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Background BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine that has been deployed in India. The results of the phase 3 trial have shown clinical efficacy of BBV152. We aimed to evaluate the effectiveness of BBV152 against symptomatic RT-PCR-confirmed SARS-CoV-2 infection. Methods We conducted a test-negative, case-control study among employees of the All India Institute of Medical Sciences (a tertiary care hospital in New Delhi, India), who had symptoms suggestive of COVID-19 and had an RT-PCR test for SARS-CoV-2 during the peak of the second wave of the COVID-19 pandemic in India between April 15 and May 15, 2021. Cases (test-positives) and controls (test-negatives) were matched (1:1) on the basis of age and gender. The odds of vaccination with BBV152 were compared between cases and controls and adjusted for level of occupational exposure (to COVID-19), previous SARS-CoV-2 infection, and calendar time, using conditional logistic regression. The primary outcome was effectiveness of two doses of BBV152 (with the second dose received at least 14 days before testing) in reducing the odds of symptomatic RT-PCR-confirmed SARS-CoV-2 infection, expressed as (1 – odds ratio) × 100%. Findings Between April 15 and May 15, 2021, 3732 individuals had an RT-PCR test. Of these, 2714 symptomatic employees had data on vaccination status, and 1068 matched case-control pairs were available for analysis. The adjusted effectiveness of BBV152 against symptomatic COVID-19 after two doses administered at least 14 days before testing was 50% (95% CI 33–62; p

Post COVID-19 sequelae are a constellation of symptoms often reported after recovering from COVID-19. There is a need to better understand the clinical spectrum and long-term course of this clinical entity. The aim of this study is to describe the clinical features and risk factors of post COVID-19 sequelae in the North Indian population. This prospective observational study was conducted at a tertiary healthcare centre in Northern India between October 2020 and February 2021. Patients aged >18 years with laboratory-confirmed COVID-19 were recruited after at least two weeks of diagnosis, and details were captured. A total of 1234 patients were recruited and followed up for a median duration of 91 days (IQR: 45-181 days). Among them, 495 (40.1%) had persistent symptoms post-discharge or recovery. In 223 (18.1%) patients, the symptoms resolved within four weeks; 150 (12.1%) patients had symptoms till 12 weeks, and 122 (9.9%) patients had symptoms beyond 12 weeks of diagnosis/symptom-onset of COVID-19. Most common symptoms included myalgia (10.9%), fatigue (5.5%), shortness of breath (6.1%), cough (2.1%), insomnia (1.4%), mood disturbances (0.48%) and anxiety (0.6%). Patients who were hospitalized were more likely to report fatigue as a feature of long COVID. Hypothyroidism (OR: 4.13, 95% CI: 2.2-7.6, p-value < 0.001) and hypoxia (SpO2 ≤ 93%) (OR: 1.7, 95% CI: 1.1-2.4, p-value 0.012) were identified as risk factors for long COVID sequelae. In conclusion, long COVID symptoms were common (22%), and 9.9% had the post COVID-19 syndrome. Myalgias, fatigue and dyspnoea were common symptoms. Patients with hypothyroidism and hypoxia during acute illness were at higher risk of long COVID.

Background: An efficient sampling is one of the key methods to identify all those affected by coronavirus disease 2019 (COVID-19). Objectives: To analyze how efficient setting up of a central sampling team would be to prevent any outbreak within the institution by minimizing the movement of suspected COVID-19 patients admitted in the inpatient wards. The secondary objective was to train maximum resident doctors to collect samples of admitted patients. Methodology: A central sampling team comprising of resident doctors from various departments was made who did sampling of the suspected COVID-19 inpatients admitted under various specialties. Results: There were a total of 341 patients [209 males (61.29%), 132 females (38.7%)] and 335 patients underwent sampling. There was a positive correlation between: (1) number of calls from a department vs percentage of positive samples in that department [Pearson correlation coefficient (R) = 0.47; P = 0.026], (2) number of samples taken by resident of a particular department from central sampling team vs number of positive samples taken by resident of that department [R = 0.8739, P = 0.01] and (3) number of visits to a department vs number of residents trained in that department [R = 0.93; P = 0.00001]. Conclusion: Formulation of a central sampling team led to changes like a separate donning and doffing area in each ward and training of many resident doctors posted in different wards. This made each ward self-sufficient in collection of samples. This venture also ensured minimal movement of suspected COVID-19 patients in the hospital and thus least exposure to the hospital staff.

A variable proportion of patients develop persistent/prolonged symptoms of Coronavirus Disease 2019 (COVID-19) infection (long COVID). We aimed to study the clinical predictors of persistent symptoms in patients with mild COVID-19 at 30 days post discharge (long COVID-19). We also tried to identify symptom clusters among mild COVID-19 patients. Fifty-seven patients admitted at a tertiary care centre after a positive RT-PCR report over a period of 2 months, were enrolled in the study. Details of presentation, history of illness, laboratory investigations and disease outcomes were recorded from documented medical records and discharge slip. The patients were contacted (telephonically) at 30 days after discharge and enquired regarding persistent symptoms, if any. Follow up data at 30 days post-discharge was available for 53 patients. Among them, the most common persistent symptom was fatigue (22.6%), followed by cough (9.4%) and myalgias (7.5%). There was a significant association of persistent symptoms with diarrhoea at presentation [OR 14.26 (95% CI 2.30-142.47; p = 0.009] and gap between symptom onset and admission [OR 1.40 (95% CI 1.08-1.93; p = 0.020] on multivariate logistic regression analysis. On cluster analysis, three phenotypes of mild COVID-19 were identified, which may have implications on monitoring and management. There appears to be a positive association of diarrhoea as a presenting manifestation and gap between symptom onset and admission with the persistence of symptoms classified as long COVID-19, even in mild illness. We also identified multiple phenotypes of mild COVID-19 illness, which warrant further exploration.

BACKGROUND Carcinoma cervix is one of the leading causes of death among women worldwide. The World Health Organization has put forth the 90-70-90 global strategy for the elimination of cervical cancer as a public health problem. It calls for 70% women to be screened at least once in their lifetime. However, this rate is as low as 1.9% for India and even lower for many other countries, making the target insurmountable, especially in resource-constrained settings. The COVID-19 pandemic made this even more challenging. OBJECTIVE This study aimed to identify bottlenecks and high leverage points and propose a technology-driven, national-level program for improving the screening of carcinoma cervix. METHODS Detailed process mapping was done to identify potential bottlenecks. A counterfactual approach was used to identify high leverage points for impact using “What if” scenarios. These findings were used to build program theory–based logic models to propose a national-level program for carcinoma cervix prevention. RESULTS Availability, accessibility, affordability, skewed distribution of infrastructure, cost implications, and limited specialist workforce were identified as bottlenecks. The COVID-19 pandemic put a strain on existing resources and worsened the situation. The existing network of primary health care workers, changes in health-seeking behavior due to COVID-19 with the increasing role of tele-health, conducive political milieu with initiatives such as Digital India Mission, and a booming start-up ecosystem were identified as high leverage points through the counterfactual approach. Using these findings, a national program was designed with program theory–based logic modeling. CONCLUSIONS The journey from

Background: Lung Cancer is the leading cause of cancer deaths in the US, making up almost a quarter of all cancer deaths. Disparities exist upon closer examination: African American (AA) males were found to have a higher incidence of developing lung cancer compared to their Caucasian counterparts. Some plausible reasons for higher incidence rates in AA patients may be due to differences in smoking habits, socioeconomic variables, and metabolism of tobacco carcinogens. Along with these factors, societal differences and lack of resources are postulated to play a significant role. These differences were also observed in clinical trials with an underrepresentation of minorities. A niche deficit exists in outcomes of racial minorities with metastatic lung and bronchial cancer.Methods: Data for this study was obtained from the 2016-18 Nationwide Inpatient Sample (NIS). This is maintained as part of the Health Care Utilization Project (HCUP) of the Agency for Healthcare Research and Quality (AHRQ). It is the largest all-payer inpatient care database in the US and comprises a 20% stratified random sample of all US hospital discharges. Further details: https://www.hcup-us.ahrq.gov/Results: We identified 238,516 patients with Metastatic Lung and bronchial cancer, of which 77.45% were Caucasians, 12.48% AAs, 4.74% Hispanics, and 2.81 % Asians and Pacific Islanders (API). Almost 40% of the study population is from the Southern region, followed by 24.25% in Midwest, 20.56% in the Northeast, and 14.81% in the West. Other race populations had the most reported deaths (10.42%), followed by APIs (10.30%), Native Americans (8.67%), Hispanics (8.75%), AAs (8.66%), and Caucasians (8.34%) (p

Introduction: Infections with drug-resistant organisms (DRO) have been associated with poor patient outcomes. To tackle this global problem, it is necessary to understand the risk factors that predispose to infections with DRO. Methodology: This was a prospective observational study conducted over a three-year period at a tertiary-care hospital. Bacterial culture isolates from patients admitted in medicine wards with community or hospital-acquired infections were included. Logistic regression analysis was used to determine risk factors for drug-resistant infections. Results: Of the 295 patients with 323 isolates included, 40 (12.3%) had non-MDR (N-MDR) infections, 86 (26.6 %) had MDR infections and 197 (61%) had possible extensively drug-resistant (P-XDR) infections. History of previous admission in the preceding three months (Odds Ratio, OR = 4.53, 95% Confidence interval, CI = 1.8 – 11.42, p = -0.01), high SOFA score at admission (OR = 1.14, 95% CI = 1.0 – 1.290, p = -0.039) and prolonged duration of ventilation (OR = 1.25, 95% CI = 1.05 – 1.41, p = -0.012) were independently associated P-XDR infections when compared to patients with N-MDR. Conclusions: High rate of multidrug-resistant infections in the studied area is alarming. In this single-centre study, we elicited various risk factors for drug-resistant bacterial infections ranging from patient characteristics to iatrogenic risk factors during the hospital stay. Infections with P-XDR and MDR isolates independently increased hospital and ICU stay duration and were associated with increased mortality.

Background Carcinoma cervix is one of the leading causes of death among women worldwide. The World Health Organization has put forth the 90-70-90 global strategy for the elimination of cervical cancer as a public health problem. It calls for 70% women to be screened at least once in their lifetime. However, this rate is as low as 1.9% for India and even lower for many other countries, making the target insurmountable, especially in resource-constrained settings. The COVID-19 pandemic made this even more challenging. Objective This study aimed to identify bottlenecks and high leverage points and propose a technology-driven, national-level program for improving the screening of carcinoma cervix. Methods Detailed process mapping was done to identify potential bottlenecks. A counterfactual approach was used to identify high leverage points for impact using “What if” scenarios. These findings were used to build program theory–based logic models to propose a national-level program for carcinoma cervix prevention. Results Availability, accessibility, affordability, skewed distribution of infrastructure, cost implications, and limited specialist workforce were identified as bottlenecks. The COVID-19 pandemic put a strain on existing resources and worsened the situation. The existing network of primary health care workers, changes in health-seeking behavior due to COVID-19 with the increasing role of tele-health, conducive political milieu with initiatives such as Digital India Mission, and a booming start-up ecosystem were identified as high leverage points through the counterfactual approach. Using these findings, a national program was designed with program theory–based logic modeling. Conclusions The journey from Conflicts of Interest None declared.

Background & objectives: In the present scenario, the most common sample for diagnosis of COVID-19 by reverse transcription polymerase chain reaction (RT-PCR) is nasal and throat swab (NTS). Other sampling options such as gargle lavage have found limited application in clinical use mostly because of unavailability of an appropriate gargling liquid. This study was conducted to assess the stability of SARS-CoV-2 RNA in normal saline at 4°C that can serve as a gargling liquid as well as a transport medium. The study also looked at the agreement between NTS and gargle lavage/saliva for the detection of SARS-CoV-2. Methods: In 29 consecutive real-time RT-PCR (rRT-PCR) positive COVID-19 patients, paired NTS, gargle and saliva samples were taken. Samples were processed by rRT-PCR for the detection of SARS-CoV-2 RNA. To assess the SARS-CoV-2 RNA stability in normal saline, gargle lavage specimens were divided into two aliquots; one subset of the specimen was run within 4-6 h along with the routine samples (NTS and saliva) and the other subset was stored at 4°C and processed after 24-30 h. Agreement between cycle threshold (Ct) values from both the runs was compared using Bland–Altman (BA) analysis. Results: The positivity rates of rRT-PCR in NTS, saliva and gargle lavage samples were 82.7 (24/29), 79.3 (23/29) and 86.2 per cent (25/29), respectively. BA plot showed a good agreement between the Ct values of fresh and stored gargle samples, stipulating that there were no significant differences in the approximate viral load levels between the fresh and stored gargle lavage samples (bias: E gene −0.64, N gene −0.51, ORF gene −0.19). Interpretation & conclusions: Our study results show stability of SARS-CoV-2 RNA in the gargle samples collected using normal saline up to 24-30 h. Gargle lavage and saliva specimen collection are cost-effective and acceptable methods of sampling for the detection of SARS-CoV-2 RNA by rRT-PCR. These simplified, inexpensive and acceptable methods of specimen collection would reduce the cost and workload on healthcare workers for sample collection.

Background & objectives: Coronavirus disease 2019 (COVID-19) has so far affected over 41 million people globally. The limited supply of real-time reverse transcription-polymerase chain reaction (rRT-PCR) kits and reagents has made meeting the rising demand for increased testing incompetent, worldwide. A highly sensitive and specific antigen-based rapid diagnostic test (RDT) is the need of the hour. The objective of this study was to evaluate the performance of a rapid chromatographic immunoassay-based test (index test) compared with a clinical reference standard (rRT-PCR). Methods: A cross-sectional, single-blinded study was conducted at a tertiary care teaching hospital in north India. Paired samples were taken for RDT and rRT-PCR (reference standard) from consecutive participants screened for COVID-19 to calculate the sensitivity and specificity of the RDT. Further subgroup analysis was done based on the duration of illness and cycle threshold values. Cohen's kappa coefficient was used to measure the level of agreement between the two tests. Results: Of the 330 participants, 77 were rRT-PCR positive for SARS-CoV-2. Sixty four of these patients also tested positive for SARS-CoV-2 by RDT. The overall sensitivity and specificity were 81.8 and 99.6 per cent, respectively. The sensitivity of RDT was higher (85.9%) in participants with a duration of illness ≤5 days. Interpretation & conclusions: With an excellent specificity and moderate sensitivity, this RDT may be used to rule in COVID-19 in patients with a duration of illness ≤5 days. Large-scale testing based on this RDT across the country would result in quick detection, isolation and treatment of COVID-19 patients.

Purpose Obesity is a global pandemic that exerts a significant burden on healthcare worldwide. Multiple cancers, as well as deaths from the same, are more prevalent in obese patients. Bariatric surgery has been shown to be the most effective way of treating obesity once other measures have been exhausted. There is no concordant data available to support that bariatric surgery can reduce the prevalence of cancer. Using one of the largest data samples, we evaluate the correlation of bariatric surgery in morbidly obese patients with the prevalence of obesity-related cancers (breast, endometrial, esophageal, colorectal, prostate, and renal) in morbidly obese patients. Patients and methods A sample of 7,672,508 morbidly obese patients was identified from the 1994 to 2004 records of the National Inpatient Sample (NIS) database, divided into those who did and did not undergo bariatric surgery, and studied for the prevalence of obesity-associated cancers. Results Obesity was predominantly seen in the Caucasian population (68.22%). The mean age of cases who underwent bariatric surgery was younger when compared to those who did not undergo the procedure (43.89±25.16 vs. 54.90±36.40, p-value0.0001). The highest bariatric surgery rate was seen in the Northeast (5.57%), followed by the West (4.15%), South (3.02%), and Midwest (2.96%) (p-value0.0001). Overall, the odds of morbidly obese patients who underwent bariatric surgery and developed cancer are: esophageal cancer 0.19 (0.1218-0.3078, p0.0001), colorectal cancer 0.0368 (0.0275- 0.0493, p0.0001), endometrial cancer 0.0155 (0.0099-0.0244, p0.0001), breast cancer 0.0712 (0.0582-0.0871, p0.0001), prostate cancer 0.0285 (0.0199-0.0408, p 0.0001) and renal cancer 0.0182 (0.0106-0.0314, p0.0001). The odds of cancer post-bariatric surgery remained significantly lower even after matching certain confounding factors. Conclusions The odds of developing breast, esophageal, prostate, renal, and colorectal cancers are significantly lower in morbidly obese patients who undergo bariatric surgery.

Persons living with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) (PLHA) enrolled from antiretroviral therapy (ART) centers located in three different cities in India – Delhi, Pune and Kolkata, and were followed up at six monthly intervals monitoring the WHO stage, CD4 counts, complete blood counts and liver and kidney function tests, for a duration of three years. The incidence of mortality among HIV/AIDS patients on ART was 5·0 per 1000 patient years (21/1410, 1.4%). Age at initiation of ART being above 35 years was the only significant predictor of mortality (log rank p = 0·018). Multivariable analysis showed significant association of an unfavourable outcome (defined as mortality or development of opportunistic infection during follow-up) with male gender (adjusted odds ratio (AOR) = 5.26, p =

Epstein-Barr Virus (EBV) is associated with the Hodgkin’s and Non-Hodgkin’s lymphoma (HL and NHL respectively). HIV is a risk factor for EBV infections and previously published data indicate that HIV infected individuals have higher chances of getting EBV infections compared to HIV uninfected individuals. Very limited information is available from India about the the prevalence of EBV in HIV positivity, with or without malignancy. In a recent study (Sinha et al. Current HIV Res 16:1–6, 2018) from All India Institute of Medical Sciences (AIIMS), New Delhi, we have shown that 2% among the HIV-1 infected individuals have malignancies including HL and NHL. To determine the prevalence of EBV among these individuals, clinical specimen obtained from ART clinic of AIIMS were tested for the presence of EBV DNA in plasma samples by quantitative real-time PCR. We have observed high prevalence of EBV (30%) among the 92 specimen tested. Prevalence is higher in patients with malignancy (37%) compared to those without maliganancy (27%). No correlation was observed with the CD4 counts or HIV viral load with EBV positivity.

357 Background: LC is one of the leading causes of cancer deaths in the US. Despite advancements in care and screening, disparities continue to be prominent when looking into minority ethnic and racial groups. This study was undertaken to study racial and gender disparity in all-cause mortality (ACM) in patients with LC. Methods: Data was obtained from 2016-18 Nationwide Inpatient Sample (NIS). Cases with a primary diagnosis of LC were identified using ICD-10 CM code “C34”. SAS 9.4 was used for data analysis. Logistic regression was performed to derive the odds ratio (OR). Results: We identified 238,516 cases with LC, 77.4% were Whites, 12.5% African American (AA), 4.7% Hispanics, and 2.8 % Asians and Pacific Islanders (API). As per Table, odds of dying were higher amongst AA, API, and Native Americans (NA) compared to Whites. The odds of ACM for AA and API remain high in all regions compared to Whites. Hispanics have significantly lower odds of ACM compared to Whites in the Southern (S) region, and no statistical difference in other regions. NA have lower odds of dying in the Northeast (NE), no statistical difference in the Midwest (MW), and higher in the S and the West (W). Being female decreases the odds of ACM overall as well as in all the regions when compared to males, but odds of dying are significantly more for females in the W when compared to females in the NE. Males have lower odds of dying in the MW and S regions, and no statistical difference in W when compared to the NE. Conclusions: Despite advancements in treatment modalities and screening, racial minorities remain at higher odds of ACM in all regions. Understanding the complex cause of these disparities and implementing interventions will be key to mitigating these disparities and moving closer to equitable outcomes in LC patients[Table: see text]

356 Background: Healthcare disparities exist in patients living with cancer which could be due to age, sex, race or sociodemographic variables. This study was undertaken to analyze the racial representation in oncology clinical trial study population of selected cancers over a period of 13 years. Methods: ClinicalTrials.gov was utilized for data collection. Clinical trials in 4 major cancers were filtered using the following criteria in advanced search: Disease, Study type: Interventional (Clinical trial), Study results: Studies with results, Status: Completed, Location: United States, Phase: 3 or 4, Last updated: 01/01/2009 to 01/01/2022. Prostate Cancer (PC), Colorectal Cancer (CRC), Breast Cancer (BC), and Lung Cancer (LC) were included in the study. Data were collected in an Excel spreadsheet and descriptive statistics were used for analysis. Comparison of racial representation was made with the National Cancer Institute Surveillance, Epidemiology and End Results Program (SEER) 2019 data for respective cancers. Results: 165 (52.21%) studies out of 316 studies, which met inclusion criteria, were disclosing racial demographic data. Breaking down into respective cancers, PC had 57.69%, LC had 59.04%, CRC had 44.12%, and BC had 46.28% clinical trials with racial demographic data. Table shows detailed racial demographic data of cancers included with comparison to SEER’s incidence data. Whites/Caucasians (Whites) were the most common race in all the cancer trials, followed by Asian/Pacific Islanders (API) in LC, CRC and BC while Blacks/African Americans (AA) being second common in PC. American Indians/Alaskan Natives (AI/AN) were least represented in all the cancer trials. In comparison to SEER’s 2019 incidence data AA and AI/AN were under-represented in all the included cancer trials, while Whites were over-represented. Conclusions: It is prudent to address the issue of racial disparities in clinical trials. To begin with, it is imperative to include racial demographics in the results, as only 52.21% trials had racial demographic data. AA and AI/AN are under-represented in all the included cancer trials while Whites were over-represented, hindering the generalization of the trial results. It is important to make changes at the grass root level, meaning at the conception of the trial and at the research regulatory level.[Table: see text]

BackgroundLong COVID, or post-COVID-19 sequelae, is being seen in a growing number of patients reporting a constellation of symptoms, both pulmonary and extrapulmonary. Studies on COVID-19 recovered patients are scarce. Thus, there is a need to add granularity to our existing knowledge about the course and long-term effects of the infection.AimTo describe the clinical details and risk factors of post-COVID sequelae in the North Indian population.MethodThis prospective observational study was conducted at a tertiary healthcare centre in Northern India between October 2020 to February 2021. Patients aged >18 years with a confirmed COVID-19 disease were recruited after at least two weeks of diagnosis and interviewed for any post-COVID-19 symptoms.ResultsOf 1234 patients recruited, who were followed up for a median duration of 91 days (IQR: 45-181 days), 495 (40.11%) patients had symptoms. In 223 (18.1%) patients, the symptoms resolved within four weeks, 150 (12.1%) patients had symptoms till twelve weeks, and 122 (9.9%) patients had symptoms beyond twelve weeks of diagnosis of COVID-19. Most common long COVID-19 symptoms included myalgia (10.9%), fatigue (5.5%), shortness of breath (6.1%), cough (2.1%), disturbed sleep (1.4%), mood disturbances (0.48%) and anxiety (0.6%). The major determinants of developing post-COVID-19 symptoms in the patients were hypothyroidism and the severity of the disease.ConclusionMost often, patients complain of myalgias, fatigue, dyspnoea, cough and disturbed sleep. Patients who are hypothyroid or have recovered from moderate to severe COVID-19 are at higher risk of developing post-COVID sequelae. Therefore, a multidisciplinary approach is required to diagnose and manage COVID-19 recovered patients.

Although management of advanced prostate cancer is evolving, a lot of work remains to be done for patients who have exhausted all options. Molecular targeting of prostate specific membrane antigen (PSMA) is valuable not only for diagnostic but also for therapeutic reasons. PSMA is thus considered to be useful in a theranostic approach. PSMA scans are upcoming diagnostic modalities which detect metastatic lesions that are missed by conventional imaging modalities. PSMA ligand therapy is also an upcoming treatment modality that has been proven to be beneficial with minimal toxicity in patients with advanced prostate cancer that have progressed on prior therapy. In this review article, we summarize the current knowledge regarding PSMA diagnostics and PSMA ligand therapies and discuss their implication in the treatment of advanced prostate cancer.

Hydroxychloroquine (HCQ) had generated considerable interest for coronavirus disease 2019 (COVID-19) prophylaxis. We conducted a prospective observational study at a tertiary care hospital in India, with dedicated COVID-19 care facilities.Primary objective was incidence of adverse effects, secondary objective being efficacy in preventing COVID-19.Healthcare workers were recruited and grouped based on voluntary HCQ prophylaxis as per national guidelines. Side effects in HCQ group were graded in accordance with national cancer institute-common terminology criteria for adverse events (NCI-CTCAE) version 5.0. At 3-7-week follow-up, groups were compared for COVID-19 exposure, symptoms development and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RT-PCR results.Among 358 participants recruited, 216 (60.3%) were males and mean age was 31.2 ± 6.6 years. Chemoprophylaxis was initiated by 258 (72%) participants. After loading dose, 7 (2.7%) reported grade 2 and 1 (0.4%) grade 3 adverse effects. Discontinuation of HCQ due to side effects was reported in 11 (4.3%) participants. Electrocardiogram was done by 50 (19.4%) participants on HCQ; no abnormalities were noted. A total of 106 (41%) among those taking and 63 (63%) among those not taking HCQ were tested for SARS-CoV-2 due to influenza-like illness or significant exposure. Among all participants, 25 (6.9%, 95% confidence interval [CI] 4.3-9.6) developed COVID-19 during the study period. In the group taking HCQ, 10 (3.9%) tested positive compared to 15 (15%) in the group not taking HCQ (HCQ is safe at the recommended dose for pre-exposure prophylaxis of COVID-19.

Anal cancer, despite being a rare malignancy, is increasing in incidence, accounting for 0.5% of all new cancer cases in the United States, with rate of new cases being 1.9 per 100,000 men and women. It is common in immunocompromised individuals, especially those with malignancy, human immunodeficiency virus (HIV) and human papillomavirus (HPV) infection. Despite similar treatment of anal cancer in both HIV-positive and negative patients, guidelines for prevention and treatment of therapy-related side effects are rarely studied. While these patients have a better prognosis on HAART, limited guidelines exist regarding appropriate therapy. There is a common link between HPV and HIV and the transmission of one is associated with increased risk of transmission of the other. HPV vaccine which is known to prevent high-grade cervical intraepithelial neoplasia is thought to also decrease the incidence of anal intraepithelial neoplasia. The association of HPV vaccine in the prevention of anal cancer in high-risk groups with HIV is a scarcely studied subject that requires further research.

Although management of advanced prostate cancer is evolving, a lot of work remains to be done for patients who have exhausted all options. Molecular targeting of prostate specific membrane antigen (PSMA) is valuable not only for diagnostic but also for therapeutic reasons. PSMA is thus considered to be useful in a theranostic approach. PSMA scans are upcoming diagnostic modalities which detect metastatic lesions that are missed by conventional imaging modalities. PSMA ligand therapy is also an upcoming treatment modality that has been proven to be beneficial with minimal toxicity in patients with advanced prostate cancer that have progressed on prior therapy. In this review article, we summarize the current knowledge regarding PSMA diagnostics and PSMA ligand therapies and discuss their implication in the treatment of advanced prostate cancer.

10516 Background: Breast cancer is the most commonly diagnosed malignancy in American women, with about 281,500 new reported cases this year, 3.8 million women living with an active or history of breast cancer, and a lifetime occurrence of 1 in 8 women in this nation. Racial disparities persist despite the advent and implementation of screening by national agencies. AA females are less likely to be diagnosed with breast cancer, and yet bear an arbitrarily high burden of mortality of this malignancy. Socioeconomic variables and lifestyle are the most plausible explanations of this discrepancy. Even in clinical trials, there remains an underrepresentation of all ethnic minorities. Encouragement of guideline based screening for all along with constant follow ups, access to health insurance and a more uniform representation in trials are the cornerstone of eliminating these disparities. Methods: Data for this study was obtained from the 2016-18 Nationwide Inpatient Sample (NIS) which comprises 20% of the total US hospital discharges. We identified all patients with a primary diagnosis of Malignant Neoplasms of Breast. In-hospital mortality, race and hospital regions for the given patients were studied. Baseline characteristics of participants were summarized using descriptive statistics. The patient population was stratified as per race, hospital region, gender, therapy they received and family history. Logistic regression was performed to derive the odds ratio while adjusting for different variables. Further details: https://www.hcup-us.ahrq.gov/ . Results: 99, 543 patients with metastatic breast cancer were identified, and almost 99% of them were females. 67% of the population was comprised of Caucasians, 16.91% African Americans (AA), 9.14% Hispanics and 3.28% Asians and Pacific Islanders (API). AAs had the most reported deaths at 5.54%, followed by APIs at 4.80% and Caucasians 4.09% (p < 0.0001). The odds of dying were significantly higher in AA population when compared to Caucasian population (OR 1.391 (1.286-1.504)), and the odds were consistently higher across all regions of the US. In terms of regional variation, it was seen that races identifying as “others' ' had significantly higher odds of dying in the North East (OR 1.646 (1.238-2.189)) and the West (OR 1.503 (1.059-2.133)). Conclusions: It is crucial to identify racial disparities in diagnosis, treatment and mortality before we devise a blueprint to tackle this incongruity. This highlights the significance of universal screening and better health insurance coverage in addition to recognition of reasons behind these differences.

Pancreatic cancer, being one of the most fatal cancers, is the 7th leading cause of death globally. Cancer that is resistant to current treatment proves that there is a need for personalized and targeted therapy, based on the tumor and genomic markers. Pembrolizumab and Larotrectinib are examples of current medications used as targeted therapy in pancreatic cancer. Pancreatic cancer has many different molecular subgroups, providing the opportunity for the development of new drugs that can target these groups. Poly (ADP-Ribose) polymerase inhibitors (PARPi) are a group of drugs inhibiting PARP to decrease the stability of the cancer cells. Currently, PARPi are mostly used in ovarian and breast cancer. There are multiple studies that have shown positive effects of PARPi in decreasing the tumor burden in advanced pancreatic cancer. PARPi are the future of pancreatic cancer management, and hence it is important to understand their mechanism, resistance pathways, and their application in the real world.

Background: The primary aim of this study is to describe current trends in racial-, age- and sex-specific incidence, clinical characteristics and burden of cerebral venous thrombosis (CVT) in the United States (US). Methods: Validated International Classification of Disease codes were used to identify all adult new cases of CVT (n=5,567) in the State Inpatients Database of New York and Florida (2006-2016) and all cases of CVT in the entire US from the National Inpatient Sample 2005-2016 (weighted n=57,315). Incident CVT counts were combined with annual US Census data to compute age and sex-specific incidence of CVT. Joinpoint regression was used to evaluate trends in incidence over time. Results: From 2005-2016, 0.47%-0.80% of all strokes in the US were CVTs but this proportion increased by 70.4% over time. Of all CVTs over this period, 66.7% were in females but this proportion declined over time (p Conclusion: The epidemiological characteristics of CVT patients in the US is changing. Incidence increased significantly over the last decade. Further studies are needed to determine whether this increase represents a true increase from changing risk factors or artefactual increase from improved detection.

Background: Hydroxychloroquine(HCQ) prophylaxis has been proposed for coronavirus disease-2019(COVID-19) This prospective observational study was conducted to

ObjectiveTo test the hypothesis that race-, age-, and sex-specific incidence of cerebral venous thrombosis (CVT) has increased in the United States over the last decade.MethodsIn this retrospective cohort study, validated ICD codes were used to identify all new cases of CVT (n = 5,567) in the State Inpatients Databases (SIDs) of New York and Florida (2006–2016). A new CVT case was defined as first hospitalization for CVT in the SID without prior CVT hospitalization. CVT counts were combined with annual Census data to compute incidence. Joinpoint regression was used to evaluate trends in incidence over time.ResultsFrom 2006 to 2016, annual age- and sex-standardized incidence of CVT in cases per 1 million population ranged from 13.9 to 20.2, but incidence varied significantly by sex (women 20.3–26.9, men 6.8–16.8) and by age/sex (women 18–44 years of age 24.0–32.6, men 18–44 years of age 5.3–12.8). Incidence also differed by race (Blacks: 18.6–27.2; Whites: 14.3–18.5; Asians: 5.1–13.8). On joinpoint regression, incidence increased across 2006 to 2016, but most of this increase was driven by an increase in all age groups of men (combined annualized percentage change [APC] 9.2%, p < 0.001), women 45 to 64 years of age (APC 7.8%, p < 0.001), and women ≥65 years of age (APC 7.4%, p < 0.001). Incidence in women 18 to 44 years of age remained unchanged over time.ConclusionCVT incidence is disproportionately higher in Blacks compared to other races. New CVT hospitalizations increased significantly over the last decade mainly in men and older women. Further studies are needed to determine whether this increase represents a true increase from changing risk factors or an artifactual increase from improved detection.

Invasive central nervous system (CNS) aspergillosis is acquired by either hematogenous dissemination or direct spread from a sinus infection. We describe a series of nine patients with CNS aspergillosis from a tertiary care teaching institute in North India who were treated with voriconazole alone or in combination with surgery. All patients who had clinical and radiological features consistent with fungal CNS infection, showed the presence of septate hyphae on histopathology/microscopy and were either culture positive for Aspergillus spp. or had serum galactomannan positivity were diagnosed as CNS aspergillosis. Clinical features, risk factors, diagnostic modalities, treatment details and outcome at last follow-up were recorded for all patients diagnosed with CNS aspergillosis. A total of nine patients were diagnosed with CNS aspergillosis. The median duration of presentation at our hospital was six months (IQR-2-9 months). Six patients had concomitant sinus involvement, while two patients had skull-base involvement as well. All patients were treated with voriconazole therapy, and three of these patients underwent surgery. All but one patient survived at the last follow-up (median duration was 14 months (IQR- 8-21.5). Two patients had complete resolution, and voriconazole was stopped at the last follow-up, and the rest of the patients were continued on voriconazole. Of the six patients who were continued on voriconazole, all but one had more than 50% radiological resolution on follow-up imaging. Invasive CNS aspergillosis is an important cause of CNS fungal infection that is often diagnosed late and requires long-term voriconazole-based therapy.

Transaxillary access is an alternative safe route for transcatheter aortic valve replacement (TAVR) whenever transfemoral access is deemed compromised. We present a case of left transaxillary (TAx) TAVR for severe symptomatic aortic stenosis (AS). A 67-year-old male with a chronic coronary syndrome

Many countries in the world are affected by severe acute respiratory syndrome (SARS) coronavirus-2 (SARS-CoV-2) disease-2019 (COVID-19) pandemic. Approximately 80% of the cases are mild symptomatic, 15% are severe and approximately 5% are critically ill. The mortality among severe and critically ill patients ranges from 17% to 78%. Elderly and patients with comorbidities have higher chances of progression to severe disease and subsequent mortality. There are no proven antiviral agents available for the management of COVID-19. Besides the viral cytopathic effects, dysregulation in immunity also contributes substantially to the pathogenesis. Treatment with immunomodulatory agents such as interleukin-6 blockers, glucocorticoids and mesenchymal stem cell therapy has been observed to be potentially beneficial. In this review, the immune response in SARS-CoV-2, the mechanism of immune dysregulation as well as potential therapeutic targets for immunomodulatory therapies are discussed.

e18246 Background: Testicular tumors are potentially curable by means of high-dose chemotherapy plus hematopoietic stem-cell rescue. This regimen is commonly used as salvage therapy, third-line or later therapy in patients with platinum-refractory disease. The utilization and real-world outcomes and complications of patients with testicular cancer undergoing autologous hematopoietic stem cell transplant (aHSCT) in United States are unknown. Methods: We queried National Inpatient Sample, a large inpatient data set in the United States, from 2005 to 2014 for male patients with testicular cancer or multiple myeloma (control group) receiving aHSCT and compared outcomes between these groups. The primary outcome was in-hospital mortality rate, and the secondary outcomes included in-hospital complications of aHSCT, length of stay and total charges. Outcomes were assessed by means of univariate analysis, multivariate regression and propensity score matched-pair analysis. Results: A total of 391 patients (weighted N = 1,909) with testicular cancer and 4,809 male patients (weighted N = 23,501) with multiple myeloma who underwent aHSCT from 2005 to 2014 were identified. Mean age of patients with testicular cancer was 32.3 years vs 59 years for multiple myeloma patients (p < 0.001) There were no differences in in-hospital mortality rates (1.5% vs 1.4%, p = 0.85) or rates of intubation (2.3% vs 1.6%, p = 0.36), sepsis (7.7% vs 7.5%, p = 0.94), bacteremia (13.5% vs 15.6%, p = 0.42), or stomatitis (43.8% vs 38.8%, p = 0.87) between patients with testicular cancer and multiple myeloma receiving autologous HSCT. However, utilization of total parenteral nutrition was higher in patients with testicular cancer (12.9% vs 4.7%, p < 0.001). There was no difference in length of stay (17.5 vs 17.5 days, p = 0.77) and total charges (121,120$ vs 123,729$, p = 0.74) between two groups. The results were consistent in multivariate and propensity score matched-pair analysis. Conclusions: The in-hospital outcomes of patients with testicular cancer receiving aHSCT appears to be similar to patients with multiple myeloma. However, overall utilization of aHSCT for testicular cancer appears to be low in United States.

The effect of hypoxia (24 h) on TNF-alpha-mediated release of endothelin-1 (ET-1) from human optic nerve head astrocytes (hONAs) and TNF-alpha- and ET-1-induced hONA proliferation was determined. ET-1 synthesis and release was quantitated using ELISA while TNF-alpha (10 nM)- and ET-1 (100 nM)-mediated hONA proliferation was assessed by CellTiter 96 aqueous one-solution cell proliferation assay, respectively. hONAs appeared to be more rounded with fewer processes following 24 h hypoxia compared to thodr seen in normoxia. Hypoxia enhanced TNF-alpha-mediated ET-1 synthesis and release (by 5-fold) and also significantly increased TNF-alpha- and ET-1-mediated hONA proliferation. PD142893 (1 microM), an ET(A/B) receptor antagonist, blocked ET-1-mediated hONA proliferation both under normoxia and hypoxia, while doing so only under normoxia following TNF-alpha treatment. Also, U0126 (10 microM; an upstream ERK1/2 inhibitor) completely blocked agonist-induced hONA proliferation in normoxia and partially blocked the same in hypoxia. These results demonstrate for the first time that hONAs secrete ET-1 and that TNF-alpha and hypoxia can regulate its levels. Moreover, hypoxia augments the proliferative responses of hONAs to TNF-alpha and ET-1. These agonist-mediated effects following hypoxia could contribute to astroglial activation as seen in glaucomatous optic nerve heads.