Hepatitis C Virus (HCV) Vertical Transmission in 12-Month-Old Infants Born to HCV-Infected Women and Assessment of Maternal Risk Factors

Background. Hepatitis C virus (HCV) is an underappreciated cause of pediatric liver disease, most frequently acquired by vertical transmission (VT). Current guidelines that include the option of screening infants for HCV RNA at 1–2 months are based on data prior to current real-time polymerase chain reaction (PCR)-based testing. Previous studies have demonstrated VT rates of 4%–15% and an association with high maternal viral load. We evaluated HCV RNA in infants with HCV VT and assessed maternal risk factors in a prospective cohort in Cairo, Egypt

Attitudes, understanding, and concerns regarding medical research amongst Egyptians: A qualitative pilot study

<p>Abstract</p> <p>Background</p> <p>Medical research must involve the participation of human subjects. Knowledge of patients' perspectives and concerns with their involvement in research would enhance recruitment efforts, improve the informed consent process, and enhance the overall trust between patients and investigators. Several studies have examined the views of patients from Western countries. There is limited empirical research involving the perspectives of individuals from developing countries. The purpose of this study is to examine the attitudes of Egyptian individuals toward medical research. Such information would help clarify the type and extent of concerns regarding research participation of individuals from cultural, economic, and political backgrounds that differ from those in developed countries.</p> <p>Methods</p> <p>We conducted semi-structured interviews with 15 Egyptian individuals recruited from the outpatient settings (public and private) at Ain Shams University in Cairo, Egypt. Interviews were taped, transcribed, and translated. Thematic analysis followed.</p> <p>Results</p> <p>All individuals valued the importance of medical research; however most would not participate in research that involved more than minimal risk. Individuals were comfortable with studies involving surveys and blood sampling, but many viewed drug trials as being too risky. All participants valued the concept of informed consent, as they thought that their permission to be in a research study was paramount. Many participants had discomfort with or difficulty in the understanding several research concepts: randomization, double-blind, and clinical equipoise. Trust in the physicians performing research was important in deciding to participate in clinical research. The small sample size and the selection bias associated with obtaining information from only those who agreed to participate in a research study represent limitations in this study.</p> <p>Conclusion</p> <p>Overall, individuals in our sample recognize the value of medical research and have a great deal of trust regarding medical research and their participation in research. There were, however, concerns with the level of research risks associated with several types of medical research. Many also demonstrated confusion with certain research methodologies. We recommend 1) enhanced educational efforts regarding general research concepts to enhance the validity of informed consent and 2) further survey studies in other areas of Egypt to determine the generalizability of our results.</p

Identifying structures, processes, resources and needs of research ethics committees in Egypt

<p>Abstract</p> <p>Background</p> <p>Concerns have been expressed regarding the adequacy of ethics review systems in developing countries. Limited data are available regarding the structural and functional status of Research Ethics Committees (RECs) in the Middle East. The purpose of this study was to survey the existing RECs in Egypt to better understand their functioning status, perceived resource needs, and challenges.</p> <p>Methods</p> <p>We distributed a self-administered survey tool to Egyptian RECs to collect information on the following domains: general characteristics of the REC, membership composition, ethics training, workload, process of ethics review, perceived challenges to effective functioning, and financial and material resources. We used basic descriptive statistics to evaluate the quantitative data.</p> <p>Results</p> <p>We obtained responses from 67% (12/18) of the identified RECs. Most RECs (10/12) have standard operating procedures and many (7/12) have established policies to manage conflicts of interests. The average membership was 10.3 with a range from 7-19. The predominant member type was physicians (69.5% of all of the REC members) with little lay representation (13.7%). Most RECs met at least once/month and the average number of protocols reviewed per meeting was 3.8 with a range from 1-10. Almost three-quarters of the members from all of the 12 RECs indicated they received some formal training in ethics. Regarding resources, roughly half of the RECs have dedicated capital equipment (e.g., meeting room, computers, office furniture, etc); none of the RECs have a formal operating budget. Perceived challenges included the absence of national research ethics guidelines and national standards for RECs and lack of ongoing training of its members in research ethics.</p> <p>Conclusion</p> <p>Our study documents several areas of strengths and areas for improvements in the operations of Egyptian RECs. Regarding strengths, many of the existing RECs meet frequently, have a majority of members with prior training in research ethics, and have written policies. Regarding areas for improvements, many RECs should strive for a more diverse membership and should receive more financial resources and administrative support personnel. We recommend that RECs include more individuals from the community and develop a continuing educational program for its members. Institutional officials should be aware of the resource capacity needs of their RECs.</p

Demography and the dual epidemics of tuberculosis and HIV: Analysis of cross-sectional data from Sub-Saharan Africa.

BACKGROUND:Convergence of tuberculosis (TB) and HIV epidemics is associated with higher morbidity and mortality risks and understanding their distribution across key demographic factors is essential for prevention and control. This analysis examines the prevalence of TB, HIV and TB-HIV coinfection across age and gender in patients with presumptive TB seeking care at the National TB and Leprosy Training Center in Nigeria. METHODS:Samples from 1603 presumptive pulmonary TB cases who provided informed consent were evaluated with a sequential testing algorithm that included a smear microscopy, cultures in liquid and broth media and then genotyping by Hain line probe assays. HIV was serially tested with two HIV rapid assays and retested with a third assay in non-conclusive samples. RESULTS:Twenty-three percent (375/1603) had confirmed pulmonary TB infection, 23.6% (378/1603) were positive for HIV infection and 26.9% (101/375) of the confirmed TB cases were HIV co-infected. Males had a higher prevalence of TB: 27.6% vs. 18.0%, p < .0001; and a lower prevalence of HIV: 19.0% vs. 29.6%, p < .0001. In the age range of 25-29 years, males were twice as likely to have TB (OR = 2.2; 95% confidence interval [CI]: 1.3-3.9, p = 0.0032) while females were five times more likely to have HIV (OR = 4.8; 95% CI: 2.6-8.9, p < .0001). Persons with TB-HIV coinfection were more likely to be young, female and less likely to be married. CONCLUSION:Younger females with a high burden of HIV may be under-diagnosed and under-reported for TB in Nigeria. Community programs for intensified and early detection of TB and HIV targeting younger females are needed in this setting

Advances in respiratory virus therapeutics - A meeting report from the 6th isirv Antiviral Group conference.

The International Society for Influenza and other Respiratory Virus Diseases held its 6th Antiviral Group (isirv-AVG) conference in Rockville, Maryland, November 13-15, 2018. The three-day program was focused on therapeutics towards seasonal and pandemic influenza, respiratory syncytial virus, coronaviruses including MERS-CoV and SARS-CoV, human rhinovirus, and other respiratory viruses. Updates were presented on several influenza antivirals including baloxavir, CC-42344, VIS410, immunoglobulin, immune plasma, MHAA4549A, pimodivir (JNJ-63623872), umifenovir, and HA minibinders; RSV antivirals including presatovir (GS-5806), ziresovir (AK0529), lumicitabine (ALS-008176), JNJ-53718678, JNJ-64417184, and EDP-938; broad spectrum antivirals such as favipiravir, VH244, remdesivir, and EIDD-1931/EIDD-2801; and host directed strategies including nitazoxanide, eritoran, and diltiazem. Other topics included considerations of novel endpoints such as ordinal scales and patient reported outcomes (PRO), and study design issues, and other regulatory considerations for antiviral drug development. The aim of this report is to provide a summary of the presentations given at this meeting

Human Leukocyte Antigen Class II Alleles (DQB1 and DRB1) as Predictors for Response to Interferon Therapy in HCV Genotype 4

Human leukocyte antigens class II play an important role in immune response against HCV. We investigated whether HLA class II alleles influence susceptibility to HCV infection and response to interferon therapy. HLA-DRB1 and -DQB1 loci were genotyped using PCR-SSO Luminex technology. According to our regimen, 41 (66%) of patients achieved sustained virological response to combined treatment of IFN and ribavirin. Frequencies of DQB1*0313 allele and DRB1*04-DRB1*11, DQB1*0204-DQB1*0313, DQB1*0309-DQB1*0313, and DQB1*0313-DQB1*0319 haplotypes were significantly more frequent in nonresponders than in responders. In contrast, DQB1*02, DQB1*06, DRB1*13, and DRB1*15 alleles were significantly more frequent in responders than in nonresponders. Similarly, DRB1*1301, DRB1*1361, and DRB1*1369 alleles and DRB1*1301-DRB1*1328, DRB1*1301-DRB1*1361, DRB1*1301-DRB1*1369, DRB1*1328-DRB1*1361, and DRB1*1328-DRB1*1369 haplotypes were significantly found only in responders. Some alleles and linkages showed significantly different distributions between patient and healthy groups. These alleles may be used as predictors for response to treatment or to susceptibility to HCV infection in the Egyptian population

Prevalence of non-tuberculous mycobacterial infections among tuberculosis suspects in Nigeria.

Nigeria is ranked in the top five countries for tuberculosis deaths worldwide. This study investigated the mycobacterial agents associated with presumptive clinical pulmonary tuberculosis (TB) in Nigeria and evaluated the pattern and frequency of mycobacterial infections over twelve calendar months period.Sputum samples from 1,603 consecutive new cases with presumptive diagnosis of TB were collected from August 2010 to July 2011. All sputum samples were incubated for detection of mycobacterial growth and those with positive acid fast bacilli (AFB) growth were tested to detect mycobacterium tuberculosis (MTB) complex and characterized to differentiate between MTB complex species. Cultures suggestive of Non-tuberculous mycobacterial infections (NTM) were sub-cultured and characterized.Of the 1,603 patients screened, 444 (28%) culture-positive cases of pulmonary tuberculosis were identified. Of these, 375 (85%) were due to strains of MTB complex (354 cases of M. tuberculosis, 20 M. africanum and one case of M. bovis) and 69 (15%) were due to infection with NTM. In contrast to the MTB complex cases, the NTM cases were more likely to have been diagnosed during the calendar months of the Harmattan dust season (OR = 2.34, 1.28-4.29; p = 0.01), and aged older than 35 years (OR = 2.77, 1.52-5.02, p = 0.0007), but less likely to have AFB identified on their sputum smear (OR = 0.06, 0.02-0.14, p<0.0001). Among those with NTM infection, cases 35 years or younger were more likely to have co-infection with HIV (3.76, 1.72-8.22; p = 0.0009) compared to those older than 35 years.The high proportion of younger patients with clinical pulmonary TB due to NTM and co-infection with HIV and the likely role of the seasonal dust exposure in the occurrence of the disease, present novel public health challenges for prevention and treatment

Performance and trend for quality of service in a large HIV/AIDS treatment program in Nigeria

BACKGROUND:As antiretroviral therapy (ART) programs expand access, there is an increase in burden to a healthcare system. These results are reduced provider-patient contact time and poor programmatic and patient outcomes. Quality management offers providers a standardized approach for addressing the appropriateness of care to be applied in resource-limited settings. This study aimed to determine the trend of performance on HIV/AIDS quality management indicators of health facilities providing ART over a period of 5&nbsp;years. METHODS:The annual performance scores of quality of care (QoC) indicators of 31 health facilities providing ART was extracted from a database covering a period of 5&nbsp;years (from October 2008 to September 2012). The data are percentages that indicate scores of each health facility assessed based on compliance to National ART guidelines categorized into several indicator domains. A Chi square statistic for the trend, as well as test for departure from the trend line was determined. The p value associated with each indicator provides the significant level for testing an alternative hypothesis that the rate of change over the period considered for that indicator does not equal to zero. The slope of the regression line also gives the magnitude of the rate of change for each indicator by healthcare level across the review period. RESULTS:Generally, performance trends showed improvement across most indicator domains. The highest improvement occurred for "3&nbsp;month loss to follow-up" and "1&nbsp;year no-visit", with scores declining from 37 to 3%, and 42% to 12% respectively. However, there was a sharp decline in performance between 2010 and 2012 in weight monitoring of patients (p &lt; 0.01), adherence assessment to ARVs (p &lt; 0.01) and hematocrit measurements (p = 0.01). The aggregate rate of change β, as obtained from the slope of the trend line is highly significant (p &lt; 0.01) for all the quality of care indicators considered, whether improving or declining. CONCLUSION:Periodic assessment to determine HIV/AIDS quality of care can guide rapid scale-up of services to achieve universal coverage in resource-limited settings. Determining trends to understand patterns is very useful for improving programmatic and patient outcomes