HIV-1 PLASMA VIRAL LOAD IN TREATMENT NAÏVE HIV-1 PATIENTS ON THEIR ENROLLMENT TO HIV CARE Chaudhari CN*, Kumar M+, Patil S#, Shamim MA#, Roy P+, Sahni AK$ *Professor Microbiology, INHS Asvini & Institute of Naval Medicine, Colaba, Mumbai; # UG Student, + Professor, $Prof & Head, Dept of Microbiology, Armed Forces Medical College, Pune Introduction It is recommended that HIV-1 plasma viral load (PVL) to be undertaken on all HIV-1 infected people right on their enrollment of HIV disease care. PVL is necessary for selection of appropriate Anti Retroviral Therapy (ART) regime; further patients with PVL > 100,000 copies/ml requires immediate initiation of ART1. Early initiation of ART is recommended with goal to lower PVL and consequent reduction in HIV-1 transmission i.e. a treatment as prevention (TasP) intervention1,2,3. In resource poor setting, it is recommended to initiate ART with CD4+T cell cut off ≤ 500 cells/ml 1,2,3. An interesting study by Murnane PM, et al4 found use of a HIV-1 PVL based algorithm to target resources in treatment of HIV-1 infected patients with high PVL more cost effective than treating all subjects with CD4+ counts ≤ 500 cells/ml. National AIDS Control Organization in India (NACO) does not recommend PVL in management of HIV-1 in adolescence or adult patients. They recommends initiation of ART at CD4+ T cell count of <350 cell/ml5. In this background, we conducted a pilot study to evaluate CD4+ T cells and HIV-1 plasma viral load in treatment naïve HIV-1 infected subjects on their entry into HIV care. Materials and methods A prospective study, Period- Aug 2011 to Dec 2013, Settings:- ART centre of a Medical College. Approved by the Institutional Ethical Committee. Study Subjects : HIV-1 infected on diagnosed of their infection & treatment naïve. Inclusion criteria: Age group- 18-60 years; WHO Clinical stage I & II. Exclusion criteria : Pregnant women; patients with co- morbidity. Specimen : Peripheral blood sample in K3-EDTA tube. Tests : Blood CD4+ and CD8+ count using BD FACS Count CD4/CD3 Kit . PVL assay by HIV- 1 Test v2.0 high pure system viral nucleic acid kits using Cobas Taqman 48 Analyser (Roche Diagnostics). Nonparametric tests used in statistical analysis with P<0.05 as significant. Results 41 subjects enrolled; 21(51.2%) males and 20(48.8%) female. Age from 20 to 56 yrs, mean 36.6 yrs (SD-8.4). CD4+T cells ranged 69 to 1260 cells/µl, mean 421 cells/µl (SD: 261). 21(51.2%) and 20(48.8%) subjects had a CD4+T cell count of ≤350 and >350 cells/µl respectively. HIV -1 PVL ranged from target not detected (TND) to 1,713,050 copies/ ml; mean 101,146 copies/ml (SD: 264,799). Table1: Different parameters in subjects with CD4+ T cells ≤350 & > 350 Table 2 : Distribution of PVL based on CD4+ T cells groups Discussion 7.3% study subjects with CD4+ T cell count >350 cells/µl had a PVL >100,000; required immediate initiation of ART1. 55.6% and 45.5% study subjects with CD4+ T cells between 350 - 500 and >500 cells/ml respectively had a PVL > 10,000 to 100,000copies/ml. COHERE (Collaboration of Observational HIV epidemiology Research Group) emphasize that the current PVL is the strongest predictor of the CD4+T cell depletion6. High PVL is associated with efficient HIV-1 transmissions; with overall increase in treatment cost. Initial PVL permits identifying these patients and targeting resources in their treatment with strategy of TasP 3,4. How are we going to diagnose these highly infectious patients with CD4+ T cells count>350cells/µl? Should we allow these infectious patients to continue transmitting HIV-1 infection? We need to explore HIV-1 PVL in management of HIV-1 infection. Acknowledgement: Study was funded by research grant from the Director General Armed Forces of India, the project AFMRC 4156/2011 References 1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available at http://aidsinfo.nih.gov/ContentFiles/AdultandadolescentGL.pdf 2. Granich RM, Gilks CF, Dye C, et al. Universal voluntary HIV testing with immediate antiretroviral therapy as a strategy for elimination of HIV transmission: a mathematical model. Lancet 2009;373:48-57. 3. Govender S, Otwombe K, Essien T, et al. CD4 Counts and Viral Loads of Newly Diagnosed HIV-Infected Individuals: Implications for Treatment as Prevention. PLoS ONE 2014;9(3): e90754. doi:10.1371/journal.pone.0090754 4. Murnane PM, Hughes JP, Celum C, et al. Using Plasma Viral Load to Guide Antiretroviral Therapy Initiation to Prevent HIV-1 Transmission. PLoS ONE 2012; 7(11): e51192. doi:10.1371/journal.pone.0051192 5. National AIDS Control Organization. Antiretroviral Therapy Guidelines for HIV infected Adult and Adolescence May 2013. Department of AIDS control. Available at www.naco.org 6. Nakagawa F, Lodwick R, Smith C, et al. Factors associated with short-term changes in HIV viral load and CD4+ cell count in antiretroviral-naive individuals. The Natural History Project Working Group for the Collaboration of Observational HIV Epidemiological Research Europe (COHERE) in EuroCoord. AIDS 2014; 28:1351–6 PVL copies/ml & CD4+ T cells   ≤ 350 cells/µl >350 -500 cells/µl >500 Total No % ≤1,000 1 4.8 11.1 3 27.3 5 12.2 1,001 to 10,000 -  - 2 18.2 7.3 10,001 to 50,000 6 28.6 22.2 11 26.8 50,001 to 100,000 10 47.6 33.3 15 36.6 >100,000 4 19.0 9.1 7 17.1 21 100.0 9 41 Parameter (SD) ≤ 350cells/µl >350 Cells/µl P value Number 21 20   Mean Age 38.7 (8.9) 34.3(7.3) P=0.05 Gender – Female (%) 6 (28.6%) 14(70.0%) P<0.013 Mean CD4+ T cells 232(88) 620(234) P<0.0001 PVL Copies/ml 153,071(363,123) 46,624(52,064) P=0.2 18 OCT 2014 HP3, REDG 612, MICROCON 2014