health canada approves wegovy as first-ever treatment for severe liver disease
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there are other medications indicated for mash, but they have yet to come to canada, so with this shift in treatment, pharmaceutical companies may be more inclined to invest in canada and its people living with mash.
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metabolic dysfunction-associated steatohepatitis, or mash, is a form of serious form of liver disease that’s driven by excess fat in the liver. it can lead to cell damage, scarring, and inflammation. in more severe cases, it can also lead to severe, life-threatening conditions, including liver cancer and cirrhosis.
up until recently, people living with mash had no viable treatment. however, health canada recently approved wegovy, a drug used to treat obesity and reduce the risk of non-fatal myocardial infarction (mi), as the first therapy option following promising results from the phase 3 essence trial, an extensive investigation into its efficacy.
dr. giada sebastiani, clinical scientist, hepatologist, and investigator with the research institute of the mcgill university health centre, was a lead researcher on the wegovy mash clinical study. she notes that the study results and subsequent health canada approval are “exciting” for pathologists, as previously they had nothing to offer beyond lifestyle interventions and some targeted, non-mash therapies.
mash impact on patients
mash is a progressive condition; once it develops, it worsens over time. it occurs when fat begins to build up in the body and eventually makes it way into the liver, where the liver tries to heal itself. eventually, that healing process leads to damage and scarring, and the liver becomes stiff and unable to function.
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in worst-case scenarios, people living with mash will end up needing a liver transplant or develop liver cancer.
“the problem is that it’s a silent disease because you don’t have symptoms, so people feel perfectly fine. they go, ‘nothing is wrong with me,’” said michael betel, president and founder of the fatty liver alliance. “it’ll progress without them knowing.”
he notes that it could be up to 20 years before a person experiences obvious symptoms that alert them to a problem. by that point, “you’re already going to the hospital” for emergency care or a transplant.
it’s not an uncommon disease, either. roughly 5.2 per cent of the canadian population is currently living with mash, with rates increasing. those numbers are expected to grow to 6.5 per cent by 2030.
“the disease has been driven by the increasing rates of obesity and type 2 diabetes, and this is due to the environmental factors in terms of lifestyles, lack of physical exercise, an increase in poor nutritional food,” said dr. sebastiani. “there’s also problems in socioeconomic status.”
the disease can still occur in individuals without type 2 diabetes and obesity, however, at rates of roughly 25 per cent, with other risk factors coming into play, including genetics, hormonal disorders, poor gut health, and sleep apnea.
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from no treatment to wegovy: what this means for patients
the treatment of mash has been largely reliant on lifestyle interventions for people who have it. things like losing weight, exercising more, eating a healthier diet, and the like, are all part of the process in halting the progression or reversing the effects of mash on the liver.
but not everyone achieves better liver health, even when they’re doing everything right in that regard, because it doesn’t take care of the whole picture of chronic disease.
dr. sebastiani notes that obesity, for example, has three pillars of care: mental health, lifestyle, and medical intervention (pharmacotherapy). mash, on the other hand, has only had two available pillars.
“they missed the full pillar, which is pharmacotherapy, for many years, decades, actually,” said dr. sebastiani. “finally, now our patients have options.”
wegovy reached approval for treatment of mash following the results of the phase 3 essence trial, which showed significant improvements in patients taking wegovy compared with placebo—mainly its effect on both the resolution of liver injury as well as fibrosis, or the scarring and thickening of liver tissue.
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complications arising from the disease can also be mitigated by this approval. for example, dr. sebastiani notes that causes of mortality in people with this disease, such as cardiovascular disease, are also improved.
“the more we reduce, not just the liver-related outcome, so reduction to progression to cirrhosis, reduction of liver cancer, reduction of the need for a liver transplant, (it will) also improve cardiovascular outcomes,” she said.
betel notes that people will no longer have to worry about not being taken seriously by their doctors or being told that there are no options, all the while losing hope for a future that doesn’t have a liver transplant—or worse.
“patients can feel that their physicians are treating this like they have a real disease,” he said. “it also brings more hope … that there might be some momentum for some new therapies now that the first one was approved.”
he notes that there are other medications indicated for mash, but they have yet to come to canada, so with this shift in treatment, pharmaceutical companies may be more inclined to invest in canada and its people living with mash.
it also empowers patients to take greater control of their health, allowing them to understand that if they live with diabetes or obesity, they are at a higher risk. when no treatment is available, people at higher risk may be less inclined to undergo screening. but the more they know about the disease, and the new arrival of an actual medication for it, the better off they’ll be.
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“it’s the most important thing,” she said. “because there are options finally arriving.”
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