P170 Efavirenz based anti-retroviral regimens in paediatrics: a peep into neuropsychiatric and biochemical derangements

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.