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Hello Sven,
Ledipasvir absorption is helped by acid but with Gaviscon it would be ok to have it 4 hours after taking medication (medication will all be in by then) and before bed (Gaviscon will be gone by morning dose).
Unlike proton pump inhibitors and H2 blockers, Gaviscon comes on fast and wears off fast.
You should get a test for Helicobacter pylori which may be the cause and can easily be treated.
YMMV
not heard of someone getting SVR 12 and then relapsing, please enlighten me if this has happened
There is one patient here who got SVR12 and relapsed.
https://fixhepc.com/forum/viral-load-and-svr/1208-svr-24-detected-again.html
It is really rare, under 5%, to relapse between SVR4 and SVR12.
It is extremely rare, under 1%, to relapse from SVR12 to SVR24
But sadly it is possible.
Mathematically it looks like this:
For the about the first 2 weeks post treatment you still have adequate levels of drug in your system to suppress most virus.
By 4 weeks you have been on your own for a good 2 weeks so any residual virus, below the level of detection, starts to multiply and usually we can find it by SVR4 – liver functions also get bad almost as quickly as they got good.
Later relapses probably represent relatively more unfit mutants. Mutation carries a price – slower replication. The wild type virus dominates in people because it is the best reproducer, so it out competes the mutants.
The growth curve is exponential, 2 4 8 16 32 64 per unit time so if we start from a really low load it takes time to get to a high enough level to measure.
Which brings us to the “how long to wait question” – being out competed does not necessarily mean disappear. Just because we can’t measure it does not mean it’s not there. Relapse after UND is proof that our tests are not sensitive enough.
With HIV resistance relates to rate of viral duplication. Provided we get rapid suppression there is very little capacity for mutation. Existing RAV mutations can persist, but new ones have limited opportunity to be created.
YMMV
I’m reminded of my wife. She has the complete opposite reaction to
It’s an interesting observation about the variations in how medications impact. Morphine sedates most people but it is go fast juice for horses. We give midazolam to children and while most are sedated some kids start bouncing off the walls.
The vast majority of people taking a 1st generation antihistamine will be a bit stoned from it. You do build up a tolerance so if, hypothetically, you were looking at adding this in starting on 25 mg at night to see, then 50 mg at night, then adding in a morning 25 mg and so on would be how I’d look to get to 75 mg twice a day. It is a BIG dose.
For those patients troubled by insomnia its probably not an insane choice. We use sedating medications like antihistamines (used to be quite commor for children), antidepressants (mirtazipine and amitriptyline) for some insomniacs because the useful sedation from things like temazepam disappears rapidly as tolerance builds up.
YMMV
Question: how does a company get approval in India to produce the generic DAA through gov’t channels.
Here is an overview about it:
YMMV
Taj Pharma are currently in the Bombay High Court.
YMMV
Hi Fitz,
I’m aware of chlorcyclizine, and also aware of some patients (who responded slowly to DAAs) using it.
Theoretically it looks ok, if you can tolerate the sedation, but it’s experimental. This drug is a first generation antihistamine (like phenergan aka promethazine) and as such is quite sedating.
My attempts to contact the owners of the study https://clinicaltrials.gov/ct2/show/NCT02118012 have been met with silence.
The trial dose is double the accepted maximum dose (75 mg/day). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d50b5154-20a3-4c5b-ad7b-08c081340b12
Lethal dose is about 50mg/kg so trial dose is theoretically safe.
The mode of action is different from DAAs so, once again, theoretically, it should not make DAAs less effective and might be a useful 3rd drug.
We are in the process of getting ethics approval to run a trial in Bangladesh using Sof+Dac+Chlorocyclizine in GT3
YMMV
I am concerned about the total effectiveness with generics, as the relapse news is now seemingly hitting full stride with people testing SVR 1-16-24.
Hi Sven, the SVR12 rates overall are > 90% which is as good as could be hoped for.
Amongst the dozens of reasons NOT to be involved (and there are lots) one of the major ones was the 100% certain knowledge that an SVR rate of 95% is also a 5% failure rate which means that I knew at least 5 out of every 100 patients would fail to SVR, even if we got real world results as good as the clinical trials, which once again, we (as in doctors) know is never the case. I resolved that if we were not seeing 90% I would reassess things. We are, which is one reason we continue.
There are literally thousands of patients taking generics so there are hundreds of people expected to fail to SVR – any one of whom might choose to sue me or others involved in their treatment. REDEMPTION is as much about CYA as it is about proving generic copies are effective, because it is only in the context of a group that an individual relapse has any context. So if a lawyer comes along an says we are starting a class action because patient’s A B and C have relapsed I’ll go good for you, but guess what, patients D E F G H I J K L M N O P Q R S T U V W X Y and Z did not, and I have the evidence, so perhaps you’d like to re-consider your case because you’re going to lose so kindly FOAD.
So is it that the voices we hear are those whom have failed SVR and the ones that are 100% done never post any further?
Yes, if you look at the forum and do a search like this (from the search tab)
Which is for posts more than 6 months ago, searched for the word “treatment”, sorted by earliest first you will see hundreds of names of people you’ve probably never heard of. They came, they treated, and they’ve moved on. Treatment gives people back their lives and while I miss their company, humour and insights, it’s the way it should be.
A big reason this forum exists is also CYA in the context of informed consent. Anyone who wanted to say I had no idea that there are side effects, that patient’s relapse, etc, etc would be hard pressed to prove that was because they were not informed. This forum is far more transparent then any drug company trial and carries far more real world information about DAA treatment than pretty much anywhere else in the world, and unlike Big Pharma trials where the results are presented with a “trust us this is what we got”, this forum makes our results pretty transparent – if generic DAAs were not delivering results you would be reading a whole lot more relapse and a whole lot less SVR.
If you’ve got a strong stomach read this http://fixhepc.com/blog/item/26-pharma-scores-rap-drug-cover-ups.html which is an article from the Australian called “Pharma Scores Rap Drug Cover Ups” reporting on this article from the BMJ http://bmjopen.bmj.com/content/5/11/e009758.full.pdf where it is noted that with Gilead’s new HIV drug Stribild they did 34 trials BUT only reported 21% of them (ie 7). You do have to wonder what the other 27 unpublished trials turned up, but it would be naive to think they contain better results.
Please let me know how one calculates the generic Harvoni with branded Harvoni successes and failures.
You do it by taking a group of CONSECUTIVE patients – 448 – in our case – and keep a log of what happens counting all the successes and all of the failures.
Interestingly we are also keeping a log of originator medication patients in Australia and, as expected seeing both success and relapse.
I have patients who have replapsed post anything and everything you could name – Harvoni, Sovaldi, Ribavirin, PEG, Olysio, Daklinza, Zepatier, V-pak – we have good, we don’t have perfect.
Treatment is a gamble. There are risks, there are benefits, there are failures and successes. There will always be better drugs just around the corner. For some people waiting may be a good option. Others will die waiting….. 500,000 last year to be more precise.
But do generics deliver similar results to the branded medications, yes, just like the HIV generics taken by about 15 million people around the world. These medications are largely made by the same companies in both originator and generic forms.
YMMV
The small package size relates to buying this weeks medication with this weeks pay which is the reality in a lot of less financially advantaged markets. The idea of buying all your medication in one go is totally out of reach for many people in countries like Bangladesh, so in context the size makes sense. I expect larger pack sizes will appear in due course, but both the production dies, and box work needs to be tooled up.
Beacon favour blister packages over bottles because it is much harder (as in expense) to fake blister packaging. Bottles are relatively easy as the bottles are standard off the shelf so a bottle of fake medication is really only stick a label on it.
YMMV
The fault is not really with Pharma.
This is an issue with our political system and the rules and regulations that facilitate such lesser good practices created by our notional representatives, who, to be blunt, no longer represent us.
Government of the people, by the people, for the people, shall not perish from the Earth.
– Abraham Lincoln
I fear that we have lost that idea and it has indeed largely perished.
Making matters worse Gilead (and pretty much every other corporation) is allowed by various laws, and carefully crafter legal fictions, to shift their profits to tax havens. I don’t blame them. People follow incentives. The incentives are misaligned with the needs of the people, and we the people need to take responsibility for having allowed things to slide down a slippery slope.
It’s a pretty neat trick – take a drug developed by someone else – to market. Ruthlessly extort governments for money using dying patients (voters) as the lever. Syphon that money through a tax haven to shareholders, who likewise avoid as much tax as possible. The problem with this is that the accretion of wealth into a small subsection of society arrests the circulation of money and in so doing slowly strangles the goose that lays the golden eggs.
While fixing our broken system seems a herculean task – where do you even start? I think it starts with recognition that there is a problem. Recognition is great but it must be followed by well considered concrete action.
千里之行，始於足下
A journey of a thousand miles begins with a single step
– Laozi
YMMV
At the current rate it may well exceed 60,000 in the first year or about 25% of patients. The government expectation was 25,000.
ASHM are now running training for GPs which is great.
YMMV
With an HCV viral load, ie pre treatment, sexual transmission with straight sex is extremely unlikely to cause infection. Anal sex is slightly more risky as blood blood contact can occur. Vaginas, penises and mouths have a relatively thick layer of cells that make blood blood contact rare and damage to the defences of both partners needs to be present at the same time.
At SVR there is zero chance of causing infection.
YMMV
Left to right: Md Monjur Alam, Md. Ebadul Karim (Managing Director), Dr James Freeman, Prof. Dr. Syed Modasser Ali (Chaiman of BMRC), and Mr James Cheng
YMMV
When I look back to this time last year, it’s amazing to see how far things have come.
We could quite well hit 30% of all patients having been treated in the first year.
YMMV
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