Thursday, March 13, 2014

APASL - New treatments promise a future free from hep C

Sofosbuvir and simeprevir are currently under review in Australia and New Zealand. They received FDA approval in the US in December 2013, European Medicines Agency (EMA) approval in January 2014 and were recognised as the treatments of choice for hepatitis C in new US guidelines for the management of hepatitis C published last month [February].


New treatments promise a future free from hep C

A new era in hepatitis C is on our doorstep with treatments boosting cure rates to over 90% and the very real prospect of eradicating the condition within the next 20 years.

The new anti-viral medications also offer a much shorter duration of treatment and fewer side effects, significantly improving the outlook for people with the disease and reducing the risk of virus transmission in the community.

Almost two-thirds of the 180 million individuals with hepatitis C live in the Asia-Pacific region, including about 300,000 Australians and 50,000 New Zealanders.

According to Professor Ed Gane, University of Auckland and Deputy Director of the New Zealand Liver Transplant Unit, identifying people with hepatitis C is now of the utmost importance along with assessing their liver disease and preparing them for antiviral treatment.

“Based on some preliminary modeling, we believe if we can increase the number of patients receiving antiviral treatment three-fold and increase the success of treatment to more than 90%, it may be possible to eradicate hepatitis C in both Australia and New Zealand within the next 20 years.”

Speaking at the 2014 meeting of the Asian Pacific Association for the Study of Liver (APASL) in Brisbane this week, Professor Gane said direct acting anti-virals such as sofosbuvir and simeprevir had improved the safety and efficacy of antiviral therapy in patients infected with the most common hepatitis C genotype 1.

By adding simprevir to the current treatment of pegylated interferon plus ribavirin and halving treatment time from 48 week to 24 weeks, cure rates have doubled from 40% to 80%. Similarly, the addition of sofosbuvir has reduced the duration of treatment to just 12 weeks and improved cure rates to 90%.

“For the most prevalent form of the hepatitis C virus (genotype 1) in the world and the hardest to treat, this is a huge leap forward,” Professor Gane said.

Sofosbuvir and simeprevir are currently under review in Australia and New Zealand. They received FDA approval in the US in December 2013, European Medicines Agency (EMA) approval in January 2014 and were recognised as the treatments of choice for hepatitis C in new US guidelines for the management of hepatitis C published last month [February].

Professor Gane said the next imminent advance for patients infected with HCV genotype 1 was an all-oral, interferon-free treatment regimen such as the combination of sofosbuvir and ledipasvir, which achieved 90-99% cure rates in phase 3 trials.

“The beauty of sofosbuvir-based treatments is that they are safe for everyone including those co-infected with HIV, those who have had a liver transplant and patients whose livers are deteriorating badly.”

“The new medications enable people to get better quickly and recover without the need for a transplant. So it is more important than ever for people with hepatitis C to be identified so they can benefit from the new wave of medications.”

“Australia has one of the highest diagnosis rates of hepatitis C in the world because they have been very successful in raising awareness, advocating and testing for hepatitis C. Japan has always been a leader in surveillance and treatment and China is doing much better now. Poorer countries in Asia-Pacific though are struggling.”

He said compared to Australia’s diagnosis rate of 90%, New Zealand was lagging behind at 40%. However a government-funded, community-based pilot project to improve uptake of hepatitis C testing, assessment and treatment was currently underway.

Professor Gane said less common forms of the hepatitis C virus (genotype 2 and 3) were also responding to the new medications.

“Twelve weeks of sofosbuvir and ribavirin has a cure rate of 98% in people infected with genotype 2 and 24 weeks of sofosbuvir and ribavirin has a cure rate of 94% in those infected with genotype 3.”

“The remaining issue will be the cost of these medications. In some countries with limited resources, it may be that they are initially rationed to people with the most severe disease. However, widespread access to affordable all-oral therapy in all countries will be needed if we want to achieve global eradication of HCV,” Professor Gane added.

Source - APASL

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