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November 2017
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Get Bloody Serious! in Surry Hills
Date: 03 Nov - 03 Nov

A workshop on how to make hep C history – from prevention to cure! Hepatitis NSW are delivering this interactive work

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December 2017
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International Volunteer Day
Date: 05 Dec - 05 Dec

International Volunteer Day (IVD) is celebrated each year on 5 December and was established by the United Nations Genera

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Hep C treatment

Hep C treatment

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Introduction

Hepatitis NSW does not want to appear to give preference or prominence to one treatment regime over another. This factsheet relates to these hepatitis C treatment drugs (in alphabetical order):

  • Epclusa (sofosbuvir/velpatasvir) two drugs combined in one pill
  • Harvoni (sofosbuvir/ledipasvir) two drugs combined in one pill
  • Sovaldi-Daklinza (sofosbuvir and daclatasvir) in separate pills
  • Sovaldi-Ibavyr (sofosbuvir and ribavirin) in separate pills
  • VIEKIRA PAK (paritaprevir/ritonavir/ombitasvir and dasabuvir) in separate pills
  • Zepatier (elbasvir and grazoprevir) two drugs combined into one pill.

Treating doctors will advise which treatment options are suitable for individual patients, based on the patient’s genotype, level of liver damage and treatment history. Depending on these factors, the treatment drug Ibavyr (ribavirin) might be added to: Epclusa, VIEKIRA PAK or Zepatier.

Other new drugs for treating hepatitis C are currently in different stages of development and/or approval. Over time, these new drugs will also likely be PBS listed and funded, and this factsheet will be amended accordingly.

Success rates of the new treatments

All the above treatments achieve cure rates around 95% or more, depending on pre-treatment variables such as the presence of cirrhosis or prior therapy. The cure rates also relate to people’s hepatitis C genotype.

Treatments and genotypes

Treating doctors will advise which treatment options are suitable for individual people. Here is a guide to the likely treatment option by genotype:

  • Patients with genotype 1a or 1b, can be offered Epclusa or Harvoni or Sovaldi-Daklinza, or Zepatier
  • Patients with genotype 1a, can be offered Epclusa or VIEKIRA PAK-Ibavyr
  • Patients with genotype 1b, can be offered Epclusa or VIEKIRA PAK
  • Patients with genotype 2, can be offered Epclusa or Sovaldi-Ibavyr
  • Patients with genotype 3, can be offered Epclusa or Sovaldi-Daklinza
  • Patients with genotype 4, can be offered Epclusa or Zepatier
  • Patients with genotypes 5 or 6, can be offered Epclusa.

Other drug combinations are approved and available and some of the above options might also include Ibavyr (ribavirin). The above combinations are the ones with best response and tolerability.

Treatment durations

Epclusa

= 12 weeks, irrespective of whether the patient has cirrhosis

Harvoni

= 8 weeks for patients with no prior treatment, no cirrhosis and viral load less than 6 million IU/mL

= 12 weeks for patients with no prior treatment, no cirrhosis and viral load more than 6 million IU/mL

= 12 weeks for patients with no prior treatment and cirrhosis

= 24 weeks for patients with prior treatment and cirrhosis

Sovaldi and Daklinza

= 12 weeks (although likely longer for patients with cirrhosis)

= 24 weeks for patients with genotype 3 and cirrhosis

Sovaldi and Daklinza plus Ibavyr

= 12 weeks for patients with genotype 1 and cirrhosis

= 12 weeks for patients with genotype 3 and cirrhosis

Sovaldi and Ibavyr

= 12 weeks for patients with genotype 2

VIEKIRA PAK

= 12 weeks for patients with genotype 1b, no cirrhosis

= 12 weeks for patients with genotype 1b, compensated cirrhosis

VIEKIRA PAK plus Ibavyr

= 12 weeks for patients with genotype 1a, no cirrhosis

= 12 weeks for patients with genotype 1a, with cirrhosis

= 24 weeks for patients with genotype 1a, cirrhosis and prior null response to treatment

Zepatier

= 12 weeks for patients with genotype 1 or 4, with no prior treatment, or with prior treatment relapse

Zepatier plus Ibavyr

= 16 weeks for patients with genotype 1a or 4, who experienced prior treatment failure.

Are new treatments taken with ribavirin or interferon injections?

Several of the new treatments, listed above, are sometimes taken with ribavirin. Importantly, all the new treatments are taken as tablets (pills) and none involve interferon injections.

Treatment side effects

Epclusa is well tolerated with only minor side effects.

Harvoni is well tolerated with only minor side effects.

Ibavyr is teratogenic and pregnancy and conception must be strictly avoided (by women AND men) while on treatment and for 24 weeks following end of treatment.

Sovaldi and Daklinza are well tolerated with only minor side effects.

Sovaldi and Ibavyr are well tolerated – aside from Ibavyr’s teratogenic effects (see below) the most common adverse events of ribavirin are anaemia, fatigue, headache, skin irritation and insomnia).

VIEKIRA PAK is well tolerated with only minor side effects. When taken with ribavirin, it is well tolerated but may be associated with anaemia, fatigue, headache, skin irritation and insomnia.

Zepatier is well tolerated with only minor side effects. When taken with ribavirin, it is well tolerated but may be associated with anaemia, fatigue, headache, skin irritation and insomnia.

A special emphasis is on pregnancy, which must be strictly avoided by both men and women treated with Ibavyr (ribavirin) in any of the previously mentioned treatment combinations (during treatment and for 24 weeks after). Pregnancy should also be avoided with the other DAA drugs. It is also recommended that DAA treatment is not undertaken while breastfeeding.

Does treatment interfere with other drugs?

Particular medicines can interfere with other medicines, or with recreational drugs (including alcohol). A useful website that lists all these interactions is based at University of Liverpool (UK). It is important to discuss what other medications or recreational drugs your patients are using.

http://www.hep-druginteractions.org/

There are some drug-to-drug interaction issues with some DAAs (for example, with St John’s Wort or the drug amiodarone which is used for heart problems) but most cases can be adequately handled with changing accompanying medications, or choice of hepatitis C medication, or through careful monitoring.

No treatment restrictions

All Australian adults who have chronic hepatitis C (any genotypes from 1 to 6) and who hold a Medicare Card are eligible to access the new treatments, regardless of their stage of disease.

There are no restrictions applied for people who inject drugs. If people are denied access or experience limited access to treatment and believe it is because of their status as a person who injects drugs, they can call either the Hepatitis Infoline on 1800 803 990 or the NSW Users and AIDS Association on 02 8354 7300 for information.

The new treatments are also available for prisoners (see far below).

Treatment access

Doctors and specialists working at hospital liver clinics can provide the new treatments.

GPs and other doctors experienced in the treatment of hepatitis C can also provide the new treatments. This expands access to treatment, especially for patients in rural areas.

See www.hep.org.au/services-directory/ for a listing of GP across NSW. This list is updated on a regular basis.

Preparing for treatment

People with hepatitis C have an initial GP or specialist assessment. This involves full blood testing and assessment of fibrosis stage, via Fibroscan or APRI test.

People with cirrhosis are referred for specialist care and treatment. People with cirrhosis require long term monitoring for complications including liver cancer. See www.hep.org.au/services-directory/ for a listing of Fibroscan availability across NSW.

It is important that all people are tested for the presence of hepatitis B prior to starting hepatitis C medications. This is because some people with hepatitis B have had increased activity of hepatitis B during treatment which may require special attention.

Filling of prescriptions

Scripts are usually filled for a month at a time. S100 scripts are written as public hospital items and need to be dispensed in the public hospital pharmacy. Hospital pharmacies will usually be able to fill scripts on the day.

The new S85 (General Schedule streamlined approval) scripts are written by GPs or specialists and are dispensed at community pharmacies. Community pharmacies don’t usually have the capacity to carry stocks of the DAA medicines, but will order them in – usually within 72 hours.

It is important to remind the community pharmacy to order in the next month’s supply of medications about a week before the medications are due to be collected.

Online pharmacies

Hepatitis C treatment drugs can also be ordered from online pharmacies. While this might not be as secure as customers picking up their treatment drugs from a local pharmacy, it will be very helpful for people who live in parts of NSW with no pharmacies that fill these scripts.

Consumers are required to

  • fill in their details online
  • phone the pharmacy
  • post the prescription to the address provided on the website.

The pharmacy must first receive the prescription. Once they receive the script, they will place the order for the medicine, which may arrive within 1-2 days and then the medicine is delivered through Australia Post.

Try the following online pharmacies…

https://www.chemistwarehouse.com.au/

https://www.epharmacy.com.au

https://www.pharmacyonline.com.au

http://www.pharmacydirect.com.au/

http://www.yourchemistshop.com.au/

http://www.royyoungchemist.com.au/

If the treatment drugs don’t appear in their ‘search’ option, people should call the online pharmacy. They can take orders over the phone (generally, a medicine doesn’t go live on their site until it’s ordered previously). Further, online pharmacies prefer to receive a call about the script beforehand so they can explain to the consumer the process.

Treatment costs

People are charged only the usual monthly co-payment paid for a prescription. This is currently $38.80 per month for general patients and $6.30 per month for concessional patients.

Treatment monitoring and follow up

Viral load is not checked while people are on treatment as the result does not affect the treatment duration. Only liver enzymes, kidney function and full blood count are checked at week 4 of treatment.

If ribavirin is required in the treatment, then most people will have blood tests every month of treatment.

Some hospital clinics may use different monitoring protocols based on whether or not people have other illnesses and the complexity and severity of their hepatitis C disease.

All people will require a PCR viral detection test 12 weeks after treatment finishes to check if they are cured. It is VERY IMPORTANT to attend for this post-treatment check up. People should not assume that treatment has cured their hep C; they should find out for sure with the final PCR test.

Defining cure

“Cure” or “SVR” (Sustained Virological Response) means that someone has cleared hepatitis C virus from their body. If someone has a PCR viral detection test which shows undetectable (no virus) at 12 weeks after treatment finished they are cured.

If hepatitis C has caused significant liver damage, clearing the virus (cure) might not mean that someone is healthy again all of a sudden. In particular, if someone has cirrhosis, they still need specialist care and monitoring. People with cirrhosis still have a potential risk of developing liver cancer, even after being cured of hepatitis C.

People should talk to their treating doctor about what “cure” should mean for them.

If treatment is not successful

In a very small number of cases, treatment does not cure hepatitis C. This can happen for many different reasons including genetics, the virus mutating, or a person missing some pills during treatment. It is important to remember:

  • There is no limit on how many times a patient can access these treatments.
  • There is no evidence to suggest that if treatment didn’t work the first time, it’s never going to work.
  • Liver specialists will do everything they can to ensure patients are cured of hep C; “no one will be left behind” is the current treatment approach.

In these cases, a person should be referred to a liver specialist who will advise on the best treatment for each individual person. Sometimes this might involve the same treatment with added Ibavyr (ribavirin) or it might be another combination altogether.

Treatment inside NSW jails

People with hep C in NSW jails will be assessed and treatment delivered under Justice Health and Forensic Mental Health Network’s (JH&FMHN) Nurse-Led Model of Care. There are 31 JH&FMHN Health Centres across NSW and most will be able to initiate and manage the new hep C treatments. To talk about accessing treatment, prisoners should first talk to the Health Centre Nurse.

For more information about hep C including treatment, prisoners can call the Hepatitis Infoline by dialling 3 on their Common Calls list. This is a free service.

Children and treatment

The PBS listing of direct acting antivirals is for Australian adults only. Children with hepatitis C should be seen and assessed by a paediatrician experienced in viral hepatitis. To find out more about monitoring and treating hepatitis C in children, contact the gastroenterology unit at The Children’s Hospital at Westmead (02 9845 3999).

 

Click here for “Hep C treatment FAQs”

For more news, subscribe to The Champion e-newsletter, and call the Hepatitis Infoline (1800 803 990).

Choose an infographic download from the bottom of the page, depending on if you print in colour or black & white.

This page was last updated 1 August 2017

Content drawn from Australian Recommendations for the Management of Hepatitis C Virus Infection: a Consensus Statement 2017, and publications of ASHMThe Kirby Institute and The Centre for Social Research in Health, and vetted by our Medical and Research Advisory Panel.

 


Infographic overview of new treatments - PDF

For an infographic / easy read overview of new treatments, download here