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Do not worry, your medication will be fine. Please read: http://fixhepc.com/kunena-2015-11-10/faq.html and the “How do I store my medications” part.
Destruction of chemical APIs occurs by heating rather than cooling.
Here is the FAQ answer:
The original manufacturers of Sofosbuvir, Ledipasvir, Daclatasvir say this in their CMI:
Keep HARVONI tablets in a cool, dry place where it stays below 30°C
Store DAKLINZA tablets in a cool dry place where the temperature stays below 30°C.
More or less all medications say something like this.
For reference:
Sofosbuvir: Melting point. 95-100 ºC
Ledipasvir: Melting Point: 186 – 190ºC
Daclatasvir: Melting Point: 166-172°CSo you could almost certainly store them at > 30 °C but if you follow the < 30 °C recommendations everything should be fine. The main issue with higher temperatures is that gelatine capsules will melt at 44 °C. The main issue with moisture is that both capsules and tablets are designed to fall apart in your stomach when they get wet. Refrigeration will be fine but does create moisture problems. While a fridge is cool and dry the problem occurs when you have warm moist air (room air) and then cool it causing the moisture to condense - you have probably seen this if you put hot food in the fridge with droplets of moisture rapidly replacing the steam on the lid. You should not freeze the medication although freezing theoretically increases the molecular stability of the APIs, and in fact the NMI certificates found here http://fixhepc.com/blog/item/16-testing-provisions-patient-safety.html state:
Recommended storage
When not in use, this material should be stored at or below 4 ºC in a closed container in a dry, dark area.
YMMV
With F0/1 the guidelines suggest 12 weeks is sufficient.
The 12/24 week decision hinges on the presence of cirrhosis. No cirrhosis 12 weeks. Cirrhosis -> 24 weeks
Here are the guidelines: http://fixhepc.com/getting-treated/genotype-specific-hepc-treaments.html
YMMV
Hi M,
Do you think it makes much difference in using size 0 capsules or the 00 with Profunnel? Getting ready to order and have heard of using both sizes? Want to order the easiest to use. Hope you are just swimming along and feeling great
YMMV
I might start adding in INRs before and after to see. With people with liver failure we can see the coags get better as their liver improves.
YMMV
A lot, we keep a complete audit trail…..
YMMV
This could be appropriate (with some renal failure) but is not enough for somebody with normal renal function.
What is there Creatinine and eGFR. Low platelets, low body weight, prior intolerance of full dose and other factors may be why.
Then again it could just be a mistake about the usual dose….
YMMV
That’s awesome news Joan So glad your side effects are minimal. I am on day four and have had insomnia from the first dose. Legs feeling a bit “rubbery” today but that’s about all. Tend to get tired in the afternoon due to lack of sleep the night before but am hoping that will ease as I only have this week off work then back to normality next week.
My nervous system is a bit shot at the moment but that, I am sure, was the build up to getting and taking the medication. I am going to take myself out to lunch (with my better half) as I need to do something other than sitting in the lounge watching telly.
Stay well and I look forward to seeing your posts, they are very encouraging.
YMMV
Hi Em Have you found that the early waking is easing off at all…I sure hope I don’t have it for 3 months….. However in saying that it is a small price to pay……
YMMV
Hi Coral I am third day in with my meds. Waking up around 4.30am-5.00am the last couple of mornings and extremely tired today but other than that no side effects really. I have had tinnitus for around 35 years and that seems to be a bit worse but when I am stressed/and or over tired it gets bad so am putting it down to that……I actually feel unusually calm today….probably because I have taken the leap toward getting rid of this horrid virus. If this is the worst the side effects get I will be a happy woman, albeit I hope the insomnia goes away…I’m back to work next week (working for 4 Lawyers) so need my wits about me……
Looking forward to hearing your progress
YMMV
GT1 F1 only needs 12 weeks so you have 8 weeks spare. Taking them may offer a slight benefit, but it would only be slight. Treatment success is probably already in excess of 95% so there are not a lot of spare % points to be had.
A hypothetical alternative would be to sell them to someone wanting to avoid a $10-15k copay, fly Business Class to Bangladesh, Nepal, India, Australia etc and source 12 weeks generics, stay in a luxury hotel while you’re there, and return home.
Now you have an extra 12 weeks medication (unlikely to be required), just had a luxury holiday, one extra person got cured, and you have spare money for Christmas.
Now that would certainly breach one or more US laws but as somebody pointed out, it would be cheaper for US insurers to fly patients to Egypt, put them up in the Presidential suite at the Hilton, get the same medication there, then fly them home.
YMMV
In brief you can walk it in on your person, but not post it in. Here is an email from somebody in France who researched it. He picked up his medication in Australia a couple of weeks ago and is now back in Paris on treatment.
James,
I have found the text of the relevant French laws on importation/exportation of medicines. This confirms my previous indications that mailing medicines into France is not allow, but that importation by personal transport of a treatment for up to 3 months is allowed and does not require authorisation (Article R5121-110, below).
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… So if you are thinking in terms of mailing from Bangladesh, and given what you know about the UK law already, it might seem that travelling to the UK for a pick-up could be a workable option for many European citizens (see again the link to French customs at end of this mail).
Best,
D
Section 10 : Importation et exportation.
Article R5121-108 En savoir plus sur cet article… <http://www.legifrance.gouv.fr/affichCodeArticle.do;jsessionid=471ACDCD8060612FB7D5C15EB9675EF0.tpdila12v_1?idArticle=LEGIARTI000026968549&cidTexte=LEGITEXT000006072665&dateTexte=20151020>
Modifié par Décret n°2013-66 du 18 janvier 2013 – art. 2 <http://www.legifrance.gouv.fr/affichTexteArticle.do;jsessionid=471ACDCD8060612FB7D5C15EB9675EF0.tpdila12v_1?cidTexte=JORFTEXT000026955060&idArticle=LEGIARTI000026957342&dateTexte=20130121>Tout médicament qui n’est pas pourvu de l’autorisation de mise sur le marché mentionnée à l’article L. 5121-8 <http://www.legifrance.gouv.fr/affichCodeArticle.do?cidTexte=LEGITEXT000006072665&idArticle=LEGIARTI000006689889&dateTexte=&categorieLien=cid>ou de l’autorisation temporaire d’utilisation mentionnée à l’article L. 5121-12 <http://www.legifrance.gouv.fr/affichCodeArticle.do?cidTexte=LEGITEXT000006072665&idArticle=LEGIARTI000006689900&dateTexte=&categorieLien=cid>ou de l’enregistrement mentionné à l’article L. 5121-13 <http://www.legifrance.gouv.fr/affichCodeArticle.do?cidTexte=LEGITEXT000006072665&idArticle=LEGIARTI000006689904&dateTexte=&categorieLien=cid> ou de l’autorisation mentionnée au 12° ou au 13° de l’article L. 5121-1 <http://www.legifrance.gouv.fr/affichCodeArticle.do?cidTexte=LEGITEXT000006072665&idArticle=LEGIARTI000006689870&dateTexte=&categorieLien=cid>ou qui n’est pas un médicament nécessaire à la réalisation d’une recherche biomédicale qui a fait l’objet d’une autorisation au sens de l’article L. 1123-8 <http://www.legifrance.gouv.fr/affichCodeArticle.do?cidTexte=LEGITEXT000006072665&idArticle=LEGIARTI000006685883&dateTexte=&categorieLien=cid>fait l’objet, avant son importation dans le territoire douanier, d’une autorisation d’importation délivrée par le directeur général de l’Agence nationale de sécurité du médicament et des produits de santé, soit dans les conditions prévues aux articles R. 5121-109 à R. 5121-114 <http://www.legifrance.gouv.fr/affichCodeArticle.do?cidTexte=LEGITEXT000006072665&idArticle=LEGIARTI000006914855&dateTexte=&categorieLien=cid>, soit au titre de l’autorisation d’importation parallèle définie aux articles R. 5121-115 <http://www.legifrance.gouv.fr/affichCodeArticle.do?cidTexte=LEGITEXT000006072665&idArticle=LEGIARTI000006914863&dateTexte=&categorieLien=cid>et suivants. Cette autorisation peut être refusée si le médicament présente ou est susceptible de présenter un risque pour la santé publique et, pour le médicament nécessaire à la réalisation d’une recherche biomédicale, si la recherche biomédicale a fait l’objet d’un refus d’autorisation.
Article R5121-109 En savoir plus sur cet article… <http://www.legifrance.gouv.fr/affichCodeArticle.do;jsessionid=471ACDCD8060612FB7D5C15EB9675EF0.tpdila12v_1?idArticle=LEGIARTI000025787979&cidTexte=LEGITEXT000006072665&dateTexte=20151020>
Modifié par Décret n°2012-597 du 27 avril 2012 – art. 5 <http://www.legifrance.gouv.fr/affichTexteArticle.do;jsessionid=471ACDCD8060612FB7D5C15EB9675EF0.tpdila12v_1?cidTexte=JORFTEXT000025757625&idArticle=LEGIARTI000025765496&dateTexte=20120430>Pour les produits finis, définis comme des médicaments ayant subi tous les stades de la fabrication, y compris le conditionnement, à l’exception des médicaments destinés à être stockés dans un entrepôt national d’exportation mentionné à l’article 277 A <http://www.legifrance.gouv.fr/affichCodeArticle.do?cidTexte=LEGITEXT000006069577&idArticle=LEGIARTI000006304331&dateTexte=&categorieLien=cid> du code général des impôts, ainsi que des médicaments importés par un particulier par une autre voie que le transport personnel, une autorisation d’importation est requise pour chaque opération d’importation.
Pour les médicaments autres que les produits finis, pour les médicaments destinés à être stockés dans un entrepôt national d’exportation défini à l’article 277 A du code général des impôts, ainsi que pour les médicaments importés par un particulier par une autre voie que le transport personnel, l’autorisation d’importation est requise pour une série d’opérations d’importation envisagées pour un médicament pendant une période maximale d’un an et pour une quantité globale donnée ; dans ce cas, l’autorisation précise le nombre d’opérations prévues, la durée de la période pendant laquelle les opérations peuvent être effectuées ainsi que la quantité globale du médicament considéré pouvant être importée ; à l’issue de la période d’autorisation, le renouvellement ne peut être obtenu que sur présentation de l’autorisation précédente et de l’indication des opérations effectuées et de la quantité importée pendant la période. L’autorisation est retournée à l’Agence nationale de sécurité du médicament et des produits de santé dès que les opérations d’importation prennent fin et au plus tard à l’issue de la période couverte par cette autorisation, revêtue de la mention des quantités effectivement importées et des dates des opérations correspondantes.
L’autorisation d’importation peut être suspendue ou supprimée par le directeur général de l’Agence nationale de sécurité du médicament et des produits de santé. Sauf en cas d’urgence, ces décisions ne peuvent intervenir qu’après que le titulaire de l’autorisation a été mis à même de présenter ses observations.
** Article R5121-110 En savoir plus sur cet article… <http://www.legifrance.gouv.fr/affichCodeArticle.do;jsessionid=471ACDCD8060612FB7D5C15EB9675EF0.tpdila12v_1?idArticle=LEGIARTI000006914856&cidTexte=LEGITEXT000006072665&dateTexte=20151020>
* Les particuliers ne peuvent importer un médicament qu’en quantité compatible avec un usage thérapeutique personnel pendant une durée de traitement n’excédant pas trois mois aux conditions normales d’emploi ou pendant la durée de traitement prévue par l’ordonnance prescrivant le médicament. Lorsqu’ils transportent personnellement ce médicament, ils sont dispensés d’autorisation.
(truncated here)
…. more Articles on the French web site….
And here is the same advice from French customs (in French)
http://www.douane.gouv.fr/articles/a11946-le-transport-de-medicaments-en-france-par-des-particuliers
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Brief translation: an amount necessary for the treatment, or by default up to 3 months of treatment, is permitted when carried by the traveller himself; the prescription should be presented to customs, but it is not compulsory. For more than 3 months of treatment, the traveller must produce the original prescription. For narcotic or psychotropic drugs, a prescription is required, and special authorisation to transport bay also be required.
YMMV
Your medication should ship tomorrow. It’s at the Pharmacy.
Your order is in the last manual batch.
Patient’s since this batch get automated emails including a tracking link that list the steps passed to date.
YMMV
Yep Mike, I’m hoping he will just go by the tests done by my GP 9/22/15. When I go for my appt on the 23rd hopefully I will know then if he will want more tests done. His nurse already gave me a heads up the insurance will also want a HIV test, drug and alcohol screen and Hep A and B vaccine, done, done and done. If it looks like he wants more tests done and insurance is going to not approve ASAP, then I’ll just go for the generics. We have a lab that will do viral loads and etc and I’ll wing it on my own. From all the reports on this site I feel it will be ok to “fly without a parachute”.
YMMV
Wow, quite a story. I could almost be the mum. Did a lot of research, got my own fibroscan done, pushed my GP for VL 15 million, genotype testing GT1a and LFTs 139 and 235, no prior treatment and got an appt. with a GI specialist , After finding out the fibroscan was F4, 20.9 kpa, I was afraid waiting the two months and who knows how long before maybe be approved for Harvoni. It seemed time to take my destiny more in my own hands. This forum, emailing with Greg, Emilio, an online appt with Dr. Freeman have helped me decide. I have ordered APIs from Mesochem and they should be here within 10 days. Now my appt with the Liver doc is the 23rd of this month. So, I might have the generics and perhaps a script for factory Harvoni. Since I have been advised I need 24 weeks of treatment, and I think the docs here are only going for 12 weeks I might just do both. Next decision is if the generics come quickly, do I start right then or wait a bit so the GI thinks I’m taking his drugs and will be monitored. I feel blessed at least I should have some options on treatment. Thank you all who have spoke with me and helped sort this out, I feel confident I have a fighting chance to live a much healthier life.
YMMV
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