Journal of Clinical and Diagnostic Research. 2020 Jun, Vol-14(6): DC05-DC09 5 5 DOI: 10.7860/JCDR/2020/44103.13781 Original Article Microbiology Section A Retrospective Analysis of Plasma Viral Load in Cases of Immunological Failure in HIV Patients on HAART from Central India: How Close are We to the 90-90-90 Target? INTRODUCTION The total number of People Living with Human Immunodeficiency Virus (PLHIV) in India is estimated to be 2.1 million in 2018 [1]. The introduction of ART into clinical practice has led to dramatic reductions in morbidity and mortality associated with the HIV infection [2]. Over the years, a change has been seen in the guidelines for initiation of ART depending on the CD4 cell counts of the patients and currently, it is initiated irrespective of the CD4 cell counts [3-6]. Initiation of ART should lead to immune recovery and PVL suppression [7]. An adequate CD4 response is defined as an increase of 50-150 cells/mm 3 /year with an accelerated response in the first three months of the treatment [8]. However, some patients fail to achieve a significant increase in CD4 count despite undetectable/low PVL (<1000 copies/ml) [1]. They are considered to have an immunological failure despite complete viral suppression and this is referred to as “immunological discordance” [9]. In some patients, a different pattern of discordant response is seen in which there is a sustained CD4+ cell count response even with persistent viraemia [10]. Previous clinical studies demonstrated that the prevalence of immunological discordance to ART ranges from 20% to 30% [10-12]. In 2014, the UNAIDS launched the 90-90-90 target which aims that by 2020, 90% of all people living with HIV will know their HIV status, 90% of these will receive sustained ART and 90% of all people receiving ART will have viral suppression [13]. According to UNAIDS 2017 data for India, 79% of people living with HIV knew their status and 56% of people living with HIV were on treatment [14]. In resource limited settings like India, the cost of treatment is very high and routine virological monitoring and genotyping resistance is not done to start the therapy and see the response to therapy [15]. With CD4 counts as the surrogate marker, immunological failure cases have been reported from various parts of the country [15-19]. However, it is important to assess their PVL to evaluate discordant responses in them, since discordant responders have shown relatively higher risk of progression to AIDS and non-AIDS related mortalities [20]. This will also help in reduction of accumulation of drug resistance mutations and improve patient outcomes by preventing unnecessary switching of regimens. Assessment of PVL will also be useful in the quantification of the third 90 goal of the 90- 90-90 target [1]. This study of retrospective analysis of PVL in cases of immunological failure in HIV patients was undertaken with the aim to find out the rate of discordance and associated co-morbid conditions in these patients. MATERIALS AND METHODS This retrospective study was carried out at the ART centre in Government Medical College and Hospital, Nagpur, Maharashtra, India with data collected from the ART cards of the patients. The project was approved by the Institutional Ethics Committee (REG. NO. -ECR/43/inst/MH/2013). According to National Aids Control Organization (NACO) guidelines, immunological failure is defined as fall of CD4 count to pre-therapy baseline (or below) or 50% fall from on treatment peak value (if known) or persistent CD4 levels below 100 cells/mm 3 , and virological failure is defined as PVL >1,000 copies/mL [1,3]. Out of a total of 5091 patients on ART, 458 patients (>16 years of age) of immunological failure who were AVANTI SAOJI 1 , MEENA MISHRA 2 , MEGHA NAVADE 3 , SURESH UGHADE 4 , SUNANDA SHRIKHANDE 5 , MOHIUDDIN QAZI 6 Keywords: Anti-retroviral therapy, Discordance, Human immunodeficiency virus ABSTRACT Introduction: Anti-Retroviral Therapy (ART) initiation in patients leads to increase in CD4 counts and decrease in the Plasma Viral Load (PVL). However, some patients fail to achieve a significant increase in CD4 count despite undetectable PVL. In spite of complete viral suppression, patients have immunological failure; this is referred as “immunological discordance”. This study is a retrospective analysis of PVL in cases of immunological failure in Human Immunodeficiency Virus (HIV) patients and aims to find out the rate of discordance and associated co-morbid conditions. Aim: To carry out a retrospective analysis of PVL in HIV patients with immunological failure on ART in a tertiary health care centre in Nagpur, Maharashtra, India. Materials and Methods: This study was carried out at the ART centre in Government Medical College and Hospital, Nagpur, Maharashtra, India. Patients (>16 years of age) of immunological failure (458) who started second-line ART during the period 2012- 2017 were included in the study. The data was coded using MS- Excel 2013 and statistical softwares OpenEpi (Version 3.01) and STATA (Version 10.1-2011, Texas, USA) were used for analysis. Results: The most common co-existing condition seen was tuberculosis. Risk of low (<100) baseline CD4 count was almost three times higher in males. Risk of immunological failure {in those with greater than 100 cell decrease after six months of Highly Active Antiretroviral Therapy (HAART)} was higher in those with low baseline CD4 counts (0-200 cells/mm 3 ) (OR- 1.39). The rate of discordance was 17.82%. The number of patients of immunological failure decreased when ART was initiated at higher CD4 counts. Conclusion: Discordance was seen in patients of immunological failure, thus, PVL assay must be done before second line ART initiation to avoid unnecessary switching of regimen. Early initiation of ART can lead to a better prognosis, thus helping us reach closer to the 90-90-90 target.