The Observatory and Fast Facts

Aug. 22, 2019


Persistent HIV in central nervous system linked to cognitive impairment. Many people with HIV on antiretroviral therapy (ART) have viral genetic material in the cells of their cerebrospinal fluid (CSF). These individuals are more likely to experience memory and concentration problems, according to new data published online in the Journal of Clinical Investigation.

A study of 69 individuals on long-term ART found that nearly half of the participants had persistent HIV in cells in their CSF, and 30 percent of this subset experienced neurocognitive difficulties. These findings suggest that HIV can persist in the nervous system even when the virus is suppressed in a patient’s blood with medication. The study was funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Mental Health (NIMH), both parts of the National Institutes of Health (NIH).

Investigators from the University of North Carolina, the University of Pittsburgh, and Yale University studied participants enrolled in the AIDS Clinical Trials Group (ACTG) HIV Reservoirs Cohort Study. This primarily male group—aged 45 to 56—of long-term HIV survivors had infections controlled with ART for on average nine years. Researchers analyzed each participant’s CSF for HIV DNA and then compared these data to each participants’ results from standard neurocognitive evaluations. About half of participants had viral DNA in cells in the CSF, indicating the presence of latent virus, even though standard HIV RNA ‘viral load’ tests of the cell-free CSF fluid were positive in only four percent of participants. Investigators also found that 30 percent of individuals with persistent HIV DNA in the CSF experienced clinical neurocognitive impairment compared with 11 percent of individuals whose CSF did not contain viral DNA.

Many researchers hypothesize that HIV-related inflammation causes HIV-associated neurocognitive disorder (HAND). The new findings suggest that the presence of persistent HIV-infected cells in the central nervous system (CNS), despite long-term ART, may play a role in neurocognitive impairment. The authors note that the overall frequency of neurocognitive impairment in this group was relatively low and that the association does not confirm that HIV DNA causes HAND. Overall, the current study found that examining CSF cells revealed a higher-than-expected prevalence of persistent HIV in the CNS, which may be a significant obstacle to efforts to eradicate HIV from the body.

Data management

ELLKAY acquires X-Link. ELLKAY, LLC, a healthcare connectivity and interoperability solutions company, announced its acquisition of the assets of Tampa-based Legal Easy, Inc., including the X-Link medical software interfacing solution.

With the strategic acquisition, ELLKAY expands its healthcare footprint and enables providers with an easier, more cost-effective way to achieve Promoting Interoperability (PI) objectives and quality measures. It also strengthens ELLKAY’s core mission of extending solutions that provide true interoperability and access to patient data at the point of care (POC).

Despite regulatory requirements and incentives including PI and the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), interoperability and data connectivity remain two of the most elusive issues in today’s healthcare market. With more than 30 years of experience in integrating disparate systems, Legal Easy, Inc. has collaborated with over 22,000 providers, 350 partners, and 1,700 resellers. The company’s core interfacing solution, X-Link, integrates disparate clinical and practice management systems and services, providing integration for more than two thirds of the practice management systems. X-Link’s direct-to-physician platform acts in real time and is easy to install, cost-effective to maintain, increases efficiency, and complements ELLKAY’s existing enterprise solutions.


CDC supports WHO declaration of Public Health Emergency of International Concern for Ebola outbreak in eastern region of DRC. As cases of Ebola continue to increase in the eastern region of The Democratic Republic of the Congo (DRC), and travel-associated cases have been reported in neighboring Uganda, the Centers for Disease Control and Prevention (CDC) fully supports the decision by the International Health Regulations Emergency Committee of the World Health Organization (WHO) to declare the outbreak a “public health emergency of international concern” (PHEIC). A PHEIC is declared if an extraordinary event poses a public health threat to other nations through the spread of disease and requires a more robust coordinated international response.

The declaration was made by WHO after the International Health Regulations Emergency Committee cited recent developments in the outbreak in making its recommendation, including the first confirmed case in Goma, a city of almost two million people in the DRC on the border with Rwanda and the gateway to the rest of DRC and the world. WHO cautioned against imposing trade or travel restrictions, which would have a negative impact on the response and on the lives and livelihoods of people in the region. 

As part of the Administration’s whole-of-government effort, CDC experts are working with the United States Agency for International Development (USAID) Disaster Assistance Response Team (DART) on the ground in the DRC and the American Embassy in Kinshasa to support the Congolese and international response. The United States government, including CDC, is working with DRC, Uganda, WHO, and other partners to support the current Ebola outbreak response by providing technical assistance and expertise in disease tracking, case investigation, contact tracing, case management, infection prevention and control, safe burials, community engagement and social mobilization, risk communication and health education, behavioral science, laboratory testing, border health, data management, vaccination campaigns, and logistics.

To rapidly identify cases and prevent further spread of Ebola, CDC is working with the U.S. Embassy in DRC to preposition CDC staff in Goma to rapidly respond to hotspots where the security situation is permissible. As of July 16, 2019, CDC staff have conducted 311 deployments to the DRC, neighboring countries, and WHO headquarters. CDC has 246 permanent staff in the three high-risk countries bordering the outbreak (South Sudan, Rwanda, and Uganda), including 43 in DRC. DRC has more than 150 graduates of CDC’s Field Epidemiology and Laboratory Training Program who are playing a central role in this public health response.

The outbreak in DRC is occurring in a region where there is armed conflict, outbreaks of violence, and other problems that complicate public health response activities and increase the risk of disease spread both locally within DRC and to neighboring countries. CDC continues to provide technical assistance to the ministries of health of DRC, Uganda, and other neighboring countries, in collaboration with the USAID DART, the U.S. Embassy in Kinshasa, the Department of State, WHO, and other local and international partners, to ensure the response is robust and well-coordinated and brings the Ebola outbreak to an end. 


NIH scientists link genetics to risk of high blood pressure among blacks. Variants in the gene ARMC5 may be associated with high blood pressure among blacks, according to a National Institutes of Health (NIH) study led by researchers at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).  

The study team identified 17 variants in the ARMC5 gene that were associated with high blood pressure by analyzing genetic research databases that include those of African descent. The study is published in the July 3, 2019, issue of the Journal of the American Heart Association.

Earlier work by the NICHD group linked some variants of ARMC5 to primary aldosteronism, a hormonal disorder that causes high blood pressure among black patients. In the current study, the researchers analyzed datasets containing genetic information from large numbers of people, including NIH’s Minority Health Genomics and Translational Research Bio-Repository Database and the Genomics, Environmental Factors and Social Determinants of Cardiovascular Disease in African-Americans Study, which are based in the United States, as well as the UK Biobank.

The researchers identified 17 variants of ARMC5 that were associated with blood pressure among blacks. One variant, called rs116201073, was “protective” and associated with lower blood pressure. It was more common than the others, and it appeared limited to people of African descent, as it is found only in Africans in the international 1000 Genomes Project.

The researchers also reconstructed the rs116201073 variant in cell lines and found that it was more active than other variants of the ARMC5 gene. However, the exact function of the ARMC5 gene is unclear, and more work is needed to understand what the gene does and how variants may protect or predispose a person to high blood pressure.

Antibacterial drug

New treatment for complicated urinary tract and complicated intra-abdominal infections. According to a recent press release, the U.S. Food and Drug Administration (FDA) has approved Recarbrio (imipenem, cilastatin, and relebactam), an antibacterial drug product to treat adults with complicated urinary tract infections (cUTI) and complicated intra- abdominal infections (cIAI). 

“The FDA remains focused on facilitating the development of safe and effective new antibacterial drugs to give patients more options to fight serious infections,” said Ed Cox, MD, MPH, director for the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “It is important that the use of Recarbrio be reserved for situations when there are limited or no alternative antibacterial drugs for treating a patient’s infection.” Recarbrio is a three-drug combination injection containing imipenem-cilastatin, a previously FDA-approved antibiotic, and relebactam, a new beta-lactamase inhibitor. 

The determination of efficacy of Recarbrio was supported in part by the findings of the efficacy and safety of imipenem-cilastatin for the treatment of cUTI and cIAI. The contribution of relebactam to Recarbrio was assessed based on data from in vitro studies and animal models of infection. The safety of Recarbrio was studied in two trials, one each for cUTI and cIAI. The cUTI trial included 298 adult patients with 99 treated with the proposed dose of Recarbrio. The cIAI trial included 347 patients with 117 treated with the proposed dose of Recarbrio. 

Recarbrio received FDA’s Qualified Infectious Disease Product (QIDP) designation. The QIDP designation is given to antibacterial and antifungal drug products intended to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act. As part of QIDP designation, Recarbrio was granted Priority Review under which the FDA’s goal is to take action on an application within an expedited time frame.

A key global challenge the FDA faces as a public health agency is addressing the threat of antimicrobial-resistant infections. Among the FDA’s other efforts to address antimicrobial resistance, is the focus on facilitating the development of safe and effective new treatments to give patients more options to fight serious infections.