TOPIC:

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

www.ebs.tga.gov.au/servlet/xmlmillr6?dbi...lsPublic)&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

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

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.

Just found it is 2(HCI)

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

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

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.

What is this about?? I'm putting 60 mg in my capsules? 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.

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.

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.

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.

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.

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.

“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

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:

fixhepc.com/forum/experts-corner/164-res...ms.html?start=6#1122

and here:

fixhepc.com/forum/experts-corner/232-diy...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.....

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