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P170 Efavirenz based anti-retroviral regimens in paediatrics: a peep into neuropsychiatric and biochemical derangements
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  1. Purba Chakrabarty1,
  2. Manasi Banerjee2,
  3. Manab Nandy2,
  4. Kalpana Datta3,
  5. Rudraprasad Acharya4,
  6. Arup Chakraborty5,
  7. Pragnadyuti Mandal6,
  8. Dipak Sarkar6,
  9. Shatavisa Mukherjee7,
  10. Mitali Basu8,
  11. Ananya Bhowmik9
  1. 1Medical College and Hospital, Kolkata, 88, College Street, Kolkata – 700073, West Bengal, India, Pharmacology, Dist – Bankura, West Bengal, India
  2. 2Medical College and Hospital, Kolkata, Pharmacology, Kolkata, India
  3. 3Medical College, Kolkata, Paediatrics, Nodal Officer and Programme Director, Paediatric Centre of Excellence in HIV Care, Regional Art Centre, Medical College and Hospital, Kolkata, India
  4. 4Medical College and Hospital, Kolkata, Psychiatry, Kolkata, India
  5. 5Medical College and Hospital, Kolkata, Community Medicine, Kolkata, India
  6. 6Medical College, Kolkata, Pharmacology, Kolkata, India
  7. 7School of Tropical Medicine, Kolkata, Patient Safety-pharmacovigilance, ADR Monitoring Centre, Kolkata, India
  8. 8Bankura Sammilani Medical College and Hospital, Medicine, Nodal Officer, Fiart Centre, Bankura, India
  9. 9Medical College and Hospital, Kolkata, Research Officer, Paediatric Centre Of Excellence in HIV Care, Regional Art Centre, Kolkata, India

Abstract

Background Combination antiretroviral therapy (ART)has transformed HIV-AIDS into a chronically manageable illness. Efavirenz is an important component for ART regimens. Quality of life should be maintained for the easy continuation of this life-long therapy. Hence the adverse drug reaction (ADR) monitoring has become an important event to achieve good adherence

Objective This study aims to assess the spectrum of clinico–biochemical and neuropsychiatric ADRs for Efavirenz based ART in paediatric HIV patients

Methods Paediatric HIV-1 patients initiated with Efavirenz based ART were followed up for biochemical changes (liver, renal, lipid, haemoglobin parameters) and neuropsychiatric adverse reactions (NPARs) till 6 months. NPAR(s) were monitored using Developmental Psychopathology Checklist and Sleep Disturbances Scale for Children. Adherence and guardian’s literacy status were analyzed for their association with the self-reporting of NPAR(s).

Results NPARs were observed to be maximum at 15thday, followed by a gradual decrease over 1stand 2ndmonth. Symptoms like learning disorder and psychosis were maximum, followed by hyperkinesis, emotional disorder and somatisation. Domains of sleep problems were maximum at 15thday, followed by a graded decrease in the 1stand 2ndmonth. Self- reporting was found to be 57.14% and 37.50% in guardian with secondary and primary education respectively. Decreased adherence was noted among 16.67% of patients, managed by proper counselling. While biochemical changes like liver function alterations were observed to be maximum at 6thmonth (30.39%) and 4thmonth (7.84%), changes in renal function and lipid parameters were observed to be maximum at 6thmonth and drop in haemoglobin at 3rdmonth.

Conclusion Sensitization about NPAR(s) should be ensured at the time of therapy initiation to warrant adherence and spontaneous reporting in order to prevent resistance and treatment failure. ART induced anaemia, altered lipid profile, liver and kidney function derangements could be life threatening. This study thus upsurges the need for focused pharmacovigilance and therapeutic drug monitoring of ART for safer patient outcomes.

Disclosure No significant relationships.

  • HIV

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