Now that the clinical trial for treating Hepatitis C is all over, I’ve been receiving requests for information about how I went with the trial.

What follows here are entries from throughout my treatment and after.

5 April 2013

After having gone on a clinical trial last year, with mixed results, another one is starting up in a few months time so I went in to the hospital for a pre-screening check-up to get started with the process, which involves doing a fibroscan, things like giving lots of blood samples for them to check up on.

Things seemed to go well, so I’ve just got to wait until the intake of people occurs for me. I’ll be in a group that comes after chronic sufferers, and after people who are new to the trial.

28 May 2013

It was up first thing this morning, to be in at CCST (Christchurch Clinical Studies Trust) at some ungodly 7 mumble-mumble time of the morning to have vitals and blood tests taken. This is the last time that I’ll be coming in for the trial that I was on last year, so they gave us a bonus payment which boosts my iPad savings in to the realms of a possibility now – hurrah.

Last year’s clinical trial was a treatment for people with Genotype 2 & 3 of the virus. It went so well that they later on brought in people with Genotype 1, which is more difficult to treat, to see how we would go. It wasn’t as effective with some of us, so there is a new trial this year specifically for us now that promises to be more successful.

25 June 2013 – CCST

Earlier on this morning I was at a physio for my shoulder, and received a call from the recruitment office at CCST. Calling them back I find out that they want me in on a clinical trial, and want me there for several hours of pre-screening come Thursday. It will be good to get started on this treatment and see if things go any better than they did for me last year.

27 June 2013 – Prescreening

This morning it was all on at CCST, the clinical studies place, for a pre-screening to take part in a study that involves some new treatment medication for hepatitis C. It’s so new that the doctor hadn’t handled anyone else in regard to this trial, so I just happen to be Cohort 1, Group 1, Patient 1. The doctor was grateful to have the paperwork from my time with this last year though, so that parts of it such as my full medical history could be cribbed from those old notes.

After the paperwork side was dealt with it was then on upstairs for a full medical check up with ECG and suchlike, including plenty of blood samples. The staff were pleased to see me again, which I guess can be partly attributed to being a patient patient, and having good veins.

The medication has strange names that are quite difficult to pronounce. Sofosbuvir is only the beginning of the strangeness, because following it with Ledipasvir results in the quite the tongue twister as you try to say “Sofosbuvir and Ledipasvir”. Things seem to go better when you make good use of the space after the “and”, but if you just carry on through without a break there, the D consonant at the end of “and” followed by L and then back down to D results in a confusing amount of tongue work. Some practice at saying “and le dip” is definitely required.

The nurses have a similar problem with pronouncing the name too as they’ve been pronouncing it as “le dip as vir” when instead the following article on new name for GS-5885 says:

GS-5885 has a new name, Ledipasvir, pronounced led’ i pas’ vir.

I might bring this up with them the next time I see them. I’m sure that they’ll appreciate it.

10 July 2013 – Not happening

An appointment with Dr Pithie was happening today about the clinical trial starting next week, but he can’t make it so someone else fills in who basically says, “It’s good to catch up” before ending the appointment. Somehow this doesn’t instil much hope with me about things to come.

16 July 2013 – Cohort 1, group 1, patient 1, day 1

My time as a guinea pig for the Vulcan clinical trial to treat (cure perhaps?) hepatitis C started today. I arrived at 7 AM and remained in the hospital bed until mid-afternoon, while they took blood tests and ECG tests, as well as a fibroscan of my liver itself.

A hospital band was put on my wrist when I arrived, but scissors couldn’t be found to remove the excess from it. Fortunately I had a dangerously sharp knife ready to hand on my Leatherman, which has previously sliced open someone’s thumb while they were testing it out, after being warned how sharp it was. The poor nurse here tried to cut my wrist band with the back of the blade the first time around. It works so much better when the sharp side of the blade is being used. After she used it again a second time on someone else, with the back of the blade once again, scissors were eventually found from somewhere else and given a permanent place there.

The procedure that they have in place for us patients is a bit different now than it used to be when I was on a similar Venus trial last year. Blood pressure tests are not done now while you’re lying in bed, but instead now require you to be sitting on the edge of the bed with your feet flat on the floor for five minutes before taking your pressure.

We will also be going in not every week, but now only every two weeks for a check up and to have our remaining pills counted. They won’t be serving breakfast either! Which is a shame, so we’ll have to arrange our own now before going in.

Speaking of pills, they aren’t provided separately any more either. The sofosbuvir and ledipasvir (pronounced led” i pas’ vir) are combined as one large pill now, which is to be taken in the morning with 3 ribavirin, and another 3 ribavirin in the evening.

I’ll be attempting to be less active this time around for the next few months, because the light-headedness from low haemoglobin that the ribavirin last year caused, is something that I would like to try and limit this time around.

30 July 2013 – Hurry up and wait

It’s been a day of hurry up and wait for me today. When trying to get to the clinical trial this morning I took a shortcut West across town, only to find that large parts are blocked off and had to wriggle my way down South before making much progress. Kilmore Street is blocked off before you get to Madras, so a loop-around at Oxford Terrace back to Barbadoes Street needs to be done. Then due to rush-hour traffic on Barbadoes I try to make my way via Gloucester Street to Manchester, but am hampered before I get there, so it’s around Latimer Square to find that Worcester and Hereford are still blocked off towards Manchester Street too. What if I wend my way down Woolsack Lane to try and get there – no? And so it’s heading back East again across Madras (can’t go South down there) over to Barbadoes Street once again, resigned to having to live with the rush hour situation until I can eventually get to St Asaph Street and at last make some Eastward progress. It seems that the only effective Westward passage across the city is still at Bealey Ave or St Asaph – no points between.

When I at last got to the clinical studies place, I was given a bed near the wall which awarded me with a good view of the concrete wall of the building. It has a good couple of inches gap from the quakes that hasn’t yet had much of anything done to it. I’m just hoping that it’s not more than just cosmetic damage. I’m told that it doesn’t let the rain in so doesn’t seem to be that much of a problem, but I have a friend who regularly visited the CTV building and was given similar info about their stairwell there, so comfort is not to be had from such statements now.

The good news though is that the TBA (to be advised) status on my being there for the whole of the next day, Wednesday, is that people in my group are not going to be involved with that. It’s groups 2 and others that will be instead – so it’s as if my group 1 is part of a control. We’re not told what to have for breakfast, or what to drink when taking meds, or checked up on all that often – only every two weeks now – so despite that I’m never-the-less going to stay fairly close to what we were doing last year, with plenty of water with the meds and such like.

26 July 2013

My stomach as of late has been playing up, with lots of gas and unpleasant bowel stuff, which I think may be due to the GS-5885 medication that I’m on with the clinical trial. I haven’t changed what I eat, and would only experience what I’m getting as either food poisoning or sucrose intolerance. So I’ll bring it up with them first thing tomorrow and see what they have to say about things.

12 August 2013 – Growing in

After waking up the other night with visions of using pliers to help see to a big toe ingrown toenail situation, the doctor today gave me a cream to put on there that he says should help. It’s supposed to be good for pain and dealing with possible infection, but I don’t want a cream to help with the pain – I want the underlying cause of the problem to be dealt with instead. I can’t start using it yet either because I should run anything medical by the clinical trial people in case of a conflict, not that I foresee anything troubling with a topical cream, but it’s best to be safe than sorry. Perhaps tomorrow I’ll be able to start treating things. It’s a bugger though that I’ve also been to keep off my feet as much as I can for the next few weeks. I had a skiing trip lined up for this weekend – but hopefully I’ll still be up to heading along and participating in spirit at the very least.

27 August 2013

It was in to the CCST early this morning for my bi-weekly check up and blood tests, and I’m about halfway through 12-week treatment. I managed to drop one of the pill bottles in the weekend at someone’s place that has tons of nooks and crannies, and it seems that I managed to retrieve all of them because the remaining pill count is what it is expected to be, phew. The doctor the last time hadn’t noted down details about the meds that I had been given for the ingrown toenail, and now want to record them so I’ll have to call them back later on with such details.

8 October 2013 – Clinical trial ends meds

The clinical trial that I was on to treat Hepatitis C has come to an end of the medication last night, which consisted of a combination pill of Sofosbuvir and Ledipasvir along with 3 ribivirin pills in the morning with food, and 3 more at night. This morning I was in at the clinical trial for an end of treatment check up, and it just-so-happened to be a more thorough check up than the usual 5 minutes resting before blood pressure and blood samples. I have a small business course that I’m supposed to be at this morning at 9:15 AM – great.

At 8 AM I arrived and explained my timing trouble, and the nurses kindly helped out and we pushed things through so that the following could all be tested in good time:

  • weight
  • 5 minutes rest before blood pressure
  • 5 minutes rest before ECG
  • blood samples
  • doctors check up examination
  • across to Hagley Outpatients for a fibroscan

We were all done by 9, so I was able to get out and off to the course, which worked out nicely thanks to the effort of the nurses.

The fibroscan results were amazingly good too. Last year I had a liver stiffness of 12, 3 months ago it was 9, and now today the stiffness is down to 4.1 which are impressive results indeed! According to this correlation chart means that I went from quite bad to medium risk, and have since gone off the chart in the healthy direction.

Fibroscan correlation chart

Source: http://hepcbc.ca/fibroscan-alternative-to-biopsy/

Now we play the waiting game, and see over the next few months whether the treatment takes, and remains effective.

3 December 2013

It was in to CCST this morning for a follow-up on my recent treatment, and results are looking good. It’s early days yet but results maintain through to the end of the year, and even to the end of the monitoring next year, then it can be said that I’ve been successfully cured of the Hepatitis C virus that I’ve had since I was 6 years old.

I’ve been noticing though that some issues crop up when I go in. The temperature gun they stick in your ear constantly fails to get results for me, and yet they still insist on still using it before pulling out a thermometer to stick under my tongue. Still, if it is because I have narrower ear canals than usual then I now have a valid excuse for things.

17 February 2014 – Blood test issues

It was in to Hagley Outpatients today for a follow up in regard to the clinical trial that I started last year, and found that the hospital has no earlier follow up results from blood tests that I’ve been having since October. As a result, they want to give me a form for a blood test for when my final health check up occurs with the study.

Good luck to them with that though, because I don’t have a physical diary in which to put loose pieces of paper. With the paperless diary that I keep on my tablet, it’s kind of hard to keep a hold of other papers, especially when they’re expected to be handed over to others later on. So instead, it’s being kept with the clinical study travel log, which results in compensation for my travel at the end of things, this way at least the blood test paperwork will be in a safe place that isn’t likely to be cleaned up out to recycling.

15 September 2014 – Conclusion

My daily blog writings have long since come to an end, but I’m since on a three-year follow up with the trial. I’m still clear of Hepatitis C, and will head back in to for further check-ups every six months. It’s been excellent taking part in this clinical trial, and I look forward to further good news too.

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