Launceston General Hospital Clinical Guideline SDMS ID: P2012/0018-001 WACSClin Proc1.

19/12 Title: Replaces: Description: Target Audience: Key Words: Policy Supported: HIV HIV (Human Immunodeficiency Virus) is a retrovirus that targets CD4 lymphocytes causing progressive immunosuppression making the body more susceptible to opportunistic infections and malignancies. It is the virus responsible for AIDS (Acquired Immune Deficiency Syndrome). Transmission is via transfer of bodily fluids including blood, semen, vaginal fluids and breastmilk. Due to advancements in treatment, mainly HAART (Highly Active Anti-Retroviral Therapy), HIV infection is now classed as a complex chronic medical condition. Issues of longevity and fertility are now becoming important rather than survival alone. The number of women living with HIV continues to increase. Approximately 0.2% of the antenatal population will be HIV infected. In Tasmania in 2009 there were estimated to be 165 HIV positive people with 19 of these women. Pregnancy does not appear to worsen HIV infection or increase the risk of death from HIV. There is however a possible small increase in prematurity, preeclampsia, gestational diabetes and low birth weight in HIV infected mothers using HAART. VERTICAL TRANSMISSION Perinatal HIV infection can occur during pregnancy, labour and delivery or during breastfeeding. The risk is highest at the time of birth. Without any interventions the risk of mother to child transmission of HIV is approximately 25%. Factors associated with increased risk of transmission include high maternal viral load, low CD4 count, prolonged rupture of membranes, premature delivery, vaginal delivery and breastfeeding. With interventions including anti-retroviral prophylaxis during pregnancy and delivery, appropriate mode of delivery, neonatal anti-retroviral prophylaxis and avoidance of breastfeeding, rates of transmission can be reduced to less than 1%. The most important step in preventing vertical transmission is identifying HIV positive pregnant women as most perinatal transmissions occur in women who have not been screened. ANTENATAL SCREENING To reduce the risk of transmission of HIV from mother to child, all pregnant women should be offered HIV screening at their first antenatal visit. This should be voluntary and with the appropriate counselling. A secondary outcome of this is the opportunity to optimise maternal health and long term outcomes. HIV in Pregnancy New Policy. HIV and pregnancy Midwives and medical officers, QVMU HIV, AIDS, pregnancy, birth, breastfeeding, HAART

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Targeted testing offered to perceived high risk women fails to identify a significant proportion of HIV positive women, therefore universal screening is recommended. However, women who continue to engage in high risk behaviours such as intravenous drug use, multiple sexual partners or with partners from endemic areas should be offered testing each trimester. Women who decline HIV screening should have this documented in their notes, and should continue to receive optimum antenatal care. Appropriate multi-disciplinary care in the case of a positive screen result is vital. Results should be told in person. Confidentiality must be maintained however women should be encouraged to disclose their status to their partners and general practitioner. Existing children should be tested for HIV. All clinicians involved in the in-hospital care of a woman need to be aware of her status. TREATMENT DURING PREGNANCY Antiretroviral treatment during pregnancy has two goals reduction of perinatal transmission and treatment of maternal HIV disease. Any maternal anti-retroviral treatment should be continued during pregnancy. The physician responsible for her HIV treatment should be consulted as soon as pregnancy is confirmed or new HIV status established in order to consider combination antiretroviral drug regimes (HAART). Transmission rates have shown to decline with increasing number of antiretroviral drugs used. The aim is full viral suppression shown by a non-detectable viral load - this has the lowest risk of mother to child transmission. If treatment is required for the womans own health, then antiretrovirals should be continued throughout the whole pregnancy avoiding efavirenz which is potentially teratogenic. If antiretroviral drugs are for prophylaxis only, combination treatment can be started after the first trimester. This usually involves Zidovudine and two other drugs. In the UK Zidovudine monotherapy has been used for women who have a low viral load, good CD4 count and are willing to have an elective LSCS. Zidovudine is rated as Category B3 during pregnancy by the Australian Drug Evaluation Committee, Therapeutic Goods Administration (ADEC TGA). There is now good data on Zidovudine use in pregnancy. The potential benefits to the mother and foetus far outweigh potential risks to the foetus. Zidovudine alone reduces the risk of transmission from 25% to 8% with minimal toxic effects. The main side effects are nausea, diarrhoea, headaches and fatigue. Viral load (HIV RNA) and CD4 counts, along with FBC, EUC and LFTs are measured during pregnancy. Complete viral suppression should be achieved within 16-24 weeks after initiation of therapy. Viral load at 34 to 36 weeks gestation is important in the decision regarding mode and timing of delivery. Prophylaxis for pneumocystis pneumonia is recommended if CD4 cell count <200. This consists of bactrim and folic acid supplementation. ANTENATAL CARE HIV is often co-existent with other medical conditions. Identification of other issues including opportunistic infections, sexually transmitted infections, medication use, substance abuse issues, viral hepatitis (B and C) and cervical screening is important. Candida, herpes simplex and bacterial vaginosis are more likely to be persistent and severe in HIV infected women. Any genital infection, even if asymptomatic, should be treated. Potentially modifiable behaviours eg smoking should be addressed. Note that the vertical transmission of HCV appears to be facilitated by HIV coinfection. Accurate determination of gestational age is important especially if a caesarean at 38 weeks is indicated. A detailed morphology scan at 18 to 20 weeks followed by a growth scan in the second and third trimester are usually recommended.

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Consideration should be given to influenza, pneumococcal, Hepatitis A and B and tetanus immunisations. Toxoplasmosis and varicella serology is recommended during pregnancy. Chorionic villus sampling is contraindicated. The safety of amniocentesis has not yet been established and specialist opinion should be sort. Women taking HAART at the time of booking should be screened for gestational diabetes at booking in. A multi-disciplinary team including sexual health or infectious diseases physician, obstetrician, midwife, paediatrician, general practitioner and social worker, is important for comprehensive antenatal care. HIV related complications including drug toxicities need to be considered in any HIV infected pregnant woman who presents acutely unwell. BIRTH Mode of Delivery: The safest way for a woman with HIV to deliver her baby depends on her HIV viral load during pregnancy. Elective Caesarean section at 38 weeks (prior to labour/ruptured membranes) should be offered to women who have not received optimal antiretroviral therapy: have not received antiretroviral therapy or who have only received monotherapy, regardless of viral load patients with a detectable viral load (>50 RNA copies per ml) women who have not had a viral load determination or with unknown antenatal care women with HIV and Hepatitis C virus co-infection (this is controversial) Elective LSCS in this situation significantly reduces the risk of mother to child transmission. Women who have had combined HAART throughout pregnancy and have an undetectable viral load at 34 to 36 weeks gestation, combined with intrapartum antiretrovirals (ie optimal viral suppression) have been found to have less than 1% risk of transmission with either vaginal delivery or caesarean delivery. In this situation it is not clear that caesarean section decreases this risk any further. The women can be offered a choice of mode of delivery either a planned vaginal delivery or elective LSCS at 39 weeks to reduce the risk of transient tachypnoea of the newborn. At delivery Zidovudine (Retrovir) is the anti-retroviral agent of choice to decrease the risk of mother to child transmission. It is used for the treatment of HIV infection and provides protection for the baby during delivery and decreases perinatal transmission when taken by the infant for six weeks after birth. Intrapartum: IV Zidovudine (Vials 200mg in 20ml). Available via Special Access Scheme (SAS) as it is not registered in Australia. Pharmacy needs to be contacted well in advance to organise supplies prior to expected date of delivery and fill in appropriate paper work. Supplies are kept on 4B if pre-arranged or in pharmacy. The on-call pharmacist needs to be contacted via switch to arrange further supply. Maternal blood should be taken for HIV PCR and CD4 count prior to starting Zidovudine. Loading dose required followed by continuous infusion starting 4 hours prior to planned caesarean or at the onset of labour or rupture of membranes, and continued until the umbilical cord is clamped. Loading dose: 2mg per kg bodyweight over one hour Maintenance: at 1mg per kg per hour until the umbilical cord is clamped. See appendix for maternal dose calculation guide.
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Other oral anti-retrovirals should be continued throughout labour. Preterm Deliveries: For preterm labour, delivery should follow the above principles. For preterm prelabour ruptures of membranes >34 weeks, delivery should be expedited either by augmentation of labour or elective LSCS as appropriate. Consideration should be given to intravenous broad-spectrum antibiotics. Preterm prelabour rupture of membranes <34 weeks is a complex clinical problem where the timing of delivery needs to balance risks of prematurity with the risk of perinatal HIV transmission. This decision needs to be individualised. Pre-labour Rupture of Membranes at Term: Delivery should be expedited. Before the advent of HAART rupture of membranes for greater than 4 hours was shown to double the risk of HIV transmission. However the evidence to date with woman taking HAART suggests that the duration of membrane rupture is not a risk factor for transmission. Immediate augmentation of labour rather than caesarean section may be appropriate in women with a low viral load and no other risk factors. Prolonged Pregnancy: there is no contraindication to membrane sweep or to prostaglandin use. MANAGEMENT AT DELIVERY Caesarean Section: surgical field kept haemostatic as possible, avoid rupturing membranes until head is delivered through surgical incision, cord should be clamped as early as possible. Complications of caesarean section are higher in women with HIV particularly postpartum fever. Vaginal Delivery: Any invasive procedure including fetal blood sampling and fetal scalp electrodes are contraindicated. Membranes should be left intact for as long as possible - amniotomy should be reserved for augmentation of labour only. Forceps are preferable to ventouse for instrumental delivery. Episiotomy should be avoided if possible. When collecting cord blood, the cord should be wiped clean so as not to contaminant the cord blood with maternal fluids. MANAGEMENT OF THE INFANT Universal standard precautions should be used. The involved Paediatrician should be notified prior to delivery. Once the infant is born, all visible blood should be towelled off. The baby should be bathed as soon as practical to remove all maternal secretions and prior to Vitamin K being administered. Staff members should wear long sleeve gowns and gloves and parents should be included if practical. Infants should be kept with the parents unless a medical indication for admission to special care nursery. HIV exposure is not an indication in itself for nursery admission. The infant should be started on anti-retroviral medication. A baseline FBC should be taken prior to starting treatment. Post exposure prophylaxis - Anti-retrovirals: infant dose of Oral Zidovudine (Syrup 50mg in 5ml) As close as possible after birth (must be within 6 hours), start oral zidovudine and continue for 6 weeks. Dose: 2mg/kg/dose every six hours Or 4mg/kg/dose twice a day. If infant vomits more than 15 minutes after dose, give next dose at next scheduled time. If infant vomits within 15 minutes of dose, give another dose if possible. If an infant is unable to tolerate oral feeds, start zidovudine infusion.
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Infant IV infusion: 1.5mg/kg/dose over 30 minutes every 6 hours. Dosages are reduced for preterm infants. Ensure that the entire bottle of Retrovir syrup is sent home with the infant (it is sufficient to complete the six weeks of therapy) and that parents have been educated on administering the medication prior to discharge. Side Effects of Zidovudine: generally well tolerated. Nausea, vomiting, headache, fever and myalgia may require reduction in dose or change in therapy. Blood counts should be monitored for anaemia, neutropenia and leucopenia. Anaemia in the infant generally resolves within six weeks after completion of zidovudine therapy. Follow-up blood work should be performed at 2 and 4 weeks after birth to check for these side effects. Contraindications: Very low neutrophil count (<0.75 x 109/L) or low haemoglobin level (<75g/L). Contact specialist if infant has hyperbilirubinaemia requiring treatment other than phototherapy or has increased transaminase levels (above five times the upper limit of normal) or renal impairment. HAART and prophylaxis against PCP is given to infants at high risk of HIV infection. HIV TESTING FOR THE INFANT Infants are tested for HIV RNA by PCR at 1 day, 6 weeks and 12 weeks of age. A confirmatory HIV antibody test is preformed at around 18 months of age. BREASTFEEDING Breastfeeding is NOT recommended in women with HIV in Australia due to the risk of viral transmission through breastmilk. Breastfeeding doubles the risk of vertical transmission. This increased risk persists despite antiretroviral medications. Formula feeds are safe and the preferred alternative. Parents should be educated on safe formula feeding. Cabergoline 1mg orally can be offered within 24 hours of birth to suppress lactation. Anti-retroviral medications are only continued in woman needing them for their own health. Contraceptive counselling is complex and should be attended by someone experienced in the field. All women who are HIV positive are recommended to have yearly cervical cytology. MMR vaccinations should be given if indicated and CD 4 count >200. Varicella immunisation is contraindicated in HIV. FOLLOW-UP NST should be performed as usual at 48 hours. There is some evidence that HIV-exposed but uninfected infants have an increased vulnerability to infections with lower specific antibody responses to unexposed infants. They do however have a robust response to routine vaccinations. Infants should receive all routine vaccinations and be under the care of a Paediatrician. No live vaccination should be given to the infant until their HIV status is clear.

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Attachment 1 Attachment 2

Resources for Women References

Performance Indicators: Review Date: Developed By: Stakeholders:

Evaluation of compliance with guideline to be achieved through medical record audit Annually verified for currency or as changes occur, and reviewed every 3 years Dr A Dennis Co-Director (Medical) Sue McBeath Co-Director (Nursing and Midwifery) Womens and Childrens Services Midwives and medical staff WACS

Prepared by E. Fisher Through Through S. McBeath Dr. A Dennis

QCIM Co Director (Midwifery /Nursing) WACS Co. Director (Medical) WACS

6348 8107 6348 8976.

3 January 2012 3 January 2012 3 January 2012

Date: January 2012

AUTHORISED BY Co Directors of Womens and Childrens Services Dr. A Dennis ..18 April 2012 Dr. A Dennis Co-Director (Medical) Womens & Childrens Services Sue McBeath 18 April 2012 Sue McBeath Co-Director (Medical) Womens & Childrens Services

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Attachment 1 Resources for Women www.uptodate.com/patients HIV and pregnancy Pozhets (The heterosexual HIV/AIDS Services) www.pozhet.org.au/women.html Positive Women Victoria (Inc) Phone: 03)90766918 www.positivewomen.org.au Paediatric HIV Service Sydney Childrens Hospital Randwick Clinical Nurse Consultant Ph: 02) 9382 1654 http://www.sch.edu.au/departments/hiv/ Booklet: Positive Pregnancy National Association of People Living with HIV/AIDS (NAPWA) 1800 259 666 http://napawa.org.au Attachment 2 References HIV and pregnancy. Royal Womens Hospital Clinical Practice Guideline, 2006. http://www.thewomens.org.au/HIVandPregnancy HIV screening in Pregnancy. SOGC Clinical Practice Guideline. J Obstet Gynaecol Can 2006;28(12):1103-1107 Mode of Delivery for Pregnant Women Infected by the Human Immunodeficiency Virus. SOGC Clinical Practice Guideline. J Obstet Gynaecol Can 2001;23(4):348-50 Antiretroviral therapy for the pregnant HIV-infected patient in resource-rich settings. UpToDate January 2011. Anderson and Cu-Uvin. Antepartum evaluation of the HIV-infected patient in resource-rich settings. UpToDate January 2011. Anderson and Cu-Uvin. Management of HIV in Pregnancy. June 2010. Royal College of Obstetricians and Gynaecologists Green-top Guideline No. 39. National Centre in HIV Epidemiology and Clinical Research (Kirby Institute). Australian HIV Surveillance Report 2009: http://hiv.cms.med.unsw.edu.au Guidelines for Paediatric Management of Infants Born to HIV+ Pregnant Women. & Nursing Care of Baby whose Mother is HIV Positive. Dec 2010. Auckland District Hospital. http://www.adhb.govt.nz/newborn/Guidelines/Infection/HIVAnd PregnantWomen.htm

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