Hi Prof

Wow point 2 is something that I'm still attempting to process. Having treated about 7 years ago with the older chemicals this is a concept I struggle to comprehend. 'Some being detectable at the end of treatment but go on to svr'. Obviously this research has been developed from the more recent DAA research, can you point us in the direction of this data? Em

My own doctor told me roughly the same thing - that almost everybody taking sofosbuvir gets to UND.

In this connection I must say that I have been taking note of some of the 'success stories' going around lately. Of course people feel reassured when their viral load declines, especially if they are using the generics. However this is not an indicator of future SVR, as all of us who have ever had a relapse or a viral breakthrough know to our sorrow. So these stories, while very encouraging and wonderful to hear, are premature if they claim that there has been a cure, unless enough time has elapsed after end-of-treatment for at least SVR12 to be established. As things are moving very fast we may get info in the future to say that SVR8 or SVR4 are good enough points with the new DAAs to assume a cure, but I have not heard of that yet.

dt

Anybody who has been correctly diagnosed as having liver cirrhosis will not find that it is gone right after achieving SVR with a 12 or 12 week treatment of the new DAAs. Or should I say, I have never heard of that happening. The liver is an organ that can regenerate itself. Some people who have had cirrhosis have reported that their level of fibrosis did improve some over time, but they were talking about years, not months. I have heard of others who were not cirrhotic that their liver fibrosis improved a lot over time, as measured by fibroscan.

dt

Concordance of sustained virological response 4, 12, and 24 weeks post-treatment with sofosbuvir-containing regimens for hepatitis C virus

The concordance between SVR at 4 weeks post-treatment (SVR4) and SVR12, and between SVR12 and SVR24, were determined, as well as positive predictive values (PPVs) and negative predictive values (NPVs). Overall, 779 of 796 patients (98.0%) with an SVR4 also achieved an SVR12, making the PPV of SVR4 for SVR12 98% and the NPV 100%. Of the 779 patients with an SVR12, 777 (99.7%) also achieved an SVR24, making the PPV of SVR12 for SVR24 >99% and the NPV 100%. Of patients who relapsed post-therapy, 77.6% did so within 4 weeks of completing therapy.

Had my first NHS blood-drawing for the current treatment this morning.

Before I went into my GP's I decided to give my treatment clinic a ring to see if they'd got my 10 day vl result through yet. Yes they had, and they'd email it to me straight away.

So I booked in at the GP's and got onto the internet on my phone. Email with PDF attachment from the clinic arrived, so I opened the PDF, which was far too big for the phone screen. Scrolled straight down to the result to see 'Not Detected'. Wow!!! Sheesh!!! After a few seconds I scrolled across and saw 'Hepatitis B DNA Viral Load'. Huh? Must be a mis-print! Went in to have some blood drawn, routine blood pressure check higher reading than usual!

Back out to car, and on the phote to the clinic. "Yes, Mr 'Alsdad' it was a HBV vl test that was requested. Wasn't that what you wanted?" Why on earth would I want one of those? I'm being treated for HCV. "Practice manager's not in 'till 10.30. I'll get her to phone you." Practice manager phoned a 11.00, after reviewing what had gone on. Couldn't apologise enough. "When can you get back in for another blood sample?" This afternoon.

So, feeling a bit like a dartboard , I'm about to head back down there.

My 'treatment' under the NHS had turned into a soap opera, and made me bite the bullet and go private. Hoping that this course isn't going to go the same way!

The clinic seems quite disorganised. But the Consultant I'm seeing is remarkably well-informed, a good listener and a nice guy.

Yeah, done Riba and Peg in 2004. I'm sure it was killing me. I hobbled into my Consultant's office one day, he looked round at me and a look of horror spread across his face. His first words were "Do you want to stop the treatment?" No 'good morning', 'how are you', or any such niceties. He was spooked. Never again.

It's just crack on with the meds now, keep having the blood tested, see where I end up. I couldn't wait for cirrhosis/liver failure, as the NHS were expecting me to do. I have an 18 yo daughter who I took across the country to start uni last Sunday, and a son in junior school. I have to givie it my best shot for them.

Hi all,

I'm on day 20 of treatment with Greg's Indian Sof/RIBA and Dac (compassionate access from RHH and thanks BMS!) I think the doc added the RIBA as a bit of insurance. I'm F3/4 (probably closer to F 3 because good platelets and albumin) and GT1b.

Can't say I have any side effects so far. In the first few days, I had a few very, very vague things that might have been due to the drugs but were so mild and barely perceptible that I decided I couldn't classify them as side effects. Started off keeping a treatment diary but abandoned it because I simply haven't had anything to write in it. Of course, I realise this doesn't mean things will continue this way.

The healing effects have been dramatic though, especially in the last week. Energy that I haven't felt in years and less muscle and joint stiffness in particular. My mood is actually up, possibly because of the change in my energy levels.

I was talking to the hep nurse at RHH yesterday and this response is typical. Interestingly, if I understood her correctly, she said they're starting to think a lot of the Ribavirin side effects might be mostly associated with taking it with interferon. Apparently those who have experienced side effects report mostly sleeplessness, headache and nausea and they now think this could actually be due to the Sof and not Riba.

Had LFTs and FBC done last Thursday. Everything within normal limits.

Hope you have as little to report as I do about bad side effects, emilio.

I have it on good authority:

The information on end of treatment "detectable" HCV RNA and SVR was contained in presentations at EASL Conference in April, so not yet fully published.

Great to hear your meds have arrived emilio. Very exciting. How long does all the testing and prep take?

What combo will you be on dointime? I see you're 1b and treatment experienced. Are you doing Sof/Riba/Dac too? If so, for how long?

Hi Ann,

I wonder if you've used up the number of tests allowed. You can only get a certain number of tests per year under Medicare though more PCRs are allowed if you're on treatment.

www.clinipathpathology.com.au/media/9812..._for_rebate_web_.pdf (See HCV info)

But I'm sure Dr James will have a better idea of wants going on.

While there's 4 PCRs per year for people on treatment, 2 VLs seems a bit stingy to me given the usually shorter treatment times for the new drugs. I think they're sending me for PCR and VL next week at the four week mark. That'll be my second and last Medicare funded VL for the year.

Edit: removed first link because I noticed it was from 2008. Don't know how accurate second link is. It's dated 2012. Suffice to say, my understanding is there is some limits on the number of tests Medicare will fund (presumably you could still pay out of pocket).

The problem is that a Medicare rebate is only payable to the pathology company if a specialist has authorised it, although when you're being treated that is not actually a requirement. We don't usually have any problem but do have a consultant physician who can authorise the testing.

In country NSW we can simply get you to have a Telehealth appointment with a specialist (needs a GP referral) or we can see you and ask our specialist to authorise the testing.

Here are the Medicare rules:

Hepatitis C Virus (HCV) Genotyping
Medicare criteria (one per year):
1. The test is requested by a specialist or consulting physician managing the patient’s treatment, and
2. Patient is hepatitis C Virus (HCV) PCR positive and being evaluated for antiviral therapy of chronic HCV hepatitis.

Hepatitis C Virus (HCV) PCR: Qualitative
Medicare criteria (one per year):
1. The patient is hepatitis C seropositive, or
2. The patient’s serological status is uncertain after testing,
or
3. The test is performed for the purpose of:
a. determining the hepatitis C status of an immunosuppressed or immunocompromised patient, or
b. the detection of acute hepatitis C prior to seroconversion where considered necessary or the clinical management of the patient,

Hepatitis C Virus (HCV) PCR: Qualitative (assessment of antiviral therapy of HCV)
Medicare criteria (4 per year):

Patient is undertaking antiviral therapy for hepatitis C.

Hepatitis C Virus (HCV) PCR: Quantitative
Medicare criteria (2 per year):
1. The test is requested by a specialist or consulting physician managing the patient’s treatment, and[/li]
2. The patient has undergone pre-treatment evaluation for antiviral therapy for chronic hepatitis C.[/li]

Hi James

Could you please explain how one would manage being on setraline/zoloft when commencing treatment of sofosbruvir and daclatsavir? I've checked out the interactions table and still don't understand the ramifications? I guess I'm asking for myself who has remained on this AD since my last treatment and for all hepers, as many would be in the same situation. If there is any question on interaction I'd like to wean off the AD prior to commencing, maybe? Em

Edit: I'm on 50mg daily, well most days when I remember!

My name is Nevil and I used to have Hep C until just recently. I was diagnosed in 1978 with non A non B hepatitis. Hep C was unknown in those days. There were no symptoms and I thought that I must be immune due to some sort of genetic superiority. I had illusions in those days.

In 2004 I went to the Doctor complaining about the usual Hep C symptoms. A blood test was done and I was told I had Hep C. Bugger! There goes my super human status. I was offered the standard Interferon/ Ribavirin treatment, but after researching the reports from people who had undergone the treatment, I decided against it.
I was type 1A, which was the most difficult to treat with these medications and the treatment was not without great risk to my health. I decided to wait in the hope that something better would come along.

As time went on my condition deteriorated and chronic fatigue plagued me to the point that I was barely able to look after myself. Then disaster stuck. I had fevers and headaches, coupled with joint pain and swollen ankles which were so bad, I could hardly walk. I thought that I was entering the terminal stage of the Hep C. I went to the hospital emergency dept. and was given a couple of Panadol Forte and no real explanation of what was going on. Finding the experience far from satisfactory and not really being in the position to travel, I remembered hearing something about Skype Doctors. It was worth a try and I sure was sick of waiting rooms.

Dr. Freeman at GP2U took on my case and had the foresight to test me for Ross River virus. It came back positive. Not exactly great news, but at least I wasn't dying yet. My perceived brush with death caused me to look seriously at the options for Hep C treatment. I'd heard about Harvoni and how effective it was with type 1 cases. The trouble is, it cost near $100,000. Some friends of mine decided to try and raise the money, but it was a lot of money to raise and it was going to take a while. I no longer felt that time was on my side and I'd heard that the price varied from country to country. Dr Freeman and I had decided on exploring the idea of going India for treatment but then discovered that Ledipasvir was not available there and the Sofosbuvir/ Ledipasvir treatment was the best treatment for type 1 cases. A friend suggested looking at China to source the drugs.

Suffice it to say, the purchase was successful at a fraction of the normal price and the drugs tested pure. After 4 weeks of treatment I tested Negative for Hep C and my liver functions have returned to normal. Miraculous really. I'm nearing the end of my 90 day treatment and I really want to urge you, if you have Hep C, not to procrastinate. Time is not on your side. Right now there is a window of opportunity to obtain effective treatment with quality drugs at affordable prices. We don't know how long that window will remain open. Believe it or not, there are people who would rather see you suffer and die, than offer affordable treatments. It's conceivable that they might try to stop the importation of cheap generics.

Every life is worth saving, start with your own.

I think that the subject of drug Resistance to NS3 and NS5A class drugs is an important one for anybody taking these classes of drugs, eg. simeprevir, ledipasvir, daclatasvir. I am not the expert on this subject, I can only cite my own story.

I did a trial back in 2007 using telaprevir, an NS3 protease inhibitor. I figured, what the he!!, the worst that can happen is that it doesn't work. I was wrong. What did happen was that most people in my arm of the trail failed to reach SVR, including me, and I was left with drug resistant variants to the NS3 class of drugs which limited my possibilities for treatment going forward.
***Nobody told me that this might happen.***

Back then I might have still done the trial even if somebody had explained to me about drug resistance. With hindsight and the knowledge that has been gained since then, I wouldn't have done it. The difference between now and back then is that now we have very effective drugs and the chances of getting to SVR first time around are very high. So the risk of failing and being left with drug resistance is very small. I am only writing about it here because nobody told me about it and I think that was wrong. Somebody should have told me. I didn't know that it was a risk that I was letting myself in for, and I should have been informed. So now you all are.

dt

Hi Em,

Do you have the liver fibrosis score for any of these people from before and after their treatments, as shown by fibroscan or biopsy? Liver function tests alone are not enough to tell us about the extent of liver scarring that there is. I am not prepared to believe that a shrivelled, lumpy cirrhotic liver can regress back to the state of a nice soft elastic unscarred liver in 12 weeks. I would love to be proved wrong about this.

dt