Neonatal HSV. Version: 1. Governance Group. Date of Approval: Date of Ratification Signature of ratifying Group Chair

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1 Paediatric Neonatal HSV Version: 1 Approval Committee: Date of Approval: Ratification Group (eg Clinical network): Date of Ratification Signature of ratifying Group Chair Author s and job titles Date issued: Review date: Key words: Main areas affected: Other stakeholders consulted e.g. other clinical networks, departments Summary of most recent changes (if updated guideline): Wessex PIER Regional Guideline Governance Group Wessex ID / Immunology network SANJAY PATEL Emanuala Pelosi, Paediatric ID consultant, UHS Sanjay Patel, Paediatric ID consultant, UHS Chrissie Jones, Paediatric ID consultant, UHS HSV, herpes, neonatal Paediatrics, NICU, PICU Obstetricians from across Wessex Relevant national or international Guidance eg NICE, SIGN, BTS, BSPED No Consultation document completed: see Appendix A Yes Total number of pages: 16 Is this document to be published in any other format? No Does this document replace or revise an existing document? No If so please identify here which document/s

2 Paediatric Contents Paragraph Page Executive Summary 3 1 Introduction Scope Purpose Acronyms 3 2 Roles and Responsibilities or Duties 3 3 Implementation (including training and dissemination) 4 4 Process for Monitoring Compliance/Effectiveness of this policy 4 5 Arrangements for Review of this document 4 6 References 4 7 Index 5 8 Appendixes Appendix I signatures of regional guideline consultation group 16 Page 2 of 16

3 Paediatric Executive Summary This guideline provides advice on the diagnosis and management of Neonatal Herpes, a rare and severe infection caused by Herpes simplex virus type 1 and 2 (HSV-1 & -2). The policy consists of two sections: the first section includes diagnostic and treatment algorithms aimed to guide paediatricians. The second section consists of background information to boost the general knowledge about Herpes Simplex Virus, Neonatal Herpes and Genital Herpes in pregnancy Introduction Neonatal Herpes (NH) is a disease caused by Herpes simplex virus (HSV) type 1 and 2. It is a rare and severe disease associated with significant morbidity and mortality. It is normally vertically transmitted at the time of delivery, when HSV replicates in the birth canal. Most mothers are asymptomatic with no past history of Genital Herpes (GH). The diagnosis of NH is challenging because the disease is rare and often non-specific in its presentation. Early diagnosis is critical for to guide the prompt initiation of antiviral treatment. 1.2 Scope This policy applies to diagnosis and treatment of Neonatal Herpes. The policy is aimed at all paediatricians across Wessex. It may also be used to provide advice to general practitioners, obstetricians and midwives. 1.3 Purpose This policy ensures that all neonates with possible HSV infection are appropriately risk assessed and receive appropriate diagnostic investigations and antiviral treatment in a consistent and timely manner 1.4 Acronyms Acronyms GH: Genital Herpes HSV: Herpes simplex virus MTCT: Mother To Child Transmission NH: Neonatal Herpes PROM: Premature Rupture Of Membrane SEM: Skin Eye & Mucosal disease ACV: Aciclovir IUGR: Intrauterine Growth Retardation PCR: Polymerase Chain Reaction TDS: Ter Die Sumendum (taken 3 times/day) CS: Caesarean Section LP: Lumbar Puncture ROM: Rupture Of Membrane VTM: Viral Transport Medium 2 Roles and Responsibilities 2a. Microbiology/virology laboratory (inc PHE regional diagnostic centre) o To provide the diagnosis of Neonatal HSV infection and to liaise with Paediatricians to advise on appropriate sample type. 2c Hospital Paediatricians Page 3 of 16

4 Paediatric o To manage neonates with Neonatal Herpes in need of antiviral treatment by following the directive of this policy, to ensure that patients received appropriate treatment in a timely manner. 3 Implementation This policy will be disseminated to all clinicians who look after newborn infants, including Infection specialists. 4 Process for Monitoring Compliance/Effectiveness Compliance with these guidelines will not be routinely reviewed unless a concern is identified. This may be through incidents, complaints, claims or performance issues. 5 Arrangements for Review of the Policy This guideline will be reviewed every three years, or earlier, in case of major advances in the diagnosis and clinical management of this disease. 6 References 1. Allen. Prevention and management of neonatal herpes simplex virus infections. Canadian Paediatric Society. April Pinninti and Kimberlin. Management of neonatal herpes simplex virus infection and exposure. Arch Dis Fetal Ed published online March Foley E et al. Management of Genital Herpes in Pregnancy, British Association for Sexual Health and HIV, Royal College of Obstetricians & Gynaecologists Kimberlin D at al. Guidance on Management of Asymptomatic Neonates Born to Women With Active Genital Herpes Lesions. Pediatrics 2013;131;e Pinninti et al. Neonatal herpes disease following maternal antenatal antiviral suppressive therapy: a multicenter case series, J Pediatrics 2012 Jul;161(1):134-8.e Kimberlin D et al, Oral Acyclovir Suppression and Neurodevelopment after Neonatal Herpes N Engl J Med October 6; 365(14): Samir S. et al. Delayed Acyclovir Therapy and Death Among Neonates With Herpes Simplex Virus Infection PEDIATRICS Volume 128, Number 6, December 2011; Kimberlin et al. Natural history of neonatal herpes simplex virus infections in the acyclovir era, Pediatrics Aug;108(2): Gutierrez, Whitley, Arvin. Herpes simplex virus infection, Infectious diseases of the fetus and newborn infant. Elsevier, Thompson and Whitley. Neonatal Herpes Simplex Virus Infections: Where Are We Now? Adv Exp Med Biol ; 697: Morrow. Clinical correlates of index values in the focus HerpeSelect ELISA for antibodies to herpes simplex virus type 2 (HSV-2), Journal of Clinical Virology 36 (2006) Page 4 of 16

5 Paediatric Index THE NEWBORN INFANT The ASYMPTOMATIC newborn infant born (vaginally or by CS) to a mother WITH visible active GH lesions during labour 1. Onset of maternal 1 st episode GH during labour OR during 3 rd trimester and No evidence of HSV type specific seroconversion 2. Mother with recurrent GH lesions PLUS additional risk factors 3. Mother with recurrent GH lesions and NO additional risk factors Appendix A1 Page 6 Appendix A2 Page 7 Appendix A3 Page 8 The ASYMPTOMATIC newborn infant whose mother has a history of GH but NO active lesions at delivery Appendix B Page 9 The SICK newborn infant with clinical presentation compatible with NH or congenital HSV Disease (from birth to the 6 th week of life) 1. Skin, Eye and Mucosal disease or SEM disease 2. Disseminated disease 3. CNS disease 4. Congenital HSV disease Appendix C Page 10 Laboratory diagnosis of Neonatal Herpes and Testing algorithm Appendix D Page Post-exposure prophylaxis Treatment of Neonatal Herpes (NH) 2. Treatment of confirmed NH 3. Empirical ACV treatment 4. HSV suppressive treatment in infants surviving NH Appendix E Page 12 BACKGROUND INFORMATION ABOUT GH AND NH Virological and Clinical classification of GH Clinical classification of NH Appendix F Page 13 Background information about Genital Herpes (GH) and Neonatal Herpes (NH) Timing and routes of HSV infection in neonates Risks factors for mother-to-child-transmission (MTCT) of HSV Appendix G Page 14 Diagnostic tests: HSV PCR and HSV-type specific serology. Appendix H Page 15 APPENDIX A1 Page 5 of 16

6 Paediatric Page 6 of 16

7 Paediatric APPENDIX A2 Page 7 of 16

8 Paediatric APPENDIX A3 Page 8 of 16

9 Paediatric APPENDIX B The asymptomatic NEWBORN INFANT born to a mother WITH history of GH but NO active lesions in labour (mother may be on ACV suppressive treatment) - Infant born at term: should be observed for signs of NH, but does not require ACV treatment. - If first clinical episode of maternal GH is in the third trimester, or at any time in case of extreme premature birth (<28 weeks), maternal HSV type-specific serology and surface swabs in the neonate should be considered. - Note that maternal suppressive ACV treatment during pregnancy does not completely eliminate HSV asymptomatic shedding and MTCT of HSV infection. - Parents and caregivers should be educated about the signs and symptoms of NH. Page 9 of 16

10 Paediatric APPENDIX C The SICK NEWBORN BABY with clinical presentation compatible with NH or Congenital HSV disease from birth to the 6 th week of life CLINICAL PRESENTATIONS: although most infected infants present within the first 2 weeks of life, onset of disease symptoms and signs may occur during the first 24 hours and has been described beyond 30 days. The absence of fever is common at the time of presentation of neonatal HSV disease. - Note that up to 40% of patients do not have skin vesicles at presentation, nor they develop them during the course of the disease. - Note that maternal suppressive ACV treatment during pregnancy does not completely eliminate HSV asymptomatic shedding and MTCT of HSV infection. Therefore, NH should be considered in the differential diagnosis in symptomatic newborns born to mothers who received suppressive treatment with ACV or valacyclovir. 1. SKIN, EYE AND MUCOSAL DISEASE OR SEM DISEASE (average onset at 5-10 days): at presentation there are skin and/or mucosal vesicles/ulcers. Skin lesions may appear in areas of trauma (ex. site of foetal scalp electrodes) and may not be frankly vesicular. Conjunctivitis and keratoconjunctivitis are typical findings. Fever and poor feeding may be present. SEM disease may progress to CNS and disseminated disease if untreated. 2. DISSEMINATED DISEASE (average onset at 5-10 days, but may occur in the first few days of life. Normally follows primary HSV infection in the mother): sepsis-like picture with respiratory and hepatic failure (HSV pneumonitis and hepatitis), adrenal glands involvement, severe coagulopathy (DIC) and marked elevation of ALT. There may be CNS involvement (65%). SEM lesions develop in 60% of children, at presentation or during the course of the illness. 3. CNS DISEASE (average onset between 1-2 weeks; normally follows recurrent maternal infection): CNS involvement (temperature instability, focal/generalised seizures, lethargy, irritability, tremors, poor feeding and bulging fontanels, which can progress to hypotension, apnea and shock ) + skin/mucosal lesions (present in about 60-70%). Morbidity of CNS disease is higher with HSV-2 than with HSV CONGENITAL HSV DISEASE. Unlikely to be missed due to the extent of involvement of affected babies. Clinical presentation at birth may vary and can include a wide variety of skin lesions (grouped vesicles, bullae, zoster-like lesions, skin erosions and denudation, aplasia cutis, erythematous patches and hypopigmented / hyper-pigmented scarring), eye disease (chorioretinitis or microphthalmia), CNS involvement (microcephaly or hydranencepahly, seizures and intra-cerebral calcifications), hepatosplenomegaly, prematurity (60%) and IUGR (25%). Skin lesions/scarring alone are uncommon (7%). Page 10 of 16

11 Paediatric APPENDIX D Page 11 of 16

12 Paediatric APPENDIX E Page 12 of 16

13 Paediatric APPENDIX F Page 13 of 16

14 Paediatric APPENDIX G Page 14 of 16

15 Paediatric APPENDIX H Page 15 of 16

16 Paediatric PIER Paediatric Innovation, Education & Research Appendix I Paediatric Regional Guideline Consultation Documentation: Trust Chichester Name of person consulted* (print) Designation of signatory $ Signature Dorchester Will Verling Hampshire Hospitals Foundation Trust Ayo Kadri Katie Yallop Poole Steve Wadams Portsmouth Amanda Freeman Salisbury Nick Brown Southampton Sanjay Patel IOW Arun Gulati * this person agrees they have read the guidelines, consulted with relevant colleagues and members of MDT, managers and patients, young people & their families as appropriate. Any queries raised during consultation and review process should be documented with responses and any changes made to guideline. $ this can be electronic for ease Page 16 of 16