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  • in reply to: Liver Cirrhosis does not disappear in 12 weeks #1285
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Yes, it won’t just disappear, but there is good reason to be optimistic about fibrosis regression…

    SVR After Therapy Reduced Inflammation, Fibrosis in HCV Patients

    “The observations of the present study strongly suggest that fibrosis regression, including resolution of cirrhosis, will occur in the vast majority of patients who will achieve SVR with these future therapies.”

    At SVR the processes driving fibrosis should stop so things should not get worse and over time there is evidence things improve for many patients.


    YMMV

    in reply to: Expert Professor by email – Viral Load Monitoring #1284
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Concordance of sustained virological response 4, 12, and 24 weeks post-treatment with sofosbuvir-containing regimens for hepatitis C virus

    The concordance between SVR at 4 weeks post-treatment (SVR4) and SVR12, and between SVR12 and SVR24, were determined, as well as positive predictive values (PPVs) and negative predictive values (NPVs). Overall, 779 of 796 patients (98.0%) with an SVR4 also achieved an SVR12, making the PPV of SVR4 for SVR12 98% and the NPV 100%. Of the 779 patients with an SVR12, 777 (99.7%) also achieved an SVR24, making the PPV of SVR12 for SVR24 >99% and the NPV 100%. Of patients who relapsed post-therapy, 77.6% did so within 4 weeks of completing therapy.


    YMMV

    in reply to: Australian Customs #1266
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Please don’t wait a few days or your medications will either be destroyed or returned to sender.

    You need to send customs the email and documents listed here: http://fixhepc.com/getting-treated/how-to-do-it/import-paperwork.html

    Customs need the missing documents supplied or they will not clear the shipment.


    YMMV

    in reply to: Australian Customs #1259
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Hello PKQ,

    Yes, it’s normal.

    The underlying issue is this. Although the physical shipment probably has all the required documents physically attached that shipment has not been inspected, so these have not been seen.

    What has been inspected is an electronic record, and that record does not have all the details.

    These details need to be sent to join up.

    Please read http://fixhepc.com/getting-treated/how-to-do-it/import-paperwork.html and follow the instructions. That should fix it.


    YMMV

    in reply to: Gamma GT #1246
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    It’s relatively rare, but if your GGT does not come down to normal I would change the Naproxen to a different NSAID.

    This is a really good site for looking up if a drug might impact on your liver http://livertox.nih.gov/

    http://livertox.nih.gov/Naproxen.htm


    YMMV

    in reply to: Gamma GT #1244
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    The impact of alcohol subsides over the course of a month or two so that won’t be a factor.

    You have a significant reduction in a short time – that’s good.

    Do you take any other medications/supplements?

    While alcohol is probably the commonest cause of increased GGT levels are increase by medications including carbamazepine, cimetidine, furosemide, heparin, isotretinoin, methotrexate, oral contraceptives, phenobarbital, phenytoin, and valproic acid.

    Smoking and being black are also associated with higher levels of GGT.


    YMMV

    in reply to: Gamma GT #1242
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    When a doctor orders Liver Function Tests (LFTs) what we get back looks like this (really simplified):

    • Bilirubin and ALP – this is a measure of how well the liver is draining and go up with cirrhosis
    • Protein/Albumin – this is a measure of how well the liver is working making stuff
    • GGT/ALT/AST – these are all liver cell enzymes that go up when liver cells die and release their innards

    So with hepatitis you see high levels of GGT/ALT/AST.

    If you had say a gallstone blocking drainage from your liver we would see high bilirubin and ALP. There might be a small increase in GGT/ALT/AST as well due to the blockage injuring the liver cells, but usually not as much as you see with hepatitis.

    So getting to your question. A change of +/- 10% is not typically significant. Your GGT has fallen by 45% so that does likely represent less liver cell death.

    Time also plays a part. GGT is typically raised in people who drink a lot. We know that if they stop drinking (which is the cause) it can take up to a month for their GGT to return to normal.

    In my experience a 2 weeks we see improvement (but not normalisation) of liver enzymes. Viral loads that have been 1,000,000 show a log 4 drop (circa 10,000 times) to below 100. I have seen 2,000,000 -> 18 in 12 days (by way of example)

    At 4 weeks previously abnormal liver functions are often totally normal, and there is no viral RNA detectable.

    So in short don’t be disappointed to see elevated LFTs and a 15-50 viral load at this point.

    You should also note that the viral load tests are done on Monday and Wednesday nights, so if you had blood taken yesterday it won’t make the Monday night run so Thursday would be the earliest time a result might be available, but it could be Tuesday week.


    YMMV

    in reply to: >99% Pure – what does it mean? #1232
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    In Australia we are 54% G1a/G1b and 37% G3a. So that accounts for 91%. We’ve seen quite a lot of G2, probably because Sof/Riba is not a bad choice for it and that’s what came online first out of India and we don’t really have G4 G5 G6 here.

    I’m pretty sure I can find a colleague in the UK who will help in which case we could arrange something.

    Price is probably the major decision maker in Led vs Dac for someone with G1. For G3 it’s definitely Dac. For G2 you’d be tossing up Sof+Riba vs Sof+Dac.

    It will almost certainly change as more data becomes available.


    YMMV

    in reply to: Private messages #1231
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Forums are public by nature but an email to james@fixhepc.com will arrive in my inbox without passing through any other hands.

    Patients can also call the 03 8672 7825 number and if they can’t get through to one of our doctors immediately leave a number and a good time for a call back.

    Big chunks of this site are generic answers to frequently asked questions, so it’s a great help to get direct feedback about what needs to be explained better.


    YMMV

    in reply to: >99% Pure – what does it mean? #1227
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    We have tested all of Sofosbuvir, Ledipasvir, and Daclatasvir at a local facility and they all look good.

    We have tested every individual dose to date, with the exception of one patient who could not afford the cost (but we had tested ever other sample from that batch). He’s at SVR so it worked, but it made me worry about “What if?”

    Going forward we have negotiated a slightly reduced price from Mesochem if we batch up orders, so we will be able to include the testing with patients not paying any more.

    For me testing is my protection – Yes, your honour, I prescribed a Hep C medication to a Hep C patient and I had confidence in that because….

    And for patients….. I use the mum test. Would I be happy with my mum getting this treatment in this way?


    YMMV

    in reply to: Incepta’s Twinvir #1223
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Not yet. We have samples from several manufacturers en-route for testing.

    Mesochem is still open for business, but they do want to batch things up. We are going to set up a buyers club to facilitate that so people can make an order that will include not only supply but also testing. Price should still be able to be the same because even though we will have to spend a bit on the testing, there will be savings on shipping and Mesochem will give us a few dollars off for making their life easier.


    YMMV

    in reply to: >99% Pure – what does it mean? #1222
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    99% purity means 99% pure medication + 1% other stuff, mostly solvents used in manufacturing.

    Testing is complex, but here it is in a nutshell:

    Mass Spectrometry establishes the exact ratio of atoms present, so water would be H20 and Sofosbuvir is C22H29FN3O9P

    Mass spec can also see impurities like stuff that you do not want including heavy metals like Lead, Arsenic, Tin….

    Now Mass Spec tells you what atoms are present in what ratios but does not tell you how they are arranged. A technology called NMR tells your the exact arrangement. You can see a simple overview of our results here:

    http://fixhepc.com/blog/item/2-sofosbuvir-ledipasvir-nmr-and-mass-spec.html

    That’s abbreviated. The full set of tests done have included:

    • Mass Balance
    • NMR
    • qNMR
    • 2D NMR
    • HPLC
    • ELSD
    • Karl Fischer
    • Thermogravimetric Analysis

    We have proven reference samples of these materials and can test any imported material against these.


    YMMV

    in reply to: >99% Pure – what does it mean? #1216
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Making a medication is not a lot different to a chemistry experiment or for that matter a back yard meth lab. Typically you add two chemicals together in a solvent, heat it to such an such a temperature for a while, do something to make what you want separate from what you don’t, then rinse and repeat.

    What this means in practical terms is that at the end of manufacture you have a lot of the thing you want (which is the > 99%) and a whole lot of traces of things you don’t want, but can not easily separate. Traces of solvents (from the process), traces of metals (from the containers used in manufacture), and traces of molecules similar, but not identical, to what you have been trying to produce.

    Here is the official Chinese analysis of Mesochem’s Sofosbuvir API http://fixhepc.com/images/coa/COA-Sofosbuvir.pdf


    YMMV

    in reply to: Numbers of SVR’s / relapses / breakthroughs #1215
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Before letting the first patient take any medication we did a lot of testing to make sure the medication was both an accurate copy and also free of impurities. Unless the drug companies have faked the data it’s reasonable to expect similar results.

    We are tracking people in exactly the way you describe (with additional things like batch numbers and medication testing results) so with time will have some pretty valid stats on this, but at the moment we don’t have enough data. Currently we have only seen 1 case where the patient has been non zero at week 4, but in a sample size of n < 100 the margin of error is +/- 10% Real cure is when you not only get to zero, but some decent period after stopping the medication remain at zero. Relapse represents not really being at zero, but rather being so low we can't measure at the end of treatment. Most relapses will happen within 12 weeks of finishing treatment http://cid.oxfordjournals.org/content/49/9/1397.full

    We could set up an open data collection poll that people could use to add their personal data and then generate some graphs. While public crowd sourced data can be manipulated it would be interesting to see.


    YMMV

    in reply to: Ledipasvir or Daclatasvir #1211
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Yes, if you look at Daclatasvir it is recommended for all types, including 2 and 3. Like ledipasvir it’s an NS5A inhibitor so you could intuit it’s a better one.

    The ALLY-2 trial in HIV co-infected patients is impressive, but the numbers remain small so it could be random statistical margin of error, or it could be real.

    Time will tell. I would be surprised if Daclatasvir ended up being shown to be inferior, but….. the jury is still out.


    YMMV

Viewing 15 posts - 1,951 through 1,965 (of 1,968 total)