1 November 2017

The second wave in the war on hepatitis C

Clinical Communicable Disease

“We ran out of people to treat in our local prison,” says Associate Professor Darren Russell, director of sexual health at the Cairns Sexual Health Service, talking about the hepatitis C elimination well under way in the region. 

It didn’t just happen by accident, he explains. The government announced it was approving the highly-awaited direct acting antivirals for Pharmaceutical Benefits Scheme listing on December 20, 2015, “and we met on December 21 to plan how we would do it, to hit the ground running”. 

When they came back from the Christmas break, Professor Russell and his team were invigorated, visiting doctors, nurses and people living with hepatitis C to let them know what the availability of new drugs would mean. 

“We’ve got a campaign to make Cairns hepatitis C free by 2020,” he says. Ten years sooner than the WHO’s goal. 

When asked how they expect to achieve that, Professor Russell quietly, almost modestly, says they are hoping it will be “a fair bit before 2020, the way we’re going”. 

“There’s about 250,000 people in this part of the world,” he says, describing Cairns and up to the tip of Cape York, “We’ve really treated all the pockets of hep C that we can find, and now we’re just mopping up.” 

But that’s not the case everywhere. Australia has signed on to the WHO goal to virtually eliminate hepatitis C by 2030, and this means reducing transmissions by 90% and deaths by 65%. 

There was a momentous uptake straight out of the gates, with more than 30,000 of the country’s quarter million people living with hepatitis C treated in the first nine months. Many of these were people with more advanced liver disease, already connected to liver clinics, and GPs similarly caring for high caseloads. 

But treatment rates are slowing, and experts say we are shifting to a new phase in the battle – one where primary care leads the charge and marginalised communities are the focus. 

“We can’t rest on our laurels,” Associate Professor Benjamin Cowie, infectious diseases physician and epidemiologist at the Doherty Institute, says.

While Australia may be leading the world in hepatitis C treatment, “there are groups in our community who are not benefiting to the same degree from this revolutionary opportunity to eliminate a chronic health condition”.  

Treating those often left behind – prisoners, injecting drug users, migrants, Indigenous and rural and remote Australians – is both an economic decision and a human rights issue, he says. 

Professor Russell, past president of the Australasian chapter of sexual health medicine of the Royal Australasian College of Physicians, says their initial efforts to treat whole groups at risk of transmitting seems to have paid off in rapidly driving down rates of new infections in Cairns.

“We planned it a bit like a military campaign,” he explains, coordinating with the alcohol and drug service, the Aboriginal Medical Service, the liver clinic, his sexual health clinic, the prison and the local general practices.

Clinicians searched through their databases and histories to find out whether they had any patients with the diagnosis, and called them in to offer treatment. The prisons already had a high rate of testing for the virus prior to the new drugs becoming available, so once identified, nurses would run blood tests, talk them through the treatment, and then let Professor Russell and his junior doctor sign off on whether they were suitable.

“It’s not particularly complex, it just needs to be done.” 

It wasn’t all easy though. Their own enthusiasm initially exceeded that of some of the staff in the clinics they linked up with.

“It is a bit of a change of concept,” Professor Russell says. “We previously had treatments for hepatitis C which were very difficult to administer, they had a lot of side-effects and really needed specialist care. These new drugs are not like that.” 

As more patients were treated with the drugs, which cure 95% or more patients who take one tablet a day for 12 weeks, attitudes evolved. 

“We had a prison with over 800 prisoners, about 10% to 15% of them had hepatitis C, and we were able to treat over 100 people within 12 months or so and clear the prison,” he says. 

“The health staff became quite proud of the work they were doing, and the prisoners were proud that they had the first prison in Australia, and perhaps the world, rendered hep C free by these treatments.”

When pushed on why they are so eager to beat even the WHO target, Professor Russell says it was a matter of looking at what was possible. 

“We had a set of circumstances here that let us do it, and we felt it would be wrong not to do it. People still die of hepatitis C and they get liver cancers if they’re not treated, so it would seem unfair to make people wait many years if we were able to treat them earlier.” 

Australia is considered to be a world leader in our approach to eliminating the chronic disease, being among the first to allow primary care doctors to prescribe the drugs and not only allowing universal access to the treatment, but making a concerted effort to reach more marginalised communities. 

One example is the way that the medications were given dual listing as section 85 and section 100 drugs. This allowed GPs in the community to prescribe without the extra training that section 100 drugs require, but also enabled clinicians in the prison system to prescribe them under section 100 and bill them to the federal government. 

Prisons can be thought of as a perfect storm, according to Professor Cowie. “Drug policy and the criminalisation of drug use means people who inject drugs are more likely to end up in prison. Then you’ve got no harm-reduction capacity, so no needle and syringe programs – no way for people to protect themselves by not sharing,” he says. 

Other prison practices, such as tattooing, piercing or other blood to blood contact, also raise the risk. “Then you put a whole lot of people with those risk factors together in one place and keep them there,” he says.  

“Treatment of people who are actively injecting means that, not only are you treating and curing that individual, but you are stopping them from transmitting infection to someone else with whom they are sharing kit.” 

In the same way that vaccines improve herd immunity by reducing the viral load in the population, “by protecting one person through treatment, you protect their downstream contacts from infection, by preventing that infection in the first place”. 

As liver clinic waiting lists disappear, GPs are having an increasing role in the treatment of people with hepatitis C. 

Research from the Kirby Institute shows that between March and December of 2016 the proportion of people treated by GPs rose from 8% to 31%, and it is only expected to increase. 

But in order to upscale treatment further, public-health experts must first overcome some myths and barriers. 

Dr Annie Balcomb, a GP in the regional NSW town of Orange, worked closely with hepatitis C patients prior to the approval of the direct acting antivirals, and now visits general practices and other medical services to offer training and insights into how to treat with the new drugs. 

She says a common misconception is thinking that there are no hepatitis C patients in a practice, when, in fact, an estimated 1% of the population have a chronic hepatitis C infection. 

This means a practice of 1000 people may have around 10 people or more needing treatment, depending on the demographics. Most GPs will have a few patients at least who have either been diagnosed in the past and lost to the system, or don’t know they have the infection. 

But instead of getting caught up in the stigma of hepatitis B and C, she thinks of it in terms of preventing liver cancer and cirrhosis. 

“These people are dying in their 50s at the moment, and liver cancer is the fastest growing cancer in Australia.”

Even beyond the obvious consequences of the infection, chronic hepatitis C is also associated with a seven-fold higher risk of diabetes, increased risks of lymphoma, skin conditions, renal failure and other long-term hepatic manifestations, Dr Balcomb notes. 

Diagnosing and staging of liver disease hasn’t been as well taught as chronic kidney disease or heart failure, Dr Balcomb says, but this is “a really exciting time to upskill and reskill”.

One pangenotypic drug has already been listed on the PBS, with another expected next year that could reduce treatment by four weeks in patients who don’t have cirrhosis. Alongside a simplified treatment regimen, there’s also been work done to simplify testing.

Clinicians without access to a fibroscan may be able to bypass it altogether by getting the patient’s AST to Platelet Ratio Index, or APRI, score. Calculators can easily be found online, and a score of less than one means hepatic fibrosis is unlikely and a fibroscan is not needed to initiate treatment.

In the viral hepatitis clinic she runs one day per week within her general practice, they have managed to cure more than 100 people since the new drugs became available. 

“It doesn’t take much time. It’s joyous. It’s far less complicated than managing diabetes,” says Dr Balcomb, who’s seen an increase in the number of GPs, especially rural and younger ones, wanting to treat people. “You can be part of a worldwide campaign to eliminate hepatitis C, just like in the days of polio.” 

Hepatitis experts strongly recommend having a low threshold for ordering tests for the virus, and Dr Balcomb notes that while any abnormal liver function results should trigger investigation, one in three patients with chronic hepatitis C don’t have an elevated ALT.

Other high-risk groups are those with a history of blood transfusions before 1990, and overseas tattoos, medical or dental procedures. In some regions such as the Middle East, and especially Egypt, experts recommend testing almost everybody. 

Because injecting drug use is one of the key routes of transmission, it can be easy to fall into assuming who might need testing, but Professor Andrew Lloyd, who was awarded the Australia Medal for his research and work in establishing the hepatitis service in the NSW prisons, says the majority of people in Australia with hepatitis  C are not recent injectors. 

In the order of 80% to 90% of Australians infected with hepatitis C chronically were infected through injected drug use. Around 80,000 or more will be recent injectors, meaning they’ve injected in the last year, and the remaining 100,000 or so may have a history of it, but be a business owner who used recreational drugs a few times, or for a few years decades ago, Professor Lloyd says. 

This is the reason that the US recommends screening the baby-boomer generation, and while we don’t have similar guidelines here, experts say greater testing is vital to find the one in five who don’t know they are infected. 

Dr Balcomb also says reminding patients that their history of drug use doesn’t need to be recorded on their medical records helps to overcome some of the fear about speaking honestly. 

One of the major barriers, especially in rural areas and among culturally and linguistically diverse communities, is stigma and fear.  

Dr Balcomb says she sees patients driving to a different town to get their blood work done or to pick up their medications because they fear people in their community knowing. It may be understandable considering the judgment that still lingers among some in the healthcare system, she says. 

“A lot of our hospitals and tertiary services, which are where a lot of the treatment initially happens, are not particularly culturally safe or welcoming places for a lot of indigenous people,” Professor Cowie says. “This is just one more reason primary care and general practitioners are really where the answer lies.” 

It’s a sentiment echoed by Professor Margaret Hellard, co-chair of the WHO strategic and technical advisory committee on HIV and Viral Hepatitis, who works with another at risk population, currently injecting drug users.  

“Never underestimate how stigmatised the person who injects drugs might feel due to previous engagement with the health service,” the Burnet Institute deputy director of programs says. “So if they are a bit sceptical and anxious, don’t be surprised.” 

As part of their Eliminate hepatitis C (EC) Partnership, Professor Hellard and her colleagues are helping to build the test and treat capacity of services that see a lot of injecting drug users, such as needle and syringe programs and opiate-substitution clinics.

 A major drawcard of this approach is that treatment is offered in spaces that are friendly and non-judgmental towards patients. 

She says treating injecting drug users will be critical to reaching the 2030 goals, and another strategy is exploring “treatment as prevention” in an investigation known as the TAP study, which encourages users to also bring their injecting partner in for treatment. 

Mobile outreach clinics, more granular data about the needs of specific areas and the development of finger prick testing may see treatment of the future become even easier. 

But in the meantime, there’s an opportunity to be part of something major, where it matters the most. 

“There are few times ever where a GP, by giving a person a tablet a day for eight to 12 weeks, will cure a chronic disease of which they were at risk of cancer and at risk of dying. Those patients are so delighted and so grateful afterwards,” Professor Hellard says, voice warming at the memory. 

“Diabetes goes on forever, many chronic diseases go on and on, this is an opportunity to provide cure,” she says. “This is a unique and unusual experience, and I think GPs, in having that opportunity to actually cure one of their patients of a chronic disease that’s providing them with not only a risk of cancer but of the anxiety surrounding that, is extraordinary.” 

“One of my favourite experiences is when you’ve cured a patient – they are so enormously grateful, it’s probably one of the most positive things that can happen to you in a day – when you give that person that result that they’re cured,” she says. 

“It should never be underestimated.”