New infective episode of COVID-19 in patients in primary care who do not require hospitalisation

NHS Learning Hub: for training on prescribing Paxlovid for clinicians, click here COVID-19 antiviral treatments

NICE TA878 update (June 2024): NICE has recommended a phased implementation of new recommendations for Paxlovid to expand its use (NICE TA878).  Further patient groups have been added (see Clinical history here). For an overview of the new recommendations, see here. There will be a further expansion of the patient groups eligible for Paxlovid during the course of 2024.

Treatment pathway

Patients will no longer be automatically contacted by the NHS after reporting a positive COVID-19 test result. Instead, patients have been advised to contact their GP practice, NHS 111, or hospital specialist as soon as possible after a positive test.

1. A patient must meet all initial assessment criteria for a COVID-19 treatment before a decision can be taken on the appropriate treatment (see criteria).
   1. Advice & Guidance or referral to the COVID Medicines Delivery Unit (CMDU) is available if there is uncertainty as to whether the patient meets the criteria (see clinical referral guidance)
2. If the initial assessment criteria are met, the GP may either:
   1. Determine if Paxlovid may be initiated in primary care without specialist support (see below).
      1. Refer to the CMDU if Paxlovid is contraindicated or not suitable. CMDU Advice & Guidance is available to discuss potential drug interactions or medical history, OR
   2. Refer for the CMDU to determine whether Paxlovid is suitable and prescribe a COVID-19 treatment if required (see clinical referral guidance)
3. There are no routine treatment options for children under 12 years or weighing less than 40kg who meet initial assessment criteria. GPs should contact the child’s specialist team directly.
4. Prompt review is required: treatment should start as soon as possible after a positive COVID-19 test and within 5 days of onset of symptoms of COVID-19.
5. Patients should be given safety netting information about how to monitor their illness, when they should seek help and the expected recovery time.
6. If prescribing Paxlovid, refer to the MHRA Drug Safety Update (November 2023) ‘Advice for healthcare professionals to provide to patients’.

Treatment options

Treatment options are defined by NICE TA878 and a national interim commissioning policy. See here for formulary entries.

First-line: Paxlovid (nirmatrelvir/ritonavir, oral antiviral for adults, 5 day course)

• There are contraindications and a significant risk of potentially serious or harmful drug interactions with Paxlovid. If a patient meets all initial assessment criteria, do not prescribe Paxlovid without carefully considering whether it is appropriate for the patient (see below)

Second-line: Sotrovimab (nMAB, single intravenous infusion)

Third-line: Molnupiravir (oral antiviral for adults, 5 day course)

• May be prescribed in primary care on the advice of a specialist if Paxlovid or sotrovimab are contraindicated or not clinically suitable. 

1) Initial assessment for consideration of a COVID-19 treatment

The patient should meet ALL of the following to be considered for treatment:

*There are no routine treatment options for children under 12 years or weighing less than 40kg. GPs should contact the child’s specialist team directly.

**If there is any uncertainty, CMDU Advice & Guidance is available here. 

2) Assessment for treatment with Paxlovid

If a patient meets ALL initial assessment criteria, Paxlovid may be initiated in primary care without specialist support if there are no clinical circumstances which require referral.

There is a significant risk of potentially serious or harmful drug interactions with Paxlovid, leading to increased toxicity from, or reduced effectiveness of concomitant medications, or reduced effectiveness of Paxlovid. Complete and accurate information on the patient’s medicines to check for drug interactions is essential to the safe prescribing of Paxlovid. See Drug Interactions with Paxlovid, below, for the Liverpool COVID-19 drug interaction checker.

CMDU Advice & Guidance may be sought if:

• not confident of completeness of medication for patients prescribed a medicine by secondary care or recent episode of care, or
• concerns over a potential drug interaction or medical history
• CMDU Advice & Guidance is available here

Refer if:

• For consideration of an alternative treatment if both the following apply: 
  • Paxlovid is contraindicated or not suitable (see circumstances below) and 
  • The patient falls within a patient group defined in section 5 of TA878 (adults; young people aged 12 to 17 years)
• Preference is for the COVID Medicines Delivery Unit to determine whether Paxlovid is suitable and prescribe COVID-19 treatment if required, or
• Five day treatment ‘window’ may be breached. Pharmacies are unlikely to have Paxlovid in stock and may have to order it (which may be up to 24 hours). If the time delay will push the patient outside the treatment ‘window’ of 5 days, then a referral is appropriate (as stocks are available to the COVID Medicine Delivery Units)
• See clinical referral guidance

Circumstances where Paxlovid is contraindicated or not suitable

*Contact patient to ensure current circumstances are taken into account. See below for questions to ask for complete information on medicines.

Drug interactions with Paxlovid

MHRA Drug Safety Update (December 2023): Nirmatrelvir, ritonavir (Paxlovid): be alert to the risk of drug interactions with ritonavir

There is a significant risk of potentially serious or harmful drug interactions with Paxlovid, leading to increased toxicity from, or reduced effectiveness of concomitant medications, or reduced effectiveness of Paxlovid.

It is essential the prescriber has complete and accurate information on the patient’s medicines to check for drug interactions including:

• OTC medicines (including herbal remedies)
• Illicit or recreational drugs
• Prescription medicines, including any medicines prescribed by secondary care
• Ask the patient whether they are receiving any medicines prescribed or administered by secondary care (including medicines delivered to their home, injections or infusions administered in out-patients or clinics, depot injections)
• Have they received any medicines through attendance at walk-in clinic, A&E, acute medical unit or day case admission?
• Has the patient recently been discharged from hospital (discharge medication may not have been confirmed with primary care)?

If the GP is not confident of the completeness of patient medication and relevant medical history, seek CMDU Advice & Guidance or refer patient to the CMDU (see clinical referral guidance)

Use the Liverpool COVID-19 drug interaction checker or Paxlovid SmPC to check for drug interactions with Paxlovid.

Using the Liverpool COVID-19 drug interaction checker

Liverpool COVID-19 Drug Interaction checker

Under COVID Drugs (column on left), select ‘Nirmatrelvir / ritonavir (5 days)’

Under Co-medications (column on right), add all of the patient’s existing medicines (more than one medicine can be added at a time)

Drug interactions will appear to the right of the screen. Click ‘More Info’ for a summary of the interaction. To obtain a pdf copy of the interacting medicines, click ‘Switch to Table View’ and scroll to the bottom of the screen.

• Green: no interaction expected
• Yellow: potential interaction likely to be of weak intensity. Additional action/monitoring or dosage adjustment is unlikely to be required. No need to withhold Paxlovid. Paxlovid can be prescribed without taking action.
• Amber: Potentially clinically significant interaction which is likely to require additional monitoring, alteration of drug dosage or timing of administration. Alternative options to replace the interacting medicine are proposed for some interactions. See below for additional considerations
• Red: These drugs should NOT be co-administered – Refer to CMDU

If there is an amber drug interaction, consider the risks and benefits of prescribing Paxlovid including:

• Practical issues such as additional monitoring and ease of dose adjustments for interacting medicine
• Whether an interacting medication might be safely withheld for a period of at least 8 days (5 day Paxlovid course and at least a further 3 days)
• Can the interacting medicine be replaced with an alternative medicine?
• Impact of stopping Paxlovid after course completion and subsequent need to reconsider management strategies used to facilitate safe use in someone taking interacting medicines when Paxlovid was initiated

If uncertain whether to prescribe Paxlovid, seek CMDU Advice & Guidance or, if appropriate, refer patient to the CMDU for consideration of alternative COVID-19 treatment (see clinical referral guidance)

Availability of oral antiviral COVID-19 treatments in the community

Paxlovid and molnupiravir are available to prescribe on FP10 prescriptions.

Discuss with patient:

• The preferred community pharmacy considering urgency of prescription.
• Patient or their representative to contact the pharmacy to confirm whether the medication will be available within the 5 day treatment ‘window’, and to let the GP know if this will not be the case.
  • If the time delay will push the patient outside the 5 day treatment ‘window’, then a referral is appropriate.
• Arranging collection by an asymptomatic patient representative.

Advice for community pharmacists

• Paxlovid and molnupiravir can be ordered from Alliance Healthcare. Treatment should commence within 5 days of onset of COVID-19 symptoms. Inform the patient or their representative if the medication will not be available within the 5 day ‘treatment window’ and ask them to report this to their GP, who can make a referral to a Covid Medicines Delivery Unit. 
  • For further information, see the formulary entries Paxlovid (note 6) and molnupiravir (note 5).
• Primary care healthcare professionals, including community pharmacy, can seek further advice from the Specialist Pharmacy Service Medicines Advice service.

Resources

Lateral flow tests: Who can order a free NHS rapid flow test and Treatments for COVID-19, including action to take if positive or negative lateral flow test. A walk-in service is available to collect lateral flow tests from a participating community pharmacy on confirmation that the patient is part of the cohort potentially eligible for COVID-19 treatments.

NHS Learning Hub: for training on prescribing Paxlovid for clinicians, click here COVID-19 antiviral treatments

MHRA Drug Safety Update (December 2023): Nirmatrelvir, ritonavir (Paxlovid): be alert to the risk of drug interactions with ritonavir