TOPIC: Expert Professor by email - Viral Load Monitoring

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.

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

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.

And from the same study:

CONCLUSION:
Data from phase III studies demonstrate that with SOF-based regimens, with or without interferon, SVR12 and SVR24 correlate closely. Thus, SVR12 can be used effectively to determine "cure" rates in trials and in clinical practice.

Hi everyone,
I have been on Chinese Dacltasvir and Sofosbuvir for the last 10 days. I am Geno 3A, and was infected since late 70s. So far no side effects at
all. My own Dr wrote the prescription and ordered my first Viral load testing. I always get copies myself, and the results say that my dr cant order those tests. Do you have any suggestions for me please? I live in the country in NSW.
Thank you in advance

Hi Ann

I would suggest booking an appointment with GP2U and the tests can be ordered through an in house specialist, all bulk billed for you. Gotta love GP2U. Em

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 Emilio,
I just booked in with Dr Freeman on GP2U on line and the website says that all GP consults are not Medicare covered. There are no specialists listed for Hepatology/Gatsroeneterology etc,. The website appears to indicate that specialists are covered by Medicare. So I cant see the bulk billing you mentioned. Is this correct. Or are the test s ordered for Hepc bulk billed? Sorry just not clear with what you mentioned
Kindest Regards

Oh so sorry just saw the follow up messages!! Talk soon Dr Freeman!!

The situation with Medicare and HepC testing are here

fixhepc.com/forum/experts-corner/105-exp...ing.html?start=6#217

Essentially a Specialist needs to authorise an initial test of viral load but during treatment a GP can order VL tests.

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.

Telehealth

Medicare funded Specialist Telehealth is a good example of rationing.

In 2011 when it was set up about 2/3 of all Australians were eligible to see a Specialist online.

On 1st Jan 2013 that number was reduced to 1/3 of all Australians.

By way of example we had a psychiatrist in Brisbane seeing patients on the Sunshine and Gold Coasts saving them ~4 hours travel. All her patients became ineligible overnight when they extended the ineligible zone from central Brisbane to to extend from Noosa in the North down over the border into NSW stopping just short of Byron Bay.

gp2u.com.au/links.html

There are about 24 million specialist consults a year. There are 140 million GP consults. Of those 160 million consults only 1/3 of the 24 million = 8 million are eligible for Medicare funded Telehealth. That's about 5%.

This has never been any funding for GP or Allied Health Telehealth and in my view the Government has done a pretty good job of killing Telehealth off. Even Medibank has given up selling their Anywhere Healthcare business to Telstra for an undisclosed sum following a $15 million loss (disclosed in their IPO).

Why it should matter if a patient uses feet, wheels, wings or video to get to their doctor is beyond me.

Hi Ann and James

I work in the health system in NSW (state) and it was my belief that telehealth was being expanded and promoted heavily, particularly in more rural remote communities. Isn't it interesting when you the look at the broader federal machinations which is essential throttling this fantastic service. In part this would be about protection of others (specialists and GP lobby) who are not taking this up as an option for patients. Why am I surprised the federal government has little understanding as to what's occurring at a state level let alone at the grass roots. And why governments insist on spending millions on IT infrastructure is beyond me? This is plug and play stuff now with technology such as skype, video chat etc. Em