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Viewing 15 posts - 1,546 through 1,560 (of 1,968 total)
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  • in reply to: Peripheral Neuropathy ? Toes? #9754
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    I was told by one doctor in the past, that too much B vitamin is not good for you and he advised to take it just twice a week.

    In most circumstances this would be good advice. Most of us don’t need vitamin supplementation (except maybe vit D) because our diet provides an adequate quantity.

    In the context of HCV and treatment there are observations that higher levels of some vitamins improved SVR rates with Interferon/Riba. As to whether this is applicable with DAAs it would be fair to say nobody know.

    With Vitamin D it is fat soluble so will build up in your system over time so chronic overdosing is a problem

    With Vitamin Bx – these are all water soluble and any excess is excreted in the urine so chronic overdosing is unlikely to be a problem.

    With HCV treatment we are talking about increasing levels for 12-24 weeks which is unlikely to cause any issues.


    YMMV

    in reply to: Blood test for Vitamin D levels #9744
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Thankyou Dr Freeman for your response. Hate the heat so am not out in the sun much at all. Mind you it is 40 degrees outside at the moment so that is one of the best reasons to avoid the outdoors! I will take the supplements for the next two weeks and when I get my four week post treatment test done I will ask my GP to run the Vitamin D one as well just to check the levels.


    YMMV

    in reply to: Peripheral Neuropathy ? Toes? #9665
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Does anyone have a feeling that your toes(or feet) have really thick socks on, when you don´t? I went online and it has a name. Peripheral Neuropathy. Is this caused by HCV? Any information will be appreciated.

    I have a few patients with peripheral neuropathy (what you are describing). Here’s the Mayo clinic list of causes:

    http://www.mayoclinic.org/diseases-conditions/peripheral-neuropathy/basics/causes/con-20019948

    Diabetes is common in people with HCV and can cause it. Vitamin deficiencies (B group) are another common one.

    Getting checked for diabetes and adding B vitamin supplementation (good for SVR too) would be a good start.

    Don’t ignore it, unless of course it goes away with treatment.


    YMMV

    in reply to: Blood test for Vitamin D levels #9664
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Hi Lynne,

    Probably no point in having it checked but if you don’t see much sun chances are your levels are low. 5 tablets on day 1 and then 2 a day for the next 2 weeks then stop would give you decent blood levels for the last 2 weeks and be highly unlikely to cause any problems.


    YMMV

    in reply to: Should I add Ribavirin to my Tx? #9663
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Hi Tim,

    Those numbers look fine. Here is all the trial data for Sof+Led

    NAIVE
    default: svr: 97%, trials: ION-1 98% (142/145) ION-3 96% 96% (165/172) Aggregate 96.8% (307/317)
    gt1a: default: svr: 97%, trials: ION-1 98% (142/145) ION-3 96% 96% (165/172) Aggregate 96.8% (307/317)
    gt1b: default: svr: 99%, trials: ION-1 100% (67/67) ION-3 98% (43/44) Aggregate 99.1% (110/111)
    F4
    default: svr: 97%, trials: ION-1 97% (32/33)
    w12: svr: 97%, trials: ION-1 97% (32/33)
    w12riba: svr: 100%, trials: ION-1 100% (33/33)
    w24: svr: 97%, trials: ION-1 97% (31/32)
    w24riba: svr: 100%, trials: ION-1 100% (36/36)
    FAIL
    default: svr: 94%, trials: ION-3 94% (102/109)
    w12: svr: 94%, trials: ION-3 94% (102/109)
    w12riba: svr: 96%, trials: ION-3 96% (107/111)
    w24: svr: 99%, trials: ION-3 99% (108/109)
    w24riba: svr: 99%, trials: ION-3 99% (110/111)

    While the 100% cure rate looks impressive with F4 + Riba the 97% represents 1 person. If you look at the numbers there is scant evidence of Riba making any difference. We know that for F3/F4 GT3 patients Riba does not improve SVR rates with 24 weeks treatment, in fact in every +Riba group the results were worse.


    YMMV

    in reply to: Do you trust Resof-L by Dr Reddy’s ? #9662
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    We use 3 facilities – Hobart, Sydney and Hong Kong.

    Just a reminder that we published all the testing data done by NMI including a full range of NMR specrta here:

    http://fixhepc.com/blog/item/16-testing-provisions-patient-safety.html

    In English that means bugger all work to do from first principles. All the data is there, so all that is required is access to the required machines. Universities often do contract work to supplement meagre research budgets so if anyone was looking to do it approaching the organic chemistry department at your local university would be the place to start.


    YMMV

    in reply to: One for the ladies in the house. #9589
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Hi Tina
    I can’t help. I had a hysterectomy 20 years ago :) Probably too much information but I didn’t want you to think I was ignoring your question. :lol:


    YMMV

    in reply to: Do you trust Resof-L by Dr Reddy’s ? #9527
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Dr Reddy’s and Cipla are the premium brands in India, but according to what I’m told the product is all being made by Hetero.

    Anyway be that as it may, you, as a consumer are not picking 3 bottles off the production line.

    Your product has passed through at least 2 hands – a distributor, and the person you got it from.

    This is part of the supply chain. I have no doubt all the big Indian manufacturers will turn out valid product.

    What you buy is some bottles with their name on them, but what you need is Sof+Led and unless you are standing at the end of the conveyor belt in the factory you need absolute trust in that supply chain that delivered it to you.

    As a side note, there are plenty of fake Rolex watches, but very few fake Citizen watches. Premium brands are the natural target.


    YMMV

    in reply to: Do you trust Resof-L by Dr Reddy’s ? #9526
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Hello Alsdad,

    This article http://timesofindia.indiatimes.com/india/Desi-generics-firms-pave-way-for-cheaper-hepatitis-C-drug/articleshow/50609836.cms

    Is reporting the study from Dr Andrew Hill I linked to. There are several things to observe:

    • Andrew’s numbers are based on customs declarations which, as many of us will be aware, may not reflect the true value of the product shipped because under declaring the value reduces the taxes payable
    • Unlike Andrew who observes, we operate in the market and know what prices are available. API prices have been falling, but are still a long way north of what Andrew suggests and at the bottom end of the market there are quality issues. I’m aware of major manufacturers that paid 3 x the suggested Sofosbuvir price to produce their well known generic Harvoni.
    • Andrew is talking about Sof+Dac. The per kilo prices for both are currently very similar, but you need 33.6 g of Sof and only 5.6 g of Dac so 86% of the API cost is Sof. Ledipasvir costs nearly 5 x as much per kg as Sof and you need 8.1 g so it costs about 120% as much as the Sof. In other words the API cost for Sof+Led is almost exactly double that of Sof+Dac

    In this part of the article:

    According to a recent WHO survey on Hepatitis C treatment, the combination is being sold in India for about Rs 46,500 or about $700 per patient for a three month regimen.

    This reference is almost certainly referring to this article:

    http://www.wpro.who.int/hepatitis/resource/features/2015_walshetal_hepc_avoidasiamissingout.pdf

    So the $700 figure refers to Sofosbuvir+Ribavirin, not generic Harvoni.

    Given that Daclatasvir is only just becoming available via Natco and generic Harvoni has been on the market for less than a month it seems a little implausible that WHO statisticians put together and published a survey over Christmas.

    Supply chain integrity has always been a key part of this site and like Greg Jefferys

    http://blogs.hepmag.com/gregjefferys/2016/01/hepatitis_c_treatmen_21.html

    I would reiterate that anyone purchasing generic Harvoni for under $1000 in India would do well to have access to HPLC, Mass Spec and NMR equipment.

    Over the course of this year I have little doubt we will see generic Harvoni prices fall below $1000 USD, but right now it is unrealistic.

    I expect prices will fall in Bangladesh first.

    If anyone reading this sources generic Harvoni in India for $700 USD send me one tablet from each bottle. I will send you a box of 6 Twinvir to replace them and publish the results here. I suspect those 6 tablets will do you more good that what you purchased.

    [video]https://www.youtube.com/watch?v=Otm4RusESNU[/video]


    YMMV

    in reply to: psavic started TWINVIR treatment #9516
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    For GT1a 12 weeks Twinvir without Ribavirin gives you a 97% chance of SVR with or without cirrhosis.

    1a, F0-3: ION-1 98% (142/145) ION-3 96% 96% (165/172) Aggregate 96.8% (307/317)

    For F4, here is the data:

    w12: {
    svr: 97,
    trials: ‘ION-1 97% (32/33)’
    },
    w12riba: {
    svr: 100,
    trials: ‘ION-1 100% (33/33)’
    },
    w24: {
    svr: 97,
    trials: ‘ION-1 97% (31/32)’
    },
    w24riba: {
    svr: 100,
    trials: ‘ION-1 100% (36/36)’
    }

    w12 == 12 weeks, w12riba == 12 weeks with Riba, w24 == 24 weeks, w24riba == 24 weeks with Riba.

    So the entire F4 trials data is based on 134 people of whom exactly 2 failed. You can’t make any statistically valid assertions on that data to say +Riba is better. Note than in a recent n=468 trails of Sof+Dac+/-Riba in GT3 F4 patients all the patients who took Riba did WORSE than those who did not.


    YMMV

    in reply to: My parcel of Magic Pills has arrived!! #9514
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Hello Chejai, feeling under the weather and flu like is quite common during the first few days. For some it lasts longer than others but with any luck you’re through the worst of it and things will steadily improve.

    A trend of getting better each day is good.


    YMMV

    in reply to: Help with my Analysis #9512
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Your platelet count is normal and nothing to worry about.


    YMMV

    in reply to: Can hep C cause strange symptoms? #9509
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    I gave him all the printouts from this site – genotype recommendations, GP Cheat Sheet etc. His DR said she won’t do anything because it’s ‘illegal’! He’s been waiting all year to get into the public Liver clinic and appointment isn’t until May 2016 – useless!

    We could see him online and get him ready for 1 march, then prescribe the appropriate meds and crack on…..


    YMMV

    in reply to: Do you trust Resof-L by Dr Reddy’s ? #9505
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Thus I agree that 750 USD for 12 weeks is possible

    What I do know is that an Indian can buy generic Harvoni for $4 a pill or $336 for a 12 week tx

    At this moment in time you are both wrong. Sorry, but there is no way to sugar coat that.

    In the future it will be possible, but right now you would need to be willing to fund (in advance and at a cost of over $1 million USD) an entire production run to get close to this price. You would probably not be getting it from India either due to the 7% royalty paid to Gilead.

    Currently in India any price below $1000 USD should be viewed as being too good to be true.

    Here is a link to what preports to be community pricing:

    https://testandtreathepatitisc.files.wordpress.com/2015/03/indian-generic-sof_ldv-summary.pdf

    And here is some expert commentary about it.

    Hi James,

    There are many things wrong in this sheet

    1. First people need to understand Hetero is the only manufacturer and Cipla , Natco and rest all just package it and sell. If you see Hepcivir L Box, it clearly says manufactured by Hetero. So why would Hetero price be higher than Cipla(in your sheet). Cipla and Dr. Reddy’s are premium brand in India over all the others ones in the sheet. Yet they have the lowest prices.
    2. The absolutely nothing called community pricing. We asked head of sales for Cipla and he confirmed that the only discount that is given is to govt agencies who source meds for BPL(Below Poverty Line) card holders. The packing and barcoding everything reflects that and not a single pill can be distributed outside the authorized BPL channel. These batches are handled directly by manufacturers and not even distributors have access let alone pharmacies.
    3. Community pricing seems like a scam to sell meds at ridiculous prices.

    I am worried, with these practices of selling Schedule H meds without prescription etc something really bad will happen and DCGI will clamp down the whole process.

    Here is Dr Andrew Hill’s expert commentary on it.

    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4403972/

    Note that he is not talking current market, but future possibility and gets to an API cost of $193 USD for Harvoni. If this statement was true:

    What I do know is that an Indian can buy generic Harvoni for $4 a pill or $336 for a 12 week tx.

    Then the current API costs would need to have been at Dr Hill’s future forecast price point 2 months ago when the APIs were ordered, prior to manufacture, distribution and sale. Of the final $336 price 57.5% would be API, 7% would be for Gilead and 35.5% ($119 USD) would be all that was available for freight, testing, manufacture, packaging, distribution and reseller margins.

    Really?

    The only people who could meet these unrealistic price expectations will not be selling valid product.

    By suggesting these prices are realistic you are doing three things:

    • Creating unrealistic patient expectations
    • Making it easy for purveyors of fake product
    • Making it hard for people providing the real thing as their prices appear too high

    Lower prices will come, but at the moment circa $1000 USD is as good as it gets for generic Harvoni and this is only for delivery in India or Bangladesh, not delivered to your door.


    YMMV

    in reply to: translation of viral load please? #9501
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    With a load below 6 million the observation is the 8 weeks treatment is enough. I would probably still do 12 myself but it is a good prognostic indicator for you.


    YMMV

Viewing 15 posts - 1,546 through 1,560 (of 1,968 total)