Browsing by Author "Fink, Valeria"
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Item A phase 4, single-arm, open-label, pilot study of maraviroc, raltegravir and darunavir/r in HIV-1 adults with triple class failure: TERCETO study(2012) Patterson, Patricia; Magneres, Claudia; Sued, Omar; Fink, Valeria; Figueroa, Maria Ines; Cesar, Carina; Gun, Ana; Cahn, Pedro; Krolewiecki, Alejandro J.The purpose of this phase 4, single-arm, open-label study was to evaluate the safety, tolerability, efficacy, antiviral and immunological activity of maraviroc (MVC) in combination with raltegravir (RGV) and darunavir/r (DRV/r) in adult HIV-1 infected patients (pts) with limited treatment options. HIV-1 pts with documented virologic triple class failure or multi-drug class resistance defined as the presence of Q151 complex, 69 insertion complex and/or≥3 TAMs for NRTIs and K103N, G190S+Y181C or Y188L mutants for NNRTIs and≥3 RAMs (L10F/I/R/V; M46I/L; I54V/M/L; V82A/F/T/S; I84V; L90M) for protease inhibitors (PIs) were offered a triple drug regimen consisting of MVC 150 mg BID, RGV 400 mg BID and DRV/r 600/100 mg BID. Safety, lipid profile and virologic efficacy were evaluated at week 4, 12, 24, 36 and 48. Between January 2010 and March 2012, 27 pts were enrolled. Screening failure rate was 52% due to undetectable viral load (pVL) or non R5 tropism type (Trofile™). Despite being heavily pre-treated pts, only 26% had negative tropism test at SCR. Baseline characteristics of 13 included pts were: 77% male, median age 43 years (IQR: 40.1–48.6), 38% had a prior AIDS-defining condition. Median BSL pVL was 23,350 cps/mL (4.4 log10) (IQR: 11,236–55,785) and median CD4 was 222 cells/mm3 (IQR: 179–318). Median time on NRTIs, NNRTIs and PIs were 10.7 (8.6–13.7), 1.7 (1.3–7.6) and 5.4 (4.7–10) years respectively. Pts had received a median of 2 PIs (IQR: 2–3). 8/13 pts showed thymidine analogue-associated mutations (TAMs), and≥2 were present in 5/13. Detectable NNRTI resistance-associated mutations (RAMs) were present in 10/13 patients. 9/13 had≥4 primary PI RAMs. At 48 weeks, 2 pts had discontinued therapy (OIs related death (cryptococcal meningitis)=1, withdrawn from the study on W36 due to blips despite not achieving criteria for virologic failure=1) and the remaining pts (11/13) achieved undetectable pVL and increased CD4 in 133 cell/mm3 from BSL (IQR: 81–174.5). Median total cholesterol levels increased from 162 mg/dL (IQR: 135-188) to 215 mg/dL (IQR: 182–237) between BSL/W48; median change in cholesterol levels: 40 mg/dL (IQR: 6.5-66). Salvage therapy including MVC, RGV and DRV/r achieved sustained reductions in pVL (<50 copies/mL) through 48 weeks of therapy in this pilot study with no treatment limiting toxicity.Item Antiretroviral therapy and Kaposi’s sarcoma trends and outcomes among adults with HIV in Latin America(2021-01-06) Castilho, Jessica L; Kim, Ahra; Jenkins, Cathy a; Grinsztejn, Beatriz; Gotuzzo, Eduardo; Fink, Valeria; Padgett, Denis; Belaunzaran-Zamudio, Pablo F; Crabtree-Ramírez, Brenda; Escuder, Maria Mercedes; Souza, Rosa Alencar; Tenore, Simone B; Pimentel, Sidnei R; Rodrigues Ikeda, Maria Letícia; de Alencastro, Paulo R; Tupinanbas, Unai; Brites, Carlos; Luz, Estela; Netto, Juliana; Cortes, Claudia; Grangeiro, Alexandre; Shepherd, Bryan E; McGowan, Catherine C; The Caribbean, Central, South America network for HIV Epidemiology (CCASAnet)Abstract Introduction Kaposi’s sarcoma (KS) remains the most frequent malignancy in persons living with HIV (PWH) in Latin America. We examined KS trends and outcomes from Latin American clinical sites in the era of increased access to antiretroviral therapy (ART). Methods Cohorts in Brazil, Peru, Mexico, Honduras, Argentina and Chile contributed clinical data of PWH ≥16 years old from 2000 to 2017, excluding patients with KS diagnosed before clinic enrolment. We compared KS incidence over time using multivariable incidence rate ratios. Predictors of KS before/at or after ART initiation and of mortality after KS were examined using Cox regression. Results Of 25 981 PWH, 481 had incident KS, including 200 ART-naïve and 281 ART-treated patients. From 2000 to 2017, the incidence of KS decreased from 55.1 to 3.0 per 1000 person-years. In models adjusting for CD4 and other factors, the relative risk for KS decreased from 2000 to 2008. Since 2010, the adjusted risk of KS increased in the periods before and ≤90 days after ART initiation but decreased >90 days after ART. In addition to low CD4 and male-to-male sex, KS risk after ART was associated with age and history of other AIDS-defining illnesses. Mortality after KS (approximately 25% after five years) was not associated with either year of KS diagnosis nor timing of diagnosis relative to ART initiation. Conclusions KS incidence in Latin America has remained stable in recent years and risk is highest before and shortly after ART initiation. Early diagnosis of HIV and ART initiation remain critical priorities in the region.Item Association between HIV-1 RNA level and CD4 cell count among untreated HIV-infected individuals(2010) Lima, Viviane D.; Fink, Valeria; Yip, Benjamin; Hogg, Robert S.; Harrigan, Richard P.; Montaner, JulioObjectives. We examined the significance of plasma HIV-1 RNA levels (or viral load alone) in predicting CD4 cell decline in untreated HIV-infected individuals. Methods. Data were obtained from the British Columbia Centre for Excellence in HIV/AIDS. Participants included all residents who ever had a viral load determination in the province and who had never taken antiretroviral drugs (N = 890). We analyzed a total of 2074 viral load measurements and 2332 CD4 cell counts. Linear mixed-effects models were used to predict CD4 cell decline over time. Results. Longitudinal viral load was strongly associated with CD4 cell decline over time; an average of 1 log10 increase in viral load was associated with a 55-cell/mm3 decrease in CD4 cell count. Conclusions. Our results support the combined use of CD4 cell count and viral load as prognostic markers in HIV-infected individuals before the introduction of antiretroviral therapy.Item Benznidazole treatment of chagasic encephalitis in pregnant woman with AIDS(2013-9) Bisio, Margarita; Altcheh, Jaime; Lattner, Jorge; Moscatelli, Guillermo; Fink, Valeria; Burgos, Juan M.; García Bournissen, Facundo; Schijman, Alejandro G.; Freilij, HéctorIn HIV infection, initiation of treatment is associated with improved clinical outcom and reduced rate of sexual transmission. However, difficulty in detecting infection in early stages impairs those benefits. We determined the minimum testing rate that maximizes benefits derived from early diagnosis.Item Biterapia con atazanavir/ritonavir más raltegravir versus terapia triple en segunda línea: Ensayo ARTE(Fundación Huésped - Sociedad Argentina de Infectología, 2023-07) Figueroa, María Inés; Sued, Omar; Cesar, Carina; Patterson, Patricia; Yamamoto, Cleyton; Fink, Valeria; Luna, Norma; Camiro-Zúñiga, Antonio; Gun, Ana; Cahn, PedroAntecedentes: La terapia dual ha surgido como un nuevo concepto para el tratamiento del VIH. Este estudio tenía como objetivo comparar un régimen dual basado en ATV/r + RAL (TD) frente a estándar de tres drogas con ATV/r + TDF/FTC (TT) luego del fracaso de un primer esquema ba- sado en INNTR.ClinicalTrials.gov, Número: NCT01829802. Método: Estudio piloto abierto, multicéntrico y aleatoriza- do. Resultado primario: proporción de sujetos con ARN del VIH-1 menor a 50 copias/mL en semana 48 (S48). Resulta- dos secundarios: discontinuaciones asociadas a eventos adversos (EA), tiempo transcurrido hasta la supresión viral, desarrollo de mutaciones de resistencia a la integrasa y proteasa, cambio en recuento de CD4. Resultados: De los 57 participantes seleccionados, 34 fue- ron asignados aleatoriamente para recibir: TD (n: 18) o TT (n: 16). En semana 48, 67% (n: 12/18) en TD tuvo respues- ta virológica y 88% (n: 14/16) en rama según el análisis FDA, intención de tratamiento/expuestos (p = NS) y 73% (TD) y 93% (TT) según análisis por protocolo (p = NS). El cambio de CD4 entre basal - S48: +119 y +52 células/μL en DT y TT, respectivamente. Cuatro participantes en TD y uno en TT presentaron fracaso virológico en la semana 48. Un participante desarrolló una mutación de resistencia a integrasa (155H). Conclusión: ATV/r+RAL como terapia dual de segunda línea mostró una tendencia al fracaso virológico más frecuente, en comparación con TT, aunque el estudio piloto no tenía potencia para demostrar esta diferencia. Este estudio está registrado en ClinicalTrials.gov, Número: NCT01829802.Item Cancer in HIV-Infected Persons From the Caribbean, Central and South America(2011) Fink, Valeria; Shepherd, Bryan E.; Cesar, Carina; Krolewiecki, Alejandro J.; Wehbe, Francisco; Cortes, Claudia; Crabtree-Ramirez, Brenda; Padgett, Denis; Shafaee, Mehdi; Schechter, Mauro; Gotuzzo, Eduardo; Bacon, Melanie; McGowan, Catherine C.; Cahn, Pedro; Masys, Daniel R.; Caribbean Central South America Network for HIV Research Collaboration of the International Epidemiologic Databases to Evaluate AIDS ProgramBackground: HIV-infected individuals have heightened cancer risk. With the advent of highly active antiretroviral therapy (HAART), the frequency of some AIDS-defining cancers (ADC) has decreased although certain non-AIDS-defining cancers (NADC) are becoming more frequent. Cancers among HIV-infected individuals in Latin American and the Caribbean have not yet been carefully studied. Methods: Cancer cases among the Caribbean, Central and South American network for HIV Research (CCASAnet) cohort were identified reviewing clinical records and pre-existing databases. Results: There were 406 cancers reported: 331 ADC (224 Kaposi sarcomas and 98 non Hodgkin lymphomas). Most frequent NADC (n = 75) were Hodgkin lymphoma and skin cancers. Seventy-three percent of NADC and 45% of ADC were diagnosed >1 year after HIV diagnosis. Fifty-six percent of ADC occurred before HAART start. Median time from HAART start until cancer diagnosis was 2.5 years for NADC and 0.5 years for ADC (P = <0.001). Within 3372 HAART starters, 158 were diagnosed with 165 cancers (82.4% ADC); 85 cases were previous to or concomitant with HAART initiation. Incidence of cancer after HAART initiation in 8080 person-years of follow-up was 7.2 per 1000 person-years (95% confidence interval = 5.5 to 9.3) for ADC and 2.7 (95% confidence interval = 1.8 to 4.1) for NADC; incidence was higher in the first 2 months, particularly for ADC (47.6). A pre-HAART ADC was a predictor of mortality after adjusting for age, sex, and CD4 at HAART initiation. Conclusions: ADC were the most frequent cancers in this region and were often diagnosed close to HIV diagnosis and HAART start. Incidence of cancer was highest around HAART initiation.Item Clinical-epidemiological features of HIV-infected patients diagnosed at age of 50 years or older(2012) Patterson, Patricia; Cahn, Susana; Sued, Omar; Fink, Valeria; Figueroa, Maria Ines; Cesar, Carina; Rojo, Marina; Ben, Graciela; Vazquez, Mariana; Cahn, PedroHIV/AIDS prevention and care efforts are directed to individuals of reproductive age (15–49 yrs). With the extension of sexual life of older people, they became a growing population at risk of HIV infection, usually not included in prevention strategies. In order to evaluate clinical profile of HIV/AIDS pts diagnosed at 50 yrs or older assisted in an HIV outpatient center in Buenos Aires, we retrospectively assessed clinical records of pts initiating care between Jan 1986 and Dec 2011. Age, CD4 cells and viral load (pVL) at HIV diagnosis and most recent value, opportunistic infections (OIs), co-morbidities and antiretroviral therapy (ARV) were recorded. Of 10,998 pts assisted in the 26-yr period, 495 (4.5%) were≥50 yrs old at HIV diagnosis; median annual diagnoses: 18.5 (IQR 3.3–30.3) without significant changes in the last 20 yrs. Demographics: median age 54.7 yrs (IQR 51.8–59.2, rank 50–80), 76.6% male. Risk behavior: HTX 61.4%, MSM 34.1%, others 4.4%. 55.4% of HIV diagnoses occurred during hospitalization or simultaneously with acute OIs. One third (n=176) had AIDS at diagnosis, 24% had history of STDs. HCV co-infection 5.7%, past HBV infection 28.1% and chronic HBV infection 5.1%. Median CD4 cells at HIV diagnosis: 223.5 (13.7%) (IQR 98.8–420.3), initial pVL 60,000 cp/mL (IQR 9,995.5–208,391). 69.3% of pts started ARV therapy during follow-up (FU), and the median time between diagnosis and treatment initiation was 3.4 mo (IQR 0.7–14); 56.9% of them started a non-nucleoside-based regimen (ZDV/3TC/EFV), 28.3% a PI-based regimen (ZDV/3TC/IDV) and 14.6% a nucleoside-based regimen (ZDV/ddI pre-HAART era). After a year (±6 mo), 63.8% pts achieved undetectable pVL and gained 136 CD4 cells from BSL (IQR 83–204). After 40.6 mo of FU (IQR 6.7-89.8), 66.3% are alive, 7.1% died (68.6% of HIV-related diseases) and 26.7% are lost to FU. Co-morbidities were present in 125 (25.3%), mainly hypertension, increased lipids, CVD and DBT. Among treated pts, 70.6% achieved pVL<50 cp/mL, with a median increase of CD4 cells up to 410 (22%) (IQR 281.5–563.9) from BSL. 51% (176) changed ARV therapy due to toxicity/AE: 54.5%, ARV failure: 29.5% and simplification: 14.8%. Stable HIV epidemic in older people reinforce the need of specific prevention approaches, while growing age of HIV individuals in care highlights to consider risks associated to older age. Late presentation to care needs to be specifically addressed. Response to treatment is remarkable high in this population.Item Decision-making in HIV clinical trials: a study with patients enrolled in antiretroviral trials(2021) Feijoo-Cid, Maria; Rivero-Santana, Amado; Moriña, David; Cesar, Carina; Fink, Valeria; Sued, OmarAbstract Objective: To explore the decisional process of people living with human immunodeficiency virus (HIV) currently enrolled in antiretroviral clinical trials. Method: Cross-sectional retrospective study. Outcome variables were reasons to participate, perceived decisional role (Control Preference Scale), the Decisional Conflict Scale and the Decisional Regret Scale. Descriptive statistics were calculated, and associations among these variables and with sociodemographic and clinical characteristics were analyzed with non-parametric techniques. Results: Main reasons to participate were gratitude towards Fundación Huesped (47%), the doctor's recommendation (32%), and perceived difficulty to access treatment in a public hospital (28%). Most patients thought that they made their decision alone (54.8%) or collaboratively with the physician (43%). Decisional conflict was low, with only some conflict in the support subscale (median=16.67). Education was the only significant correlate of the total decisional conflict score (higher in less educated patients; p=0.018), whereas education, recent diagnosis, living alone, lower age, being man and doctor's recommendation to go to Fundación Huésped related to higher conflict in different subscales. Nobody regretted to participate. Conclusions: The decision making regarding participation in HIV trials, from the perspective of participants, was made respecting their autonomy and with very low decisional conflict. Currently, patients show no signs of regret. However, even in this favorable context, results highlight the necessity of enhancing the decision support in more vulnerable patients (e.g., less educated, recently diagnosed or with less social support), thus warranting equity in the quality of the decision making process. Keywords: Clinical trial; Conflicto decisional; Decisional conflict; Ensayo clínico; Human immunodeficiency virus; Participación del paciente; Patient participation; Virus de la inmunodeficiencia humana. ©2020 SESPAS. Published by Elsevier España, S.L.U. This is an open access article under the CCBY-NC-NDlicense (http://creativecommons.org/licenses/by-nc-nd/4.0/).Item Design and Development of an Electronic Health Record According to Argentine Gender Identity La(2022-06) Giraldo, Liliana; Fink, Valeria; Cahn, Florencia; Aristegui, Ines; Caceres, Betiana; Sued, Omar; Cesar, CarinaHealth information systems face the challenge of collecting data on patients’ gender identity. The absence of this information may lead the patients to situations of vulnerability and discrimination. The objective of this study is to describe the process of designing and developing an Electronic Health Record according to the Argentine Gender Identity Law. This health record allows clinics to record legal names and surnames, other social names, gender identity, sex at birth, and legal sex.Item Engaging female sex workers in their health care through stakeholder mapping and participatory analysis in Buenos Aires, Argentina(2024-04) Esandi, Maria Eugenia; Walmsley, Sharon; Zalazar, Virginia; Panizoni, Estefania; Serrao, Camila; Acuña, Rodrigo; Frontini, Emilia; Zeltman, Ana Clara; Trejo, Maria Celia; Cardozo, Nadir; Romero, Marcelo; Orellano, Georgina; Ortiz, Zulma; Loutfy, Mona; Duran, Adriana; Cahn, Pedro; Aristegui, Ines; Fink, Valeria; MAS por Nosotras Study GroupCis and trans female sex workers (FSW) face marginalization and struggle to access sexual and reproductive health and rights (SRHR) services. The COVID-19 pandemic worsened these disparities. January-April 2023, we conducted stakeholder mapping (SM) with SRHR policies and programs decision-makers, implementers and users in Buenos Aires, Argentina. This strategy aims to identify, classify and categorize stakeholders based on the power and agreement level of SRHR policies and plans implemented during the pandemic. A qualitative study was conducted through focus groups with FSW and interviews with healthcare providers analyzed with the DEPICT model (methodology for collaborative data interpretation with the community) to investigate facilitators and barriers from their perspectives. Considering the challenges in identifying the appropriate stakeholders, this approach became crucial. The landscape is dynamic, influenced by the sociopolitical context, and recent shifts in government. Following SM, we categorized 147 stakeholders Supporters (68%) and promoters (16%) outnumbered blockers (10%), observers (3%) and neutral (3%) in implementing new policies aimed at SRHR services for FSW. The qualitative interviews revealed barriers including the pervasive impact of intersectional stigma and discrimination, violence, failures in intersectoral articulation and coordination, and difficulties in scheduling of appointments for SRHR services. Facilitators identified improvements in transgender healthcare services in the last decade and the emergence of community assets as pivotal, particularly during the pandemic. SM was invaluable for identifying and characterizing the priorities of key stakeholders for designing policies affecting SRHR services. The inclusion of community perspective, while challenging, enriched our understanding of barriers and facilitators while empowering the community to express their needs. Despite structural barriers and challenges posed by the pandemic, community organizations have displayed resilience, emerging as a vital support system for FSW. We highlight the importance of collaborative efforts and comprehensive approaches in addressing the unique needs of FSW in Argentina and similar contexts.Item Exploring the Decision‑Making Process of People Living with HIV Enrolled in Antiretroviral Clinical Trials: A Qualitative Study of Decisions Guided by Trust and Emotions(Springer Nature, 2023-07) Feijoo-Cid, Maria; Arreciado Marañón, Antonia; Huertas, Ariadna; Rivero-Santana, Amado; Cesar, Carina; Fink, Valeria; Fernández-Cano, María Isabel; Sued, OmarThe informed consent is an ethical and legal requirement for potential participants to enroll in a study. There is ample of evidence that understanding consent information and enrollment is challenging for participants in clinical trials. On the other hand, the reasoning process behind decision-making in HIV clinical trials remains mostly unexplored. This study aims to examine the decision-making process of people living with HIV currently participating in antiretroviral clinical trials and their understanding of informed consent. We conducted a qualitative socio-constructivist study using semi-structured interviews. Eleven participants were selected by purposive sampling in Argentina until data saturation was reached. A content analysis was performed. The findings highlight the fact that some participants decided to enroll on the spot, while others made the decision a few days later. In all cases, the decision was based on different aspects of trust (in doctors, in the clinical research site, in the clinical trials system) but also on emotions associated with HIV and/or treatment. Moreover, while people living with HIV felt truly informed after the consent dialogue with a researcher, consent forms were unintelligible and unfriendly. The immediacy of patient decision-making has rarely been described before. Enrollment in an HIV clinical trial is mainly a trust-based decision but this does not contradict the ethical values of autonomy, voluntariness, non-manipulation, and non‐exploitation. Thus, trust is a key issue to be included in reshaping professional practices to ensure the integrity of the informed consent process.Item Exposición ocupacional al virus de la hepatitis C(2007) Ricart, Javier J.; Fink, Valeria; Cabrini, Mercedes; Figueroa, Maria Ines; Laufer, Natalia; Cahn, PedroLa transmisión ocupacional de virus de hepatitis C (VHC) es un área de creciente preocupación dada la falta de profilaxis y la poca información de su prevalencia en el medio hospitalario. Sobre 128 exposiciones ocupacionales ocurridas en el Hospital Diego Paroissien entre1999 y 2003 hubieron 8 casos de exposición a VHC (6.3%) y un caso de seroconversión posterior a la exposición (0.8%). No existiendo en la actualidad terapia preventiva para VHC resulta de gran interés la posibilidad de tratamiento de la infección aguda. La mayor parte de los autores coincide en recomendar el tratamiento del episodio agudo de hepatitis por VHC basado en la evidencia actual, aunque aún no está bien definida la mejor estrategia diagnóstica y terapéutica. El acatamiento de las Normas de Precauciones Universales sigue siendo en la actualidad la más importante medida preventiva para evitar la infección ocupacional por VHC en el personal de salud y la de mejor equilibrio costo-beneficio.Item Immunodeficiency at the start of combination antiretroviral therapy in low-, middle-, and high-income countries.(2014-1) IeDEA and ART Cohort Collaborations; Avila, D.; Althoff, K. N.; Mugglin, C.; Wools-Kaloustian, K.; Koller, M.; Dabis, F.; Nash, D.; Gsponer, T.; Sungkanuparph, S.; McGowan, Catherine C.; May, M.; Cooper, D.; Chimbetete, C.; Wolff, Marcelo; Collier, A.; McManus, H.; Davies, M. A.; Costagliola, D.; Crabtree-Ramirez, Brenda; Chaiwarith, R.; Cescon, A.; Cornell, M.; Diero, L.; Phanuphak, P.; Sawadogo, A.; Ehmer, J.; Eholie, S. P.; Li, P. C.; Fox, M. P.; Gandhi, N. R.; González, E.; Lee, C. K.; Hoffmann, C. J.; Kambugu, A.; Keiser, O.; Ditangco, R.; Prozesky, H.; Lampe, F.; Kumarasamy, N.; Kitahata, M.; Lugina, E.; Lyamuya, R.; Vonthanak, S.; Fink, Valeria; d'Arminio Monforte, A.; Luz, P. M.; Chen, Y. M.; Minga, A.; Casabona, J.; Mwango, A.; Choi, J. Y.; Newell, M. L.; Bukusi, E. A.; Ngonyani, K.; Merati, T. P.; Otieno, J.; Bosco, M. B.; Phiri, S.; Ng, O. T.; Anastos, Kathryn; Rockstroh, J.; Santos, I.; Oka, S.; Somi, G.; Stephan, C.; Teira, R.; Wabwire, D.; Wandeler, G.; Boulle, A.; Reiss, Peter; Wood, R.; Chi, B. H.; Williams, C.; Sterne, J. A.; Egger, M.To describe the CD4 cell count at the start of combination antiretroviral therapy (cART) in low-income (LIC), lower middle-income (LMIC), upper middle-income (UMIC), and high-income (HIC) countries. Methods: Patients aged 16 years or older starting cART in a clinic participating in a multicohort collaboration spanning 6 continents (International epidemiological Databases to Evaluate AIDS and ART Cohort Collaboration) were eligible. Multilevel linear regression models were adjusted for age, gender, and calendar year; missing CD4 counts were imputed. Results: In total, 379,865 patients from 9 LIC, 4 LMIC, 4 UMIC, and 6 HIC were included. In LIC, the median CD4 cell count at cART initiation increased by 83% from 80 to 145 cells/mL between 2002 and 2009. Corresponding increases in LMIC, UMIC, and HIC were from 87 to 155 cells/mL (76% increase), 88 to 135 cells/mL (53%), and 209 to 274 cells/mL (31%). In 2009, compared with LIC, median counts were 13 cells/mL [95% confidence interval (CI): 256 to +30] lower in LMIC, 22 cells/mL (262 to +18) lower in UMIC, and 112 cells/mL (+75 to +149) higher in HIC. They were 23 cells/mL (95% CI: +18 to +28 cells/mL) higher in women than men. Median counts were 88 cells/mL (95% CI: +35 to +141 cells/mL) higher in countries with an estimated national cART coverage .80%, compared with countries with ,40% coverage. Conclusions: Median CD4 cell counts at the start of cART increased 2000–2009 but remained below 200 cells/mL in LIC and MIC and below 300 cells/mL in HIC. Earlier start of cART will require substantial efforts and resources globally.Item Improved diagnosis of Strongyloides stercoralis using recombinant antigen-based serologies in a community-wide study in northern Argentina(2010) Krolewiecki, Alejandro J.; Ramanathan, Roshan; Fink, Valeria; McAuliffe, Isabel; Cajal, Silvana P.; Won, Kimberly; Juarez, Marisa; Di Paolo, Adriana; Tapia, Laura; Acosta, Norma; Lee, Rogan; Lammie, Patrick; Abraham, David; Nutman, Thomas B.The serodiagnosis of Strongyloides stercoralis infection by enzyme-linked immunosorbent assays based on crude antigen (CrAg-ELISA), while useful, has been limited by the reliance on crude parasite extracts. Newer techniques such as the luciferase immunoprecipitation system assay (LIPS), based on a 31-kDa recombinant antigen (termed NIE) from S. stercoralis and/or the recombinant antigen S. stercoralis immunoreactive antigen (SsIR), or the NIE-ELISA have shown promise in controlled settings. We compared each of these serologic assays in individuals from both regions of the world in which S. stercoralis is endemic and those in which it is not. A comprehensive stool evaluation (sedimentation concentration, Baermann concentration with charcoal cultures, agar plate, and Harada-Mori) and four different serologic techniques using CrAg-ELISA or recombinant NIE-ELISA as well as LIPS using NIE alone or in combination with a second recombinant antigen (NIE/SsIR-LIPS) were compared among individuals with parasitologically proven infection (n = 251) and healthy controls from regions of the world in which the infection is nonendemic (n = 11). Accuracy was calculated for each assay. The prevalence of S. stercoralis infection was 29.4% among Argentinean stool samples (n = 228). Sedimentation concentration and Baermann were the most sensitive stool-based methods. NIE-LIPS showed the highest sensitivity (97.8%) and specificity (100%) of the serologic assays. The calculated negative predictive value was highest for both the NIE-LIPS and CrAg-ELISA (>97%) irrespective of disease prevalence. No cross-reactivity with soil-transmitted helminths was noted. NIE-LIPS compares favorably against the current CrAg-ELISA and stool evaluation, providing additional accuracy and ease of performance in the serodiagnosis of S. stercoralis infections irrespective of disease prevalence.Item Improving care for women living with HIV: initial outcomes of an integration experience(2012) Fink, Valeria; Zurita, Daniela; Tejo, Marta; Perez, Hector; Cesar, Carina; Figueroa, Maria Ines; Patterson, Patricia; Sued, Omar; Cahn, PedroBackground Women living with HIV are at higher risk of developing HPV-related diseases. Albeit they are systematically referred for cervical cancer screening, difficulties in obtaining timely appointments are the main barrier for an adequate gynecological care. In our unit, according to a previous survey, 67% of women reported this problem. Therefore, in January 2011 the integration of HIV and gynecological care was sought through the provision of gynecological care within the Infectious Diseases Unit in our hospital. Methods A weekly specific clinic for women living with HIV cared by HIV and gynecological specialists was implemented. Appointments are given at the HIV clinic, with no need of referral. Pap smear and colposcopy are offered in the same place. Data are collected through standardized forms. Baseline data from the first hundred patients referred are presented. Results Ninety-six women were assisted. Median age was 40 years (IQR 36–46.5). Median time from HIV diagnosis was 10.6 years (IQR 4.9–16.4). 82% patients were on HAART. Median CD4 cell count was 473 cells/cc (IQR: 287–614) and 49% had viral load<50. 48% lacked a gynecological control for the last 2 years. 24% had been previously diagnosed and/or treated for HPV-related pathology. Cervical Pap smear results (n=94): 59% were negative; 20% had LGSIL and 2% had HGSIL. Of those diagnosed with SIL, 29% had history of HPV-related lesions. Of note, 23% had infections or inflammatory results. Clinically significant abnormal colposcopies were seen in 21/93 (23%) patients. Of those, 30% were diagnosed SIL in the Pap smear. Conclusions Integrating the gynecologist with the ID Unit allowed women living with HIV easier access to gynecological control. The high number of abnormalities in the Pap smears detected in this pilot study reinforces the need of improving cervical cancer screening for prevention and early treatment through integrated approaches.Item Incidence of virological failure and major regimen change of initial combination antiretroviral therapy in Latin America and the Caribbean: an observational cohort study(2015-11) Cesar, Carina; Jenkins, Cathy A.; Shepherd, Bryan E.; Padgett, Denis; Mejía, Fernando; Rocha Ribeiro, Sayonara; Cortes, Claudia; Pape, Jean W; Sierra Madero, Juan; Fink, Valeria; Sued, Omar; McGowan, Catherine C.; Cahn, Pedro; Caribbean; Central and South America Network for HIV Epidemiology (CCASAnet) of the International Epidemiologic Databases to Evaluate AIDS (IeDEA) ProgramBackground: Access to combination antiretroviral therapy (ART) is expanding in Latin America (Mexico, Central America, and South America) and the Caribbean. We assessed the incidence of and factors associated with regimen failure and regimen change of initial ART in this region. Methods: This observational cohort study included antiretroviral-naive adults starting ART from 2000 to 2014 at sites in seven countries throughout Latin America and the Caribbean. Primary outcomes were time from ART initiation until virological failure, major regimen modification, and a composite endpoint of the first of virological failure or major regimen modification. Cumulative incidence of the primary outcomes was estimated with death considered a competing event. Findings: 14,027 patients starting ART were followed up for a median of 3.9 years (2.0-6.5): 8374 (60%) men, median age 37 years (IQR 30-44), median CD4 count 156 cells per μL (61-253), median plasma HIV RNA 5.0 log10 copies per mL (4.4-5.4), and 3567 (28%) had clinical AIDS. 1719 (12%) patients had virological failure and 1955 (14%) had a major regimen change. Excluding the site in Haiti, which did not regularly measure HIV RNA, cumulative incidence of virological failure was 7.8% (95% CI 7.2-8.5) 1 year after ART initiation, 19.2% (18.2-20.2) at 3 years, and 25.8% (24.6-27.0) at 5 years; cumulative incidence of major regimen change was 5.9% (5.3-6.4) at 1 year, 12.7% (11.9-13.5) at 3 years, and 18.2% (17.2-19.2) at 5 years. Incidence of major regimen change at the site in Haiti was 10.7% (95% CI 9.7-11.6) at 5 years. Virological failure was associated with younger age (adjusted hazard ratio [HR] 2.03, 95% CI 1.68-2.44, for 20 years vs 40 years), infection through injection drug use (vs infection through heterosexual sex; 1.60, 1.02-2.52), and initiation in earlier calendar years (1.28, 1.13-1.46, for 2002 vs 2006), but was not significantly associated with boosted protease inhibitor-based regimens (vs non-nucleoside reverse transcriptase inhibitor; 1.17, 1.00-1.36). Interpretation: Incidence of virological failure in Latin America and the Caribbean was generally lower than that reported in North America or Europe. Our results suggest the need to design strategies to reduce failure and major regimen change in young patients and those with a history of injection drug use.Item Latin American and the Caribbean Code Against Cancer 1st edition: Infections and cancer(Elsevier, 2023-10) Herrero, Rolando; Carvajal, Loretto J.; Camargo, M. Constanza; Riquelme, Arnoldo; Porras, Carolina; Ortiz, Ana Patricia; Camargo, Luis Aranha; Fink, Valeria; van De Wyngard, Vanessa; Lazcano-Ponce, Eduardo; Canelo-Aybari, Carlos; Balbin-Ramon, Graciela; Feliu, Ariadna; Espina, CarolinaAbout 13% of all cancers around the world are associated with infectious agents, particularly in low-resource settings. The main infectious agents associated with cancer are Helicobacter pylori (H. pylori), that causes gastric cancer, human papillomavirus (HPV) that causes cervical, vulvar, vaginal, penile, anal, and oropharyngeal cancer, hepatitis B and C viruses that cause liver cancer, and human immunodeficiency virus (HIV), associated with cancers of the cervix, Kaposi sarcoma (KS) and non-Hodgkin´s lymphoma. In Latin America and the Caribbean (LAC), about 150,000 cancer cases are caused annually by infections. The LAC Cancer Code Against Cancer consists of a set of 17 evidence-based and individual-level cancer prevention recommendations targeted to the general population, suited to the epidemiological, socioeconomic, and cultural conditions of the region, and tailored to the availability and accessibility of health-care systems. The recommendations with respect to infection-driven malignancies include testing and treating for H. pylori in the context of specific public health programs, vaccination against HPV and Hepatitis B Virus (HBV) and detection and treatment of chronic infections with HBV, Hepatitis C virus (HCV) and HIV, in addition to the promotion of safe sex and use of condoms to prevent sexually transmitted infections (STI). Countries, policy makers, health care systems and individuals should consider the adoption of these recommendations to help reduce the incidence and mortality of infection-related cancers in LAC, to improve quality of life of individuals and reduce the costs of cancer care in the region.Item Oral and anal microbiome from HIV-exposed individuals: role of host-associated factors in taxa composition and metabolic pathways(Springer Nature, 2023-07) Lacunza, Ezequiel; Fink, Valeria; Salas, María E.; Canzoneri, Romina; Naipauer, Julián; Williams, Sion; Coso, Omar; Sued, Omar; Cahn, Pedro; Mesri, Enrique A.; Abba, Martín C.Evidence indicates that the microbiome plays a significant role in HIV immunopathogenesis and associated complications. This study aimed to characterize the oral and anal microbiome of Men who have Sex with Men (MSM) and Transgender Women (TGW), with and without HIV. One hundred and thirty oral and anal DNA-derived samples were obtained from 78 participants and subjected to shotgun metagenomics sequencing for further microbiome analysis. Significant differences in the microbiome composition were found among subjects associated with HIV infection, gender, sex behavior, CD4+ T-cell counts, antiretroviral therapy (ART), and the presence of HPV-associated precancerous anal lesions. Results confirm the occurrence of oncogenic viromes in this high HIV-risk population. The oral microbiome in HIV-associated cases exhibited an enrichment of bacteria associated with periodontal disease pathogenesis. Conversely, anal bacteria showed a significant decrease in HIV-infected subjects (Coprococcus comes, Finegoldia magna, Blautia obeum, Catenibacterium mitsuokai). TGW showed enrichment in species related to sexual transmission, which concurs that most recruited TGW are or have been sex workers. Prevotella bivia and Fusobacterium gonidiaformans were positively associated with anal precancerous lesions among HIV-infected subjects. The enrichment of Holdemanella biformis and C. comes was associated with detectable viral load and ART-untreated patients. Metabolic pathways were distinctly affected by predominant factors linked to sexual behavior or HIV pathogenesis. Gene family analysis identified bacterial gene signatures as potential prognostic and predictive biomarkers for HIV/AIDS-associated malignancies. Conclusions: Identified microbial features at accessible sites are potential biomarkers for predicting precancerous anal lesions and therapeutic targets for HIV immunopathogenesis.Item Rates and Reasons for Early Change of First HAART in HIV-1-Infected Patients in 7 Sites throughout the Caribbean and Latin America(2010) Cesar, Carina; Shepherd, Bryan E.; Krolewiecki, Alejandro J.; Fink, Valeria; Schechter, Mauro; Tuboi, Suely H.; Wolff, Marcelo; Pape, Jean W.; Leger, Paul; Padgett, Denis; Sierra Madero, Juan; Gotuzzo, Eduardo; Sued, Omar; McGowan, Catherine C.; Masys, Daniel R.; Cahn, Pedro; Caribbean, Central and South America Network for HIV Research (CCASAnet) Collaboration; International Epidemiologic Databases to Evaluate AIDS (IeDEA) ProgramBackground: HAART rollout in Latin America and the Caribbean has increased from approximately 210,000 in 2003 to 390,000 patients in 2007, covering 62% (51%-70%) of eligible patients, with considerable variation among countries. No multi-cohort study has examined rates of and reasons for change of initial HAART in this region. Methodology: Antiretroviral-naïve patients >or= 18 years who started HAART between 1996 and 2007 and had at least one follow-up visit from sites in Argentina, Brazil, Chile, Haiti, Honduras, Mexico and Peru were included. Time from HAART initiation to change (stopping or switching any antiretrovirals) was estimated using Kaplan-Meier techniques. Cox proportional hazards modeled the associations between change and demographics, initial regimen, baseline CD4 count, and clinical stage. Principal findings: Of 5026 HIV-infected patients, 35% were female, median age at HAART initiation was 37 years (interquartile range [IQR], 31-44), and median CD4 count was 105 cells/uL (IQR, 38-200). Estimated probabilities of changing within 3 months and one year of HAART initiation were 16% (95% confidence interval (CI) 15-17%) and 28% (95% CI 27-29%), respectively. Efavirenz-based regimens and no clinical AIDS at HAART initiation were associated with lower risk of change (hazard ratio (HR) = 1.7 (95% CI 1.1-2.6) and 2.1 (95% CI 1.7-2.5) comparing neverapine-based regimens and other regimens to efavirenz, respectively; HR = 1.3 (95% CI 1.1-1.5) for clinical AIDS at HAART initiation). The primary reason for change among HAART initiators were adverse events (14%), death (5.7%) and failure (1.3%) with specific toxicities varying among sites. After change, most patients remained in first line regimens. Conclusions: Adverse events were the leading cause for changing initial HAART. Predictors for change due to any reason were AIDS at baseline and the use of a non-efavirenz containing regimen. Differences between participant sites were observed and require further investigation.Item Redesigning an Electronic Health Record in Argentina to Improve Comprehensive Health Care and Clinical Research(2022-06) Giraldo, Liliana; Fink, Valeria; Cahn, Florencia; Caceres, Betiana; Sued, Omar; Duda, Stephany; Cesar, CarinaUpdating electronic health record systems to meet new clinic needs and government regulations presents an ongoing challenge for health care organizations. To redesign an existing system for two HIV clinics in Argentina, we employed a three-phase approach of exploration, participatory design, and prototyping. The process and resulting architecture of the HIV-centered "RedClin" electronic health record may inform electronic health records at other clinics in Latin America and worldwide.