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Monitoring PBC progression

Monitoring a range of biomarkers and fibrosis helps you stay on top of your overall liver health.

The marks of progression

Biochemical markers (biomarkers) can tell you a lot about what’s going on inside your body. When it comes to staying on top of primary biliary cholangitis (PBC) progression, it’s important to monitor all the biomarkers related to PBC and overall liver health. Overall liver health includes (but is not limited to) disease progression, biomarkers and fibrosis, and treatment response. Monitoring alkaline phosphatase (ALP) and bilirubin alone is not enough.

Monitoring biomarkers can be done through a simple routine blood test. It is also important to monitor your fibrosis progression (“liver stiffness”), which can be done with a noninvasive tool.

Key biomarkers of PBC progression

Different biomarker levels can increase at specific stages in disease progression, which is why looking at multiple biomarkers is essential in managing PBC.

Learn how your doctor uses these measurements to determine PBC’s impact on your liver with a simple blood test.

Key biomarkers of PBC progression

Take a deeper dive into what each biomarker means for your liver health

Cholestasis

Alkaline phosphatase (ALP): An enzyme found in the liver and bone, which is important for breaking down proteins; elevated levels could mean liver disease.

Gamma-glutamyl transferase (GGT): This enzyme is typically the first liver enzyme to rise in the blood when bile ducts become obstructed and is used as a confirmatory test to determine if high ALP is due to liver disease.

Bilirubin: A yellow bile pigment formed during the breakdown of red blood cells, it’s processed by the liver and excreted in stool; when the liver is not working properly, bile can accumulate in the blood and tissues of the body and can make the skin, and sometimes the eyes, appear yellow (jaundice).

Inflammation

Alanine aminotransferase (ALT): An enzyme found in the liver that helps convert proteins into energy for the liver cells. When the liver is damaged, ALT is released into the bloodstream and levels increase.

Aspartate aminotransferase (AST): An enzyme that helps the body break down amino acids; AST can be elevated as a result of damage to tissues of the body, including the liver; AST is also known as serum glutamic oxaloacetic transaminase.

Fibrosis & cirrhosis

Albumin: A protein made in the liver that enters your bloodstream and keeps fluid from leaking out of your blood vessels into other tissues; dropping levels may suggest cirrhosis development.

Platelets: These cells help your blood form clots (think scabs when you get a cut). Low platelet counts are common in people with cirrhosis.

ALP, ALT, and AST levels can also help predict the risk of liver transplant or death—the longer levels remain high, the greater the risk.

Healthcare provider expert guidelines recommend checking blood liver tests every 3 to 6 months.

Monitoring fibrosis progression

Biomarkers can tell you a lot about your risk for PBC progression, but so can monitoring fibrosis levels. Fibrosis has an impact on the liver’s ability to function properly. As it progresses, it can lead to end-stage liver failure, transplant, or death. Measuring and tracking your fibrosis levels is important to understanding how your treatment is working in slowing PBC progression.

Imaging tests such as FibroScan® or magnetic resonance elastography can be used to assess fibrosis levels.

Fibrosis progression should be measured every 12 to 24 months, depending on how you are responding to treatment.

Everyone’s PBC progression will differ

It's important to work closely with your healthcare team in deciding your personal treatment journey.

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Common symptoms of PBC

The most common symptoms are:

  • Pruritus
    (itching of the skin)
  • Fatigue
    (feeling tired all over)

Other symptoms include, but are not limited to, dry eyes and mouth, and trouble remembering or concentrating.

Everyone experiences symptoms differently, and some people living with PBC don’t experience symptoms at all. It’s also normal for symptoms to appear, disappear, or continue at any stage. How severe your symptoms are is also not related to how far the disease has progressed or how well your treatment is working.

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Indication and Important Safety Information

What is OCALIVA?

OCALIVA is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well enough to UDCA, or alone for adults who cannot tolerate UDCA. It is not known if taking OCALIVA will improve your chance of survival or improve your symptoms of PBC. It is not known if OCALIVA is safe and effective in children.

What is the most important information I should know about OCALIVA?

OCALIVA may cause serious side effects including:

Worsening of liver problems or liver failure, in some cases leading to liver transplant or death, has happened in people with primary biliary cholangitis (PBC) with liver cirrhosis when taking OCALIVA.

Before you start OCALIVA, and during your treatment with OCALIVA, your healthcare provider will do tests to check your liver. These tests will help your healthcare provider decide if it is safe for you to start taking OCALIVA and safe for you to continue taking OCALIVA.

Tell your healthcare provider right away if you have any of the following symptoms of worsening liver problems during treatment with OCALIVA:

  • Swelling of your stomach‑area from a build‑up of fluid; yellowing of your skin or the whites of your eyes; black, tarry, or bloody stools; coughing up or vomiting blood, or your vomit looks like “coffee grounds”; mental changes such as confusion, sleepier than usual or harder to wake up, slurred speech, mood swings, or changes in personality.

Tell your healthcare provider right away if you have any of the following symptoms during treatment with OCALIVA and they are severe or do not go away:

  • Stomach‑area pain; nausea, vomiting, or diarrhea; loss of appetite or weight loss; new or worsening fatigue; weakness; fever and chills; light‑headedness; less frequent urination

Who should not take OCALIVA?

Do not take OCALIVA if you:

  • have PBC with liver cirrhosis with symptoms such as fluid in the stomach‑area or confusion (decompensated liver cirrhosis) or with abnormalities in certain tests that check your liver.
  • have a complete blockage of the bile ducts in your liver or gallbladder.

What are the possible side effects of OCALIVA?

OCALIVA may cause serious side effects, including:

  • See “What is the most important information I should know about OCALIVA?”
  • Severe Itching (pruritus). Itching is a common side effect and can sometimes become severe (intense itching or itching over much of your body). Severe itching can cause discomfort, problems sleeping, and problems doing daily activities and usually needs to be treated. Tell your healthcare provider if you get severe itching or if your itching gets worse.
  • Lower HDL‑C (“good” cholesterol). OCALIVA can lower high levels of HDL‑C. Your healthcare provider will check your cholesterol levels during treatment with OCALIVA.

The most common side effects of OCALIVA include: tiredness; stomach pain and discomfort; rash; joint pain; mouth and throat pain; dizziness; constipation; swelling in your hands, ankles, or feet; fast or irregular heartbeat; fever; changes in how your thyroid gland works; dryness, irritation, redness, crusting or drainage of the skin (eczema).

These are not all the possible side effects of OCALIVA. Call your doctor for medical advice about side effects.

What should I tell my healthcare provider before taking OCALIVA?

Before taking OCALIVA, tell your healthcare provider about all of your medical conditions, including if you:

  • are pregnant or plan to become pregnant. It is not known if OCALIVA will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if OCALIVA passes into your breastmilk. Talk with your healthcare provider about the best way to feed your baby if you take OCALIVA.

Tell your healthcare provider about all the medicines you take, including prescription and over‑the‑counter medicines, vitamins, and herbal supplements. OCALIVA can affect the way certain medicines work. Certain other medicines may affect the way OCALIVA works.

The risk information provided here is not complete. To learn more, please talk to your healthcare provider.

Please click here for Full Prescribing Information and Medication Guide for OCALIVA.

Available by prescription only.

To report negative side effects of OCALIVA, please contact Intercept Pharmaceuticals, Inc. at 1-844-782-ICPT or you may report to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.