After “astonishing” preliminary results from new drugs

As the burden of Hepatitis C (HCV) associated liver failure and liver cancer rises  in our community so hepatitis C therapy is undergoing radical and rapid change, says Centenary’s Prof Geoff McCaughan.

A review has shown how the next generation drugs telaprevir and boceprevir, approved by the TGA in 2011 for use by patients with the most common genotype 1 of the blood-borne viral infection, are significantly improving outcomes for patients living with hepatitis C.

The review, published in the Medical Journal of Australia (MJA) today (Monday, June 4), describes how these drugs, when used in conjunction with existing therapy, boost the percentage of patients who clear the virus from 45% to 70%.

Not only do the new drugs allow more patients to be cured, they also work much faster than conventional therapy. The review indicates that adding the drugs to conventional therapy allowed treatment times to be halved, from 12 months to 6 months, for around half of the patients without impacting on outcomes.

Prof McCaughan, writing in an MJA editorial published in today’s MJA, said progress in the field is astonishing.

There are also even newer kinds of drugs coming down the development pipeline.

“It seems likely that, within five years, we will have short-duration anti-hepatitis C therapy with minimal side-effects and cure rates above 90%,” said Prof McCaughan, who is head of the Liver Injury and Cancer group at the Centenary Institute and a physician based at Sydney’s Royal Prince Alfred Hospital.

“The challenge then will be how we can deliver such therapies to the 200,000 Australians with hepatitis C infection.”

Treatment times could be wound in to three months with further advances, Prof McCaughan said.

He said the long duration, side-effects and uncertain outcomes of conventional hepatitis C therapy see many people go without treatment.

Among patients with chronic infections, it is thought just 2% per year are receiving the antiviral therapy which could stop them from progressing to end-stage liver disease.

“… by moving hepatitis C treatment from hospital clinics into the community these new therapies will potentially reduce stigma and may stimulate increased testing and treatment for hepatitis C infection,” Prof McCaughan said.

“Short treatment duration, high cure rates and low toxicity will mean that all hepatitis C-infected patients should eventually receive curative therapy.”

Professor McCaughan is Assistant Director of the Centenary Institute and head of the Institute’s Liver Injury and Cancer program. He is also Director of the Australian National Liver Transplant Unit at Royal Prince Alfred Hospital.

He is available for media interviews on Sunday 3 and before 0800 and after 1100 on Monday June 4.

For interviews contact:

• Suzie Graham, the Centenary Institute, 0418 683 166, s.graham@centenary.org.au
• Or Niall Byrne, Science in Public for Centenary, 0417 131 977, niall@scienceinpublic.com.au

Paper online at: https://www.mja.com.au/journal/2012/196/10/end-chronic-hepatitis-c-virus-infection-sight (MJA paywall).

What is hepatitis C?

Hepatitis C is a blood-borne viral disease transmitted mainly by injection with infected needles. While the condition can eventually lead to serious liver disease such as cirrhosis, liver cancer and liver failure, many patients with hepatitis C do not display symptoms until their liver starts to fail, which can be up to 15 years after the virus was first contracted.

Hepatitis C is a serious problem. At present, of about 220,000 Australians thought to be infected by hepatitis C, nearly a quarter are already suffering moderate to severe liver disease. But fewer than one in fifty is treated each year, and about 11,000 new cases are diagnosed annually.

Unlike hepatitis A and B, there is no vaccine for hep C, making any improvements in treatments even more important. At present the disease is overwhelmingly associated with intravenous drug use, but in the past poor infection control during blood transfusions has also been to blame.

What happens if chronic hepatitis C infection is not treated

People with chronic hepatitis C infection who do not receive treatment can progress to liver cirrhosis and, ultimately, liver failure placing them in need of a life-saving liver transplant.

These patients face a long waiting list and a tight supply of livers suitable for transplant. Many do not survive the wait.

Liver cirrhosis is also responsible for 90% of liver cancer cases and ranks #8 overall in causes of death in the world. In Australia, the rate of liver cancer has increased 4-fold in the past 20 years and liver cancer is the 3rd leading cause of cancer deaths in the world. Sadly, this trend is expected to continue.

Conventional treatment for hepatitis C

There is no vaccine for Hepatitis C and existing treatment is expensive, prolonged, has many side effects and is not largely successful. The existing therapy uses two drugs – ribavirin and pegylated interferon.

The hope is to develop new Hepatitis C anti-viral therapies that do not involve interferon, as this accounts for many of the side-effects of conventional treatment. The arrival of new direct-acting agents to target hepatitis C supports this aim.

New drugs for hepatitis C

The new drugs, boceprevir and telaprevir, are the first in a new class of direct antiviral agents which target hepatitis C.

The drugs have been approved by Australia’s Therapeutic Goods Administration (TGA) so far for treatment of adults with chronic hepatitis C genotype-1 who are previously untreated or have failed previous treatment.

Patients receive the new drugs for the first 12 weeks of either a 24 or 48 week drug regimen that still includes the current Standard of care drugs Interferon and Ribavarin. Both boceprevir and telaprevir d are awaiting listing on the Pharmaceutical Benefits Scheme.

In the US at present a course of the new treatment costs between $45,000 and $85,000, but that’s a lot less than the estimated $130,000 plus $15,000 a year in therapy for a liver transplant.

Preliminary results in small numbers of patients however indicate that even newer drugs directed against different parts of the hepatitis C can be used without Interferon .These drugs seems to have low side effects , can cure patients in up to 90% of cases and only require 3-6 months of therapy. How they will be used in combination is currently under study in many world-wide clinical trials.

About Professor Geoffrey McCaughan

Professor McCaughan can provide expert comment liver disease, liver cancer and transplantation, gastroenterology and hepatitis. His titles are:

Assistant Director of the Centenary Institute

Head of the Institute’s liver injury and cancer program

Director of the Australian National Liver Transplant Unit at Royal Prince Alfred Hospital

About the Centenary Institute

The Centenary Institute is an independent leader in medical research seeking improved treatments and cures for cancer, cardiovascular, autoimmune, liver, genetic and infectious diseases. We are working to discover new prevention, early diagnosis and treatment options to enable each generation to live longer, healthier lives than the one before. Centenary’s affiliation with the RPA Hospital and the University of Sydney means that our discoveries can be quickly applied to the fight against disease in the clinic. More at: http//www.centenary.org.au/