 24 weeks of sofosbuvir-velpatasvir.
And these results are also worth looking at (lots of < 90% SVR results in there): http://www.ncbi.nlm.nih.gov/pubmed/26551051
So in bigger studies it does not look superior to Daclatasvir.....
YMMV
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3897323/
Historically, Phase II and Phase III clinical trials of hepatitis C virus (HCV) treatments have defined sustained virological response (SVR) as an undetectable HCV RNA 24 weeks after end of treatment (SVR24).
Using < 15 is cheating although I have heard privately that some patients stay detectable but < 15 for a long time, so they still have some trace of virus but it is so mutated it can barely duplicate. < 15 means detected but too low to count. On treatment, early on before we get to undetectable, I can imagine some residual RNA from destroyed virus being present but post treatment UND aka undetectable is the definition of success.
YMMV
As Kevin said the key things a doctor needs to know are:
- Genotype
- Fibrosis level – cirrhosis or not?
- Medications currently being taken
- Past treatment
The recommendations are here: http://fixhepc.com/getting-treated/genotype-specific-hepc-treaments.html
For most people 12 weeks Sof+Dac is fine.
With cirrhosis 24 weeks and consider adding Ribavirin
With GT 3 consider adding Ribavirin
Interferon is not really recommended anymore.
YMMV
-
AuthorPosts