Advancing Healthcare for Women with Liver Disease – Sponsor Content

The human liver is a remarkable organ.

Every day it performs hundreds of vital functions—processing nutrients, cleansing the body of toxins, and filtering blood, among other duties. It also has the rare ability to repair itself, a unique feature that allows it, even with some damage, to continue doing what it was meant to do: help keep us healthy. But when the liver is under siege—by disease, viruses, or chronic conditions—it affects the body in profound ways.

“I was constantly tired, and no matter how much I rested, it wasn’t enough,” says Maria Morais, a registered nurse who suffered for years before being diagnosed with primary biliary cholangitis (PBC), a chronic autoimmune condition affecting the liver. “Often liver diseases can be invisible, but I was basically gaining and losing 20 pounds of fluid each week for months. It was like being pregnant over and over again.”

Today, liver disease, an umbrella term for a range of conditions, affects 4.5 million Americans. Women in particular are prone to several of these conditions, including PBC, which affects around 130,000 individuals in the U.S., mostly women over the age of 40. Not only is PBC a potentially life-threatening disease, its primary symptoms—pruritus (severe itching) and fatigue—are often difficult to decipher. As a result, people suffering from the disease often have to wait far too long for an accurate diagnosis. In Morais’ case, she eventually required a liver transplant.

For years there have been limited treatment options for PBC, resulting in many people living with painful and sometimes debilitating symptoms. That is beginning to change, however, thanks to medical advancements and increased awareness.

“The liver is quite a resilient organ,” says Gené van den Ende, Vice President of U.S. Medical Affairs at Gilead Sciences, the American biopharmaceutical company with decades of experience treating liver disease. “You need to have a significant amount of damage before you start seeing symptoms, which means not everybody is being diagnosed and treated as quickly as they should. But Gilead is bringing research into markets to educate the right healthcare providers to ensure we can get the right level of care for people and diagnose more quickly.

The Challenges of Primary Biliary Cholangitis

For many people suffering from PBC, a diagnosis can come as a huge relief. Some sufferers wait years to understand what is causing their symptoms, in part because the most common symptoms can be relatively generic.

“Many people living with PBC feel tremendously tired, and can have severe itching on their body, which could be caused by several illnesses” says Betty Chiang, Vice President of U.S. Medical Affairs Virology at Gilead Sciences. “If you look at their chart history, though, there are often signs of PBC that went unrecognized for years.”

The disease usually progresses slowly. It disrupts bile flow out of the liver, which eventually leads to toxic acids accumulating in it. If not effectively treated, PBC will result in the destruction of cells in the bile ducts, causing potentially irreversible liver damage. At first, the outward symptoms can be minimal.The long term consequences, however, may be significant leading people to—as a last resort for a cure—add their name to a liver transplant waiting list.

PBC sufferers can also find themselves isolated, with a diminished quality of life. Chronic fatigue and searing itchiness make it difficult to maintain social connections, and some people find it challenging to continue in their work. As a result, many suffer impacts to mental health as well.

Compounding the problem for early diagnosis is that liver disease has often been stereotyped as a consequence of poor lifestyle choices. This faulty assumption can prove harmful. Not only can it make it difficult to talk about the disease and its symptoms among family, friends, and even doctors, it can delay PBC diagnosis further. The truth is, PBC is not related to alcohol or dietary habits. The condition’s roots are unknown—linked somehow to an autoimmune condition—but it is certainly not self-inflicted. People of all heritages and socioeconomic status can develop PBC.

“That’s the problem with this condition, it’s very nonspecific,” says Chiang. “Every person can have some of these non-specific symptoms, so unless you really listen empathetically to the person in front of you and consider their lab results, PBC often goes undiagnosed. And by the time you do take it seriously, the disease may have progressed and the bile ducts could already be inflamed.”

A History of Tackling Challenging Diseases

Research into PBC is evolving, with new insights and treatment approaches emerging. Gilead Sciences is dedicated to advancing scientific progress as part of its long-standing focus on intractable diseases.

Early on, Gilead Sciences became a leader in providing effective treatments for HIV, a scientific focus it carries on today. In 35 years, its researchers have developed 13 different HIV medications, one of which was the first single-tablet regimen to treat the virus. The company has also spent more than three decades working on challenging liver diseases, and in that time it has helped pioneer cures for hepatitis C and transform hepatitis B into a manageable condition. Each success in treating one disease often offered scientific insights into the next.

“With HIV, we knew that it wasn’t going to take a single medication to treat it,” says Chiang, “so we started to work on combination therapies, and scientific discoveries from this work led to treatments for hepatitis B and C.”

Now, Gilead’s decades of expertise in treating liver conditions like hepatitis is helping in their efforts against PBC—not only from a purely scientific perspective, but also when it comes to the long process of getting approval for a new treatment. With rare diseases like PBC, it’s often challenging to recruit people for trials and complete follow-ups. Fewer people have the disease, so extra effort is necessary to find them. Also, as a chronic disease, the timeline for studying the effectiveness of a treatment is greatly expanded, requiring extra dedication and robust networks in the healthcare community. But experience pays off. Research efforts are underway to better understand the drivers of symptoms such as itching and impaired bile flow in PBC. Gilead Sciences is committed to supporting progress in this field through continued scientific exploration.

“Working in pharmacology, it’s not often that we are actually driving for cures, but Gilead is fairly unique in that regard,” says van den Ende. “We’ve been in a situation where we’ve actually cured the disease, as in the case of hepatitis C, and now we’re taking our learnings there to other liver diseases, like PBC.”

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