5.3. Antiviral drugs
Restrictions:
Restricted to specialist use for the treatment of cytomegalovirus (CMV) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT).
5.3.1. HIV infection
Where combination preparations include several medicines from the same class, they are included in that particular sub-section (e.g. protease inhibitors). Cross-class combinations can be found in sub-section 5.3.1.5.5.3.1.1. Nucleoside reverse transcriptase inhibitors
Restrictions:
- The treatment of HIV infection is restricted to use by HIV specialists.
- Use in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults at high risk is restricted to specialist use only by consultants in sexual health and infectious disease consultants.
Prescribing Notes:
Non-Formulary indications:
- Treatment of HIV-1 infected adolescents aged 12 to <18 years with nucleoside reverse transcriptase inhibitor resistance or toxicities precluding the use of first-line agents
Restrictions:
Restricted to use by HIV specialists.
Prescribing Notes:
For treatment of hepatitis B see section 5.3.3.
5.3.1.2. Protease inhibitors
Restrictions:
Restricted to use by HIV specialists. Use in naïve HIV-1 infected adults in combination with other antiretrovirals is further restricted to when other treatments are not tolerated or inappropriate.
5.3.1.3. Non-nucleoside reverse transcriptase inhibitors
Restrictions:
Restricted to use by HIV specialists.
Prescribing Notes:
Potentially fatal liver toxicity and skin reactions have been reported.
Restrictions:
Restricted to HIV specialists use only as detailed in the prescribing notes below.
Prescribing Notes:
- As combination treatment of HIV-1 infection in treatment naive adult patients
- In combination with other antiretroviral medicinal products, for the treatment of HIV-1 infection in antiretroviral treatment naive patients aged 12 to 18 years of age and older with a viral load (VL) ≤ 100,000 HIV-1 RNA copies/ml
5.3.1.4. Other retrovirals
Restrictions:
The use in combination with other antiretroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults and adolescents above 12 years of age is restricted to use by HIV specialists.
Restrictions:
Restricted to use by HIV specialists in patients with triple-class resistant HIV-1 infection or in combination with other treatments in adult patients who are intolerant or resistant to non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) or when these options are compromised due to drug-drug interactions.
5.3.1.5. Other HIV combination preparations
Combination preparations that consist of drugs from the different classes of HIV medicines are included in this sub-section.
Restrictions:
Restricted to use by HIV specialists for the treatment of adults infected with HIV-1 without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.
Restrictions:
Restricted to use by HIV specialists for treatment of adults infected with HIV-1 who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor (NNRTI) or integrase inhibitor.
Restrictions:
Restricted as outlined in the Prescribing Notes section below.
Prescribing Notes:
Treatment of adults and adolescents (aged 12 years and older with body weight at least 35kg) infected with human immunodeficiency virus-1 (HIV-1) without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir is restricted to use by HIV specialist only.
Restrictions:
Restricted to use by HIV specialists.
Prescribing Notes:
Please note: Only this combination preparation containing cobicistat is included in the Formulary. Cobicistat tablets as a separate preparation (Tybost®) are not recommended for use by the Scottish Medicines Consortium and are non-Formulary.
Restrictions:
Use in the treatment of HIV infection is restricted to use by HIV specialists only.
Use for the pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk men who have sex with men, including adolescents (with body weight at least 35 kg) is restricted to specialist use for those patients who have renal or bone issues for whom other alternative PrEP options are not suitable.
Restrictions:
The use for the treatment of HIV-1 infection in treatment naive adults, or treatment experienced adults without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with viral load ≤100,000 HIV-1 RNA copies/mL, is restricted to HIV specialists only.
5.3.2. Herpesvirus infections
5.3.2.1. Herpes simplex and varicella–zoster infection
Prescribing Notes:
Aciclovir and other antiviral agents are only useful in varicella and herpes zoster if started within 48 hours of the appearance of rash, with the exception of ophthalmic shingles where the use may be justified up to 7 days after the development of rash.
5.3.2.2. Cytomegalovirus infection
Restrictions:
Use for the prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT) is restricted to specialist use only in accordance with national protocols.
Restrictions:
Use in HIV and Ophthalmology is restricted to specialist use by HIV specialists and ophthalmologists specialising in ocular issues associated with HIV infection respectively. The use of valganciclovir for the prevention of cytomegalovirus (CMV) disease for patients who have received a solid organ transplantation from a CMV postive donor is restricted to initiation by physicians experienced in the care of post-transplant patients. However, GPs are able to prescribe on the advice of a specialist for this indication in order to complete the course duration (which may vary between 100-200 days dependent on type of organ transplanted).
5.3.3. Viral hepatitis
Restrictions:
Restricted to initiation by, or on the advice of, a specialist treating hepatitis B in accordance with local protocol.
Prescribing Notes:
Adefovir for the treatment of hepatitis B is subject to an agreed Shared Care Protocol whcih allows the ongoing prescribing to be carried out by the patient's GP under guidance and review by the acute specialist.
To access this Shared Care Agreement, and others, click here
Restrictions:
Restricted to specialist use for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV-RNA positive patients with compensated liver disease with evidence of significant fibrosis (METAVIR stage ≧ F2) whose disease has responded inadequately to interferon-based therapy or who are ineligible to receive interferon-based therapy due to intolerance or contraindications.
Restrictions:
Restricted to initiation by, or on the advice of, a specialist treating hepatitis B in accordance with local protocol. Use for the treatment of chronic hepatitis B infection in adults with decompensated liver disease is not recommended by SMC and is non-Formulary.
Prescribing Notes:
Entecavir for the treatment of hepatitis B is subject to an agreed Shared Care Protocol whcih allows the ongoing prescribing to be carried out by the patient's GP under guidance and review by the acute specialist.
To access this Shared Care Agreement, and others, click here
Restrictions:
The treatment of chronic hepatitis C virus (HCV) infection in adults is restricted to specialist use only in accordance with local protocol
Restrictions:
Restricted to initiation by, or on the advice of, a specialist treating hepatitis B in accordance with local protocol.
Prescribing Notes:
Lamivudine for the treatment of hepatitis B is subject to an agreed Shared Care Protocol whcih allows the ongoing prescribing to be carried out by the patient's GP under guidance and review by the acute specialist.
To access this Shared Care Agreement, and others, click here
Restrictions:
Use in the treatment of chronic hepatitis C (CHC) in adult patients is restricted to specialist use in patients with genotype 1, 3 and 4 chronic hepatitis C in accordance with local protocol and implementation plan.
Prescribing Notes:
Treatment choice will continue to be directed by national guidance.
Restrictions:
Restricted to specialist use only in accordance to national guidelines for the treatment of chronic hepatitis C (CHC).
Restrictions:
Restricted to specialist use only. Use subject to Hepatitis MCN protocol with pegylated interferon alfa in hepatitis C.
Restrictions:
The use in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults is restricted to specialist use in accordance with local protocol (under development).
Prescribing Notes:
The SMC restriction on use is as follows:
Sofosbuvir is accepted for use in patients with genotypes 1 to 6. Use in treatment-naive patients with genotype 2 is restricted to those who are ineligible for, or are unable to tolerate, peginterferon alfa. Use of the 24-week interferon-free regimen of sofosbuvir in combination with ribavirin in patients with genotype 3 is restricted to those who are ineligible for, or are unable to tolerate, peginterferon alfa.
Restrictions:
Use in the treatment of chronic hepatitis C virus (HCV) infection is restricted to specialist use in accordance with local protoclol for the following patient groups:
- Genotype 1 chronic HCV infection
- Genotype 2 chronic HCV infection
- Genotype 3 chronic HCV infection
- Genotype 4 chronic HCV infection
- Genotype 5 chronic HCV infection
- Genotype 6 chronic HCV infection
- Patient with decompensated cirrhosis, irrespective of genotype
Restrictions:
Restricted to initiation by, or on the advice of, a specialist treating hepatitis B in accordance with local protocol.
Prescribing Notes:
Tenofovir for the treatment of hepatitis B is subject to an agreed Shared Care Protocol whcih allows the ongoing prescribing to be carried out by the patient's GP under guidance and review by the acute specialist.
To access this Shared Care Agreement, and others, click here
Restrictions:
Use in the treatment of chronic hepatitis C virus (HCV) infection is restricted to use in accordance with local protocol in patients who have failed to acheive a sustained virologic response (SVR) with a direct-acting anti-viral (DAA) or who are DAA-naive, have genotype 3 (GT3) HCV infection, with or without cirrhosis, and are suitable for treatment with an eight-week course.
5.3.4. Influenza
Restrictions:
Oseltamivir use in the prophylaxis of influenza is subject to NICE TA158 and the treatment of influenza is subject to NICE TA168.
Restrictions:
- Zanamivir use in the prophylaxis of influenza is subject to NICE TA158 and the treatment of influenza is subject to NICE TA168.
- Zanamivir IV Infusion is restricted to specialist use for the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ≥6 months) when:
- The patient's influenza virus is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir and/or
- other anti-viral medicinal products for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient.