The process of initiating treatment is simple:
- Genotype by looking it up or ordering HCV Genotype
- Fibrosis by fibroscan, Hepascore, ELF score or biopsy. See www.hep.org.au/services-directory for fibroscan locations. You may find getting a Hepascore or ELF score (blood tests) easier than getting a Fibroscan.
- Past Treatment
The quickest way to make an accurate evidence based prescription is to use our HCV Decision Support Tool which can be found here:
Simply fill in the requested values, select the guidelines you wish to use and press calculate. The tool will automatically convert kPA, Hepascore or ELF score values to the F0-F4 fibrosis scale. Not only will you get a precise list of prescription options, they are sorted by expected SVR (Sustained Virological Response aka Cure) rate. You can print these out or print to a PDF for your records. The show trials button will show you all the trials on which these recommendations are based.
Alternatively you can refer to the treatment guidelines below where you will also use the 3 items - genotype, fibrosis, and past treatment - described above:
These guidelines will inform 3 selections:
- Sofosbuvir 400 mg od + Ledipasvir 90 mg od OR Sofosbuvir 400 mg od + Daclatasvir 60 mg od OR Viekira Pak
- 12 weeks or 24 weeks treatment
- With or without the help of Ribavirin (which patients hate due to side effects, but can be a useful booster)
Now we need to look for reasons to favour one option over the others (if there are options)
- Medications (Daclatasvir and Ledipasvir in particular have many interactions) you can check with this tool http://www.hep-druginteractions.org/checker
- Contraindications (amiodarone)
- Allergies (unlikely)
- Blood results indicating severe illness like anaemia, thrombocytopaenia that say NO ribavirin
For a quick 15 minute video tutorial about Ribavirin please watch Professor Graeme Foster's talk: https://www.youtube.com/watch?v=vCcpES8O6P0
Now you have decided on the best medications and duration, prescribe them.
This is 100% medico-legally defensible - Yes your honour I chose to prescribe proven Hep C medications to a Hep C patient. This decision was entirely appropriate, done according to established guidelines, and with full patient informed consent.
You should inform patients that at some point in the future these medications will be available (effectively for free) via your local subsidy process (like has just happened in Australia). The vast majority will say they are either sick of waiting or can't afford to wait, but they should be informed.
Accessing Generic Medications
Helping the patient safely access these medications completes your duty of care around making a prescription.
NSW Health and the Australian Society of HIV Medicine have issued this guidance:
As you will note there are two organisations flagged as reasonable places to source medications. You are looking at one and will find the full details on the FixHepC Buyers Club page.
Please read the following to see why we are a trusted source and satisfy any concerns you may have:
To see why we are a trusted source and satisfy any concerns you may have.
Now the patient has access to the medications, here is what monitoring on treatment looks like:
- Baseline FBC, Cr&E, LFTs, Hep C Viral Load with reasonable currency + AFP and liver ultrasound for those with cirrhosis looking for Hepato-Cellular Carcinoma (HCC)
- 4/52 into treatment FBC, Cr&E, LFTs, Hep C Viral Load
- Repeat Viral Load at 4 week intervals if not undetected 4 weeks after commencing treatment (once undetected there is little value in repeating unless virological breakthrough seems likely - LFT elevations will flag this)
- EOT (End Of Treatment) exit bloods
Hep C Viral Load can be quantitative (undetectable, <15, or 15-100,000,000) or qualitative (undetected/detected). Quantitative makes sense early on in treatment, but once <15 has no extra value over a qualitative detected/undetected.
In Australia Medicare will pay for 2 quantitative and 4 qualitative tests a year. Note that Medicare will only fund Hep C viral load testing when it is a) ordered by a specialist or b) ordered by a GP for a patient having treatment so please make sure you add "Having DAA treatment for HCV" in the clinical notes or your patient will get either a bill or the test won't get done. Also note that for quantitative testing you need a specialist to authorise it (they don't have to order it) but you need to add something like "Having DAA treatment for HCV. Authorised by Dr John W Freeman FRACP". Apparently GPs can't be trusted by the HIC to order this test alone....
Typical side effects are listed here: Side Effects.
With headache and insomnia being relatively common, know that aspirin, paracetamol and ibuprofen, morphine, methadone and tramadol all work for headache and don't interact. For insomnia temazepam, diazepam, oxazepam and zolpidem all work and don't interact.
For answers to typical patient questions please consult our Frequently Asked Questions section.
The typical treatment experience is usually very favourable. No, or minimal side effects with many patients by week 4 feeling better than they have in years.
Ribavirin is a different kettle of fish. It is a fake guanosine so gets incorporated in all DNA/RNA with the result it impacts on all dividing cells as well as the hep C virus. Anaemia is a very common side effect. Dose reduction or cessation may be required. The dose is 1000 mg if < 75 kg and 1200 mg if > 75 kg daily in two divided doses. Reduction by one or two 200 mg capsules a day is a reasonable first response to falling Hb or platelets. Frequent monitoring (weekly or fortnightly) will catch ADRs like anaemia before they become a major problem. Asymptomatic changes to the numbers do not warrant concern.
Ribavirin is a booster so don't avoid it because it needs more monitoring. Your patients will get better results if it is prescribed as per guidelines than if not. It is generally only required in patients with cirrhosis.
SVR (Sustained Virological Response)
Treatment success rate is about 90-95% and is measured with SVR. SVR is counted in weeks from the cessation of medication.
- SVR24 is the gold standard - zero viral load at 24 weeks post treatment and represents a < 1% chance of ever seeing the virus again.
- SVR4 represents a 97% chance of making SVR24 (96% chance of cure)
- SVR12 represents a 99.7% chance of making SVR24 (99% chance of cure)
Hep C Ab (Antibody) Levels versus Hep C RNA
When a person clears the virus HCV RNA will not be detectable. This is reported as HCV RNA Not Detected.
Hep C Antibody levels fall over time but patients who have been cured will continue to test positive for Hep C Antibodies for years. A positive Antibody test is thus normal and does not say anything about the current status of the disease, only a test for HCV RNA can answer the question about recurrence and if the virus has returned.
Cirrhosis and Fibrosis
There is good evidence for regression of fibrosis at SVR.
Patients with cirrhosis should be monitored every 6 months for Hepatocellular Carcinoma. While the AFP test is a guide it is possible the have an HCC with a normal AFP. Ultrasound, triple phase CT, or MRI are all good ways to look for HCC
PATIENTS WITH CIRRHOSIS AND WHO HAVE HAD A PRIOR HCC NEED VERY CLOSE MONITORING as recent studies have suggested an unusually high rate of HCC recurrence in this population post DAA therapy.
DAAs have a minimal side effects on treatment and offer an excellent prospect of cure.
Patients can continue to work while being treated and typically feel better within a week.
DAAs are low risk to prescribe and patients are grateful for your help.
If you are a doctor interested in offering this service to your patients or would like to help manage patients through their online (video) platform please contact GP2U. GP2U has high paying sessional work available that can be done from your practice, home or anywhere with a good internet connection.
If this page has been printed you can access the online version at: http://fixhepc.com/gp