The hard-earned lessons and multiple setbacks that characterised the fight to control HIV could provide a template for tackling the fast-advancing public health danger of NASH (non- alcoholic steatohepatitis) fatty liver disease.
The inflammation and cell damage condition, which can lead to cirrhosis and cancer, is projected to continue rising alongside diabetes rates, yet it is only on the doorstep of recognition. The parallels with the early days of HIV are evident: limited public awareness, threadbare policy, accelerating scientific research but no approved medicines.
Gilead, which has suffered two recent NASH therapy trial knock-backs, believes medical and scientific advances need to be welded to comprehensive patient engagement to engineer effective responses to what is being labelled as the next public health crisis – NASH now outstrips alcohol as the most prevalent cause of liver transplants in the United States.
It is an approach the company forged in the heat of the 30-year fight for the HIV community and which remains at the core of its efforts for improved treatments and access.
“How we approach this is important. The payers and healthcare systems need to work together on this because hospital managers or healthcare system directors are not seeing fatty liver disease on their big budget spreadsheets,” said Mike Elliott (pictured above), Vice President of Medical Affairs for Europe, Middle East & Australasia for Gilead Sciences.
“It’s not viewed as a major problem yet but, if you dig deeper, you can see it emerging so there is a whole education and understanding piece to be done about its impact. It’s time to examine and discuss the data and decide which routes to take.”
Emerging clarity
NASH is a tough area. Although the mechanisms are complex, with inflammation, fat deposition and fibrosis caused by different metabolic pathways, we understand them and broadly know what sort of medicines to use. The data is still evolving but, as obesity grows, fatty liver disease is becoming more common and a more common cause of liver cirrhosis and transplant.
“I think more clarity will emerge over the next year and we will find one or two good targets. But we have barely started to understand the impact and cost that health systems will face.”
Gilead is funding eight to ten global projects under the NASH Models of Care Program that aims to develop multi-disciplinary pathways to screening, identifying and treating high-risk NASH patients. The strategy echoes its HIV heritage and continuing practice of working closely with patient groups in all aspects of drug development.
“A strong connection between science and society is vital and success is based on partnerships,” added Mr Elliott. “There are standard elements around any condition – the hospitals, the researchers, the pharma companies, the healthcare system – and results are always better when they work together. We found that in HIV and hep B; the countries that brought these elements together well achieved the best results for patients.
“Increasingly, we are involving patients very early on. The old model of pharma companies and regulators designing the trials and providing solutions to the patients right at the end has been largely reversed. We consult early on about their experience and get much better ideas by talking to the patients. They, in turn, recognise that they may not be able to have the medicine they specifically want but, if they have input into the key factors, we will end up with a much better final piece.”
Improving access
Gilead is now progressing on a first-in-class inhibitor of the HIV-1 capsid function that could be administered just twice yearly and is advancing with research to eliminate HIV reservoirs.
“We have good medicines available and we have people in the health systems who understand how to manage it, reduce risk and treat HIV but there is more work to be done,” added Mr Elliott. “There is still stigma and access to care is not what we would like it to be across some groups.
“Let’s just say we have the medical system in a good place but we haven’t got the access to care and a normal quality of life quite right yet. The research is moving forward positively. Work on cleaning out the reservoirs and driving the virus out, or at least managing it, is progressing and we are collaborating with research organisations and other companies to push that forward.
“We are also looking at new approaches such as capsid or long-acting injectable.”
He added: “We have medicines that provide good treatments for a broad group of patients, particularly those ageing with HIV. We have improved the safety and got the efficacy at a very high level and zero resistance. We have also worked hard to get the right price and guidelines for the health systems but we also need to continue supporting education activities.
“Getting close to communities with patient support activities and grassroots projects, whether that’s about ageing or stigma reduction, is a key element of our work.”
An indication of the success of the pharmaceutical industry’s concerted effort against HIV is the projection that, by 2030, more than 50% of people with the condition will be aged over 50 and prone to other medical conditions such as heart disease and cancer.
Patient feedback
Gilead’s HIV Age Positively programme has more than $17m in global grant funding for community projects that tackle equality, community action, personal health and health services for people living longer with HIV.
“We have a lot of people at Gilead who have worked across Europe in HIV nursing and med- icine and know patients managing the disease so we can prioritise the projects with the most impact,” added Mr Elliott.
“We have picked successful projects in education and independent research but the important thing is that we keep asking ourselves what we can do better and keep listening to patient feedback.
“We make sure the science is understood and we use that feedback to make sure our medicines are available and used in the right way. You could call that a business benefit but I call it a patient benefit because working in isolation derives
less benefit. Our aim is for our medicines to be understood and used appropriately and widely.”
Fatty liver disease is in its infancy and its malignancy is not threatening an epidemic on the scale of HIV/AIDS yet, but a co-ordinated response as it becomes more prevalent could neutralise its worst impact on society.
There is no sign of obesity rates subsiding so, with a close link established between weight and fatty liver disease risk in research papers, adopting a unified game plan is imperative.
Learning the lessons of history and applying them will put industry and society in a strong position to cope with future threats.