Need-To-Know News on Hepatitis C Treatment – Updated May 2015

Click to download a copy

Click to download a copy

Introduction

Hepatitis C treatment continues to develop at a rapid pace, so we’ve updated our fact sheet to help you make well-informed decisions about your treatment plan.   You can download your copy here.

Please bear in mind, the information and comments we’ve presented here are not intended as a substitute for professional medical advice. Always refer to your GP, liver specialist or hepatology (liver) nurse for expert advice on the type of treatment that is best suited to your individual situation.

Hepatitis C Treatment: An overview

For many years, the standard treatment for hepatitis C has been pegylated interferon and ribavirin, both of which cause significant side-effects. But with groundbreaking new treatments becoming available, we anticipate that over the next few years at least 9 out of 10 people could be cured of hepatitis C by taking a short course of tablets with very few side-effects.

The improvements in treatment for hepatitis C began a few years ago:

  • In April 2013, boceprevir and telaprevir, the first direct acting antiviral medicines (DAAs) to be used in combination with standard treatment, were subsidised by the government through listing on the Pharmaceutical Benefits Scheme (PBS) for people with hepatitis C genotype 1.

  • In December 2014, simeprevir, a second generation protease inhibitor was listed on the PBS for people with hepatitis C genotype 1 replacing the use of boceprevir and telaprevir.

The improvements will keep coming; interferon-free treatment options with higher cure rates and fewer side-effects are getting close but none are available on the PBS yet.

What’s the current treatment for hepatitis C in Australia?

Treatment at the moment is tailored according to the particular genotype or strain of hepatitis C that you have. In Australia, the most common are genotype 1 (54%) and genotype 3 (37%). Collectively, genotypes 2, 4, 5 and 6 have less than 10% prevalence in Australia. The information provided below is therefore focused on treatment options for people with genotype 1 and genotype 3 infection.

Treating hepatitis C genotype 1

In December 2014, the treatment for genotype 1 changed to include weekly pegylated interferon injections, with twice-a-day ribavirin tablets, and a once-a-day tablet of simeprevir (Olysio), a second generation protease inhibitor.  

Simeprevir replaces previous treatment regimens using boceprevir or telaprevir. Compared to boceprevir or telaprevir, it is easier to take (no fatty food requirements), better tolerated (fewer side-effects) and safer (few complications).

The treatment regime begins with triple therapy of simeprevir, ribavirin and pegylated interferon for the first 12 weeks. This is followed by ribavirin and pegylated interferon for an additional 12 or 36 weeks. Your length of treatment will be determined by your doctor. Prior treatment responses and/or how quickly the virus responds to treatment this time will be considered. If the virus doesn’t respond well to treatment it may be stopped.

Simeprevir is not recommended for use if you have previously been treated with pegylated interferon and ribavirin and either boceprevir or telaprevir, as there is no data to suggest that there would be a clinical benefit.

Treating hepatitis C genotype 3

For hepatitis C genotype 3, treatment has remained unchanged for many years and includes a combination of weekly pegylated interferon injections and daily ribavirin tablets over a period of 26 weeks.

What are the side-effects of current treatments?

The side-effects of pegylated interferon and ribavirin can be significant, which is one reason why treatment rates remain so low in Australia.

Possible side-effects from pegylated interferon and ribavirin include:

  • Mild to severe mood disturbances
  • Anaemia
  • Slow blood-clotting
  • Fatigue
  • Flu-like symptoms
  • Dry skin
  • Rash
  • Insomnia
  • Decreased appetite
  • Weight loss
  • Hair loss.

Ribavirin can also cause birth defects and is therefore not suitable for women who are pregnant or trying to get pregnant.

Additional possible side-effects related to simeprevir include:

  •             Skin rashes or itchy skin
  •             Skin sensitivity to sunlight
  •             Constipation
  •             Nausea.

Often, the body’s tolerance of treatment is reduced the longer the treatment lasts. Therefore, for most people, shortening the duration of treatment can result in higher tolerance and fewer/lesser side-effects.

If you experience side-effects, the earlier you seek advice from your doctor, the better. Early intervention and careful monitoring can often minimise side-effects.

In rare cases, treatment may be stopped to avoid progression of significant life-threatening side-effects.

Mixing other medicines with hepatitis C treatments

Mixing your medications can be dangerous, if you need to take other prescription or over-the counter medicines during your treatment, always check with your specialist first. This includes herbal medicines such as St. John’s wort or milk thistle, which should not be taken with simeprevir.

What are my chances of being cured with current treatments?

On average, there is a 70% to 80% success rate with current treatments. However, there are many personal factors that influence treatment outcomes for individuals. To get a better understanding of how well you’re likely to respond to current treatments, make an appointment with your doctor.

The success of your treatment can be improved by taking your prescribed medicines regularly, so be sure to follow your doctor’s instructions consistently.

How will my response to treatment be monitored?

Your response to treatment is monitored by taking blood tests at intervals to measure the amount of virus in your blood. What your doctor will be looking for is a Sustained Virological Response (SVR). This means that the virus drops to undetectable levels while you are undergoing treatment and remains undetectable for six months after you complete the treatment. Simply stated, it means you’re cured.

What if treatment doesn’t work for me?

If your treatment doesn’t result in a cure this time, remember there is hope in the form of new medicines that might be suitable for you. Stay in touch with your doctor for regular liver health checks and updates on the release of new treatments offering higher cure rates.

 What do the new hepatitis C treatments offer?

New interferon-free treatment options will be the next major step in hepatitis C treatment in Australia. Generally by using a combination of new interferon-free medicines, very high cure rates can be achieved with far fewer side-effects than current treatments.  The cure rates for those who are living with cirrhosis or people who didn’t previously respond well to treatment will also improve markedly.  In some cases there may still be a need to combine the new medicines with pegylated interferon and/or ribavirin to achieve the highest possible cure rate.

When will new treatments be available in Australia?

Interferon-free treatment options in Australia are getting much closer. In May 2015 following a review of submissions made to an expert panel, recommendations were made to the government to provide affordable PBS access to several new hepatitis C treatments. The medicines recommended by the experts on the Pharmaceutical Benefits Advisory Committee are:

  • sofosbuvir (Sovaldi®)
  • ledipasvir/sofosbuvir (known as Harvoni®), and
  • declatasvir (Daklinza®)
  • Importantly, the recommendation did not recommend limiting access to the new medicines to those with more severe liver disease.

Once the price for the medicines is set the Federal Cabinet will need to approve the funds to subsidise the medicines before they can be added to the Pharmaceutical Benefits Scheme and made available at an affordable cost.

This process can be complex and subject to delays. As a general rule, you need to be eligible for Medicare to access medicines subsidised by the government on the PBS; however, there are some exceptions.

In addition to the medicines mentioned above, another new treatment option combining ombitasvir, paritaprevir and ritonavir co-packaged with dasabuvir (Viekira Pak) will be considered by the expert panel in July 2015 for treatment of hepatitis C genotype 1 and the outcome will be known in late August 2015.

Hepatitis Australia will post updates of any progress towards PBS listing as they are  announced, so keep an eye on our website for further information www.hepatitisaustralia.com.

Don’t put your health at risk by waiting too long

It’s easy to understand why you might prefer to wait for interferon-free treatments to become available. However, by waiting, you could be putting your health at risk.

If you’re 40 years of age or over, you’re likely to experience an accelerated rate of liver damage which increases your risk of developing cirrhosis, liver cancer or liver failure. This is called the ‘Liver Danger Zone’.

You should also bear in mind that symptoms of liver disease may not be felt until the liver is significantly scarred.

Please don’t put your health at risk by waiting too long for treatment. Make an appointment with your doctor to have a liver health assessment and treatment discussion with your doctor at least once a year.

What does a liver health assessment involve?

Your doctor will give you a clinical examination and blood tests. They may also use a Fibroscan® – a quick, non-invasive test (similar to an ultrasound) that measures the level of liver scarring to determine the severity of liver disease.

For further information on the liver health assessments see our:

If you have chronic hepatitis C and particularly if you are in the ‘Liver Danger Zone’, ask your doctor about having a regular liver health check-up today. A liver check-up is nothing to worry about, it is simple, easy and it could save your life.

Page Updated: 13 May 2015