HIV in Pregnancy - Management of



Canberra Hospital and Health Services

Clinical Guideline

Human Immunodeficiency Virus (HIV) in Pregnancy

|Contents |

Contents 1

Guideline Statement 2

Scope 2

Section 1 – Communication and Confidentiality 2

Section 2 – Minimising the Risk of Maternal - Child Transmission 3

Section 4 – Mode of Delivery 6

Section 5 – Intrapartum Zidovudine 6

Section 6 – Immediate care of the newborn baby 7

Section 7 – Neonatal antiretroviral therapy (HIV prophylaxis) 7

Section 8 – Newborn HIV testing and discharge needs 9

Implementation 12

Related Policies, Procedures, Guidelines and Legislation 12

References 12

Search Terms 13

Attachments 13

Attachment 1 - Antenatal Checklist 15

Attachment 2: Discharge checklists 16

Attachment 3: Schedule of antenatal visits 18

Attachment 4: Additional Recommendations for pregnancy related care for women with HIV 20

|Guideline Statement |

Key Objective

To guide optimal antenatal, intrapartum and postpartum care for women with HIV, and their newborn babies.

Alerts

For immediate HIV related advice whilst the woman is in hospital, please contact the woman’s nominated HIV physician. If they are not available, please contact the Infectious Diseases physician on call. Call through switch at Canberra Hospital telephone: 6244 2222

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|Scope |

This document applies to clinical staff in Obstetrics and Gynaecology, Neonatology, Sexual Health and Infectious Diseases. It also applies to Canberra Hospital and Health Services pharmacy staff and to medical, midwifery and nursing students working under supervision.

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|Section 1 – Communication and Confidentiality |

• A copy of this guideline should be kept at the FRONT of the woman’s antenatal clinical record

• Ensure woman’s identifying details are NOT included in any email communication relating to HIV. If required, name and date of birth may be sent through to treating team members in a separate email

• If the woman does not provide consent for their GP to receive their discharge summary this should be clearly documented in notes and GP details in ACTPAS and BOS should be reviewed

• All medical and nursing/midwifery staff involved in the woman’s care should be familiar with this guideline

• A single room, in antenatal and postnatal wards, is required to ensure confidentiality is maintained

• Family members including older children and grandparents, friends and other visitors are often NOT aware of the woman’s HIV diagnosis. If family or friends are present, please do NOT discuss ANY issue related to the mother or the baby which may be associated with HIV (such as maternal medications, neonatal medications, HIV blood testing, formula feeding, or follow-up), unless you have the consent of the mother to do so.

• Early discharge of the baby is not advisable to ensure the baby is tolerating medication for neonatal prophylaxis, has discharge medication available, and has had initial blood tests

• The contents of the guideline are discussed with the woman (and their partner as applicable) and a copy is offered to the woman.

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|Section 2 – Minimising the Risk of Maternal - Child Transmission |

Advances in the management of HIV during pregnancy have reduced the risk of transmission from up to 50% to 50 copies/ml at delivery ensure that additional requirements for neonatal prophylaxis are:

o Agreed with HIV physician

o Clearly documented in maternal record

o Discussed with neonatologist

o Ordered through CH&HS Pharmacy and available in Birthing as above.

Obstetric team (medical and midwifery) at delivery:

• Liaise with neonatology registrar to ensure the baby commences neonatal HIV prophylaxis immediately after delivery

• Order maternal HIV viral load at delivery

• Advise HIV treating clinician that the baby has been born and request consultation during business hours.

HIV physician:

• Continue to provide HIV related care

o If the woman’s viral load is already below detectable, repeat viral load is recommended at least once every trimester, at 36 weeks and at delivery

o If the woman’s viral load is detectable at > 50 copies/ml, more frequent review is required

o Organise maternal proviral DNA testing early in pregnancy to ensure primers amplify maternal virus and can be validly used for testing of the infant

o Consider need for antiretroviral dose increase in trimester 2/3 (darunavir twice daily, Consider dose increase for lopinavir and atazanavir)

o Advise of community supports including Aids Action Council ACT

• Discuss inclusion of perinatal HIV exposure in baby’s records at Canberra Hospital (hospital records, Pathology and Canberra Sexual Health Centre (CSHC))

o Discuss strategies to respond to any queries about this if their child needs ACT hospital care in future. This will also apply to GP records

o Offer a copy of “Just a part of life: disclosing to your child” Positive Living NSW 2011

• Encourage GP involvement in care

o If the woman does not have a GP, discuss, encourage and facilitate referral for GP care, including disclosure of HIV status. The GP Liaison Unit at Canberra Hospital are available to assist woman to find a GP (tel: 6244 4183 or GPLIAISON.GPLIAISON@.au); as can the Medical Advisor, HIV program, ACT Medicare Local

o If the woman has a GP, but the GP is not aware of her HIV status, discuss, encourage and support disclosure prior to the baby’s birth

• Work closely with FMU

o If the woman’s viral load is expected to be > 50 copies/ml at delivery, advise on additional neonatal prophylaxis

o Confirm management with the woman, ensure she has been offered a copy of this guideline and has an opportunity to ask any HIV related questions

• Liaise with Infectious Diseases (ID) physicians

o As ID will be called if the nominated HIV physician cannot be contacted, provide ID with a summary care plan for the mother and her baby well before expected date of birth

• Provide hospital consultation to mother and baby after delivery

o Advise on dose reduction if HIV medication dosage has been increased in third trimester

o Ensure mother has enough medication on discharge until her own six week follow-up with HIV physician

o Clarify how parents will receive results of the baby’s initial HIV test

• Review mother and baby at about 3 weeks, with initial proviral DNA result

o Unless the baby has been referred for paediatric follow-up, oversee all follow-up HIV testing (and Hepatitis B and C testing if required) until 18 months of age

o Complete Australian Paediatric Surveillance Unit (APSU) paperwork in relation to the mother’s care in pregnancy

o Check that initial APSU paperwork in relation to the baby has been completed

Neonatologist:

• Provide antenatal consultation

o Consult with the woman at 28 weeks - arranged by the FMU specialist through PA of the Neonatal Department, tel; 6174 7565

o Disseminate the information about the woman and the treatment plan for the baby to the neonatal team. Ensure that if an e-mail is sent, no personal details are included in the same e-mail containing information about the HIV status of the woman

• Ensure a neonatal registrar will be present at birth

o commence appropriate antiretroviral therapy for the baby

• Provide care for the baby until discharge

o Order intial HIV proviral DNA and blood tests for the baby as per Section 8 of SOP

o Ensure that a copy of results are requested to HIV physician

o Remind registrar that maternal HIV status does not need to be included in Blue Book

o Follow up blood test results and inform HIV physician of the results

o Arrange follow up of the baby by the HIV physician, unless paediatric follow-up is indicated

o Complete initial APSU paperwork for the baby

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|Section 4 – Mode of Delivery |

HIV viral load 50 copies/ml and 50 copies/ml. UK/Ireland data in 2008 report HIV transmission in three of 2309 (0.1%) of women with HIV viral load 50 and 1000 copies/ml at 36 weeks – recommend caesarean section

• Caesarean section is recommended.

• Intrapartum IV zidovudine may be recommended or considered depending on maternal viral load - see below. Continue all usual oral medications.

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|Section 5 – Intrapartum Zidovudine |

US CDC and UK BHIVA guidelines also differ regarding intrapartum zidovudine when maternal HIV viral load is less than 10 000 copies/ml. US guidelines recommend intrapartum zodivudine at viral

load >400 copies/ml. BHIVA guidelines suggest there is no evidence to support intrapartum zidovudine if viral load is 10 000 copies/ml or unknown – recommend intrapartum zidovudine

Start IV zidovudine immediately for women who present in labour, or with ruptured membranes. Start IV zidovudine three to four hours before planned caesarean, and as soon as possible prior to emergency caesarean, to maximise placental transfer to the baby prior to delivery:

• Loading dose: zidovudine 2mg/kg over one hour, and continue with

• Maintenance dose: zidovudine 1mg/kg/hr until umbilical cord is clamped

See Appendix 4: Calculation for maternal intravenous zidovudine infusion

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|Section 6 – Immediate care of the newborn baby |

Minimise the baby’s contact with maternal blood:

• On birth of the head, gently wipe the baby’s eyes free of secretions

• If suction is required, use gently to avoid damage to mucous membranes

• Clamp the cord as soon as possible

• Towel dry the baby

• Ensure baby’s skin is thoroughly cleaned prior to administration of vitamin K or Hepatitis B vaccine and /or Hepatitis B Immunoglobulin

• Commence neonatal antiretroviral therapy as soon as possible (see Section 7 below)

• Bath as soon as possible

• Formula feeding only. Support for mother in relation to this – she is likely to face pressure from relatives and friends to breastfeed. (see BFHI recommendations for acceptable medical reasons for artificial feeding (WHO, NH&MRC)

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|Section 7 – Neonatal antiretroviral therapy (HIV prophylaxis) |

• Antiretroviral therapy should be commenced immediately after delivery and be continued for 4 weeks

• Choice of antiretroviral therapy for the neonate depends on maternal viral load near delivery, maternal HIV antiretrovirals and maternal HIV resistance profile.

• If the maternal viral load is 50 copies/ml: additional medications are required

• Give zidovudine immediately, dosage as below

• Give additional medications as documented in clinical record

In the absence of maternal resistance, the following 3 medication regimen is recommended for infants of mother’s with viral load >50 copies/ml:

• zidovudine 4mg/kg/dose PO q12h x 4 weeks

• lamivudine 4mg/kg/dose PO q12h x 4 weeks

• nevirapine 2 mg/kg/day for first week, then 4 mg/kg/day for week 2; stop end of week 2

Do not delay administration of zidovudine if other medications are not immediately available.

If there is a history of maternal HIV antiviral resistance, consultation with paediatric HIV/Infectious Diseases specialist at Sydney Children’s Hospital is recommended.

NOTES:

• zidovudine can be given Intra Venous (IV) for preterm infants – see below

• Check dose adjustment for all oral medications if infant is preterm

• Nevirapine has a long half life. It imperative that zidovudine and lamivudine continue for the full 4 weeks to work in conjunction with residual nevirapine and to reduce the risk of nevirapine resistance should the baby be HIV infected

• Do not use lopinavir/ritonavir (Kaletra) - it is contraindicated in newborn period


If maternal viral load is unknown, for example a woman presents unexpectedly:

• Give zidovudine immediately, as per dosage below

• Seek urgent input from on-call Infectious Diseases physicianConsider additional neonatal prophylaxis as per maternal viral load >50 copies/ml, depending on maternal history

• Request urgent maternal HIV viral load

Note:

Neonatal prophylaxis should continue for 4 weeks.

This duration is consistent with UK guidelines and current Australian practice. It is noted that the US CDC guidelines currently (January 2013) stipulate 6 weeks. Longer duration of therapy may increase the risk of side effects and does not appear to offer any benefit

Zidovudine dosage

1. Oral zidovudine:

• Babies ≥ 35 weeks gestation 4mg/kg/dose PO q12h x 4 weeks

• Babies 30 – 34 weeks gestation 2mg/kg/dose PO q12h x 2 weeks, then

increase to 2mg/kg/dose PO q8h x 2 weeks

• Babies 50 copies/ml at delivery) require PJP prophylaxis with cotrimoxazole from 4 weeks of age until they have a HIV negative result at 3 month testing:

• Cotrimoxazole 2.5mg/kg/dose 12 hourly on 3 days per week

• For simplicity:

• Cotrimoxazole 0.31mL/kg/dose 12 hourly Mondays, Wednesdays and Fridays

• Where Cotrimoxazole = trimethoprim 8mg – sulphamethoxazole 40mg/mL.

Doses expressed as trimethoprim component. Give doses with feeds

Immunisations

HIV exposed infants should receive all normal childhood immunisations (birth, 6 weeks and 4, 6, 12 and 18 months).

Notification to Australian Paediatric Surveillance Unit

The Australian Paediatric Surveillance Unit (APSU) summarises key data on babies born to mothers with HIV, even if they are subsequently confirmed as HIV antibody negative.

The Neonatologist is responsible for completing information for the baby, and the HIV specialist for the mother. Forms can be found at and

All information is coded (first two letters of last name and first two letters of given name) and once received by APSU, further coded so that name code or date of birth is not available in any public access format.

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|Implementation |

This Clinical Guideline will be accessible to all relevant stakeholders via the electronic policy/ guideline register on the ACT Health intranet. Education on the implementation of the guideline will be provided at appropriate multidisciplinary education sessions.

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|Related Policies, Procedures, Guidelines and Legislation |

Policies

• Health Directorate Nursing and Midwifery Continuing Competence Policy

• Consent and Treatment

Procedures

• CHHS Healthcare Associated Infections Clinical Procedure

• CHHS Patient Identification and Procedure Matching Policy

Guidelines

• CHHS Fasting Guidelines – Elective and Emergency Surgery

Legislation

• Health Records (Privacy and Access) Act 1997

• Human Rights Act 2004

• Work Health and Safety Act 2011

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|References |

1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Sep. 14, 2011; pp 1-207. Available at . Accessed May 2013

2. British HIV Association and Children’s HIV Association: Guidelines for the management of HIV infection in pregnant women. April 2012. Accessed May 2013.

3. Human Immunodeficiency Virus (HIV) In Pregnancy. Policy, Guideline and Procedure Manual May 2012. The Royal Women’s Hospital Melbourne. Accessed May 2013.

4. Giles, Michelle L. HIV and pregnancy: how to manage conflicting recommendations from evidence-based guidelines. AIDS 27(6): 857-862, March 2013

5. Monitoring Paediatric HIV infection and Perinatal Exposure to HIV in Australia. Australian Paediatric Surveillance Unit.

6. Accessed May 2013

7. Australian Health Ministers’ Advisory Council 2012, Clinical Practice Guidelines: Antenatal Care – Module 1. Australian Government Department of Health and Ageing, Canberra Accessed May 2103

8. British HIV Association, BASHH and FSRH guidelines for the management of the sexual and reproductive health of people living with HIV infection 2008.

9. National Health and Medical Research Council (NH&MRC) (2013) Infant Feeding Guidelines Information for health workers

10. World Health Organisation (2010) Guidelines on HIV and infant feeding

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|Search Terms |

HIV, Human deficiency virus, AIDS, Antiretroviral, pregnancy

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|Attachments |

Attachment 1: Antenatal Checklist

Attachment 2: Discharge checklists

Attachment 3: Schedule of antenatal visits

Attachment 4: Additional Recommendations for pregnancy related care for women with HIV

Disclaimer: This document has been developed by Health Directorate, Canberra Hospital and Health Services specifically for its own use. Use of this document and any reliance on the information contained therein by any third party is at his or her own risk and Health Directorate assumes no responsibility whatsoever.

(to be completed by the HCID Policy Team)

|Date Amended |Section Amended |Approved By |

|Eg: 17 August 2014 |Section 1 |ED/CHHSPC Chair |

| | | |

Attachment 1 - Antenatal Checklist

FMU Obstetrician at booking, and review at 28 weeks.

EDD:

Planned mode of birth: Vaginal Caesarean section Date: _____________

Zidovudine infusion: Yes No if yes, availability in Birth Suite confirmed on Date: ___________

|Treating team |Name |Contact details |

|HIV | | |

|Physician | | |

|Obstetrician | | |

|Neonatologist | | |

|GP (if aware of HIV diagnosis) | | |

|Woman’s usual HIV Medication |Dose |3rd trimester dose adjustment if required |

| | | |

| | | |

| | | |

|Results in pregnancy |

|Date |HIV viral load (copies/ml) |Date |HIV viral load (copies/ml) |

| | | | |

| | | | |

| | | | |

| | | | |

|Discussions |Notes |Name & Date |

|Confidentiality – who from CH&HS will know about | | |

|woman’s diagnosis, any specific concerns | | |

|Mode of birth, risks and benefits | | |

|Formula feeding | | |

|Zidovudine syrup for the baby for 4 weeks | | |

|HIV testing for the baby | | |

|Midcall/NAPSS Nurse visits on discharge | | |

|Follow-up with HIV Physician at 6 weeks | | |

|Other concerns relating to this pregnancy | | |

Attachment 2: Discharge checklists

1. Discharge checklist for infant - neonatal team to complete

HIV specialist informed of delivery and invited to consult? (Yes (No

Initial HIV testing at Day 1-2 (or later) completed? (Yes (No

Copy of result requested to HIV physician and GP (if consent) (Yes (No

Parents aware of how to access result? (Yes (No

Check parents aware of how to get baby’s 6 week HIV test (Yes (No

Request form for 6 week test provided (Yes (No, see HIV physician

If yes, copy of result requested to HIV physician and GP (if consent) (Yes (No

Paediatrician follow-up required and arranged (Yes (No, not required

If yes, state name of paediatrician _______________________________________

6 week GP follow-up advised (Yes (No

(CHECK if GP aware of maternal HIV and seek permission to send discharge summary to GP)

Midcall/NAPPS organised (Yes (No

If no, state reason _____________________________________________

(CHECK if parents are aware if Midcall/NAPPS are informed of maternal HIV and neonatal HIV prophylaxis. Ensure Midcall/NAPPS are aware of all confidentiality requirements as per section 1)

Discharge medication:

Zidovudine (plus other neonatal prophylaxis if indicated) arranged (Yes (No

APSU notification CHILD completed (Yes (No



2. Discharge checklist for mother – postnatal ward team to complete

Mum has enough HIV medications until at least (Yes (No

6 week follow-up with HIV specialist

If maternal HIV medications adjusted in 3rd trimester, (Yes (No

mum aware of when to reduce back to usual dose

6 week HIV specialist follow-up appointment arranged (Yes (No

6 week GP follow-up advised (Yes (No

(CHECK if GP aware of diagnosis and permission to send discharge summary to GP)

Any other arrangements? __________________________________________________

Attachment 3: Schedule of antenatal visits

|When |Who and what |Investigations |

|Pregnancy confirmed|GP/ HIV team: | |

| |prompt referral to FMU |Standard pregnancy booking bloods, including |

| |FMU: |Hepatitis B, Hepatitis C and syphilis |

| |Discuss principles of care: |Iron studies |

| |Maternal HIV medication |Thyroid function tests if not done in last 1 year|

| |Mode of delivery according to viral load | |

| |Neonatal HIV prophylaxis |Varicella IgG and rubella IgG |

| |Bottle feeding |if no known immunity |

| | |consider need for chlamydia , gonorrhoea and |

| |Discuss options for prenatal diagnosis: |trichomonas PCR by vaginal swab |

| |screening by blood test and nuchal translucency preferred over invasive |Pap smear if not done in last year |

| |procedures (CVS and amniocentesis) | |

| |If CVS or amniocentesis is indicated, ideally defer until maternal HIV viral |Advise annual influenza vaccination |

| |load is adequately suppressed |Advise acellular pertussis vaccination |

| |Notify HIV team (Canberra Sexual Health Centre, tel: 62442184, fax 62853395) | |

| |if woman has not been previously referred | |

| | | |

| |HIV specialist: | |

| |If woman not already on treatment, advise on timeframe for commencement and | |

| |arrange appropriate review | |

|12-14 weeks |FMU: | |

| |Midwife booking visit |Check booking bloods/investigations. |

| |Obstetrician visit |Nuchal translucency ultrasound at 12-13 weeks |

| |Discuss immunisations and plan for pregnancy | |

| | | |

| |HIV specialist: | |

| |Routine review if viral load already below detectable |Seek consent for all HIV testing to be in full |

| |If treatment has been deferred, aim for commencement not later than 14 weeks |name, if not already provided |

| |(trimester 2) and repeat viral load 2-4 weeks after commencement |HIV viral load |

| | |HIV DNA to ensure primers detect maternal virus |

| | |and HIV DNA can be used to assess infection in |

| | |neonate |

|19 weeks |FMU: | |

| |Midwife visit |Morphology ultrasound |

|24 weeks |FMU: | |

| |Midwife visit |Give form for bloods |

| |Obstetrician visit: discuss birth plan. | |

| |Consent for and book caesarean section if planned | |

| |Consent for intrapartum zidovudine if applicable | |

| |Ensure zidovudine (an other HIV prophylaxis as indicated) is available in | |

| |Birth Suite | |

|26-27 weeks |FMU: | Bloods for GTT, FBC, antibody screen, |

| | |+/- repeat syphilis, Hepatitis B, Hepatitis C if|

| |HIV specialist: |required |

| |Review adherence, need for trimester 3 dose increase |HIV viral load and CD4 count at 26-28 weeks |

|28 weeks |Midwife visit, review blood results | |

| |Meet with Neonatology | |

|30-32weeks |Obstetrician/midwife visit - review results and plan | |

| |discuss formula, feeding, tour postnatal ward | |

|34 weeks |Obstetrician visit - review birth plan | |

| |Confirm admission arrangements | |

| |Ensure appropriate neonatal HIV prophylaxis and IV zidovudine if indicated is | |

| |in delivery suite | |

| | | |

| |HIV specialist: 34-36 weeks | |

| |Review birth plan |HIV viral load at 34-36 weeks |

| |Ensure adequate HIV medication for at least 12 weeks until 6 week postnatal | |

| |review | |

|36 weeks |Midwife visit |Low vaginal swab for Group B strep |

| | | |

| | |Review expectations for birth, and postnatal care|

| |GP visit | |

|37 weeks |Anaesthetic consult if having caesarean section (unless being admitted day |FBC and G and H day prior to CS (if planned) |

| |prior to surgery). | |

| |Midwife visit | |

|38 weeks |Caesarean section (C/S) if planned. |C/S Last on list, unless being admitted day prior|

| | |to surgery in order to give time for zidovudine |

| |Otherwise weekly midwife visits and Obstetrician review at 40 weeks re |pre-op |

| |postdates plan | |

|Postnatal visit 4-6|FMU: | |

|weeks | | |

| | | |

| |HIV specialist: | |

| |Review | |

| |Ensure infant testing at 4-6 weeks and 3 months | |

| |Check APSU notification MOTHER completed | |

| | | |

Attachment 4: Additional Recommendations for pregnancy related care for women with HIV

Commencement of HIV therapy

• All pregnant women who require therapy for their own health should receive a combination antepartum antiretroviral (ARV) drug regimen containing at least three drugs for treatment, which will also reduce the risk of perinatal transmission

• Combination antepartum drug regimens are also recommended for prevention of perinatal transmission in women who do not yet require therapy for their own health.

• ARV prophylaxis is more effective when given for a longer than a shorter duration. Therefore, ARV drugs should be started as soon as possible in women who require treatment for their own health, and without delay after the first trimester in women who do not require immediate initiation of therapy for their own health, although earlier initiation can be considered in these women as well.

Prenatal diagnosis

• screening by blood test and nuchal translucency preferred over invasive procedures (CVS and amniocentesis)

• If CVS or amniocentesis is indicated, ideally defer until maternal HIV viral load is adequately suppressed.

Pre-labour rupture of the membranes (term)

In all cases of term pre-labour spontaneous rupture of the membranes (ROM), delivery should be expedited

• maternal HIV viral load ................
................

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