The Efficacy and Safety of Imusil® Tablets in the Treatment of Adult Patients With Mild COVID-19: A Prospective, Randomized, Multicenter, Open-Label Study.

Introduction Coronavirus disease 2019 (COVID-19) is a serious concern of the new era. Along with antiviral synthetic medications, there is a need to discover efficacious herbal antiviral medicines with minimum side effects in patients against COVID-19. This study aimed to assess the efficacy and safety of Imusil® among patients with mild COVID-19. Methods A prospective, randomized, multicenter, open-label, interventional study was conducted in patients with mild COVID-19 infection. Patients received either Imusil one tablet four times a day (seven days) along with the standard of care (SoC) or only SoC. The study endpoints were reverse transcription-polymerase chain reaction (RT-PCR) negativity, changes in cycle threshold (CT), clinical improvement, change in blood inflammatory indexes, and safety assessment. Results A total of 100 patients were enrolled, and 98 received at least one dose of treatment. The median age of patients was 36.0 years, and 58 were males. By day 4, 85.4% of patients in the Imusil+SoC group tested negative for RT-PCR compared to 64% of patients exhibiting the same outcome in the SoC group (P=0.0156). After eight days, clinical improvement was observed in all patients from the Imusil+SoC group, while in the SoC group, clinical improvement was observed in 94.0% of patients (P=0.4947). During follow-up visits, the average C-reactive protein (CRP) levels decreased from baseline in both treatment groups. The decrease in the levels of CRP (-7.3 mg/dL versus -5.5 mg/dL), D-dimer (-231.0 ng/mL versus -151.6 ng/mL), and interleukin 6 (IL-6) (-2.3 pg/mL versus -2.0 pg/mL) at eight days was comparatively higher in the Imusil+SoC group versus the SoC group. There were no serious treatment-emergent adverse events in the drug arm. Conclusion Imusil provides effective antiviral activity and safety in mild COVID-19 patients. Imusil ensures faster RT-PCR negativity and clinical improvement and ensures effective reduction of inflammatory markers such as CRP, D-dimer and interleukin 6.

Efficacy of Tetravalent Dengue Vaccine: A Systematic Review and Meta-Analysis.

Dengue is one of the neglected tropical diseases caused by flavivirus. Live-attenuated tetravalent vaccine is launched for the age group of 9-45 years. It is given in three doses schedule. Eleven studies were included in meta-analysis by following PRISMA guidelines. Healthy persons in the age group of 2-45 years were included in these studies. Statistical analysis was done by "R" software. Pooled relative risk among vaccinated versus control group was calculated using random-effect model. Pooled dengue vaccine efficacy was calculated from relative risk. Heterogeneity and publication bias were assessed using Baujat and funnel plot, respectively. Adverse effects following immunization were reviewed. Pooled vaccine efficacy is 58% (95% confidence interval 46%-67%). I 2 statistics is 81.4%.

Spatial mapping and socio-demographic determinants of COVID-19 mortality in India.

BACKGROUND: COVID-19 is caused by SARS-CoV-2. The first case of COVID-19 was detected in Wuhan city of China in December 2019. Geographic information system (GIS) mapping is important for the surveillance of infectious diseases. OBJECTIVES: The objectives of the study are to map spatially total cases and case fatality rate of COVID-19 and to build a linear regression model for mortality based on socio-demographic variables. METHOLOGY: We plotted the epidemiological data of COVID-19 of Indian states as on 11th May 2021 using the Q-GIS software. We used socio-demographic variables as the predictors of COVID-19 mortality and developed a linear regression model. RESULTS: Adjusted R-squared in linear regression model based on socio-demographic variables for COVID-19 deaths is 0.82. CONCLUSIONS: There are spatial variations in COVID-19 cases and deaths.

Impact of practice modification on oral health status of students: An interventional study from a tribal area of India.

CONTEXT: Tooth decay precipitated by poor oral hygiene is one of the most common oral diseases that affect 60-90% of school children. It not only interferes with speech, self-esteem but pain caused by decay also affects nutrition intake, resulting in malnutrition with abnormal cognitive development. AIM: To evaluate the impact of health education and supervised brushing intervention on their oral health status. SETTINGS AND DESIGN: Cross-sectional interventional study. METHODS AND MATERIALS: The study was conducted on students of class 8th, 9th, and10th of an Ashramshala (tribal residential school). All the students present in the school on the day of data collection were included in the study. A semistructured questionnaire was used for data collection. A qualified dentist, who is part of research team, conducted oral examination of the students. They were asked to demonstrate their brushing method and relevant observation was noted. The oral health status of the students was analyzed using DMF (decayed, missed, and filled) index and oral hygiene index- simplified score (OHI-S). Three training and educational sessions of one hour each were conducted separately for each class and a separate session was conducted for the teachers and caretakers of the school. Thereafter, randomly selected students (peers) were asked to demonstrate the technique to their peers to ensure proper understanding. Compliance was ensured through weekly follow ups to the school by the research team. DMF score and OHI-S were recalculated after 3 months and compared with their previous scores. STATISTICAL ANALYSIS: Chi-square test, one-way analysis of variance and paired t-test were used for analysis. RESULTS: The mean DMF and OHI-S score of the students was 2.61+/-2.309 and 2.11+/-0.96, respectively. A significant change (P = 0.021) in OHI scores was observed as a result of intervention. CONCLUSIONS: Promoting healthy dental practice with supportive supervision form the cornerstone for good health and hygiene.

Health needs of adolescent girls living in an urban slum of a metropolitan city- A mixed method approach.

CONTEXT: Adolescents constitute nearly 21% of the population in India. They are more likely to be constrained than adults from access to and timely use of appropriate care. Adolescence in girls is a turbulent period. The changes that take place during this period need to be made stress free. These are mostly physiological, for which simple family remedies can be found out. OBJECTIVES: 1. Assessing the health needs of adolescent girls living in an urban slum. 2. Identifying the barriers in accomplishing the health needs. METHODOLOGY: This was a community-based cross-sectional study with mixed method approach. A focus group discussion was held with 13 adolescent girls. FGD results were used to prepare a questionnaire to interview 80 adolescent girls. RESULTS: The FGD revealed adolescent girls needed more information on menstrual hygiene, reproductive health, and its associated illness. Totally, 45% of the adolescent girls belonged to the age group 17-19 years. About 90% had inadequate knowledge on reproductive health. They preferred group sessions over one-to-one session on these topics and their mother as the source of information. CONCLUSION: The reproductive and sexual healthcare education that is currently being imparted to the girls need to be devised in such a way that it empowers them. A family member-the mother needs to be trained so that she can make this age transition smooth and stress free. The correct scientific knowledge will help in ensuring sustainable development.

GeneXpert HIV-1 quant assay, a new tool for scale up of viral load monitoring in the success of ART programme in India.

BACKGROUND: Recent WHO guidelines identify virologic monitoring for diagnosing and confirming ART failure. In view of this, validation and scale up of point of care viral load technologies is essential in resource limited settings. METHODS: A systematic validation of the GeneXpert® HIV-1 Quant assay (a point-of-care technology) in view of scaling up HIV-1 viral load in India to monitor the success of national ART programme was carried out. Two hundred nineteen plasma specimens falling in nine viral load ranges (<40 to >5 L copies/ml) were tested by the Abbott m2000rt Real Time and GeneXpert HIV-1 Quant assays. Additionally, 20 seronegative; 16 stored specimens and 10 spiked controls were also tested. Statistical analysis was done using Stata/IC and sensitivity, specificity, PPV, NPV and %misclassification rates were calculated as per DHSs/AISs, WHO, NACO cut-offs for virological failure. RESULTS: The GeneXpert assay compared well with the Abbott assay with a higher sensitivity (97%), specificity (97-100%) and concordance (91.32%). The correlation between two assays (r = 0.886) was statistically significant (p < 0.01), the linear regression showed a moderate fit (R2 = 0.784) and differences were within limits of agreement. Reproducibility showed an average variation of 4.15 and 3.52% while Lower limit of detection (LLD) and Upper limit of detection (ULD) were 42 and 1,740,000 copies/ml respectively. The misclassification rates for three viral load cut offs were not statistically different (p = 0.736). All seronegative samples were negative and viral loads of the stored samples showed a good fit (R2 = 0.896 to 0.982). CONCLUSION: The viral load results of GeneXpert HIV-1 Quant assay compared well with Abbott HIV-1 m2000 Real Time PCR; suggesting its use as a Point of care assay for viral load estimation in resource limited settings. Its ease of performance and rapidity will aid in timely diagnosis of ART failures, integrated HIV-TB management and will facilitate the UNAIDS 90-90-90 target.

Predictors of bisexual behaviour among MSM attending intervention sites may help in prevention interventions for this bridge to the heterosexual epidemic in India: data from HIV sentinel surveillance.

BACKGROUND: Indian cultural tradition demanding marriage, many MSM howsoever they self-identify are likely to be married or have sex with women. To consolidate India's HIV prevention gains, it is important to understand and address the interaction between the MSM and heterosexual epidemics in India and create specific interventions for bisexual MSM. The challenge is to identify and intervene this hard to reach population. Data from HIV Sentinel Surveillance 2011 among MSM in four Indian states were analyzed to assess predictors and prevalence of bisexual behaviour in MSM. METHODS: Between March-May 2011, 4682 men (15-49 years) who had anal/oral sex with a male partner in the past month, attending intervention sites and consenting for an un-linked anonymous survey answered an 11- item questionnaire and provided blood for HIV test by finger stick at 19 designated surveillance sites. RESULTS: Of 4682 MSM tested overall, 5% were illiterate, 51% reported only receptive anal intercourse, 21% only penetrative and 28% both. 36% MSM had ever received money for sex. Overall 6.8% were HIV infected. 44% MSM were bisexual in the last six months. On multivariate analysis, 'being bisexual' was found to be independently associated with 'older age': 26-30 years [AOR = 3.1, 95% CI(2.7, 3.7)], >30 years [AOR = 6.5, 95% CI(5.5, 7.7)]; 'reporting penetrative behaviour alone' with other men [AOR = 5.8, 95% CI(4.8, 7.0), p<0.01] and 'reporting both penetrative and receptive behaviour' [AOR = 2.7, 95% CI(2.3, 3.1) p<0.01]. Those who both paid and received money for sex [AOR = 0.49, 95% CI (0.38, 0.62)] were significantly less likely to be bisexual. CONCLUSIONS: A substantial proportion of men receiving services from Targeted Intervention programs are bisexual and the easy opportunity for intervention in this setting should be capitalised upon. Focusing on older MSM, as well as MSM who show penetrative behaviour with other men, could help in reaching this population.

Mycobacterium avium-intracellulare brain abscess in HIV-positive patient.

Mycobacterial opportunistic infections are a major cause of morbidity and mortality among patients living with HIV (PLHIV) worldwide. Nontuberculous mycobacterial (NTM) infection is one of the leading causes of opportunistic infection in patients with advanced acquired immunodeficiency syndrome i.e., with CD4 count less than 50/cu.mm. Mycobacterium avium complex (MAC) is among the most common opportunistic bacterial infections in those patients with advanced immunodeficiency apart from cryptococcal meningitis, progressive multifocal leukoencephalopathy, etc. Common presentations of mycobacterium avium complex are fever, lymphadenitis and respiratory disease. Immune reconstitution disease is also known to manifest with MAC infections in PLHIV on highly active antiretroviral therapy. Very few cases of central nervous system involvement due to NTM infection have been described. We are reporting a case of advanced acquired immunodeficiency who presented with brain abscess due to Mycobacterium avium intracellulare.

Pathologic study of pandemic influenza A (H1N1) 2009 cases from India.

The pandemic influenza A (H1N1) 2009 originated in Mexico and rapidly spread to the United States and many other countries. India reported the first pandemic influenza case in May 2009. Autopsy studies describing the pathology of pandemic influenza infection in humans have appeared in the literature and most of these were from Western countries. We present the clinicopathologic features in 46 fatal cases with confirmed pandemic influenza A (H1N1) 2009 virus infection during August 2009 to October 2010. Postmortem needle biopsy tissues were examined for histopathological changes and distribution of virus antigen by immunohistochemistry. The results are comparable with previous autopsy studies. Diffuse alveolar damage was the consistent finding in the lung tissues. However, underlying medical conditions were not noted in the cases from present study. Consistent presence of viral antigen was noted in the bronchiolar epithelium without any reference to the duration of illness. This study also emphasizes the use of the postmortem needle biopsy technique whenever an autopsy is not possible.

A cross-sectional study of the sociodemographic profile of juveniles under institutional care in the city of Mumbai.

OBJECTIVES: To study the sociodemographic profiles of children under institutional care, identify the characteristic features of the families prone to have destitute children, and suggest measures for prevention of destitution of children in the community. MATERIAL AND METHODS: A questionnaire-based cross-sectional study was conducted in a population of 507 boys and girls from 6 to 18 years admitted to four different institutes for care and support. A sample of 170 children was selected using systematic random sampling technique. A survey was done to study the health status of the children. Data was analyzed using SPSS software. Frequency and proportion were calculated and chi square test was used. P value of >0.05 was considered significant. RESULTS: 65.9% of children were in the 6 to 12 age group. 63.5% were Hindu by religion. The majority i.e., 80.9% of the boys and 80% of the girls were urban in origin, 82.4% of the juveniles were from nuclear families, 40.0% of boys and 62.3% of the girl juveniles were from lower socioeconomic status. 75% of boys and 25% of the girls had been child laborers just before institutionalization. Only 12.7% of juveniles were from large families, the rest, the majority (87.3%) were from medium to small sized families. CONCLUSIONS: Nuclear families of medium to small size which belong to the lower socioeconomic status and of urban origin were found to be unable to provide care and support to their children putting them at the risk of becoming destitute.

Direct imaging of pH1N1 2009 influenza virus replication in alveolar pneumocytes in fatal cases by transmission electron microscopy.

Human influenza virus pandemics constitute a major global public health issue. Although studies on autopsy specimens from the recent pandemic by the 2009 influenza A (H1N1) virus have revealed a broad spectrum of pathologic findings, direct electron microscopic studies of the lung tissue from influenza fatalities are few. In this study, we examined five well-preserved pulmonary necropsy specimens from fatal cases of laboratory-confirmed pH1N1 from India. The novel observations in comparison with earlier reports included direct imaging of influenza virus budding within dilated cisternae of pneumocytes, cell-free virus emerging from the cell membrane of a pneumocyte in the alveolar lumen, presence of polymorphonuclear cells with red blood cells as inflammatory exudates close to hyaline membranes and extensive cytoplasmic degeneration of epithelial cells of the alveolar lining. These observations are in consistent with the earlier findings and emphasize the possible role of this virus directly infecting cells of the lower respiratory tract as a key event in the rapid pathogenesis of pH1N1 disease process.

Mortality & clinical characteristics of hospitalized adult patients with HIV in Pune, India.

BACKGROUND & OBJECTIVE: In India, data regarding mortality and clinical characteristics of hospitalized HIV-infected patients are sparse, which may limit the effectiveness of new hospital-based HIV programmes providing antiretroviral therapy (ART). The objective of our study was to determine mortality and clinical characteristics of hospitalized HIV-infected individuals in a high HIV prevalence region of India. METHODS: A retrospective chart review was done of known HIV-infected adults admitted to the Medical Service of a large, public hospital in Pune, India, from January 2002 to November 2003. RESULTS: A total of 655 HIV-infected patients were identified; 489 (74.7%) were male and 4 (0.6%) were on ART. The most common illnesses reported were tuberculosis (55.8%), diarrhoea (4.2%), and alcoholic liver disease (3.7%) . The inpatient mortality was 172 (26.3%). The most common causes of death of the 172 people were tuberculosis (52.9%) and cryptococcal meningitis (7.6%). In multivariate analysis, factors associated with increased mortality were male sex (adjusted odds ratio (AOR) 1.92, 95% CI: 1.08-3.41), haemoglobin level < 7 g/dl (AOR 2.75, 95% CI:1.23-6.14), length of stay < 2 days (OR 5.78, 95%, CI: 1.82-18.4), and cryptococcal meningitis (OR 4.44, 95% CI:1.19-16.6). INTERPRETATION & CONCLUSION: In the era prior to widespread ART, a high inpatient mortality of 26 per cent was found among hospitalized HIV-infected individuals. Thus, while hospitalization is an important access and referral point for HIV care and treatment, earlier identification of HIV-infected persons must occur to ensure they will optimally benefit from the government's ART programme.