Home Forums Main Forum Experts Corner Compounding The Correct Weights To Use

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  • #4788
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Drugs can exist in either the form of a free base (just the drug) or a salt (drug+some small inorganic) or with water or solvent included in the crystals. With the DAAs Sofosbuvir is a pure free base crystal so 400 mg = 400 mg. With Ledipasvir the form used is Ledipasvir Acetone where a small quantity of acetone is present in the crystals. With Daclatasvir the form used is Daclatasvir 2 HCl (Daclatasvir 2 hydrochloride) where a small quantity of hydrochloric acid is present.

    If you are going the DIY home compounding route:

    With Ledipasvir it is Ledipasvir Acetone you should use:

    95.9 mg Ledipasvir Acetone is 90 mg Ledipasvir

    https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=222848&agid=(PrintDetailsPublic)&actionid=1

    ledipasvir acetone solvate 95.9 mg

    With Daclatasvir it is Daclatasvir 2 HCl (Daclatasvir 2 hydrochloride) you should use:

    66 mg Dalatasvir 2HCl is 60 mg Daclatasvir

    http://packageinserts.bms.com/pi/pi_daklinza.pdf

    Tablets: 60 mg daclatasvir (equivalent to 66 mg daclatasvir dihydrochloride)

    With Sofosbuvir 400 mg is the correct quantity per dose – it’s free base not a salt.

    400 mg Sofosbuvir is 400 mg Sofosbuvir

    DON’T PANIC

    If you for example made up caps with 60 mg Daclatasvir 2HCl rather than 66 mg do not panic – it is highly unlikely to make any difference in your clinical outcome due to the relatively wide therapeutic window which allows “one size fits all” dosing at 60 mg.

    See this for a more in depth discussion http://fixhepc.com/forum/experts-corner/232-diy-dose-adjustment.html#1776


    YMMV

    #4789
    Avatar photoberrinice
    • Guardian Angel
    • ★★★★★
    @berrinice

    Hi there my friend uses daclatasvir Di HCI – is that within a high grade standard. Also, do you know if Bristol Myer Squibb’s daclatasvir bitter or non bitter if chewed accidently. Cheers.

    #4790
    Avatar photoberrinice
    • Guardian Angel
    • ★★★★★
    @berrinice

    Just found it is 2(HCI)

    #4804
    cole
    • Topics: 0
    • Replies: 7
    • Total: 7
    • Novice
    @cole

    Hi Dr. Freeman,
    Quick question does this means that the correct dosage of Daclatasvir from Mesochem is 66mg?
    Thank you.

    #4818
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    Yes, you need 66 mg of Daclatasvir 2 HCl to provide 60 mg of Daclatsvir free base equivalent to the BMS formulation.


    YMMV

    #4823
    panamajo
    • Topics: 5
    • Replies: 22
    • Total: 27
    • Treatment Warrior
    • ★★★
    @panamajo

    Shoot, I was putting 60 gms into my capsules and for the 1st two weeks I was just winging it as I did not have a proper scale. Maybe this is why I was not clear at my 4th week PCR. My viral load was 16. Thanks for the info Dr Freeman.

    #4826
    Avatar photoLife
    • Guardian Angel
    • ★★★★★
    @life

    What is this about?? I’m putting 60 mg in my capsules? :dry: :dry: since 6 weeks

    panamajo wrote:

    Shoot, I was putting 60 gms into my capsules and for the 1st two weeks I was just winging it as I did not have a proper scale. Maybe this is why I was not clear at my 4th week PCR. My viral load was 16. Thanks for the info Dr Freeman.

    #4828
    Avatar photoAlsdad
    • Guardian Angel
    • ★★★★★
    @alsdad

    It was an issue I raised early on, but couldn’t get a definitive answer. So I put an average 63mg of Mesochem Dac in each cap as a happy medium. Good that we now have an answer. As the Doc states, it’s not a crisis if you’re dosing about 60mg of the dihydrochloride. I got to UND on my dose in two weeks.

    #4831
    Avatar photoLife
    • Guardian Angel
    • ★★★★★
    @life

    Ok, thank you, Alsdad!!!

    Alsdad wrote:

    It was an issue I raised early on, but couldn’t get a definitive answer. So I put an average 63mg of Mesochem Dac in each cap as a happy medium. Good that we now have an answer. As the Doc states, it’s not a crisis if you’re dosing about 60mg of the dihydrochloride. I got to UND on my dose in two weeks.

    #4833
    Avatar photoAlsdad
    • Guardian Angel
    • ★★★★★
    @alsdad

    And I should add that I’m a tall, well-built guy (95kg), so I’m technically at the ‘wrong’ end of the ‘one size fits all’ dose.

    #4878
    miko3
    • Topics: 5
    • Replies: 82
    • Total: 87
    • Guardian Angel
    • ★★★★★
    @miko3

    Well that explains why the original 6mg of dac I got off Mesochem made the 100 capsules I got back from the compounding chemist.
    I wonder why a competant compounding chemist didn’t pick up on that one as Declatasvir Hydrochloride was on the sealed packet?
    Anyway I still got virus undetected at 4wks on the lowered dose,in case anyone else is panicking.


    Gen 1b 40yrs,tx naive, f3/f4.VL too high to quantify.
    Started tx 12Oct.sof and riba India via greg.Dac from Mesochem.
    4wk result virus not detected,all liver functions in normal ranges.
    Only SE intermittent insomnia.Feel great and grateful otherwise

    #4889
    Avatar photoLife
    • Guardian Angel
    • ★★★★★
    @life

    Thanks you guys, I’m 55kg so… :)

    miko3 wrote:

    Well that explains why the original 6mg of dac I got off Mesochem made the 100 capsules I got back from the compounding chemist.
    I wonder why a competant compounding chemist didn’t pick up on that one as Declatasvir Hydrochloride was on the sealed packet?
    Anyway I still got virus undetected at 4wks on the lowered dose,in case anyone else is panicking.

    #4944
    gary
    • Topics: 2
    • Replies: 34
    • Total: 36
    • Treatment Warrior
    • ★★★
    @gary

    “Do ya feel lucky….Punk? Well….do ya?”

    The things we ponder at 2:30 am when sleep is elusive seem so relevant at the time but in the light of day maybe not so much. Though I tell my brain to let logic overrule emotion it seems to have a mind of its own and peppers me with unwanted questions, as I guess is happening to others.

    Regarding the weight issue (and how it impacts the length of treatment issue).

    Does this mean that those of us who are DYI need to reconsider our treatment regime? As someone mentioned, the long-term effects are not known so I would like to do the minimum amount, as I guess some others would. I had decided to take all of the meds as I thought the extra Sofo & Dac would benefit me but after reading various posts including Dr. Freeman’s “GT3: High SVR rates with Daclatasvir” I am undecided but am (strongly) leaning toward not doing so.

    1. It seems that many of us DYI folk have about 100 doses. Is there a benefit to taking the “extra” Dac? Is it indeed “extra” as the “overall” dose we are taking is/was less than the recommended, though most of us probably fall within the “one dose fits all” category? After redoing the remaining capsules (54) to get to the recommended dose I will have about 10 days “extra” of both.
    2. Is taking the extra Sof worthwhile/potentially harmful in the long term? I rounded my order up so have extra Sof.
    3. Is it dependent on Genotype, cirrhosis or not, past treatment meds/relapse or treatment outcomes, our weight, whether there is a Santa Claus?
    4. Is it dependent on when one becomes undetected – at 2 weeks vs. 4, 6, etc? Out of the hodgepodge of determinants this is my favorite as it would seem to suggest the meds have been cleaning out any remaining bad guys for a longer or shorter period of time so would necessitate a shorter or longer treatment regime. Is this an accurate assumption?
    5. Are these questions an exercise in futility as no one really has a clear answer so we should stop thinking of these things in the wee hours and just base our decisions on Clint’s question, “Do ya feel lucky….Punk? Well….do ya?”

    My specifics are: GT3B, taking Mesochem Dac/Sof, treatment naïve, no cirrhosis, no Fibroscan, AST down from 74 to 23, ALT down from 140 to 21, and viral load down from 5.6 L.IU/mL to 2.2 L.IU/mL as of tests after 16 days tx, now commencing 6th week.

    Any advice/guesstimates would be much appreciated

    #4955
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    All the trial data (past Phase 1) typically relates to the chosen dose and a 2 DAA combination of Sof+Dac or Sof+Led (+/- Riba)

    All drugs have a therapeutic window which is discussed here:

    http://fixhepc.com/forum/experts-corner/164-resistance-and-treatment-failure-mechanisms.html?start=6#1122

    and here:

    http://fixhepc.com/forum/experts-corner/232-diy-dose-adjustment.html#1776

    So for most people 10% either way is not going to make any great difference.

    On the time aspect we do see 16 weeks working better than 12 so there is just no way I would leave spare pills un-swallowed but I would stop when I ran out of the other 1/2 of the combo

    Chances are you will do well, but if you draw the short straw and have to retreat it’s not like it’s the end of the world as we know it. This is the end of the world as we know it…..

    [video]https://www.youtube.com/watch?v=Z0GFRcFm-aY[/video]


    YMMV

    #4976
    Avatar photomgalbrai
    • Guardian Angel
    • ★★★★★
    @mgalbrai

    Well Gary,
    When its all said and done, its all said and done.
    So, having said that, I am going back to what I was doing, which isn’t done.
    Mike


    Curehcvnow@gmail.com
    http://forums.delphiforums.com/generichcvtx

    G 1a F-1
    Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
    11/17/15 4 wk lab ALT 17 AST 16 <15
    11/18/15 Started Harvoni
    12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
    1/14/16 Fin. Tx
    7/07/16 UND SVR 24

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