CLINICAL GUIDELINES ID TAG. Sandra Kilpatrick, Lyn Watt

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1 CLINICAL GUIDELINES ID TAG Title: HIV positive pregnant women- Antiretroviral guidance Authors: Designation: Speciality / Division: Directorate: Sandra Kilpatrick, Lyn Watt Pharmacist Obstetrics- IMWH Acute Services Date: May 2017 Consulted upon: Approved by: (Name of AMD) Yes Mr D Sim, Joanne McGlade Applicable to: (delete Yes / No as appropriate) Dept./Division Only: YES- IMWH Review Date May 2020 Clinical Guidelines ID CG0251[1] 0

2 HIV Positive Pregnant Women Antiretroviral Guidance Whilst all women are planned to be delivered at The Royal Jubilee Maternity Hospital, it is possible that women may present in labour to their closest hospital. Due to this possibility a pack containing the necessary antiretrovirals and information for intrapartum and postpartum care for the mother and the infant will be held in Delivery Suite CAH & DHH (for mother and infant) to allow initiation of Antiretroviral Therapy (ART). See flowchart in Appendix A for details of dosage and procedure. Note: There will also be a registrar/ consultant for HIV/GUM on call, who can be contacted through the Royal Hospitals switchboard. It is imperative that the mother and infant receive antiretrovirals at the prescribed time exactly. For example if a drug is prescribed for 9 am, it should not be given any later than this. Giving the dose later means that there is a break in treatment. Any delay in starting therapy or any break in therapy puts the patient at serious risk. If there is a delay in starting medication, if a dose is given later than prescribed or if a dose is missed the virus will use this time to multiply and may become resistant to the prescribed drugs. This has serious consequences for the mother/infant. **** THIS WILL BE TREATED AS A CRITICAL INCIDENT **** INTRAPARTUM to treat one mother & POSTPARTUM for one infant The following stock of antiretrovirals will be included in the pack. Brand Name Strength Quantity Drug Name Zidovudine Retrovir 200mg/20ml 10 vials (AZT) injection Injection Lamivudine (3TC) Epivir 150mg 60 tablets tablets Zidovudine oral solution Retrovir 50mg/5ml One 200ml bottle Nevirapine tablets Viramune 200mg 14 tablets Raltegravir tablets Isentress 400mg 60 tablets Version 2 June 2016 Sandra Kilpatrick and Lyn Watt Pharmacy Department CAH 1

3 The woman should have their own supply of antiretrovirals. CAH and DHH do not hold many antiretrovirals in stock. If these are required it may be quickest to obtain these medications from the woman s home. If this is not possible then contact the pharmacy department or, if out of hours, the pharmacist on-call who will arrange a supply to be obtained from the Royal Group of Hospitals. Pathway 1 Women on ARV treatment Look up most recent HIV viral load (within 4 weeks) - Result maybe in A/N proforma or accessed via Belfast Trust LabCentre# If VL > 70 IU/ml* or if no VL within 4 weeks - Discuss with HIV consultant in GUM and obstetric consultant - Assess trend of serial VL and trajectory /patient adherence - Consider following Pathway 2 If VL < 70 IU/ml* - Assess for other factors that may increase risk of MTC e.g. amnionitis, concurrent STIs, patient nonadherent to ARV (post VL date) Other factors- - Discuss with HIV consultant in GUM and obstetric consultant - Consider following Pathway 2 No other risk - Manage delivery as per noninfected woman - If ROM > 34 weeks gestation, delivery should be expedited with augmentation of labour *70 IU/ml equates to approx. 40 HIV RNA copies/ml; MTC- mother to child transmission; # The SP number for checking laboratory viral load results can be found at the top of the Mother s care plan. Version 2 June 2016 Sandra Kilpatrick and Lyn Watt Pharmacy Department CAH 2

4 Pathway 2 - Women not on ARV or on mono therapy or if viral load >70* IU/ml DO NOT delay delivery, in ORDER of priority Aim to deliver < 6 hours from ROM by caesarean section TOP PRIORITY AVOID vaginal delivery where at all possible Prescribe and administer ARV drugs STAT as per situations below (the emergency drug pack is held on delivery suite) If mother is not on ARV and has an unknown viral load the primary aim in giving the mother the drugs is to load up the baby to a reasonable prophylactic level. The time required for this must be balanced against risk of infection when there is ROM. The base risk of infection increases by 2% every hour after the first four hours of ROM. If the woman is only diagnosed in labour send 2 X clotted bloods for confirmation of HIV status to Regional Virology Lab using routine virology form. If vaginal delivery is unavoidable, avoid invasive testing that may encourage maternal-fetal blood exposure (e.g. fetal scalp monitoring, fetal blood sampling). If instrumental delivery is indicated, forceps is preferable to ventouse. Contact obstetric HIV consultant, GUM HIV consultant and neonatal team ASAP. Transfer to RJMH only with regional team approval and if time permits. For 4 most probable situations for drugs see below Situation 1: Woman not on ARV treatment, labour at term - Nevirapine 200mg stat - Prescribe (and give first dose ASAP) o Raltegravir 400mg BD o Lamivudine 150mg BD^ o DO NOT STOP POST PARTUM - IV zidovudine throughout labour and delivery Situation 2: Woman not on ARV treatment and pre-term labour - Nevirapine 200mg stat (+ Tenofovir 490mg stat - only available RJMH) - Prescribe (and give first dose ASAP) o Raltegravir 400mg BD o Lamivudine 150mg BD^ o DO NOT STOP POSTPARTUM - IV zidovudine throughout labour and delivery Situation 3: Woman on combined ARV treatment - Nevirapine 200mg stat - Continue ARV orally take lamivudine150mg instead of Combivir (zidovudine 300mg/lamivudine 150mg) while IV zidovudine is running^ - IV zidovudine throughout labour and delivery - CHECK CAREPLAN only stop ARV postpartum if clearly documented Situation 4: Woman on mono ARV treatment - Nevirapine 200mg stat - IV zidovudine throughout labour and delivery - CHECK CAREPLAN only stop ARV postpartum if clearly documented ^ (Note: Combivir (zidovudine 300mg/lamivudine 150mg) cannot be given while IV zidovudine is running as it will result in a double dose of zidovudine being given. Therefore lamivudine 150mg only should be given while IV zidovudine is being administered. Once IV zidovudine has stopped Combivir (zidovudine 300mg/lamivudine 150mg) can be continued). Version 2 June 2016 Sandra Kilpatrick and Lyn Watt Pharmacy Department CAH 3

5 Prior to delivery the consultant neonatologist and HIV consultant will advise on prophylaxis ART for the baby i.e. whether mono or triple therapy is deemed appropriate. The consultant on-call for HIV/GUM can be contacted through the Royal Hospitals switchboard. After delivery the infant will be prescribed ART by the neonatal registrar as soon as possible after birth and must be administered within 4 hours. It should be continued for 4 weeks. If triple therapy including lamivudine and nevirapine suspensions is required, these are kept in NNU (CAH) & SCBU (DHH) and can be started quickly. For dosing of these drugs see Guidelines for the Management of the HIV Positive Pregnant Women in Northern Ireland including Guidelines for the Management of the HIVexposed Infant Feb In most situations the baby will require oral zidovudine. The zidovudine injection is only needed when oral medication is not tolerated. NNU (CAH) & SCBU (DHH) hold the following medicines: Drug Brand name Strength Quantity Zidovudine oral liquid Retrovir 50mg/5ml One 200ml bottle Lamivudine Oral Solution Epivir 50mg/5ml One 240ml bottle Nevirapine suspension Viramune 50mg/5ml One 240ml bottle Zidovudine (AZT) injection Retrovir 200mg/20ml Injection. ( 10mg/ml 20ml amps) 5 vials The dose of intravenous zidovudine for an infant is different for term and preterm neonates- please refer to Appendix B - Protocol for Administration of intravenous Zidovudine to Infant. In most situations the infant will require oral zidovudine. The zidovudine injection is only needed when orals are not tolerated. For full details on the preparation and administration of intravenous zidovudine to the mother please refer to Appendix C - Protocol for Administration of Zidovudine to Mother. Version 2 June 2016 Sandra Kilpatrick and Lyn Watt Pharmacy Department CAH 4

6 IMPORTANT POINTS Postpartum antiretrovirals for mother: In some cases the mother will continue to take antiretrovirals after delivery. The HIV consultant will state whether the mother should stop taking these medicines. If no information has been given, prescription should continue until advice has been received from the HIV consultant. Breastfeeding is not recommended due to the risk of transmission of virus to the infant. Zidovudine is contra-indicated in new born infants with hyperbilirubinaemia requiring treatment other than phototherapy, or with increased transaminase levels over five times the upper limit of normal. Reference: Retrovir IV for infusion and Retrovir oral solution, SPC 23/02/ accessed 19/05/2016. Antiretroviral Drug Interactions Antiretroviral drugs interact with many medicines. Interactions can have serious consequences if the interacting drug reduces the level of the antiretroviral drug. In this instance the virus will recognise the reduced concentration of the antiretroviral drug, which could have long term consequences for the woman. Antiretroviral drugs can either reduce the concentration of other drugs, making them less effective or increase the concentration thereby increasing the side effects and the risk of toxicity. The following website is a useful resource: HIV Drug Interactions, university of Liverpool Version 2 June 2016 Sandra Kilpatrick and Lyn Watt Pharmacy Department CAH 5

7 Discharge Prescriptions for Mother and Infant Prescriptions for the mother and infant should be completed at least one day before discharge. The mother must be given written instructions on the infant s dose. Neonatal antiretrovirals must be sent to pharmacy to be labelled with dosage instructions for the mother /carer to continue post exposure prophylaxis at home as prescribed by the neonatal registrar. This is important as missed doses can result in treatment failure and would be treated as a critical incident. Please seek advice from the pharmacy department before discharge. Further supplies of antiretrovirals for the mother are provided by the HIV consultant/registrar at clinic visits in RVH. All antiretrovirals are supplied by the pharmacy department RVH. Version 2 June 2016 Sandra Kilpatrick and Lyn Watt Pharmacy Department CAH 6

8 Appendix A Guideline for administration of zidovudine to mother and baby Woman to receive intrapartum zidovudine Continue with oral zidovudine until zidovudine infusion started. Continue other oral antiretroviral therapy (ART) throughout delivery * Admitted in labour Start zidovudine infusion immediately Planned caesarean section Start zidovudine infusion 4 hours before Planned vaginal delivery Start zidovudine infusion at onset of labour Other situations e.g. emergencies or ROM Case by case basis Loading dose infusion: 2 mg/kg/hour for one hour Maintenance dose infusion: 1 mg/kg/hour. Continue until umbilical cord clamped oral zidovudine Yes Does baby need triple therapy? See individualised plan in mother s notes. No Does baby tolerate oral medication? Yes No See guideline for management of HIV exposed infant zidovudine iv infusion >34 weeks: 4mg/kg bd for 4 weeks weeks: 2mg/kg bd for 2 weeks THEN 2 mg/kg tid for 2 weeks <30 weeks: 2mg/kg bd for 4 weeks >34 weeks: 1.5 mg/kg qid For 4 weeks < 34 weeks: 1.5 mg/kg bd for 4 weeks Doses of antiretrovirals other than zidovudine should be given at the correct times during the infusion. See individualised plan for instructions on continuing/discontinuing antiretrovirals after delivery. Ensure most up-to date version available. In some situations it may not be possible to administer intrapartum zidovudine e.g. emergencies. Inform consultant obstetrician (tel 32003) and consultant neonatologist (tel 32441), HIV consultant (tel 34050) as appropriate. Version 2 June 2016 Sandra Kilpatrick and Lyn Watt Pharmacy Department CAH 7

9 Appendix B Protocol for the Administration of Intravenous Zidovudine in NNU / SCBU Only administer intravenous zidovudine when oral medication is not tolerated. Zidovudine must be diluted before administration with glucose 5%. The concentration should be 2mg/ml. Preparation: Withdraw 10ml from a 50ml bag of glucose 5%. Withdraw 10ml (100mg) drug from a vial of zidovudine 200mg/20ml. Add the 10ml (100mg) zidovudine to the remaining glucose 5% in the bag. Invert several times to mix well. This solution now contains 2mg/ml. To administer 1.5mg/kg, withdraw 0.75ml/kg of this solution and administer over 30 minutes. Note: Should the product appear cloudy either before or after dilution, or during infusion, the preparation should be discarded. If this happens a new preparation must be made to finish the dose. Doses must be given at the times prescribed. Any delay in treatment or a break in treatment puts the infant at serious risk. Reference SPC Zidovudine, Retrovir 10mg/ml for IV infusion February 2016 accessed 19/05/ Version 2 June 2016 Sandra Kilpatrick and Lyn Watt Pharmacy Department CAH 8

10 Appendix C Protocol for Administration of Zidovudine To Mother To prepare zidovudine infusion for use at delivery: Zidovudine injection for intravenous infusion is available as 10mg/ml in 20ml vials (200mg/20ml). Use the table below as a guide to calculate the volume of zidovudine injection required. Dilute before administration with glucose 5% or sodium chloride 0.9% to a concentration of between 2mg/ml and 4mg/ml. Withdraw a volume of fluid, from a 250ml or 500ml bag, equal to that of zidovudine to be added. The table indicates the final volume of fluid required according to patient s weight. Then add the required volume of zidovudine to the bag. Mix well. This preparation will be sufficient for nine hours of treatment. Weight (kg) Quantity of zidovudine for nine hours Volume of zidovudine 10mg/ml injection to be added Final volume of infusion Concentration Rate Loading dose i.e. 2mg/kg for one hour, then maintenance dose Maintenance dose i.e. 1mg/kg/hour until umbilical cord clamped mg 50 ml 250ml 2.0 mg/ml 50ml/hour 25ml/hour mg 55 ml 250ml 2.2 mg/ml 50ml/hour 25ml/hour mg 60 ml 250ml 2.4 mg/ml 50ml/hour 25ml/hour mg 65 ml 250ml 2.6 mg/ml 50ml/hour 25ml/hour mg 70 ml 250ml 2.8 mg/ml 50ml/hour 25ml/hour mg 75 ml 250ml 3.0 mg/ml 50ml/hour 25ml/hour mg 80 ml 250ml 3.2 mg/ml 50ml/hour 25ml/hour mg 85 ml 250ml 3.4 mg/ml 50ml/hour 25ml/hour mg 90 ml 250ml 3.6 mg/ml 50ml/hour 25ml/hour mg 95 ml 250ml 3.8 mg/ml 50ml/hour 25ml/hour mg 100 ml 250ml 4.0 mg/ml 50ml/hour 25ml/hour mg 105 ml 500ml 2.1 mg/ml 100ml/hour 50ml/hour mg 110 ml 500ml 2.2 mg/ml 100ml/hour 50ml/hour mg 115 ml 500ml 2.3 mg/ml 100ml/hour 50ml/hour mg 120 ml 500ml 2.4 mg/ml 100ml/hour 50ml/hour mg 125 ml 500ml 2.5 mg/ml 100ml/hour 50ml/hour mg 130 ml 500ml 2.6 mg/ml 100ml/hour 50ml/hour mg 135 ml 500ml 2.7 mg/ml 100ml/hour 50ml/hour mg 140 ml 500ml 2.8 mg/ml 100ml/hour 50ml/hour mg 145 ml 500ml 2.9 mg/ml 100ml/hour 50ml/hour mg 150 ml 500ml 3.0 mg/ml 100ml/hour 50ml/hour This table is a guide for calculation purposes. If a patient weighs 77Kg then 770mg is required for 9 hours. If infusion is to continue for longer than 9 hours make up another infusion bag as above and infuse at 1mg/kg/hour i.e. continue with maintenance dose. Note: Should the product appear cloudy either before or after dilution, or during infusion, the preparation should be discarded. If this happens a new preparation must be made to finish the dose. Doses should be given at the appropriate times prescribed. Version 2 June 2016 Sandra Kilpatrick and Lyn Watt Pharmacy Department CAH 9

11 References and Further Reading Guidelines for the management of HIV positive pregnant women in Northern Ireland BHIVA guidelines for the treatment of HIV-1-positive adults with antiretroviral therapy BHIVA guidelines for the management of HIV infection in pregnant women 2012 (2014 interim review) Information for use in delivery of HIV positive mother. The Royal Group of Hospitals Handbook of Injectable Drugs 14 th Edition Lawrence A. Trissel American Society of Health-System Pharmacists. Version 2 June 2016 Sandra Kilpatrick and Lyn Watt Pharmacy Department CAH 10