Back in February 2015 I met a patient with Hepatitis C who was looking to access Harvoni.

What followed was a journey of exploration looking first the India, then to the Middle East, and then to China.

The goal was pretty simple - find a reliable legal way to get the right medications to the right patients.

While on the surface it might seem as simple as doctor writes script, patient gets medication, and 12 weeks later they are cured, it's not quite that simple. I won't attempt to speak for any other doctors but my personal concerns included

1. Is this legal? (YES)
2. Am I allowed? (YES and NO)
3. Are there any risks? (YES a truck load)
4. What happens if something goes wrong? (SHTF)
5. Can I just ignore it and make it someone else's problem?

Looking at each of these in turn.

In terms of simple legality I can as a GP write a script for just about anything (provided there is a valid medical reason). There is no doubt there is a valid reason to prescribe these medications - they work. A patient can legally import 12 weeks supply of a medication, provided it's not on the prohibited imports list (these medications are not), and provided they have a valid prescription a patient can possess these medications (like any other S4 or S8 medication - these are S4).

So now we move to the subject of being allowed. The first part of this is really the question "Will the medical board strike me off the register for doing it?" The answer to this is probably closer to maybe than yes or no. Doing it with due care and informed patient consent it should be a no. Done without due care and we definitely get into a grey area. The second part is that to order a Hep C viral load, or a genotype (and have it bulk billed under Medicare) a specialist has to authorise that testing. This is a pretty big deal given each test costs $200. Fortunately I have consultant colleagues willing to authorise the testing.

Now we get to the risks. These include things like:

1. Do I know enough about these medications and their side effects to safely prescribe them? (Yes, I can look that up)
2. How do I know the patient will actually get the right medications? (It's not like I'm sending them to a trusted pharmacy down the road)
3. What if the patient does not reach SVR?
4. Where does my implicit duty to treat end and my responsibility to do no harm begin?

Although I've only treated a small group of patients to date the expected side effects and complications are already evident - headaches, anaemia, and treatment failure. I expected to see them all and they are being managed on a case by case basis.

And then we get to the last question can I just ignore it? For me the answer was no, I would not be able to sleep at night knowing I could help, but chose not to..... Although for me the answer was no, I could not ignore it, I would not think any the less of a doctor who declined to be involved.

This site is not the work of any one person. It represents the combined efforts of a group of interested people to help make accessing these life saving medications possible.

Hi Alsdad,

Thank you for your response. You're quite correct, Mesochem will supply without a prescription, and I have ordered 3 months of medication from them. I should have said 'imported' rather than 'Chinese', and I have now corrected this.

However, over the last several years, I have seen several GPs plus 4 specialists and 1 liver clinic. All of them have flatly refused to have anything to do with generic hep C medication. So I still need to find a GP who is willing to oversee my treatment, and I will still need further medication, which will require a prescription for imported generics.

So the question still stands.

Hello Dr Freeman,

I am new to this board so let me start by saying that I applaud your work to help all of us with hepC. I wish that there were more of you out there.

I note that for your successes you publish 2 PCR's which show that this person has become UNDetected. While this is encouraging and does prove the antiviral activity of the Mesochem drugs, we know that SVR is the only real measure of successul treatment for hepC. So would you be willing to post the numbers that you are obtaining from the Mesochem drugs regarding SVR12 / relapses / breakthroughs? It would also be helpful to know for those patients their hepC profile, ie. genotype, cirrhosis or not, treatment experienced or not and which drugs already experienced. Also the treatment drugs used and the duration of treatment. Also any adverse events with the side effects. All anonymously of course.

I think that this would be very helpful for those of us considering using the Mesochem drugs. I realise that it is early days and maybe too early for the SVR's to be coming through. However a table of running totals would at least give us some insight as to the efficacy and safety of the Mesochem drugs.

Many thanks for your consideration,
dointime

Before letting the first patient take any medication we did a lot of testing to make sure the medication was both an accurate copy and also free of impurities. Unless the drug companies have faked the data it's reasonable to expect similar results.

We are tracking people in exactly the way you describe (with additional things like batch numbers and medication testing results) so with time will have some pretty valid stats on this, but at the moment we don't have enough data. Currently we have only seen 1 case where the patient has been non zero at week 4, but in a sample size of n < 100 the margin of error is +/- 10%

Real cure is when you not only get to zero, but some decent period after stopping the medication remain at zero.

Relapse represents not really being at zero, but rather being so low we can't measure at the end of treatment.

Most relapses will happen within 12 weeks of finishing treatment cid.oxfordjournals.org/content/49/9/1397.full

We could set up an open data collection poll that people could use to add their personal data and then generate some graphs. While public crowd sourced data can be manipulated it would be interesting to see.

We have tested all of Sofosbuvir, Ledipasvir, and Daclatasvir at a local facility and they all look good.

We have tested every individual dose to date, with the exception of one patient who could not afford the cost (but we had tested ever other sample from that batch). He's at SVR so it worked, but it made me worry about "What if?"

Going forward we have negotiated a slightly reduced price from Mesochem if we batch up orders, so we will be able to include the testing with patients not paying any more.

For me testing is my protection - Yes, your honour, I prescribed a Hep C medication to a Hep C patient and I had confidence in that because....

And for patients..... I use the mum test. Would I be happy with my mum getting this treatment in this way?

Hi Everyone

Once I commence my treatment I will be providing a running commentary on how things progress for me, including baseline liver function (LF) and viral load (VL), start date, side effects, 4 week LF and VL. So in about 2/3 weeks I will be treating for 12 weeks with sofosbruvir and daclatsavir.

Daclatsavir is an NS5A similar to Ledipravir however it hasn't been researched to the extent of Ledipravir. Here is information on the Ally 2 trial which (www.nejm.org/doi/full/10.1056/NEJMoa1503153) which convinced me to give it a crack.

For a 12 week supply of both Sofosbruvir and Daclatsavir I paid $925 US ($1350 AU) and will be having both tested for purity and capsulised for approximately $450 AU in Tasmania. As I speak the APIs (powders) are in transit from China to Australia and should arrive next week. So welcome to Emilio's Place and I look forward to sharing my journey. Peace. .Em

Em,

I find that really interesting Em. For myself, I don't feel I want to risk a 12 week duration without riba, even though for my hepC profile the AASLD recommends it. I read the Gilead trial results for ION2 and Sirius, which are the trials most interesting for me, and it seems clear that for 12 weeks I could expect <100% but for 24 weeks it would almost certainly be 100%. The 12 weeks with riba option would for me probably also be 100%, but based on previous experience the riba would give me a repeat of the rash from hell, which I don't fancy. Like you I am favouring the sof/dac combo rather than the sof/led combo.

Therefore, as there seem to be no safety issues with the 24 week option, even for cirrhotics, I am going for that if I can get it. I don't care if it is more than necessary. The recommendations are meant to be for everybody but each individual has to look to their own circumstances. I do wonder if more doctors would be willing to prescribe 24 weeks if it were not for the swinging price of the drugs and the fact that their hands are tied. I wouldn't do 2 NS5As either, for the same reasons as you. The thing I am not sure about is how good an indicator it is to be UND or not at week 4? So because I am not sure I would just carry on to 24 weeks regardless. Do you know of any research which can tell us more about this? My thinking around it has been to have a PCR before EOT and in time for the results to arrive before EOT. IF I were not UND at that point then clearly I would carry on, but if I were UND then what would I do? I'm not sure.

I am genotype 1b
no cirrhosis
treatment experienced with Telaprevir (NS3 protease class)

I would be most interested to hear how you go with your tx.

Best,
DT

Had some blood taken yesterday, tenth day of my treatment on Mesochem Dac and Greg's Indian Sof. Was due to see my consultant tomorrow morning, but he's gone on the sick. First result back was my GGT (which was the only important raised level in a comprehensive set of tests I had done before I started treatment), which is down from 357 to 194. Can this be considered a normal fluctuation, or is it an indication that the treatment is working?

Having a viral load test done from the same blood-drawing, but that will take a few days to come through.

Thanks for that info Dr Freeman.

I'm in the UK, and this set of tests are being done at a private lab because my NHS Consultant declined to get involved in this treatment in any way, shape or form. The clinic said up to five days for viral load result, but the Phlebotomist (sp?) said sometimes it's much quicker.

I stopped drinking alcohol Easter 2014. Would it still be a factor?

My pre-treatment levels were:

ALT 28
AST 26
Biluribin 8
ALP 89

Anxiously waiting for my viral load result now

Never smoked, white ethnicity.

I'm on 500mg Naproxen BD, Paracetamol as required (usually 1000mg in the morning) for non-rheumatoid arthralgia and myalgia. 10mg Ramipril daily for raised BP.

For years I took high doses of curcumin and milk thistle, but stopped these a month before starting my Sof/Dac treatment.

I dab a bit of Dermovate occasionally on bits of psoriasis I get, but mostly use E45 on them.

Ok, thanks for that.

I'm going to update this thread as my treatment progresses if that's ok.

Hi Emilio,

I had an ultrasound scan a few months ago. Based on that and my bloods, the NHS consultant who has declined to get involved with my generic treatment assessed me as having no liver damage and therefore, not currently suitable for the latest treatments (only cirrhotics are currently being treated on the NHS with them). As an aside, he also showed his ignorance (or worse) in a letter to my GP in which he stated that I, being genotype 3 and intolerant of Interferon, couldn't have the new meds anyway because my genotype requires interferon in the combination. Ignorant, or economical with the truth? This is a hepatology consultant in a centre of excellence btw!!!

Yeah, as I said, I'll post updates as I find stuff out.

Yes, ultrasound, Emilio. The Consultant who is overseeing my current treatment privately was astonished when he found out I hadn't had a fibroscan. We tried, unsuccessfully, betwwen us, to find a local private clinic that ofeers the service.

I've attached the letter (with all names and references redacted) that my GP practice and myself received from my NHS Consultant wrt this.

The last letter from said Consultant, which I was informed about by phone call from my GP practice, was his declining their request to monitor my bloods during the current treatment. My GP practice have agreed to do blood tests for liver and kidney function (first drawing on Tuesday). But their viral load tests are done at Dr Helpful's clinic, so I will continue to have those done privately at £225 a go.

Like you said, I'll find out where my liver is up to in a few weeks.

A few comments on the website and related generic initiative:

1. The website is really well set-up, with very accessible information.
2. The advice re prolongation of treatment based on HCV viral load monitoring is incorrect. There is no relationship between on-treatment monitoring and treatment outcome (assuming high level adherence, as in clinical trials). In fact, many patients in clinical trials have had "detectable" HCV RNA at end-of-treatment and still achieve sustained viral clearance. There is clearly no relationship between week 4 (or other timepoints) and sustained viral clearance, so extending treatment duration (as we did with interferon-based treatment) does not make sense in the interferon-free era, including in the case described below.
3. HCV RNA monitoring is probably only useful for adherence monitoring (or purity monitoring in case of generics). So, would still advise a week 4 HCV viral load, based on adherence/purity monitoring.
4. Treatment duration may need to be longer (24 weeks), based on pre-treatment factors (e.g. SOF/LDV or SOF/DCV for GT1 cirrhosis treatment experienced; SOF/DCV for GT3 cirrhosis treatment naive and experienced).
5. It is very important that the only patients that use SOF/ribavirin 12 weeks are those with GT2 (and possibly GT4 for 24 weeks). It is a sub-optimal regimen for GT1 and GT3.
6. The field is moving so quickly at present that there is a real need to keep updating. The AASLD/IDSA guidelines are probably the most frequently updated, and should soon have guidance on SOF/DCV. EASL guidelines are good for SOF/DCV.

I do understand patients desperation

* Comment - the site content has been corrected in line with point 2

Re on-treatment virological monitoring, patients do feel reassured when they see how quickly and profoundly the viral load declines. But, the data indicates that basically 100% of patients taking sofosbuvir-based regimens will suppress virus to incredibly low levels and generally very quickly. Eventually, we may only do one HCV viral load testing after commencing treatment, either 12 or 24 weeks post-treatment. For now, and particularly for patients on generics, it is very reasonable to do week 4, end-of-treatment (week 12 or 24 depending on duration), and then 12 or 24 weeks post-treatment.

Education of primary care and other practitioners is vital.