COVID-19 treatments and clinical trials for liver disease patients

Posted on: 12th April 2022
Recent update
12/04/22 – People with weakened immune systems are eligible for COVID-19 treatment if they develop symptomatic COVID-19. We know that some eligible liver patients have experienced delays and problems accessing these treatments.

We have been in regular communication with NHS England and other relevant bodies to highlight these issues and seek clarification.

Remember to act quickly if you test positive for COVID-19 so you can access the antiviral and antibody treatments available to you.  Follow the steps below:

  1. Register your positive LFT here: https://www.gov.uk/report-covid19-result or call 111 or 119.  You should be contacted within 24 hours.
  2. If  you are not contacted automatically, you should contact your GP or consultant.  Let them know:
    • It has been over 24 hours since you registered your positive test
    • About any COVID-19 symptoms you’re experiencing
    • That you are in the category eligible for COVID-19 treatments and require treatment within five to seven days of experiencing symptoms
  3. You can raise the issue directly with the following health bodies.

NB People who are not eligible via the routes above are being advised to join the PANORAMIC trial but we are aware they are experiencing a large volume of registrations.  They advise people to register as soon as symptoms start to improve their chance of having access to treatment via the study.

Antiviral treatments for COVID-19 have been made available to patients who are at highest risk of getting seriously ill from COVID-19.

Vaccines are the primary defence against coronavirus, but new treatment options are available to at-risk patients who are infected. So far in the pandemic treatments have been used in very unwell patients in hospital but the latest treatments can help patients in the earliest stages of infection.

Antivirals are treatments used to either treat those who are infected with a virus or sometimes protect exposed individuals from becoming infected. They target the virus at an early stage, preventing progression to more severe, or even critical, symptoms.  These treatments include monoclonal antibody treatments such as sotrovimab and antiviral treatments such as molnupiravir - the first of the two oral antivirals that have been procured by the Antivirals Taskforce. These treatments must be used as soon as possible after symptoms start following a positive PCR test.

Follow these links for specific information about treatments in Wales and Scotland.

Who is eligible for treatment?

Patients at highest risk of COVID can access these treatments through new NHS COVID Medicines Delivery Units (CMDU).  This includes patients decompensated liver disease, cirrhosis, have had a liver transplant, or if you are a liver disease patient on immunosuppressive therapy.

Outside the highest risk groups patients can take part in the PANORAMIC study into antivirals, if they are over the age of 50 or have other risk factors such as obesity.

Current treatments being offered

Molnupiravir is an antiviral medicine that works by stopping the virus that causes coronavirus (COVID-19) from growing and spreading.

It's used to treat early COVID-19 infection and help to prevent more severe symptoms.

Molnupiravir is only available on prescription. However, you will only be eligible to have the medicine either:

If you are in the high risk group you may be sent a letter and a PCR test that you can do at home should you develop symptoms of COVID-19.

If you test positive for COVID-19, are self-isolating, and eligible, you will be contacted by the NHS within 24 hours of your positive test result. They will give you instructions on where you’ll have the treatment, and how to get there and back safely. This will usually be by text, email or phone.

You will then be given an assessment to see if molnupiravir is right for you. If it's suitable they'll tell you how you will get the medicine. It may be sent to you at home or a hospital pharmacy may arrange for the medicine to be delivered to you. It can also be collected by someone else such as a friend, relative or NHS volunteer responder.

Molnupiravir comes as capsules. You'll need to start taking the capsules as soon as possible after you have tested positive for COVID-19 and within 5 days of your symptoms starting.

If you are eligible for COVID-19 treatment you will usually be offered neutralising monoclonal antibodies (nMAbs), such as sotrovimab (Xevudy), before molnupiravir.

Key facts

  • You will take 4 molnupiravir capsules twice a day for 5 days. Even if you start to feel better it's important that you complete the course.
  • It's important that you start taking molnupiravir within 5 days of getting COVID-19 symptoms.
  • Molnupiravir starts working very soon after taking it.
  • Common side effects of molnupiravir include feeling dizzy and headaches. If you feel dizzy, do not drive, cycle or use tools or machinery.
  • Molnupiravir is not recommended during pregnancy. It's important to use reliable contraception while taking molnupiravir and for 4 days after your last dose.

Further information available here: Molnupiravir: a medicine to treat coronavirus (COVID-19) - NHS (www.nhs.uk)

Sotrovimab is a biological medicine. It's also known as a neutralising monoclonal antibody (nMAb).

nMAbs are synthetic proteins that act like human antibodies in the immune system. They are made by cloning an antibody that can stick to the spike protein of the virus and neutralise it. They stick to the virus and stop it from getting into your lungs and causing an infection.

If you are eligible for COVID-19 treatment you will usually be offered neutralising monoclonal antibodies (nMAbs) such as sotrovimab as a first treatment rather than antiviral medicines.

It's usually given to you through a drip in your arm (infusion). It will be given in hospital or at a local centre.

If you have tested positive for COVID-19, are self-isolating, and are eligible, you will get instructions on where you'll have the treatment, and how to get there and back safely.

Key facts

  • Sotrovimab will keep working in your body and help prevent reinfection from COVID-19 for at least 4 weeks.
  • The dose of sotrovimab is 500mg. It's given to your through a drip in your arm (infusion) over 30 minutes. You'll only need 1 dose.
  • The most common side effects include feeling sick, feeling dizzy, an itchy rash or redness or warmth on your skin.
  • If you feel dizzy after your treatment, do not drive a car, ride a bike, or use tools or machinery.

Further information: Sotrovimab: a medicine that treats coronavirus (COVID-19) - NHS (www.nhs.uk)

Remdesivir is an antiviral treatment given through infusion like sotrovimab however unlike sotrovimab which only requires one treatment, remdesivir is given over three separate days.

It is an RNA polymerase inhibitor that disrupts the production of viral RNA, preventing multiplication of the virus.

PF-07321332 (Nirmatrelvir) plus ritonavir, (brand name Paxlovid) is an oral antiviral. This is a course of treatment that can either be collected by a friend or family member without COVID or delivered to a patient’s home. The full course of treatment should be taken, and patients should follow the prescribing clinician’s advice. Data suggests this treatment reduces the risk of hospitalisation by up to 88% however it is not suitable for patients with certain health conditions or on some other medications.

How are people being made aware of COVID-19 treatments?

Primary route

  • Some eligible people have been informed by the NHS by letter or email.
  • These patients should have been sent PCR testing kit by Test and Trace to keep at home.

Secondary route

  • Some patients will not have receive a letter from the NHS but should have be contacted by their consultant instead. Their consultant will tell them to phone Test & Trace on 119 to request a PCR test to keep at home. This includes:
    • Newly diagnosed patients
    • Many eligible cancer patients

If you think you are eligible, and have not been contacted by letter, please contact your consultant.

How do you access the COVID-19 treatments if you are eligible?

NHS OUTREACH ROUTE (For most patients):

  • Patient tests positive via PCR (or lateral flow test from 10 February)
  • CMDU automatically contacts patient within 24 hours and assesses & prescribes treatment
  • Sotrovimab and remdesivir offered in a CMDU setting – usually hospital.
  • Antiviral usually delivered to a patient’s home

PATIENT IN-REACH

  • Patient tests positive via PCR (or lateral flow test from 10 February)

Patient will need to contact GP or 111 or consultant for referral to CMDU

Further information

Further information about COVID-19 treatments are available here: Treatments for coronavirus - www.nhs.uk/CoronavirusTreatments

A wider group of patients will be able to join the national study for antiviral treatments called PANORAMIC.  See more information below.

COVID-19 clinical trials

A national study ‘PANORAMIC’, run by the University of Oxford in close collaboration with GP hubs, has now launched and is recruiting around 10,000 UK patients at risk of serious illness from COVID-19 to have the opportunity to take the treatment molnupiravir at home after receiving a positive PCR test.

Those at highest risk who test positive for the virus - including the patients listed below - will also be able to access either molnupiravir or the novel monoclonal antibody Ronapreve outside of the study from 16 December.

Clinically extremely vulnerable liver disease patients
This is the list of those with liver disease considered to be at highest risk:

  1. Any patient with liver cirrhosis and decompensation or complication as defined by the presence or recent history (within 12 months) of ascites, hepatic encephalopathy, hepatocellular carcinoma, variceal bleed or fluid retention.
  2. Other people who have also been classed as clinically extremely vulnerable by their clinician based on clinical judgement and an assessment of their needs. GPs and hospital clinicians have been provided with guidance to support these decisions.
  3. Patients who are actively on the liver transplant waiting list or who have received a liver transplant.
  4. Patients with chronic liver disease who are on immunosuppressants

People who do not fall into the high risk categories above can sign up to the PANORAMIC study through their website. It is crucial that eligible participants enrol in the study urgently to ensure that they have the opportunity to access antiviral treatments within the first five days of COVID-19 symptoms.

Taking part in the study will require participants to complete a daily diary for 28 days through the PANORAMIC website or receive a phone call from the trial team on days 7, 14 and 28 to speak about their symptoms. The first set of results from the trial are anticipated in early 2022.

Molnupiravir has shown in clinical trials to reduce the risk of hospitalisation or death for at-risk, non-hospitalised adults with mild to moderate COVID-19 by 30% and Ronapreve reduced the risk by 70%.

Those at highest risk who test positive for the virus including people who are immunocompromised and cancer patients,- will also be able to access either molnupiravir or the novel monoclonal antibody Ronapreve outside of the study from 16 December.

Those being prescribed a monoclonal antibody treatment will be invited to attend the NHS Covid Medicines Delivery Unit (CMDU), while those receiving molnupiravir can either get someone to collect it for them or have it delivered to their home. The NHS has been setting up CMDUs since the summer.

 

Melody study

The Melody study aims to assess antibody responses following three Covid-19 vaccine doses in people who have received solid organ transplants and  people with rare autoimmune diseases receiving immunosuppression. It will include up to 12,000 people.   To register, go to http://melodystudy.org

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