Rallying cry to defeat blight of hepatitis

Curing hepatitis C with a safe, short course of medicines would have been unbelievable only five years ago

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Curing hepatitis C with a safe, short course of medicines would have been unbelievable only five years ago.

Not only has this become a reality, but the global community is marshalling forces to actually eliminate viral hepatitis altogether within the next 14 years.

And not a moment too soon.

Today, more people are dying from hepatitis than ever before. In fact, viral hepatitis is the biggest cause of death globally, responsible for 1.46 million deaths in 2013 alone. It’s a bigger killer than HIV, tuberculosis or malaria, which took the lives of 1.3 million, 1.2 million and 0.5 million that same year, respectively.

But hepatitis hasn’t received the same attention from health groups or world leaders as these other diseases.

“When you compare viral hepatitis to HIV, it’s chalk and cheese in terms of private and public sector funding,” said Professor Gregory Dore, head of the Viral Hepatitis Clinical Research Program, Kirby Institute for Infection and Immunity in Society at the University of NSW.

“We often say that hepatitis has to make do with the crumbs off the table of other major health issues such as HIV. But that’s improving a little.”

Whereas HIV had had the benefit of thousands of UN staff dedicated to its prevention, treatment and care, hepatitis had only had a handful, he said.

The tide might be turning though.

At the end of May, Australia joined the other 193 member countries of the World Health Organisation in unanimously committing to eliminating viral hepatitis by 2030.

The countries signed on to the first-ever Global Viral Hepatitis Strategy, forming the biggest commitment to combating hepatitis so far.

The elimination of hepatitis B and C as a public health threat is defined as achieving a 90% reduction in new infections, and a 65% reduction in deaths compared with the rate expected if no new campaigns were introduced.

In the past, the term “disease elimination” often referred to complete termination of any new infections in a population. Eliminating a disease as a public health problem is a less absolute goal.

According to WHO estimates, if we carry on as we are, 19 million people will lose their lives to hepatitis-related illness between 2015 and 2030. If the targets are reached, 7.1 million lives could be saved over this time period.

Because cirrhosis and hepatocellular carcinoma secondary to chronic hepatitis B and C infections account for 90% of all deaths from viral hepatitis, the intervention will focus on these two diseases.

Globally, both of these blood-borne infections are commonly transmitted through mother-child transmission, unsafe injecting and medical procedures, and sometimes through sexual contact.

Mother-child transmission is a significant cause of the spread of hepatitis B in places such as sub-Saharan Africa and east Asia, where a high proportion of the population is infected.

Currently, hepatitis B cannot be eradicated in an individual, but antivirals can keep viral levels low.

Without treatment, 20% to 30% of people infected with hepatitis B or C will develop one of these two sequelae, causing 11.8 million deaths from hepatitis B and 7.2 million deaths from hepatitis C by 2030.

So prevention is key.

The WHO strategy is four-pronged: to immunise infants, to prevent mother-child transmission, to improve blood and injection safety, and reduce harm for injecting drug users.

Mother-child transmission: The hepatitis B vaccine is highly effective for infants and is inexpensive, and children who receive all three doses are protected for life.

By 2020, the aim is to increase the number of infants who receive the vaccine from 82% to 90% worldwide.

To reduce the rate of mother-child transmission, the aim is to improve the proportion of children receiving the birth-dose vaccine from 38% to 90%.

Other promising interventions, such as testing and treating pregnant women, may also be used.

A recent randomised, controlled trial showed that treating mothers with tenofovir during pregnancy could reduce transmission of the virus from 7% to zero in women who took the medication as intended, and had minimal side effects.

Blood transfusions: To totally eliminate the spread of hepatitis B via blood transfusion by 2030, every blood donation must be screened, up from the current 89% globally. There has been some improvement in blood and injection safety, and by 2010 the unsterilised injecting device reuse was as low as 5.5%. The medical principle of “first do no harm” must safeguard against people getting infected from health care services, the WHO states.

Intravenous drug use: Another strategy to cut hepatitis B and hepatitis C transmission is to boost the number of clean needle or syringe sets supplied to people who inject drugs from 20 per person per year to 300. This is the minimum needed for effective harm reduction, according to WHO calculations.

Existing infection: But even if new infections dropped to almost zero, there are up to 400 million people already infected with chronic hepatitis B and/or C.

For this group, the plan is to expand treatment.

Exciting developments in the pharmacological treatment of hepatitis C has been powerfully motivating in the decision to bring viral hepatitis under control, and the rest of the world will be closely watching the success or failure of Australia’s hepatitis C elimination attempt.

Instead of a protracted course of interferon, which had severe side-effects, people with chronic hepatitis C now have access in Australia to an eight to 24-week treatment regimen, which often consists of only one pill per day, and is well tolerated.

This new generation of direct-acting antiviral drugs have higher cure rates than previous therapies, and are easy for patients to access in primary care.

Just last month, the European regulator recommended approving Gilead’s new combination therapy treatment which would be a cure for all six genotypes of hepatitis C.

For now, Australia is in a unique position, and has been praised by the international community for providing universal access to the new treatments.

“In Australia we have an incredible opportunity to head towards elimination, particularly in hepatitis C given we’ve just had the PBS listing of these amazing new therapies, that cure 95% of people, generally in three months of treatment, and with limited toxicity,” said Professor Dore.

Thanks to this, modelling from the Burnet Institute for Virology and Communicable Disease Research suggests that our country may even hit the elimination target up to four years early.

Reports from the first few months since the medications’ listing showed an incredible number of people coming forward for therapy, Professor Dore said.

So far an estimated 13,000 to 16,250 patients had started treatment since the drugs were first listed in March, which means it might not be crazy to think we would reach the goal of treating 40,000 in the first year, he said.

But eliminating all viral hepatitis across the world will take time and money, and sufficient political will.

While high-income countries will fund their own strategies for eliminating hepatitis, low- and middle-income countries will need at least $S11.9 million to execute the strategies.

Rather than a big investment in donor money to those countries however, it might be more important for Australia to focus on implementing our own hepatitis elimination strategy well, Professor Dore said.

“I think our role, and it’s a very important role, is to demonstrate what can be achieved when you get everything in place – so when you’ve got good screening programs that are targeting people at risk and where the testing is basically free, where you’ve got access to these new therapies broadly include people that are at all extents of liver disease, people that have ongoing drug and alcohol use and where you’ve got practitioners that broadly can prescribe,” Professor Dore said.

Australia is unique in that it had not only specialists who could prescribe hepatitis C therapy, but GPs could as well. This enhanced the practitioner base and helped to build the foundation for a rapid scale up, he said.

Another drawcard of Australia’s approach to hepatitis C is that the government has managed to enter into contractual agreement with the pharmaceutical companies to ensure major discounts on the price of treatment.

“So you have an arrangement where you can have a universal access program because you’ve got the economics sorted out,” Professor Dore said. “Australia is a great test case of what can be achieved, so a lot of countries will be looking to us to see what happens in next couple years in terms of the extent of our scale up.”

For many other countries, these goals might be more aspirational than achievable.

“It’s a very, very big ask globally,” Professor Dore said. “2030 is not that far away, and there is a lot of work to be done.”

In particular, screening is going to be a big priority to overcome the current problem where only a relatively small minority of patients with chronic hepatitis are aware of their infection.

This is the fifth and final target for the WHO member countries.

To meet it, it will to be necessary to bring the proportion of people who know their hepatitis status up from fewer than 5% now, to 30% by 2020, and 90% by 2030.

And in these people, treatment needs to be easier and more available.

The WHO target is to raise the treatment rates of hepatitis B and C from less than 1% of eligible people to 80%.

This may be difficult given the wholesale costs of treatments for hepatitis C may be around $60,000, however some countries offer generic versions for less than $500 and this could, and should, drop lower.

In light of these lower prices, WHO guidelines now recommend testing and treatment for viral hepatitis.

World Health Organisation agreements give governments the political licence to divert money from one disease area to another, but that doesn’t ensure that governments will actually be able to pull it off. Economic and political factors may impede the ideal rollout of certain strategies, and in the past harm minimisation and the treatment of the poor or prison populations have been overlooked.

“It’s important to set targets and show commitment,” Professor Dore said. “It’s on the radar that this is a major health issue and burden.”

While it’s a start, it needs to be backed up by further action.

National plans were a crucial first step for countries to take, in terms of getting partners working together and allocating funds, Professor Dore said.

Raquel Peck, chief executive of the World Hepatitis Alliance, welcomed the unprecedented commitment to tackling hepatitis, but agreed that governments now needed to implement effective and funded viral hepatitis national plans.

“These plans play an essential role in defining a country’s vision, priorities, budgetary decisions and course of action for improving and maintaining the health of its people,” Ms Peck said.

“It is crucial that governments make provision for a dramatic scale up in intervention practices, such as testing, and provide a greater focus on at-risk and hard-to-reach populations.”.

But so far only 36 countries have developed a national plan, while another 33 are preparing one.

With World Hepatitis Day coming up on July 28, hepatitis groups are launching the “NOhep” movement to mobilise support for action across different countries, at different levels. They are appealing for patients, patient groups, medical professionals and policy makers to build public awareness of this as a global health problem.

But in the lead up to Australia’s federal election, Hepatitis Australia is urging politicians to start approaching the disease the same way they do HIV.

Politicians needed to break their silence and speak up in support of the WHO campaign, as well as to add their voices to the movement to break down stigma against the disease.

“Despite being invited to participate, each health minister and Australian government over the last five years has not issued any public statement for World Hepatitis Day, yet in contrast, ministerial media releases and/or public statements for World AIDS Day have been the norm,” Hepatitis Australia said.

The bottom line being, if countries were able to get together and implement these hepatitis strategies, that would ultimately lead to stronger health systems for all.