SOUTHERN WEST MIDLANDS NEWBORN NETWORK Hereford, Worcester, Birmingham, Sandwell & Solihull Title Management of infants born to an HIV Positive Mother Author Dr Steve Welch Date Guideline Agreed: May 2009 Date of review: May 2011 Version no. Final Version 1 Related guidelines/policies: 1.0 Introduction Perinatal HIV infection is a preventable condition. Prevention requires antenatal testing of all pregnant women, and optimal medical and obstetric management of the woman and her baby. The single most important intervention is antiretroviral therapy (ART) during pregnancy to reduce maternal HIV viral load at the time of delivery. This protocol addresses the management of infants born to women known to have HIV. It should be remembered that women may become infected with HIV after a negative test at booking, so all infants in whom HIV is suspected clinically should be tested, irrespective of the mother s antenatal test result. All women who have not been tested at booking should be offered a test at every opportunity, including after delivery. 2.0 Risk Reduction Treatment during pregnancy now usually comprises 3 antiretroviral drugs given to the mother, with the aim of reducing her HIV viral load below the limit of detection by the time of delivery, which may be vaginal or by Caesarean section. Treatment with zidovudine monotherapy and delivery by elective Caesarean section remains an acceptable alternative for some women with a low baseline viral load. With these interventions, mother to child transmission rates are below 1%. Factors which may increase the risk of transmission are: Detectable maternal viral load at delivery Invasive antenatal procedures Invasive perinatal procedures or laceration to infant Rupture of membranes > 4 hours Emergency Caesarean section Prematurity Antenatal infection Chorioamnionitis Neonatal infection Breastfeeding 3.0 Post Exposure Prophylaxis Most infants can be managed with zidovudine monotherapy as post-exposure prophylaxis (PEP) and complete avoidance of breastfeeding. Infants at higher risk of transmission will need three drug PEP, and infants of women with drug-resistant virus will need an individualised PEP regimen. Zidovudine commonly causes reversible myelosuppression in infants, and nevirapine may cause hepatitis. Rarely, antenatal drug exposure may cause severe lactic acidosis. Infants who are not able to tolerate oral drugs (for example, due to extreme prematurity) can be given intravenous zidovudine. Other drugs may be added once the infant is able to take oral medication, but advice should be sought on this to avoid selecting viral drug resistance if the risk of infection is high.
4.0 Investigations All infants of HIV-infected women will require a series of blood tests, starting on the first day after birth, to determine whether or not they are infected. PCR for HIV pro-viral DNA should detect true infection of the infant. Blood should be sent from baby at birth, 6 weeks and 12 weeks. A PCR for HIV pro-viral DNA and a viral load should also be sent from the mother on the day of delivery. If all 3 tests on the infant are negative, and the mother s pro-viral DNA result is positive, the infant is considered uninfected. If the mother s pro-viral DNA result is negative, this may indicate that the usual test may not detect HIV infection in the baby, ie be false negative. In this case, RNA PCRs need to be performed on the baby, this should be discussed with the regional paediatric HIV unit at Heartlands Hospital. A further blood test to confirm disappearance of transplacental maternal anti-hiv antibody should be sent from all babies born to HIV-infected women at 18-24 months. Babies who are considered at high risk of infection may need their second test earlier than 6 weeks, and should be discussed early with the regional paediatric HIV unit at Heartlands Hospital. All babies with a positive PCR for HIV at any time should be referred urgently to the regional paediatric HIV unit at Heartlands Hospital. 5.0 Protection from other infections Neonatal vitamin K and routine infant immunisations, except BCG, should be given according to the normal schedule. BCG vaccination should not be given until the infant is known to be uninfected with HIV. Because the risk of HIV infection is low, most infants do not require co-trimoxazole prophylaxis against Pneumocystis jiroveci pneumonia (PcP). Infants at higher risk should be discussed with the regional paediatric HIV unit at Heartlands Hospital. 6.0 Contact Information Specialist advice may be obtained from either Dr Hackett or Dr Welch at Heartlands Hospital via switchboard on 0121 424 2000, or from clinical nurse specialists Yvonne Heath (07976 650 598) or Sally Scott (07966 925 217). 7.0 Communication Disclosure of the diagnosis to the mother s GP should be encouraged, but this should not be done without consent. Written communication with the infant s GP and in the Red Book should not mention the mother s disease status, until she has given her permission for this. The Consultant directing the care for infants born to HIV positive mothers should be reported to the National Survey of HIV in Pregnancy and Childhood (NSHPC) using the BPSU orange card system. 8.0 Legal Issues In rare circumstances, parents do not agree to treatments, and it may be necessary to obtain interventions from courts or social services to supervise postnatal care to reduce the risk of the infant being infected. 9.0 Supporting Information For more detailed guidance and references see the British HIV Association guideline Management of HIV infection in pregnant women (2008) at www.bhiva.org/cms1221368.asp
ALGORITHM FOR INFANTS OF HIV POSITIVE MOTHERS. Resuscitate as necessary Immediate bathing is not essential, but it is a good idea to remove any visible blood or maternal fluids and clean skin before im or iv injections RESUSCITATION (as atraumatic as possible) Clarify the level of risk for the baby and consult the care plan. If the mother has a resistant virus, an individualised regimen will be in the care plan LOWER RISK BABY (- a baby born to a HIV +ve mother who is not in the high risk category) HIGH RISK BABY (SEE DEFINITIONS below) Suggest Consultant discusses with ID team Treatment to start on day 1 FIRST DOSE SHOULD BE GIVEN BEFORE THE BABY LEAVES LABOUR WARD, AND IN ANY CASE WITHIN 4 HOURS OF BIRTH Zidovudine for (See table for doses) IM Vitamin K after bathing and drying Zidovudine Lamivudine Nevirapine for for for 2 weeks (See table for doses) If the mother has a drug-resistant virus an individualised regime will have been documented in the care plan IM Vitamin K after bathing and drying Cotrimoxazole from Baseline HIV DNA PCR from the infant should be taken within 48 hours of birth Do not use cord blood. Bloods to be taken Send at least 1.0 ml of baby (NOT cord) blood (in EDTA) to Virology, mark request form PCR for HIV Pro-Viral DNA Send a sample for FBC A sample of the mother s blood (8 ml in EDTA) should be sent with the baby s first PCR, to ensure the PCR primers used can detect the maternal virus. A viral load should also be sent from the mother Ensure a copy of mother s results will come to the Paediatrician Follow up If low risk of transmission, first follow-up at 6 weeks of age If higher risk, discuss with regional paediatric HIV unit at Heartlands Record maternal viral load, hepatitis B and syphilis serology in baby s notes Definitions HIGH RISK BABY: Mother has had < antiretroviral therapy before delivery Mother has persistently detectable viral load despite ART The mother is found to be HIV infected after the infant has delivered, and the infant is less than 72 hours old. The mother has had rupture of membranes > 4 hours Baby s skin or mucosa have been breached, eg scalp electrode or accidental injury during Caesarean section RESISTANT VIRUS: Previous drug exposure may have selected for resistant virus in the mother. Infants of these women need an individualised regimen which will be documented in the care plan.
Treatment Scenarios Scenario Infant Treatment Duration Comments / Suggested doses Mother on zidovudine monotherapy + PreLabour Caesarean Section + IV zidovudine in labour Mother on combination antiretroviral therapy Viral Load (VL) <50: Combination contains zidovudine Combination does not contain zidovudine Mother presents with non-suppressed HIV and no previous antiretroviral exposure (e.g. premature labour / Rupture Of Membranes; presentation at term with no antiretroviral therapy) Mother presents with non-suppressed HIV and previous ART exposure (e.g. preterm labour / ROM; presentation at term) Maternal HIV diagnosis ascertained after delivery (no previous ART) Mother with history of multiple ART exposure and resistance Premature or unlikely to tolerate oral feeds: Maternal VL<50 Monotherapy zidovudine Monotherapy zidovudine Use the nucleoside with most experience in mother s regime: lamivudine>abacavir>didanosine Combination Therapy zidovudine + lamivudine + nevirapine Combination Therapy Seek expert advice Combination Therapy zidovudine + lamivudine + nevirapine, start as soon as possible after delivery, but if presents after 48-72 hours maybe too late for PEP, unless mother is breast feeding. Well term infant, zidovudine 4mg/kg BD (see below for premature / sick infant doses) Well term infant, zidovudine 4mg/kg BD (see below for premature / sick infant doses) May use zidovudine, if no history of maternal resistance, or mother not on stavudine. lamivudine 2mg/kg BD; abacavir 2mg/kg BD; didanosine 100mg/m 2 OD. If possible, avoid didanosine due to feeding restriction Well term infant, zidovudine 4mg/kg BD (see table 3 for prem / sick infant doses) + lamivudine 2mg/kg BD + nevirapine 2mg/kg OD 1 st week and nevirapine 4mg/kg OD 2 nd week (use nevirapine 4mg/kg OD for 2 weeks if the mother has received > 3days nevirapine). Stop nevirapine after two weeks, in view of long half-life. Continue other drugs for full. Will need to tailor therapy according to maternal resistance pattern / antiretroviral dug exposure history Well term infant, zidovudine 4mg/kg BD (see table 3 for prem / sick infant doses) + lamivudine 2mg/kg BD + nevirapine 2mg/kg OD 1 st week and nevirapine 4mg/kg OD 2 nd week (use nevirapine 4mg/kg OD for 2 weeks if the mother has received > 3days nevirapine). Stop nevirapine after two weeks, in view of long half-life. Continue other NRTI s for full. Seek expert advice Will need to tailor therapy according to maternal resistance IV zidovudine monotherapy Maternal VL>50 IV zidovudine plus antenatal maternal nevirapine * NRTI = Non Reverse-Transcriptase inhibitor eg Zidovudine, Lamivudine pattern / ART exposure Switch to oral therapy once tolerated. Discuss with regional paediatric unit at Heartlands Hospital before adding in other dugs.
Recommended Drug Doses Zidovudine doses for premature infants and intravenous doses: Zidovudine (AZT / ZDV) (Retrovir Oral Intravenous 3- Term 4mg/kg BD 2mg/kg QDS Prem (30-34 wks) 2mg/kg BD for 2 weeks then 2mg/kg TDS for 2 weeks Prem (<30wks) 2mg/kg BD for 4 weeks Term 1.5mg/kg QDS Prem 1.5mg/kg BD Doses for combination oral PEP: Zidovudine Lamivudine Nevirapine Well term infant 4mg/kg BD for (see above for prem / sick infant doses) 2mg/kg BD for 2mg/kg OD 1 st week THEN 4mg/kg OD 2 nd week (use 4mg/kg OD for 2 weeks if the mother has received > 3days nevirapine). Stop NVP after two weeks, in view of long half-life. Continue other NRTI s for full Co-trimoxaxole prophylaxis doses for high-risk infants Co-trimoxazole (septrin) Neonate 900mg/ m 2 OD Mon/Wed/Fri <6 months 120mg OD Mon/Wed/Fri 6-12 months 240mg OD Mon/Wed/Fri
Patient (Baby) Addressograph Baby s Record for baby s notes Mother s Name: 1 Delivery Details Date of birth / / Time of birth : Birth weight gms EDD..gestation Mode of Delivery (with emergency/ elective instrumentation)... 2 Baby MUST receive 1 st dose antiretrovirals on labour ward within 4hrs delivery Drug Dose Duration Dose Calculate at delivery Zidovudine (AZT) 4mg/kg BD (reduced dose if <34 wks gestation) ALTERNATIVE/ additional 1 st dose antiretroviral Date / / Time 1 st dose antiretrovirals : 3 Blood Tests day 1 Cord blood is not appropriate for any test FBC EDTA sample to virology for proviral DNA test This must be sent at same time as mother s virology tests. Mother s name should be given on the form 4 Other Actions Confirm hepatitis status of mother and give neonatal immunisation as required. Give Paediatric advice sheets Baby should have first paediatric appointment at age 6 weeks Inform Paediatric team before discharge: N.B BCG vaccination of the infant should be delayed until the results of all PCR tests are known. 5 Discharge Baby should be discharged by paediatric registrar or consultant, who should ensure that:baby s information on this record is complete Correct blood tests have been collected from baby TTO for infant (to complete 4 week course) given, with stop date written on. signature discharging Doctor: NAME DATE