Is LIVDELZI right
for me?

Is LIVDELZI
right for me?

LIVDELZI could be the next step in your primary biliary cholangitis (PBC) treatment plan.

Amanda

Real LIVDELZI patient

People featured are compensated by Gilead.

Amanda, a woman with PBC, smiling while kayaking with her husband in a pond

LIVDELZI could be the next step in your primary biliary cholangitis (PBC) treatment plan.

Ask your healthcare provider if LIVDELZI is right for you.

On this page:

How LIVDELZI is different
Jump to
  • How LIVDELZI is different
  • LIVDELZI and your treatment goals
  • Talking to your healthcare provider

    • How is LIVDELZI different?

    LIVDELZI is the only treatment for adults with PBC to significantly improve key PBC lab results and itch.

    In the clinical trial, LIVDELZI:

    Icon of medical laboratory results

    Improved key
    PBC lab results

    in significantly more people compared with placebo at 1 year

    See LIVDELZI results
    Icon showing reduction in ALP levels

    Lowered alkaline phosphatase (ALP) to normal

    at 1 year, in significantly more people compared with placebo

    Learn about normal ALP
    Icon of person experiencing itchy skin, a common PBC symptom

    Reduced
    itch

    starting at 1 month, with significant improvement seen at 6 months

    See how itch is measured

    Who participated in the clinical trial?

    A total of 193 people participated for 12 months
    Icon representing the LIVDELZI® (seladelpar) arm [or group]

    128 took LIVDELZI with or without ursodiol

    Icon representing the placebo arm [or group]

    65 took ursodiol and placebo, or just placebo (only 4 people took just placebo)

    What were the key goals and results of the clinical trial?

    LIVDELZI was studied to see if it could help:

    Improve key PBC lab results

    62%
    of people taking
    LIVDELZI

    vs

    20%
    of people taking
    ursodiol alone

    achieved the main trial goal of improving all 3 of these key PBC lab results at 12 months:

    1. Lowering ALP levels to less than 1.67x the top of the normal range
    2. Lowering ALP levels at least
      15% from start of trial
    3. Achieving normal
      bilirubin levels

    Lower ALP to normal

    25%
    of people taking
    LIVDELZI

    vs

    0%
    of people taking
    ursodiol alone

    achieved a secondary goal of the trial by achieving a normal ALP level at 12 months.

    Reduce itch

    LIVDELZI
    lowered NRS
    scores by
    3.2
    points
    on average

    vs

    Placebo
    lowered NRS
    scores by
    1.7
    points
    on average

    at 6 months for people who had an NRS score of ≥4 at the start of the trial, which was a secondary goal of the trial. Itch reduction was maintained from months 6 to 12. The NRS is a scale of 0 to 10 that measures itch severity, with 0 being no itch and 10 being the worst possible itch. The average NRS score at the start of the trial was 6.1 for LIVDELZI (49 people) and 6.6 for the placebo group (23 people).

    NRS=Numerical Rating Scale.

    LIVDELZI safety and tolerability

    The most common side effects for LIVDELZI in the clinical trial include headache, stomach (abdominal) pain, nausea, abdominal swelling (distension), and dizziness.

    LIVDELZI has an established safety profile and a lower discontinuation rate (3.1%) due to side effects vs placebo (4.6%).

    icon-desktop-home-quote
    “My liver lab numbers started coming down after 1 month.”
    Christine

    Real LIVDELZI patient

    imgmobileislivdelzirightformechristinequotes2x

    Person featured is compensated by Gilead.

    Icon representing the LIVDELZI® (seladelpar) arm [or group]

    About Christine

    Christine lives in New York, where she built a real estate brokerage business and raised 2 sons with her husband. In her downtime, she paints to relax from the competitive nature of selling homes in the big city.

    Icon representing the LIVDELZI® (seladelpar) arm [or group]

    Diagnosis

    While at a doctor’s visit, Christine’s healthcare provider noticed some red flags in her liver numbers and called her back to the hospital that same day for more tests, which led to her PBC diagnosis. The next few months proved difficult. Her itch symptoms were sudden and severe. She would wake up in the night and take cold showers just to try to numb the sensation.

    Icon representing the LIVDELZI® (seladelpar) arm [or group]

    Treatment with LIVDELZI

    Christine was prescribed ursodiol, but wasn’t able to continue taking it. It seemed like she was running out of options. Then her liver specialist mentioned LIVDELZI. Now, she’s responding to treatment and is grateful to see her liver numbers are looking better than before.

    Amanda, a woman with PBC, standing on a yellow background

    LIVDELZI and your treatment goals

    When you have honest conversations about how treatment is going, it can help you and your healthcare provider pick a treatment option or switch from one treatment to another. Here are a few things to consider when having these ongoing treatment discussions:

    • Improving your PBC itch
    • Taking your other conditions or treatments into account
    • Reducing your key PBC levels (like ALP)
    • Finding a treatment that fits with your daily routine
    Icon for Downloading LIVDELZI® (seladelpar) conversation guide

    The LIVDELZI Conversation Guide

    Ready to talk with your healthcare provider about LIVDELZI but not sure where to start? This conversation guide can help you figure out questions and concerns to cover at your next appointment.

    Download the guide
    icon-desktop-home-quote
    “Learn about your treatment options, and work with your healthcare provider. If you’re not seeing results with ursodiol alone, ask what else is possible.”
    Angela

    Real LIVDELZI patient

    imgmobileislivdelzirightformeangelaquotes2x

    Person featured is compensated by Gilead.

    Icon representing the LIVDELZI® (seladelpar) arm [or group]

    About Angela

    Angela lives in Georgia and is a proud mother of 3 adult sons. A mental health specialist who enjoys camping and fishing, Angela loves the outdoors and spends her time off going out into the wild with family members.

    Icon representing the LIVDELZI® (seladelpar) arm [or group]

    Diagnosis

    After being diagnosed with PBC in March of 2023, Angela suddenly found herself struggling with depression. The symptoms of PBC became so distracting that she had to take a leave of absence from the work that means so much to her.

    Icon representing the LIVDELZI® (seladelpar) arm [or group]

    Treatment with LIVDELZI

    Angela’s initial PBC treatment with ursodiol helped, but she and her healthcare provider believed she could do better. On her latest visit, the liver specialist noted that, with LIVDELZI, Angela has been able to maintain her ALP improvement and reduced itch.

    Talking to your healthcare team about LIVDELZI

    If you’re ready to talk to your healthcare provider about LIVDELZI, doing a little planning before your next appointment may be helpful. You’ll want to make sure you say everything you want to say and get all your questions answered. Taking some simple steps to be prepared can help make that happen.

    Preparing for your appointments

    Before your next visit, write down what you want to talk about, such as:
    1. Concerns you’re having with your current treatment, including continued symptoms or side effects
    2. Reasons why you want to talk about changing your treatment plan
    3. Questions you have about your current treatment or LIVDELZI

    Bring your list to your next visit to talk about it with your healthcare provider, and check out the tips below to see how some real LIVDELZI patients prepare to advocate for themselves.

    img-desktop-is-livdelzi-right-for-me-amanda-pfp

    Amanda

    “I write down any questions I have about my current treatment, including any symptoms or side effects.”

    img-desktop-is-livdelzi-right-for-me-jennifer-pfp

    Jennifer

    “I make a list of the short- term and long-term goals that I want to achieve with treatment.”

    img-desktop-is-livdelzi-right-for-me-angela-pfp

    Angela

    “I have a notebook that I bring to the visit where I jot down any treatment questions.”

    img-desktop-is-livdelzi-right-for-me-wendy-pfp

    Wendy

    “I make sure to track my symptoms, like itch, so my doctor gets a clear picture of what I’m experiencing.”

    img-desktop-is-livdelzi-right-for-me-christine-pfp

    Christine

    “I ask my son if he can come along so he can learn about my treatment plan for himself, and help keep me organized.”

    Jennifer, a woman with PBC, discussing treatment options with her doctor

    Starting the conversation

    Sometimes starting the conversation is the hardest part. To get the conversation going, you can say something as simple as:

    “I read about LIVDELZI, and I’d like to know if it might work for my treatment plan.”

    You can also bring up LIVDELZI when you and your healthcare provider are already discussing other things related to your PBC, such as the results of a FibroScan, your latest PBC lab levels, or your symptoms. For example, you could ask:
    • Can LIVDELZI help treat my PBC?
    • Could LIVDELZI be used to help lower my ALP to normal?
    • Can LIVDELZI help reduce my PBC itch?
    Icon for Downloading LIVDELZI® (seladelpar) conversation guide

    The LIVDELZI Conversation Guide

    Use this guide to think through treatment goals before your next appointment.

    Download the guide
    Jennifer, a woman with PBC, gardening in a yard with her husband
    With once-daily dosing, LIVDELZI can fit into your routine
    See how to take LIVDELZI
    With once-daily dosing, LIVDELZI can fit into your routine
    Jennifer, a woman with PBC, gardening in a yard with her husband

    APPROVED USE AND IMPORTANT SAFETY INFORMATION

    What is LIVDELZI?

    Read more Expand keyboard_arrow_up_isi Collapse keyboard_arrow_down_isi

    Tap for Important Safety Information, including serious side effects for bone fractures and changes in liver tests.

    Expand ISI_plus_icon Collapse isi_remove icon

    What is LIVDELZI?

    LIVDELZI is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well to UDCA, or used alone in patients unable to tolerate UDCA.

    LIVDELZI is not recommended for use in people who have advanced liver disease (decompensated cirrhosis). Symptoms of advanced liver disease may include confusion; having fluid in the stomach area (abdomen); black, tarry, or bloody stools; coughing up or vomiting blood; or having vomit that looks like “coffee grounds”.

    It is not known if taking LIVDELZI will improve your chance of survival or prevent liver decompensation.

    It is not known if LIVDELZI is safe and effective in children.

    See more

    APPROVED USE AND IMPORTANT SAFETY INFORMATION

    What is LIVDELZI?

    LIVDELZI is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well to UDCA, or used alone in patients unable to tolerate UDCA.

    LIVDELZI is not recommended for use in people who have advanced liver disease (decompensated cirrhosis). Symptoms of advanced liver disease may include confusion; having fluid in the stomach area (abdomen); black, tarry, or bloody stools; coughing up or vomiting blood; or having vomit that looks like “coffee grounds”.

    It is not known if taking LIVDELZI will improve your chance of survival or prevent liver decompensation.

    It is not known if LIVDELZI is safe and effective in children.

    Important Safety Information

    What are the possible side effects of LIVDELZI?

    LIVDELZI can cause serious side effects, including:

    • Bone fractures. Taking LIVDELZI may increase your risk of bone fractures. Tell your healthcare provider about any bone fractures, or if you develop pain, or have changes in your ability to move around.
    • Changes in liver tests. Increased liver enzymes in the blood have happened when taking more LIVDELZI than prescribed. Your healthcare provider will do tests to check your liver before you start and during treatment with LIVDELZI.

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

    • swelling of your stomach area (abdomen) from a build-up of fluid
    • yellowing of your skin or the whites of your eyes
    • pain on the right side of your stomach (abdomen)
    • black, tarry, or bloody stools
    • coughing up or vomiting blood, or your vomit looks like “coffee grounds”
    • mental changes such as confusion, being sleepier than usual or harder to wake up, slurred speech, mood swings, or changes in personality

    The most common side effects of LIVDELZI include headache, stomach (abdominal) pain, nausea, abdominal swelling (distension), and dizziness.

    Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of LIVDELZI.

    What should I tell my healthcare provider before taking LIVDELZI?

    Tell your healthcare provider about all of your medical conditions, including if you:

    • have advanced liver disease.
    • think you may have a blockage of the bile ducts in your liver (biliary obstruction).
    • are pregnant or plan to become pregnant. It is not known if LIVDELZI will harm your unborn baby.
      • Pregnancy safety study. If you become pregnant while taking LIVDELZI, tell your healthcare provider right away. There is a pregnancy safety study for women who take LIVDELZI during pregnancy. Talk to your healthcare provider about providing information to the LIVDELZI pregnancy safety study. The purpose of this pregnancy safety study is to capture information about your health and your baby’s health. You or your healthcare provider can report your pregnancy by calling 1-800-445-3235.
    • are breastfeeding or plan to breastfeed. It is not known if LIVDELZI passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you take LIVDELZI.

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

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
    1-800-FDA-1088.

    Please see Important Facts about LIVDELZI.

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