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Additional file 1. Effectiveness/efficacy of COVID-19 vaccines, COVID-19 vaccines applied in each country, Literature search on epidemiological parameters, Transmission dynamic parameters, General population baseline utility values per-country, Disutility value per disease state, Economic evaluation disaggregated results by country, Deterministic sensitivity analysis, Model calibration, Interactive online CEA model, Advisory board, References.

Background Numerous vaccines have been evaluated and approved for coronavirus disease 2019 (COVID-19). Since pregnant persons have been excluded from most clinical trials of COVID-19 vaccines, sufficient data regarding safety of these vaccines for the pregnant persons and their fetus have rarely been available at the time of product licensure. However, as COVID-19 vaccines have been deployed, data on the safety, efficacy or effectiveness, reactogenicity, and immunogenicity of COVID-19 vaccines for pregnant persons and neonates are becoming increasingly available. A living systematic review (LSR) of the safety and effectiveness of COVID-19 vaccines for pregnant persons and newborns could provide information necessary to help guide vaccine policy decisions. Methods We aim to conduct a LSR based on biweekly searches of medical databases (e.g., MEDLINE, EMBASE, CENTRAL) and clinical trial registries to systematically identify relevant studies of COVID-19 vaccines for pregnant persons. Pairs of reviewers will independently select, extract data, and conduct risk of bias assessments. We will include randomized clinical trials, quasi-experimental studies, cohort, case-control, cross-sectional studies, and case reports. Primary outcomes will be the safety (i.e., impacts on obstetric and neonatal outcomes), efficacy or effectiveness of COVID-19 vaccines in pregnant persons. Secondary outcomes will be immunogenicity and reactogenicity. We will conduct paired meta-analyses, including pre-specified subgroup and sensitivity analyses, and will use the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to evaluate the certainty of evidence. Conclusion This will be the first living systematic review (LSR) and meta-analysis assessing the safety, reactogenicity, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons. An online interactive dashboard for data visualization using Microsoft Power BI will be developed to regularly update and disseminate the latest findings (an in-progress version is available at https://safeinpregnancy.org/lsr/). In addition, the findings will be disseminated through publications and presentations.

espanolObjetivo. Existen combinaciones genericas de dosis fija (FDC) de darunavir/ritonavir (DRV/r) en Argentina. Las experiencias con estas FDCs en terapia dual siguen siendo limitadas. Nuestro objetivo fue describir los resultados clinicos y virologicos en pacientes expuestos a FDC DRV/r + raltegravir (RAL) 400 mg cada12 h en la practica clinica. Pacientes y metodos: Analisis retrospectivo de historias clinicas electronicas de pacientes infectados por VIH con FDC DRV/r + RAL en Argentina (2014-2018). Los individuos fueron clasificados como: “grupo de cambio” (GC, carga viral [CV] indetectable con toxicidad/comorbilidad) y “grupo virologico” (GV, viremia detectable e infeccion por VIH multirresistente). Resultados. De 7.380 pacientes en tratamiento antirretroviral (TAR), 116 (1.5%) recibieron FDC DRV/r + RAL, siendo 58% GC. El 60% recibio DRV/r 800/100 mg (resto, 600/100 mg). La mediana (IQR) de edad y de linfocitos T-CD4+ fueron: 52 (42-58) anos y 373 celulas/µL (202-642). El 98% tenia experiencia en TAR con una mediana de 3 (IQR 2-5) tratamientos previos. Las razones para el cambio (GC) fueron las comorbilidades renales (57%), cardiovasculares (54%) y oseas (14%). La mediana de exposicion fue 18 meses. En GC, 98% y 96% tuvieron CV indetectable a 6 y 12 meses; en GV, 89% y 87% a 6 y 12 meses. Ningun paciente requirio suspension debido a toxicidad o intolerancia. Conclusion. En esta cohorte de pacientes experimentados en TAR, la FDC DRV/r + RAL fue eficaz y segura. Dicha terapia puede considerarse una opcion para pacientes con comorbilidades y/o VIH multirresistente. EnglishObjective. There are generic fixed-dose combinations (FDCs) of ritonavir-boosted darunavir (DRV/r) available in Argentina. Experiences with these FDCs in dual therapy remain limited in clinical practice. We aimed to describe clinical and virologic outcomes in patients exposed to FDC DRV/r + raltegravir (RAL) 400 mg every 12 h in a real-life setting. Patients and methods. Retrospective analysis of electronic medical records of HIV-infected patients under FDC DRV/r + RAL in an HIV clinic in Argentina (2014-2018). Individuals were classified as “switch group” (SG, undetectable viral load [VL] with any toxicity/comorbidity) and “virologic group· (VG, detectable viremia and infection by multidrug-resistant HIV). Results. Of 7,380 patients on ART, 116 (1.5%) received FDC DRV/r + RAL, being 58% in SG. Sixty percent received DRV/r 800/100 mg dose (rest, 600/100 mg). The median (IQR) age and CD4+ T-cell count were: 52 (42-58) years, and 373 cell/µL (202-642). Ninety-eight percent were ART-experienced with a median of 3 (IQR 2-5) prior treatments. Main reasons for switch (SG) were renal (57%), cardiovascular (54%) and bone (14%) comorbidities. Median exposure to DRV/r + RAL was 18 months. Among patients in SG, 98% and 96% had undetectable VL at 6 and 12 months; in the VG, 89% and 87% had undetectable VL at 6 and 12 months. No patient required suspension due to toxicity/ intolerance. Conclusion. In this cohort of mostly experienced HIV-infected patients, FDC DRV/r + RAL was effective and safe. Such therapy may be considered an option for patients with comorbid conditions and/or with multidrug-resistant HIV.

Background: The spread of severe acute respiratory syndrome coronavirus 2, causative agent of the coronavirus disease 2019 (COVID-19), has necessitated widespread lockdown to mitigate the pandemic This study examines the influence of resilience on the impact of COVID-related stress and enforced lockdown on mental health, drug use, and treatment adherence among people living with HIV (PLWH) in Argentina Setting: PLWH residing predominantly in Buenos Aires Metropolitan Area and urban regions of Argentina were identified from a private clinic electronic database Methods: Participants completed an anonymous online survey to evaluate the impact of COVID-19 on economic disruption, resilience, mental health outcomes (depression, anxiety, stress, and loneliness), adherence to HIV treatment, and substance use We performed ordinary least squares and logistic regressions to test whether resilient coping buffered the impact of economic disruption on mental health and drug use during quarantine Results: A total of 1336 PLWH aged 18-82 were enrolled The impact of economic disruption on mental health DF(1,1321) = 8 86, P = 0 003 and loneliness DF(1,1326) = 5 77, P = 0 016 was buffered by resilience A 3-way interaction between resilient buffering, stress, and sex was significant DF(1,1325) = 4 76, P = 0 029 Participants reported less than excellent adherence to medication (33%), disruption to mental health services (11%), and disruption to substance abuse treatment (1 3%) during lockdown Discussion: The impact of COVID-stress and lockdown on emotional distress seemed mitigated by resilience coping strategies, and the buffering impact of resilience on perceived stress was greater among women Results highlight PLWH's capacity to adhere to treatment in challenging circumstances and the importance of developing resilience skills for better coping with stress and adversity [ABSTRACT FROM AUTHOR] Copyright of JAIDS: Journal of Acquired Immune Deficiency Syndromes is the property of Lippincott Williams & Wilkins and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission However, users may print, download, or email articles for individual use This abstract may be abridged No warranty is given about the accuracy of the copy Users should refer to the original published version of the material for the full abstract (Copyright applies to all Abstracts )

Objetivos: Evaluar la influencia de la cuarentena por COVID-19 en variables epidemiológicas clave con respecto a la prevención de la transmisión materno infantil (TMI) del VIH en Ciudad de Buenos Aires (CABA). Métodos: Análisis retrospectivo de los datos agregados de TMI de las principales maternidades de CABA. El año pandémico (2020) se comparó con los años no pandémicos 2018-2019. Resultados: Se observó una reducción del total de nacimientos en 2020 en comparación con 2019 y 2018 (11640 vs. 14031 y 15978, respectivamente). La proporción de nacidos vivos en madres VIH+ (MEV) fue 0,88% en 2020 sin diferencia con 2019 y 2018 (0,94% y 0,93%), p> 0,05 para todas las comparaciones. Entre las MEV, el diagnóstico intraparto fue del 2,9% para 2020, sin diferencias con 2019 (2,25%) y 2018 (9,3%), p> 0,05 (todas las comparaciones); el 8,8% comenzó el tratamiento antirretroviral con >28 semanas de edad gestacional en 2020 frente al 16% y el 18,05% en 2018 y 2019 (p> 0,05, todas las comparaciones). La prevalencia de la carga viral indetectable en el momento del parto fue del 67% en 2020 frente al 64% en 2018 y del 65,4% en 2019 (p> 0,05, todas las comparaciones). La transmisión perinatal fue 0% en 2020 vs 1.33% en 2018 y 2.25% 2019 (p> 0.05, todas las comparaciones) Conclusiones: En la primera ola de la pandemia de COVID 19 no se observó ningún impacto perjudicial en la proporción de MEV asistidas, diagnóstico intraparto de VIH, inicio tardío del TARV y TMI en CABA.

The spread of SARS-CoV-2 required widespread lockdown to mitigate the pandemic. Argentine authorities imposed preventive social isolation for 234 days (March 20th to November 9th 2020). This measure led to major changes in the population's lifestyle.To examine the influence of COVID-19 lockdown measures on the metabolic profile of HIV-infected patients in Argentina.Retrospective cohort study of 10,239 HIV-infected patients under follow up in a private clinic for HIV care. Adult patients with ongoing antiretroviral therapy (ART) and a baseline determination of blood glucose, total cholesterol, HDL-cholesterol and triglycerides done before lockdown (BL: second semester of 2019) and a second determination during lockdown (DL: May 2020) were included. Patients with recent changes in ART that may have metabolic impact, those starting lipid/glucose lowering agents and pregnant women were excluded. Categorical variables were compared using the χ2 test or Fisher's exact test, and continuous variables using the t-test or the Mann-Whitney test. A two-tailed value of p0.05 was considered significant.540 individuals were included, median of age was 47 years and 74.6% were male. Median body mass index was 26.1 and 94.6% had low cardiovascular risk. There was a significant increase in the percentage of patients that met criteria for hyperglycemia (BL 4.8% and DL 8.5%, p0.001). We also observed significant (p0.001) increase in median (IQR) BL vs DL values in LDL-cholesterol [109 (90-128) vs 118 (97-139) mg/dL]; and triglycerides [120 (87-172) vs. 132 mg/dL (96-184)]. The proportion of patients with hyper-LDL cholesterolemia according to individual cardiovascular risk increased from 12.6 to 17.2% (p = 0.04).Our results suggest that quarantine, at least in its initial phases, may have a negative impact on the metabolic profile of this population.

Background Rapid assessment of COVID-19 vaccine safety during pregnancy is urgently needed. Methods We conducted a rapid systematic review, to evaluate the safety of COVID-19 vaccines selected by the COVID-19 Vaccines Global Access-Maternal Immunization Working Group in August 2020, including their components and their technological platforms used in other vaccines for pregnant persons. We searched literature databases, COVID-19 vaccine pregnancy registries, and explored reference lists from the inception date to February 2021 without language restriction. Pairs of reviewers independently selected studies through COVIDENCE, and performed the data extraction and the risk of bias assessment. Discrepancies were resolved by consensus. Registered on PROSPERO (CRD42021234185). Results We retrieved 6757 records and 12 COVID-19 pregnancy registries from the search strategy; 38 clinical and non-clinical studies (involving 2,398,855 pregnant persons and 56 pregnant animals) were included. Most studies (89%) were conducted in high-income countries and were cohort studies (57%). Most studies (76%) compared vaccine exposures with no exposure during the three trimesters of pregnancy. The most frequent exposure was to AS03 adjuvant, in the context of A/H1N1 pandemic influenza vaccines, (n = 24) and aluminum-based adjuvants (n = 11). Only one study reported exposure to messenger RNA in lipid nanoparticles COVID-19 vaccines. Except for one preliminary report about A/H1N1 influenza vaccination (adjuvant AS03), corrected by the authors in a more thorough analysis, all studies concluded that there were no safety concerns. Conclusion This rapid review found no evidence of pregnancy-associated safety concerns of COVID-19 vaccines or of their components or platforms when used in other vaccines. However, the need for further data on several vaccine platforms and components is warranted, given their novelty. Our findings support current WHO guidelines recommending that pregnant persons may consider receiving COVID-19 vaccines, particularly if they are at high risk of exposure or have comorbidities that enhance the risk of severe disease.

BackgroundPregnant women with COVID-19 are at an increased risk of severe COVID-19 illness as well as adverse pregnancy and birth outcomes. Many countries are vaccinating or considering vaccinating pregnant women with limited available data about the safety of this strategy. Early identification of safety concerns of COVID-19 vaccines, including their components, or their technological platforms is therefore urgently needed.MethodsWe conducted a rapid systematic review, as the first phase of an ongoing full systematic review, to evaluate the safety of COVID-19 vaccines in pregnant women, including their components, and their technological platforms (whole virus, protein, viral vector or nucleic acid) used in other vaccines, following the Cochrane methods and the PRISMA statement for reporting (PROSPERO-CRD42021234185).We searched literature databases, COVID-19 and pregnancy registries from inception February 2021 without time or language restriction and explored the reference lists of relevant systematic reviews retrieved. We selected studies of any methodological design that included at least 50 pregnant women or pregnant animals exposed to the vaccines that were selected for review by the COVAX MIWG in August 2020 or their components or platforms included in the COVID-19 vaccines, and evaluated adverse events during pregnancy and the neonatal period.Pairs of reviewers independently selected studies through the COVIDENCE web software and performed the data extraction through a previously piloted online extraction form. Discrepancies were resolved by consensus.ResultsWe identified 6768 records, 256 potentially eligible studies were assessed by full-text, and 37 clinical and non-clinical studies (38 reports, involving 2,397,715 pregnant women and 56 pregnant animals) and 12 pregnancy registries were included.Most studies (89%) were conducted in high-income countries. The most frequent study design was cohort studies (n=21), followed by surveillance studies, randomized controlled trials, and registry analyses. Most studies (76%) allowed comparisons between vaccinated and unvaccinated pregnant women (n=25) or animals (n=3) and reported exposures during the three trimesters of pregnancy.The most frequent exposure was to AS03 adjuvant in the context of A/H1N1 pandemic influenza vaccines (n=24), followed by aluminum-based adjuvants (n=11). Aluminum phosphate was used in Respiratory Syncytial Virus Fusion candidate vaccines (n=3) and Tdap vaccines (n=3). Different aluminum-based adjuvants were used in hepatitis vaccines. The replication-deficient simian adenovirus ChAdOx1 was used for a Rift Valley fever vaccine. Only one study reported exposure to messenger RNA (mRNA) COVID-19 vaccines that also used lipid nanoparticles. Except for one preliminary report about A/H1N1 influenza vaccination (adjuvant AS03) - corrected by the authors in a more thorough analysis, all studies concluded that there were no safety concerns.ConclusionThis rapid review found no evidence of pregnancy-associated safety concerns of COVID-19 vaccines that were selected for review by the COVAX MIWG or of their components or platforms when used in other vaccines. However, the need for further data on several vaccine platforms and components is warranted given their novelty. Our findings support current WHO guidelines recommending that pregnant women may consider receiving COVID-19 vaccines, particularly if they are at high risk of exposure or have comorbidities that enhance the risk of severe disease.

Introducción: Las personas que viven con VIH (PVV) tienen mayor riesgo de complicaciones de salud mental. Para mitigar la propagación del COVID-19 en nuestro país se estableció una cuarentena temprana. Estudiamos el impacto del estrés relacionado con COVID-19 y la cuarentena en hombres que tienen sexo con hombres que viven con VIH (HSHV) en Argentina. Materiales y métodos: Realizamos una encuesta anónima en abril-mayo de 2020. Se incluyeron PVV en seguimiento en una institución privada en Argentina. Se evaluaron la adherencia a medidas preventivas de COVID-19 y al tratamiento antirretroviral, el acceso a recursos, factores psicosociales y el consumo de sustancias durante la cuarentena. Este análisis se centró en los resultados de HSHV. Resultados: Entre 1336 participantes incluidos, 596 se autoreportaron HSHV (mediana de edad de 44 años, RIC 35-52). La adherencia a la cuarentena fue del 96,8%; la pérdida de empleo en el hogar 55,4%. Se observó interrupción en la obtención de medicamentos antirretrovirales en el 4,9% y el 29,9% reportó adherencia subóptima. Los problemas de salud mental fueron frecuentes: depresión (14,1%), soledad (15,6%) y ansiedad (20,2%). Conclusiones: Nuestro estudio evidenció alta adherencia a las medidas preventivas al inicio de la cuarentena y dificultades en el acceso a los servicios de salud. La pandemia de COVID-19 ha comprometido la economía del país; este estudio muestra su impacto en el acceso de los HSHV a recursos básicos. Dado que la salud mental de los HSHV ha sido afectada, la pandemia resalta la necesidad de una visión integral de la salud de nuestros pacientes.

The COVID-19 pandemic poses a risk to mental health and may disproportionately affect people living with HIV (PLWH). This study examined the interaction of social support and resilient coping in predicting depressive symptoms among PLWH. PLWH residing in Buenos Aires, Argentina and in Miami, Florida (US) were asked to complete an anonymous survey on the impact of COVID-19. Statistical analysis included ordinary least squares regression. A total of 1,554 participants were included. Mean age was 47.30 years; 63.70% were men. A test of three-way interaction of social support × resilient coping × study site indicated differences by site (b = -0.63, p = 0.04, 95%CI [-1.24, -0.02]). In Argentina, higher levels of social support and resilient coping were associated with lower depressive symptoms. Lower levels of social support and resilient coping were associated with higher depressive symptoms. The impact of COVID-19 on mental health illustrates the need for developing innovative strategies to support resilience and to enhance coping with stress and adversity among PLWH.La pandemia de COVID-19 presenta riesgos importantes para la salud mental y puede afectar desproporcionadamente a personas con VIH. Este estudio examinó el efecto entre el apoyo social y la resiliencia para afrontar situaciones difíciles en predecir síntomas depresivos en personas con VIH. Personas con VIH residentes de Buenos Aires (Argentina) y Miami, Florida (EE.UU) completaron una encuesta anónima sobre el impacto del COVID-19. El análisis estadístico incluyó un modelo clásico de regresión lineal con mínimos cuadrados ordinarios. Se incluyeron 1554 participantes. La edad promedio fue 47.30 años y 63.7% eran hombres. La prueba de interacción de apoyo social × resiliencia para hacer frente a situaciones difíciles × país indicó diferencias entre países (b = −0.63, p = 0.043, IC 95% [1.24, −0.02]). En Argentina, los participantes con mayor apoyo social y resiliencia para hacer frente a situaciones difíciles mostraron síntomas depresivos más bajos; y aquellos con menor apoyo social y resiliencia para hacer frente a situaciones difíciles, mostraron síntomas depresivos más altos. Este efecto no se observó en los participantes de Miami. El impacto de COVID-19 en la salud mental en personas con VIH ilustra la necesidad de desarrollar estrategias innovadoras para apoyar la resiliencia y mejorar el enfrentamiento del estrés y la adversidad.

The spread of severe acute respiratory syndrome coronavirus 2, causative agent of the coronavirus disease 2019 (COVID-19), has necessitated widespread lockdown to mitigate the pandemic. This study examines the influence of resilience on the impact of COVID-related stress and enforced lockdown on mental health, drug use, and treatment adherence among people living with HIV (PLWH) in Argentina.PLWH residing predominantly in Buenos Aires Metropolitan Area and urban regions of Argentina were identified from a private clinic electronic database.Participants completed an anonymous online survey to evaluate the impact of COVID-19 on economic disruption, resilience, mental health outcomes (depression, anxiety, stress, and loneliness), adherence to HIV treatment, and substance use. We performed ordinary least squares and logistic regressions to test whether resilient coping buffered the impact of economic disruption on mental health and drug use during quarantine.A total of 1336 PLWH aged 18-82 were enrolled. The impact of economic disruption on mental health ΔF(1,1321) = 8.86, P = 0.003 and loneliness ΔF(1,1326) = 5.77, P = 0.016 was buffered by resilience. A 3-way interaction between resilient buffering, stress, and sex was significant ΔF(1,1325) = 4.76, P = 0.029. Participants reported less than excellent adherence to medication (33%), disruption to mental health services (11%), and disruption to substance abuse treatment (1.3%) during lockdown.The impact of COVID-stress and lockdown on emotional distress seemed mitigated by resilience coping strategies, and the buffering impact of resilience on perceived stress was greater among women. Results highlight PLWH's capacity to adhere to treatment in challenging circumstances and the importance of developing resilience skills for better coping with stress and adversity.