Markers of rapid HIV progression among untreated Argentinean seroconverters M.E. Socías, O. Sued, N. Laufer, H. Mingrone, C. Acuipil, E. Loiza, L. Amante,

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Markers of rapid HIV progression among untreated Argentinean seroconverters M.E. Socías, O. Sued, N. Laufer, H. Mingrone, C. Acuipil, E. Loiza, L. Amante, C. Remondegui, M. Lázaro, D. Pryluka, M. Cabrini, M.I. Figueroa, G. Turk, A. Gun, M.B. Bouzas, M.C. Iannella, H. Salomón, A. Krolewiecki, H. Pérez, P. Cahn, on behalf of Grupo Argentino de Seroconversión Study Group Grupo Argentino de Seroconversión FRAX0104

Grupo Argentino de Seroconversión Background Diagnosis of Primary HIV Infection (PHI) has important clinical and public health implications. Indication of treatment at this stage remains controversial. Understanding early host-virus interactions may help develop new treatment and prevention strategies.

Grupo Argentino de Seroconversión Cohort description Multicenter Registry of PHI patients started in centers 152 patients HIV/AIDS in Argentina 120,000 PLWHA 60,000 know their status 44% live in Buenos Aires city and surroundings

Grupo Argentino de Seroconversión Objectives To describe clinical and immunological outcomes and identify potential predictors of progression during the first year of infection among Argentinean seroconverters.

Grupo Argentino de Seroconversión Material & Methods Inclusion Criteria: –>16 years old –Confirmed acute or recent HIV infection: Negative or Indeterminate WB plus positive virological test Positive WB plus negative HIV test within the previous 6 months –HIV diagnosis between –≥ 1 year of follow-up

Grupo Argentino de Seroconversión Material & Methods Definitions: –“Symptomatic” PHI: ≥ 1 symptom associated with Acute Retroviral Syndrome (ARS). –“Severe symptomatic” PHI: B or C events, or other non-AIDS related serious events at the time of seroconversion. –HIV progression: Clinical criteria: B or C event, or death Immunological criteria: CD4 cell count < 350 cells/  L

Grupo Argentino de Seroconversión Baseline characteristics (n=134) Sex: 109 male (81%), 25 female (3 pregnant) Age, median: 32 years old (IQR 25-39) Risk: MSM 53 % Heterosexual 37% IDU 1% HIV-test: Negative WB 9% Indeterminate WB 40% Seroconversion 51% 28 cases with HIV-positive partner Median Viral load: 4.87 log copies/ml (IQR ) Median CD4: 479 cells/  L (IQR ) Requested by patients in 33%

Grupo Argentino de Seroconversión Morbidity and mortality associated with acute HIV infection Symptomatic PHI: 99 patients (74%) Severe symptomatic PHI: 26 patients –7 Opportunistic infections –9 B events –10 non-AIDS defining serious events Hospital admission: 35 patients (26%) 1 death (disseminated histoplasmosis)

Factors Associated with Severe Symptomatic PHI Grupo Argentino de Seroconversión n=26 Risk FactorOR95%CIp Age > 30 years Male sex Diagnosis ≥ MSM HIV RNA > 100,000 copies/mL CD4 cell-count < 350 cells/  l Diagnosis based on physician suspicion <0.001

Grupo Argentino de Seroconversión 12-month follow-up 134 PHI patients Initiated HAART 42 Progressed* 3 (7%) Untreated 92 Progressed*: 24 (26%) - Clinical: 12 (1 death) - Immunological: 12 * HIV progression: -Clinical: B or C event, or death. -Immunological: CD4 < 350 cells/  l. * HIV progression: -Clinical: B or C event, or death. -Immunological: CD4 < 350 cells/  l. p=0.01

Risk Factor Univariate modelMultivariate model HR95%CIpHR95%CIp Male sex Diagnosis ≥ Age > MSM Baseline CD4 cell- count ≤ 350 cell/  l Baseline HIV RNA ≥ 100,000 copies/mL HIV RNA at 6 months ≥ 100,000 copies/mL Symptomatic PHI Predictors of Disease Progression in untreated patients Grupo Argentino de Seroconversión n=92

Grupo Argentino de Seroconversión Time to Progression of HIV Disease Among Untreated Patients n=92 13% 34% p=0.04

Grupo Argentino de Seroconversión Conclusions In our cohort, PHI was associated with significant morbidity. One quarter of untreated patients would require HAART during the first year of HIV infection. Symptomatic PHI and high baseline VL were associated with more rapid HIV progression within the first year of infection. HAART should be considered in PHI- patients with ARS or high baseline VL.

Grupo Argentino de Seroconversión SITES Hospital Fernández Fundación Huésped Centro Médico Huésped Hospital Muñiz Hospital San Antonio de Areco Sanatorio Otamendi Hospital de Bariloche Hospital San Roque de Jujuy Nexo Asociación Civil Sanatorio Trinidad Hospital Aeronáutico de Córdoba Sanatorio San Lucas Hospital de Guernica Aclires LABORATORIES CNRS Horacio Salomón Manuel Gomez Carrillo Gabriela Turk Dario Dilernia FUND HUESPED Ana Gun H. MUÑIZ M Belén Bouzas Inés Zapiola H. FERNANDEZ Osvaldo Cando PHYSICIANS Lorena Abusamra Marcela Acosta Carolina Acuipil Viviana Alonso Liliana Amante Graciela Ben Ariel Braverman Mercedes Cabrini Pedro Cahn Cecilia Cánepa Daniel Cangelosi Juan Castelli Mariana Ceriotto Carina Cesar María Collins Fabio Crudo Andrea Duarte Gustavo Echenique M Inés Figueroa Valeria Fink Claudia Galloso Palmira Garda Alejandro Krolewiecki Natalia Laufer Marita Lázaro Alberto Leoni Eliana Loiza Horacio Mingrone Marcela Ortiz Patricia Patterson Héctor Pérez Norma Porteiro Daniel Pryluka Carlos Remondegui Raúl Román M. Eugenia Socías Omar Sued J Gonzalo Tomás Javier Yave Carlos Zala Grupo Argentino de Seroconversión Study Group We are in debt to all the patients of Grupo Argentino de Seroconversión. Financial Support: Partially funded by Fogarty International Center (Grant # D43 TW ).

Grupo Argentino de Seroconversión

Thank you for your attention!!! If you need more information please contact: “Protocolo PHI”: Eugenia Socías

Grupo Argentino de Seroconversión CharacteristicAll (N=134) Symptomatic PHI YES (n=99)NO (n=35)p Age at HIV diagnosis, mean years (SD)33.4 (10.7)33.8 (10.37)32.2 (11.64)0.44 Male sex, n (%)109 (81.3)79 (79.8)30 (85.8)0.61 Education, n (%) High school or more 79 (75.2)59 (72.8)20 (83.4)0.3 Place of birth, n (%)74 (67.9)56 (67.5)18 (69.2)0.61 Employed, n (%)82 (70.7)62 (70.5)20 (71.4)0.89 Reason for HIV test, n (%) Physician’s suspicion 61 (48.4)56 (59.6)5 (15.6)<0.001 Patient request42 (33.3)27 (28.7)15 (46.9) Routine23 (18.3)11 (11.7)12 (37.5) Risk factor for HIV transmission, n (%) MSM71 (53)51 (51.5)20 (57.1)0.788 Heterosexual50 (37.3)38 (38.4)12 (34.3) IDU1 (0.7)1 (1)0 (0) Missing12 (9)9 (9)3 (8.6) HIV RNA, median log 10 copies/mL (IQR) 4.87 ( )5.12 ( )4.36 ( )<0.001 CD4 cell-count, median cells/  l (IQR) 479 ( )466 ( )533 ( )0.019 HAART initiation, n (%)42 (31.3)38 (38.4)4 (11.4)0.003

Progression-free Survival Among Untreated Patients Stratified by Baseline VL Grupo Argentino de Seroconversión

Spearman: 0.48 (p<0.001)Pearson: (p=0.02)