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50th International Liver Congress

Hepatitis C – realising the dream

Last year’s European Association for the Study of the Liver (EASL) International Liver Congress (ILC) in London garnered huge media coverage and record-breaking attendance due to the very positive data presented on the new combination treatments that can cure (sustained virologic response) up to 97 per cent of hepatitis C patients within three months.

This year, the 50th anniversary of the meeting, saw further positive data on the new treatments presented.

Over 100 Irish hepatitis C patients, those with advanced liver failure, have already been cured by the new combination treatments. The patients received these treatments across clinical trials, compassionate access, and the HSE’s early access programme under the Irish Hepatitis C Outcomes and Research Network (ICORN), which was launched in November.

Over 12,000 people have been diagnosed with hepatitis C in Ireland, but an estimated 20,000-30,000 are undiagnosed, with 8,000 people currently accessing tertiary specialist treatment. There are seven specialist treatment centres across the country.

Some €30 million has been provided in the HSE National Service Plan for 2015 to commence the phased roll-out of the national hepatitis C treatment programme. This programme will treat on the basis of clinical need, and treat at least 400 people in 2015 with severe liver disease, ‘compensated cirrhotics’. However, the funding has yet to be released.

At a briefing in Vienna for Irish media on the current situation for hepatitis C patients in Ireland, organised by AbbVie, Dr Diarmaid Houlihan, Consultant Hepatologist, St Vincent’s Hospital, Dublin, called on the HSE to release the funding so that the national phased treatment programme can commence immediately.

“It is extremely disappointing. We have been ready to go for some months. There is unease among clinicians that we haven’t started yet. How many will suffer because of these delays? I’ve had experience of it already and around the country it’s happening too,” Dr Houlihan commented.

While the reimbursement price has not yet been revealed, the treatments are expected to cost in the region of approximately €50,000 per patient. Three hepatitis C patients with serious liver disease attending St Vincent’s have already paid privately for the drugs instead of waiting for HSE reimbursement. One patient mortgaged his house and ended up paying over €100,000 to be treated over 16 weeks, he was so desperate to be cured, Dr Houlihan revealed.

One patient mortgaged his house and ended up paying over €100,000 to be treated over 16 weeks, he was so desperate to be cured

The cost of a liver transplant is €120,000, not including years of chronic care beforehand and the lifelong monitoring treatment afterwards, so the new drugs will create significant savings in the long run, Dr Houlihan pointed out. In addition, only 44 liver transplants were carried out in Ireland last year, down 15-20 per cent on good years, with a knock-on effect on waiting lists. Furthermore, he noted there is still a five-year mortality rate of 20 per cent with successful transplants, and 10-year survival is 70 per cent at best, while the rate of re-transplantation with hepatitis C patients is twice the rate of patients with any other disease, and long-term survival is also poorer.

“We have the highest waiting list now for many, many years, if not ever. It’s donor shortage. We need livers, and liver disease is rising. Sadly, we have had a very real mortality toll on our waiting list in 2014 and 2015. About 10-to-15 per cent on the list die waiting annually,” Dr Houlihan said.

There is also an annual 5-to-10 per cent chance of developing liver cancer for these patients, as well as a similar risk for developing decompensation.

He added that the women who were infected with hepatitis C through anti-D “have been very understanding” to date about waiting for the roll-out of the new combination treatments, and the fact those with advanced liver disease or liver failure are being treated first.

Just over 1,700 people were infected with hepatitis C through receipt of contaminated blood and blood products in Ireland. While some of these patients have died due to their disease or been cured, about 500 have active disease. There have been suggestions of a separate funding stream to fast-track their treatment

“We also have an ethical obligation to reach out around the country, to methadone centres around the country, to look for the cirrhotics that haven’t quite accessed care… there is a burden of advanced liver disease out there,” Dr Houlihan stated, adding that identifying hepatitis C patients with fibrosis is another challenge.

The HSE told the Medical Independent (MI) it is in the process of putting in place the necessary governance structures to support the national hepatitis C treatment programme roll-out.

Speaking to this newspaper, Minister for Health Leo Varadkar said: “The early access programme has produced really good results and I got the figures back from ICORN the other day, and they have really exceptional results. They have been authorised to go onto the next group of people based on clinical need. The actual programme itself hasn’t been approved but I expect that to go to Government in the next couple of weeks.”

On the horizon

At the media briefing Dr Juan Carlos Lopez-Talavera, Vice President Medical Affairs Head, Hepatology, AbbVie, spoke about the ongoing refinement of the new hepatitis C treatments and how the treatment landscape has been revolutionised since the first treatments.

He pointed out that the development of the latest combination treatments means that hepatitis C is the first viral disease that now has a cure.

“Back in 1987 I honestly thought we would never cure hepatitis C. Then there was interferon and I thought we would need one year of therapy maybe and we would not cure everybody but I kept learning, learning more about the virus. So how far can we go with this virus? We have gone from one year of treatment to potentially four weeks in just over 25 years. There is no other chronic virus that has a cure; this is the first one,” he commented,

Dr Lopez-Talavera said that there is now promising early data on hepatitis C patients achieving a cure within six weeks of treatment, and some patients who had not finished the prescribed full treatment cycle have been cured with one month of treatment. This means that treatment costs could reduce significantly in the future.

He pointed out that a lot of patients were unsuitable for the previous hepatitis C treatment regimens and for interferon. He added that for those who were suitable, tolerability was a significant issue, unlike the latest combination treatments.

“The new treatments are so safe, everyone can take them. So the problem, per se, is not the cost of the medication but the fact that there are so many more patients to treat, as the treatments are so good,” he said, confirming that AbbVie is working with governments and healthcare providers on how to maximise access.

In the long term, eventual eradication of hepatitis C is the ultimate goal, Dr Lopez-Talavera agreed.

Also speaking during the media session was Charles Gore, President of the Executive Board, World Hepatitis Alliance, who highlighted the lack of awareness about the global burden of hepatitis C. He contended that the symptoms of the disease and its patient profile mean it is not given as much prominence as cancer or other more “sympathetic” diseases.

“I also think viral hepatitis has been tremendously overlooked in global health so we have a legacy of that. So that means within a ministry of health there are very few people working on it and they are not in high-powered positions… though viral hepatitis annually kills more people globally than HIV, malaria and TB, and yet it has nothing like the awareness or recognition, ” Mr Gore said.

Perspectives

During the ILC in Vienna, there was a special opening ceremony for an art exhibition aimed at increasing understanding the human burden of hepatitis C. It is titled Perspectives — Art, Liver Diseases and Me and was created and supported by AbbVie, with donations from EASL.

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Irish painting in the Perspective exhibition. Left: Vaida Varnagiene, Your Inner Landscape, acrylic and mixed media on canvas. Right: Ronan O’Reilly, Der Weg (The Path), watercolour on paper

Perspectives is an art collection of more than 80 pieces of work from 25 different countries, including Ireland, designed to add a different dimension to the understanding of liver diseases.

Each artistic expression carries a message of hope and a passionate desire to help people better understand the impact of these diseases on patients and society. All artworks were inspired by patients’ perspectives. Artists met with patients and represent moments of meaning of the HCV burden, stigma and hope.

Trial data update on treatment

The Medical Independent (MI) received an update on AbbVie’s latest trial data on its investigational combination hepatitis C regimen. During the conference, AbbVie presented data in 29 abstracts from its ongoing hepatitis C clinical development programme.

Data presented included sub-analyses of the recently approved VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets), Phase 3b studies, including a head-to-head comparison of AbbVie’s three direct-acting antiviral treatment with telaprevir-based therapy and phase 2/3 studies investigating AbbVie’s combination treatment in genotype 1 (GT1) and genotype 4 (GT4).

The majority of Irish patients (64 per cent) are infected with genotype 1, which has traditionally been the most challenging genotype to cure. In clinical trials, the VIEKIRAX + EXVIERA (dasabuvir tablets) combination was found to clear the virus from the systems of 97 per cent of genotype 1 patients.

AbbVie’s ongoing hepatitis C pipeline development programme focuses on investigating a pan-genotypic, ribavirin (RBV)-free, once-daily treatment that may also allow for treatment durations of as little as eight weeks.

Preliminary results from a phase 2b study (n=79) of ABT-493 and ABT-530 in non-cirrhotic GT1 patients receiving the RBV-free recommended regimen for 12 weeks demonstrated a sustained virologic response rate at four weeks post-treatment (SVR4) of 99 percent (n=78/79). These results included both GT1a and GT1b, treatment-naïve and pegylated-interferon and RBV prior null responders.

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