Author Interviews, HIV, NEJM, Yale / 17.08.2018

MedicalResearch.com Interview with: Brinda Emu, MD Assistant Professor of Medicine (Infectious Diseases) Yale School of Medicine MedicalResearch.com: What is the background for this study? Response: This was a Phase 3 study of a new antiretroviral agent, ibalizumab, for the treatment of HIV-1 infection.  Ibalizumab is a monoclonal antibody that targets the CD4 receptor on host cells.  CD4 is the receptor that HIV uses to infect CD4+ T cells.  By binding to the CD4 receptor, ibalizumab prevents viral entry.  This study recruited patients that harbor multi-drug resistant HIV and were failing their current regimen of antiretroviral agents, and thus had limited options for treatment of their HIV-1 infection using approved medications. (more…)
Author Interviews, HIV, Pharmaceutical Companies / 16.08.2018

MedicalResearch.com Interview with: TaiMed BiologicsStanley Lewis, M.D. TaiMed Biologics Irvine, CA 92614 MedicalResearch.com: What is the background for this study? Response: The phase III clinical trial was conducted to assess the efficacy and safety of Trogarzo™ (ibalizumab-uiyk) injection in patients with multidrug resistant HIV-1. The study design was approved by the FDA. Results obtained were included in the New Drug Application submitted to the FDA which approved Trogarzo™ on March 6, 2018. The phase III, open-label study, enrolled 40 patients with multidrug-resistant (MDR) HIV-1 in whom multiple antiretroviral therapies had failed. All patients at baseline were experiencing viral failure. After a seven-day control period, patients received an intravenous 2000 mg loading dose of Trogarzo™ which was the only change made to their antiretroviral regimen. Through the 24-week treatment period of the study, patients were given a maintenance dose of 800 mg of Trogarzo™ every two weeks along with an optimized background regimen that included at least one additional fully active agent. (more…)
Author Interviews, Cancer Research, Gastrointestinal Disease, HIV, JAMA / 05.08.2018

MedicalResearch.com Interview with: Shan Rajendra MBBCh, MSc , MD, FRCP, FRACP Professor of Medicine University of New South Wales Director of Medicine & Clinical Executive Director Bankstown-Lidcombe Hospital Director Gastro-Intestinal Viral Oncology Group Ingham Institute for Applied Medical Research Sydney  MedicalResearch.com: What is the background for this study?   Response: High-risk human papillomavirus(HPV)  infection has been strongly associated with a subset of Barrett’s dysplasia and oesophageal adenocarcinoma. The research question was; Does HPV status of Barrett’s high-grade dysplasia and esophageal adenocarcinoma influence survival as in viral positive head and neck cancers? We therefore sought to determine the prognostic significance of esophageal tumor HPV status and associated viral transcriptional markers (E6/E7 mRNA and p16INK4A) and TP53. (more…)
Author Interviews, HIV, Merck / 02.08.2018

MedicalResearch.com Interview with: merck Kathleen Squires MD Director, Division of Infectious Diseases Jefferson University Hospitals and Ming-Tai Lai, PhD Senior Principal Scientist, Biology Discover Merck   MedicalResearch.com: What is the background for this study? What are the main findings?  Dr. Squires: The DRIVE-FORWARD study is a pivotal, randomized, double-blind, Phase 3 study that evaluated the safety and efficacy of doravirine (DOR), a non-nucleoside reverse transcriptase inhibitor (NNRTI) in treatment-naïve adults with HIV-1 infection. Data from week 48 of this trial have previously been presented demonstrating that doravirine met its primary endpoint of non-inferior efficacy compared to ritonavir-boosted darunavir (DRV+r). In addition, at 48 weeks, a secondary endpoint showed that the doravirine-treated group had statistically significant lower levels of fasting LDL-C and non-HDL-C versus the DRV+r group. The data presented at AIDS 2018 are week 96 data from the DRIVE-FORWARD trial. At week 96, the doravirine group demonstrated efficacy of 73.1% compared with 66.0% in the DRV+r group, a treatment difference of 7.1% (95% CI: 0.5, 13.7)  Two participants in the DOR treatment group developed genotypic and phenotypic resistance to DOR through 96 weeks of treatment. The rate of discontinuation of therapy due to adverse events was 1.6 percent in the DOR group and 3.4 percent in the DRV+r group. Doravirine is a late-stage investigational NNRTI for the treatment of HIV-1 infection in treatment-naïve adults and is being evaluated both as a once-daily single-entity tablet in combination with other antiretroviral agents, and as a once-daily fixed-dose combination regimen with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF). Earlier this year, Merck announced that the FDA accepted for review two New Drug Applications (NDAs) for doravirine for the treatment of HIV-1 infection in treatment-naïve adults. The NDAs are based upon the findings at week 48 of two ongoing Phase 3 trials, DRIVE-FORWARD and DRIVE-AHEAD, evaluating the efficacy and safety of doravirine and the fixed-dose combination regimen of DOR/3TC/TDF, respectively. The FDA has set a target action date of October 23, 2018 for both applications. Dr. Lai: This study aimed to characterize the mutant viruses selected in treatment-naïve participants through week 48 from DRIVE-FORWARD and DRIVE-AHEAD, and to assess the impact of selected mutations on non-nucleoside reverse transcriptase inhibitor (NNRTI) susceptibility and viral fitness. All of the seven doravirine (DOR)-resistant mutants are either partially susceptible or susceptible to etravirine. Mutants containing the F227C substitution were shown to be hypersusceptible to some nucleoside reverse transcriptase inhibitors (NRTIs) such as azidothymidine (AZT), tenofovir (TFV), lamivudine (3TC), and MK-8591. Among the 12 participants who developed efavirenz (EFV) resistance, 9 of the EFV-resistant clinical mutants were susceptible to DOR with fold-change <2.5. The majority of DOR-selected viruses identified in the treatment-naïve participants in clinical trials to date retain susceptibility to etravirine and hypersensitivity to some NRTIs, with low replication capacity. In addition, the majority of EFV-selected viruses retain susceptibility to DOR.  (more…)
Author Interviews, CDC, Infections / 26.07.2018

MedicalResearch.com Interview with: Dr. Megin Nichols DVM, MPH, DACVPM Lead , Enteric Zoonoses Activity Division of Foodborne, Waterborne, and Environmental Diseases National Center for Emerging and Zoonotic Infectious Diseases CDC Veterinarian MedicalResearch.com: What is the background for this announcement? Response: Each year, CDC and multiple states investigate several multistate outbreaks of Salmonella infections linked to contact with live poultry in backyard flocks. Seventy outbreaks of Salmonella infections have been linked to contact with poultry in backyard flocks since 2000. (more…)
Author Interviews, Flu - Influenza, Genentech / 26.07.2018

MedicalResearch.com Interview with: Mark Eisner MD MPH Mark D. Eisner, MD, MPH Vice President, Product Development Immunology, Infectious Disease, and Ophthalmology Genentech   MedicalResearch.com: What is the background for this study? Would you briefly explain how baloxavir marboxil differs from other flu treatments?  Response: CAPSTONE-2 is a Phase III multicenter, randomized, double-blind study that evaluated a single dose of baloxavir marboxil compared with placebo and oseltamivir in people 12 years and older who are at a high risk of complications from the flu. The high risk inclusion criteria in CAPSTONE-2 were aligned with the Centers for Disease Control and Prevention (CDC), which defines people at high risk for serious flu complications to include adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, diabetes or heart disease. For these people, flu can lead to hospitalization or even death. Participants enrolled in the study were randomly assigned to receive a single dose of 40 mg or 80 mg of baloxavir marboxil (according to body weight), placebo or 75 mg of oseltamivir twice a day for five days. The FDA recently accepted a New Drug Application (NDA) and granted Priority Review to baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older. The NDA was based on results from the Phase III CAPSTONE-1 study of a single dose of baloxavir marboxil compared with placebo or oseltamivir 75 mg, twice daily for five days, in otherwise healthy people with the flu. Results from a placebo-controlled Phase II study in otherwise healthy people with the flu were included as supporting data in the NDA. The FDA is expected to make a decision on approval by December 24, 2018. Baloxavir marboxil is a first-in-class, single-dose investigational oral medicine with a novel proposed mechanism of action designed to target the influenza A and B viruses, including oseltamivir-resistant strains and avian strains (H7N9, H5N1). Unlike other currently available antiviral treatments, baloxavir marboxil is the first in a new class of antivirals designed to inhibit the cap-dependent endonuclease protein within the flu virus, which is essential for viral replication. By inhibiting this protein, baloxavir marboxil prevents viral replication earlier in the flu virus life cycle. (more…)
Author Interviews, HIV, JAMA / 25.07.2018

MedicalResearch.com Interview with: Michael S. Saag, MD Professor,Division of Infectious Diseases UAB MedicalResearch.com: What is the background for this study? What are the main findings? 
  • An update of prior recommendations made by the IAS-USA, which have been updated every 2 years since 1996
  • Cover ARVs for prevention and treatment of HIV infection
  • Developed by an international panel of 16 volunteer experts in HIV research and patient care appointed by the IAS–USA
    • Members receive no compensation and do not participate in industry promotional activities while on the panel
  • Primarily for clinicians in highly resourced settings; however, principles are universally applicable
  • Reviewed data published or presented from September 2016 through June 2018
  • Rated on strength of recommendation and quality of evidence
(more…)
Author Interviews, Global Health, HIV / 25.07.2018

MedicalResearch.com Interview with: Professor Donna Spiegelman ScD Susan Dwight Bliss Professor of Biostatistics Director, Center for Methods in Implementation and Prevention Science (CMIPS)­­­­­­, Yale School of Public Health Professor, Department of Statistics and Data Science, Yale University Director, Interdisciplinary Methods Core, Center for Interdisciplinary Research on AIDS Yale School of Medicine MedicalResearch.com: What is the background for this study? Response: HIV infections can be transmitted from mothers to their infants during pregnancy, childbirth, and  breastfeeding.  Without access to a package of health services that includes antiretroviral medicines and counseling on best breastfeeding practices, it is estimated that 25% of children born to HIV-positive mothers become infected with HIV.In low-resource settings, 50% of these children die before their second birthday. A 32% increase in under-five mortality between 1988 and 2003 prompted the Kenyan government to establish Prevention of Mother to Child Transmission of HIV (PMTCT) programs in over 10,000 health facilities. This achievement was supported by U.S.President’s Emergency Fund for AIDS Relief (PEPFAR), the which contributed over $248 million to PMTCT programs in Kenya between 2004 and 2014. Although this investments in PMTCT coincided with a remarkable halving of Kenya’s under-five mortality rate, it is unknown whether this improvement can be causally attributed to PEPFAR funding for PMTCT. During the 2000s, child mortality decreased across most of sub-Saharan African countries.  These regional trends, rather than PEPFAR funding, may explain all or part of Kenya’s reduction in over 10,000 in child mortality. To help identify whether PEPFAR’s investments in PMTCT made a causal contribution to this reduction in child mortality, we used statistical methods to assess whether the amount or “dose” of PEPFAR funding provided to different provinces in Kenya was associated with increased HIV testing among pregnant women, which is a critical first step in identifying which women need PMTCT, and reduced infant mortality in Kenya. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Infections, JAMA, Pediatrics, University of Pittsburgh / 25.07.2018

MedicalResearch.com Interview with: Idris V.R. Evans, M.D.,MA Assistant Professor Department of Critical Care Medicine University of Pittsburgh MedicalResearch.com: What is the background for this study? What are the main findings? Response: New York State issued a state-wide mandate in 2013 for all hospitals to develop protocols for sepsis recognition and treatment. This mandate was called “Rory’s Regulations” in honor of Rory Staunton, a boy who died from sepsis in 2012. Pediatric protocols involved a bundle of care that included blood cultures, antibiotics, and an intravenous fluid bolus within 1–hour. We analyzed data collected by the NYS Department of Health on 1,179 patients from 54 hospitals and found that the completion of the pediatric bundle within 1 hour was associated with a 40% decrease in the odds of mortality.  (more…)
Author Interviews, Cancer Research, ENT, HPV / 25.07.2018

MedicalResearch.com Interview with: Eric Adjei PhD, MA Saint Louis University Center for Health Outcomes Research (SLUCOR) St. Louis, Missouri  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Survivors of head and neck cancer (HNC) develop second primary cancers (SPCs) at a higher rate than most common cancers. This is concerning because the number of HNC survivors are increasing due to advancements in treatment and technology. Patients whose head and neck cancer was caused by smoking and alcohol are different than those whose HNC were caused by human papillomavirus (HPV). We therefore used data from 2000-2014 National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) 18 database to examine if the incidence and the type of SPC that patients with smoking-related HNC develop were different from those from HPV-related head and neck cancer. First, independent of group of HNC (HPV-related or not), we found that SPCs among survivors of head and neck cancer were high, with about 1-in-8 patients developing an SPC. Additionally, irrespective of whether the index . head and neck cancer was from smoking-related or HPV-related, the majority of SPCs were second malignancies in head and neck region (e.g. tongue, gum, mouth floor etc), lung and esophagus. However, we observed different incidence rates between the two groups. Patients with smoking-related head and neck cancer developed SPCs at a higher rate (14%) than those with HPV-related HNC (10%). (more…)
Author Interviews, HIV, OBGYNE, Pediatrics, Pediatrics, STD / 24.07.2018

MedicalResearch.com Interview with: Monika K. Goyal, M.D., M.S.C.E., senior study author Assistant professor of Pediatrics and Emergency Medicine Children’s National Health System Washington, DC  MedicalResearch.com: What is the background for this study? Response: Patients with pelvic inflammatory disease (PID) are at an increased risk for syphilis and HIV. We know that adolescents account for 20 percent of the 1 million cases of PID that are diagnosed each year. We also know that an estimated one in four sexually active adolescent females has a sexually transmitted infection (STI). While screening for syphilis and HIV is recommended when diagnosing PID, actual screening rates among adolescents have been understudied. This multi-center study aimed to quantify rates of HIV and syphilis screening in young women diagnosed with . pelvic inflammatory disease in pediatric emergency departments and to explore patient- and hospital-specific characteristics associated with screening for these two sexually transmitted infections. (more…)
Author Interviews, Biomarkers, Infections / 21.07.2018

MedicalResearch.com Interview with: David K. Hong, M.D. VP Medical Affairs and Clinical Development at Karius MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Invasive fungal infections (IFI) are a cause of significant mortality and morbidity in immunocompromised patients. The diagnosis of IFIs is challenging, and often requires an invasive biopsy in order to identify the causal pathogen. There is a need for non-invasive methods of fungal identification to help guide targeted anti-fungal therapy. (more…)
Author Interviews, CDC, Infections / 20.07.2018

MedicalResearch.com Interview with: wash-hands-well . CDC wellAaron E. Glatt, MD, FACP, FIDSA, FSHEA Chairman, Department of Medicine & Hospital Epidemiologist South Nassau Communities Hospital Clinical Professor of Medicine Icahn School of Medicine at Mount Sinai Oceanside, NY 11572  MedicalResearch.com: What is the background for the CDC alert regarding a multistate outbreak of multidrug-resistant Salmonella Reading infections linked to raw turkey products?   Is this Salmonella strain different or more dangerous than other Salmonella food poisoning outbreaks?  Response: The CDC has reported that as of yesterday, there have been 90 people infected with Salmonella Reading from 26 states. No deaths have been reported, but 40 patients to date required hospitalization. There was a previous outbreak of S. Reading in 2016 related to contaminated alfalfa sprouts, but this organism is not that much different nor is it more virulent than many other salmonella strains.  (more…)
Author Interviews, CDC, Infections, JAMA / 20.07.2018

MedicalResearch.com Interview with: Dr. Katherine Fleming-Dutra MD Deputy Director Office of Antibiotic Stewardship CDC MedicalResearch.com: What is the background for this study? Response: Antibiotics are life-saving medications that treat bacterial infections. Any time antibiotics are used, they can lead to antibiotic resistance and could cause side effects such as rashes and adverse events, such as Clostridium difficile infection, which is a very serious and sometimes even fatal diarrheal disease. This is why it is so important to only use antibiotics when they are needed. When antibiotics aren’t needed, they won’t help you and the side effects could still hurt you. A previous study* reported at least 30% of antibiotic prescriptions written in doctor’s offices and emergency departments were unnecessary. However, the data from that study did not include urgent care centers or retail health clinics. We conducted the current analysis to examine antibiotic prescribing patterns in urgent care centers, retail health clinics, emergency departments, and medical offices. *Fleming-Dutra, K., et al. (2016). "Prevalence of Inappropriate Antibiotic Prescriptions Among US Ambulatory Care Visits, 2010-2011." JAMA: the Journal of the American Medical Association 315(17): 1864-1873. https://jamanetwork.com/journals/jama/fullarticle/2518263 (more…)
Alzheimer's - Dementia, Author Interviews, Herpes Viruses / 20.07.2018

MedicalResearch.com Interview with: Prof Ruth Itzhaki Emeritus Professor Division of Neuroscience & Experimental Psychology The University of Manchester MedicalResearch.com: What is the background for this study? Response: The background arises from the unexpected discovery, made by my lab almost 30 years ago, that the DNA of the common virus, herpes simplex virus type 1 (HSV1), known as the "cold sore" virus, was present in a high proportion of autopsy brains from elderly humans. Subsequently, we found that HSV1, when in brain of people who have a specific genetic factor, APOE-e4, confers a strong risk of developing Alzheimer's disease. We found also a parallelism with cold sores in that APOE-e4 is a risk for the sores, which occur in about 25-40% of people infected with HSV1. We then looked for links between the effects of HSV1 infection of cells in culture and AD, and found some major associations between virus and disease. Firstly, HSV1 causes an increase in the formation of a small protein called beta amyloid, which is the main component of the abnormal "plaques" seen in Alzheimer's Disease brains. Secondly, we discovered that in AD brains, the viral DNA is located precisely within amyloid plaques, which suggests that the virus is responsible for the formation of these abnormal structures. Thirdly, we confirmed the finding of another lab that HSV1 causes the increased formation of an abnormal form of the protein known as tau, which is the main component of the other characteristic abnormality of Alzheimer's Disease brains - "neurofibrillary tangles". All these discoveries suggested that the damage caused by HSV1 leads eventually to the development of AD. Lastly, we showed that treating HSV1-infected cells in culture greatly reduces the formation of beta amyloid and abnormal tau. This suggests that antiviral agents might be used for treating Alzheimer's Disease patients. (more…)
Author Interviews, Biomarkers, Infections, NEJM, University of Pittsburgh / 19.07.2018

MedicalResearch.com Interview with: David T. Huang, MD, MPH Associate Professor, Critical Care Medicine, Emergency Medicine, Clinical and Translational Science Director, MACRO (Multidisciplinary Acute Care Research Organization) Director, CRISMA Administrative Core (Clinical Research, Investigation, and Systems Modeling of Acute illness) University of Pittsburgh MedicalResearch.com: What is the background for this study? Response: The overuse of antibiotics has become a serious threat to global public health, causing antibiotic resistance and increasing health care costs. Physicians have long known that antibiotics are usually unnecessary for acute bronchitis and for some other cases of lower respiratory tract infections, and that antibiotics treat only bacterial infections, not viral. But in daily practice, many physicians often prescribe them. Previous research had reported that using a biomarker blood test and following an antibiotic guideline tied to the test results could reduce antibiotic use in lower respiratory tract infections. In February 2017, the U.S. Food and Drug Administration approved the biomarker test that measures procalcitonin – a peptide that typically increases in bacterial infections, but not viral. We conducted the Procalcitonin Antibiotic Consensus Trial (ProACT) trial to evaluate whether a procalcitonin antibiotic prescribing guideline, implemented for the treatment of suspected lower respiratory tract infection with reproducible strategies, would result in less exposure to antibiotics than usual care, without a significantly higher rate of adverse events. The ProACT trial involved 14 predominately urban academic hospitals. We enrolled 1,656 adult patients who presented to the hospital emergency department and were initially diagnosed with a lower respiratory tract infection. All the patients were tested for their procalcitonin levels, but the results were shared only with the physicians of the patients randomly assigned to procalcitonin-guided antibiotic prescription. (more…)
Author Interviews, Infections, PLoS / 13.07.2018

MedicalResearch.com Interview with: Nine-banded armadillo image credit: Dr. Richard Truman, USPHS, Public Domain (2014)John S. Spencer, Ph.D. Colorado State University Fort Collins, Colorado MedicalResearch.com: What is the background for this study? Where can armadillos be found? What are the main findings?  Response: The ancient disease leprosy, a disease causing skin lesions, nerve damage, disfigurement and disability, is caused by the bacterium Mycobacterium leprae, and is mainly spread by aerosol infection (coughing and sneezing) from human to human. It is rare in the United States (less than 200 cases on average per year), while it is endemic in Brazil, where over 25,000 new cases were diagnosed last year. In addition, zoonotic transmission of leprosy by nine-banded armadillos (Dasypus novemcintus, pictured at left) has been shown to occur in the southern United States, mainly in Texas, Louisiana and Florida. Nine-banded armadillos originated from South America, and expanded their range from Mexico into Texas in the 1800’s, eventually spreading north and east throughout the gulf states. People in Brazil, particularly in rural areas, hunt and kill armadillos as a dietary source of protein. In the small town of Belterra in western Pará state in the Brazilian Amazon region, a survey of 146 residents showed that around 65% of people had some contact with armadillos, through hunting, preparing the meat for cooking, or by eating them. A group of individuals who ate armadillos most frequently (more than once per month and up to twice a week) had a significantly higher antibody titer towards the M. leprae-specific antigen PGL-I and an almost two-fold higher risk of being diagnosed with disease, a significant risk.   (more…)
Author Interviews, Infections / 10.07.2018

MedicalResearch.com Interview with: Thomas A Russo, MD, CM The Departments of Medicine, and Microbiology and Immunology The Witebsky Center for Microbial Pathogenesis University at Buffalo-State University of New York, and the Veterans Administration Western New York Healthcare System Buffalo, New York MedicalResearch.com: What is the background for this study? What is Klebsiella pneumoniae? Response: K. pneumoniae is an important bacterial pathogen that cause a number of different infections. Presently, two pathotypes exist that behave very differently. Classical K. pneumoniae, which is most common in North America and Europe primarily causes infections in the healthcare setting, usually in patients with co-morbidities. Also, it is becoming increasingly antimicrobial resistant, making treatment challenging. Hypervirulent K. pneumoniae, which is more common in the Asian Pacific Rim,  can cause infections in otherwise healthy individuals, often causes infection in multiple sites, and these sites are usually not infected by classical K. pneumonia, such as the eye, brain, and aggressive soft-tissue infection (necrotizing fasciitis). Hypervirulent K. pneumonia strains are also becoming antimicrobial resistant, albeit at a slower rate than classical K. pneumoniae at this time. There are some differences how infections due to these two pathotypes are managed. It would also be ideal to track the prevalence and relative antimicrobial resistance of these two pathotypes, but up until now this could not be reliably done because there was not a validated test that could differentiate them. The goal of this study was to identify biomarkers that could accurately differentiate classical from hypervirulent K. pneumoniae.  (more…)
Author Interviews, Beth Israel Deaconess, HIV, Lancet, Vaccine Studies / 08.07.2018

MedicalResearch.com Interview with: Dan Barouch, M.D., Ph.D. Professor of Medicine Harvard Medical School Ragon Institute of MGH, MIT, and Harvard Director, Center for Virology and Vaccine Research Beth Israel Deaconess Medical Center Boston, MA 02215 MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study demonstrates that the mosaic Ad26/Env HIV vaccine candidate induced robust and comparable immune responses in humans and monkeys. Moreover, the vaccine provided 67% protection against viral challenge in monkeys.    (more…)
Author Interviews, Infections, NEJM / 05.07.2018

MedicalResearch.com Interview with: Dr. Dennis E. Hruby PhD Chief Science Officer of SIGA Technologies Corvallis, OR MedicalResearch.com: What is the background for this study?  Response: Naturally occurring smallpox was declared eradicated in 1980 following coordinated decades-long global vaccination campaigns. However, there is a significant concern that smallpox, which is both highly contagious and highly lethal, could be used as a potential bioweapon. DNA synthesis technology and the possibility of unaccounted for smallpox stocks pose significant risks. While there are two publicly acknowledged stocks of smallpox virus held by the United States and Russia, some believe that additional stores of the virus could be in the hands of governments or organizations that might use them to cause harm. The DNA sequence of the smallpox genome is in the public domain and could potentially be synthesized in a laboratory from scratch or created by genetically modifying a similar virus. Currently, there are no therapies approved for the treatment of smallpox infection. A smallpox bioterror attack could be especially damaging because the majority of today’s population is not immune to the virus, as routine vaccination ended in the 1970s. It is estimated that without vaccination or treatment, each person infected with smallpox would infect 5 - 7 others. Rapid spread from person-to-person can occur through speaking, breathing or touching. Smallpox also can be transmitted by direct contact with infected fluids and contaminated objects. Furthermore, vaccination must occur within 3-5 days of exposure to smallpox, when patients are still asymptomatic, to be effective. These limitations underscore the need for an effective smallpox antiviral therapy, in addition to any available vaccine. (more…)
Author Interviews, Cost of Health Care, Hospital Acquired, Medicare / 02.07.2018

MedicalResearch.com Interview with: Michael S. Calderwood, MD, MPH, FIDSA Regional Hospital Epidemiologist Assistant Professor of Medicine Infectious Disease & International Health MedicalResearch.com: What is the background for this study?   Response: Prior work by Lee et al. (N Engl J Med 2012;367:1428–1437) found that the 2008 CMS Hospital-Acquired Conditions (HAC) policy did not impact already declining national rates of central line-associated bloodstream infections (CLABSIs) or catheter-associated urinary tract infections (CAUTIs). We studied why this policy did not have its intended impact by looking at coding practices and the impact of the policy on the diagnosis-related group (DRG) assignment for Medicare hospitalizations. The DRG assignment determines reimbursement for inpatient hospitalizations. (more…)
Author Interviews, Diabetes, Infections / 27.06.2018

MedicalResearch.com Interview with: Sandrine Levet PhD Preclinical Study Manager GeNeuro MedicalResearch.com: What is the background for this study? Response: Human endogenous retroviruses (HERVs), remnants of ancestral viral genomic insertions, are known to represent 8% of the human genome and are associated with several pathologies. In particular, the envelope protein of HERV-W family (HERV-W Env) has been involved in multiple sclerosis pathogenesis. A previous study published in JCI Insight revealed that HERV-W Env is also involved in Type 1 diabetes (T1D) pathogenesis. In this study, we observed that HERV-W-Env protein and RNA are detected respectively in sera and peripheral blood mononuclear cell (PBMC) of T1D patients. We also demonstrated that this pathogenic protein is expressed by acinar cells in human T1D pancreas and is associated with the recruitment of macrophages within the pancreas of these patients. HERV-W Env also displays direct pathogenic properties as it inhibits insulin secretion by human islets of Langerhans. (more…)
Author Interviews, CDC, HIV, University of Michigan / 26.06.2018

MedicalResearch.com Interview with: Rogério M. Pinto, LCSW, Ph.D. Associate Professor Associate Dean for Research School of Social Work University of Michigan Ann Arbor, Michigan MedicalResearch.com: What is the background for this study? Response: This research, published in Health Education & Behavior (https://doi.org/10.1177/1090198118760681),highlights the crucial role of providers of social and public health services in helping patients to access lifesaving HIV services. Before 2012, providers were encouraged and trained to link patients to behavioral interventions to help patients modify their behaviors to protect themselves against HIV transmission and infection. A shift in policy from targeting anyone at risk to those at highest risk (called “High Impact Prevention”) made these interventions less available (they were actually discontinued) and new policy dictated that providers should have as many people as possible access HIV testing and link them to HIV primary care in order to receive antiretroviral medication. (more…)
Author Interviews, Hospital Acquired, Infections / 22.06.2018

MedicalResearch.com Interview with: Richard Stanton, PhD Health Scientist, Division of Healthcare Quality Promotion Centers for Disease Control and Prevention MedicalResearch.com: What is the background for this study? Response: We used whole genome sequencing (WGS) to investigate an outbreak of carbapenem-resistant Enterobacteriaceae (CRE) that occurred in an acute care hospital in Kentucky over a six month period in late 2016. The outbreak included 18 cases of CRE. (more…)
AHA Journals, Allergies, Author Interviews, Infections, JAMA / 17.06.2018

MedicalResearch.com Interview with: “Lone Star Tick” by Katja Schulz is licensed under CC BY 2.0Jeffrey Wilson, MD, PhD Research Fellow, Allergy & Immunology University of Virginia  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Galactose-α-1,3-galactose (α-Gal) represents an oligosaccharide that is present in mammalian products and is the causal allergen in a syndrome of delayed red meat allergy (commonly called α-Gal syndrome). Sensitization to this allergen has been linked to tick bites, specifically the lone star tick in the United States. Thus, sensitization to α-Gal (and the prevalence of subjects with symptomatic red meat allergy) is relatively common where the lone star tick is common, i.e- the southeast. For a variety of reasons we hypothesized that specific immune sensitization (which relates to IgE antibody production) to α-Gal would be a risk factor for coronary artery disease. To address this possibility we measured IgE specific to α-Gal in 118 adults subjects from central Virginia who had undergone advanced cardiac imaging with a technique called intravascular ultrasound. Out of the cohort 26% of the subjects in the study had the sensitivity to α-Gal. The main finding was that subjects with the IgE sensitization to α-Gal had greater amounts of atherosclerosis, as well as atherosclerotic plaques with more unstable characteristics. This association was significant when controlled for traditional cardiovascular risk factors such as hypertension, diabetes and lipids levels. (more…)
Author Interviews, Environmental Risks, Infections, Zika / 17.06.2018

MedicalResearch.com Interview with: “Bromeliad” by Selena N. B. H. is licensed under CC BY 2.0André Wilke, Ph.D. Post Doctoral Associate Division of Environment & Public Health Department of Public Health Sciences University of Miami Miller School of Medicine Clinical Research Building Miami, Florida 33136 MedicalResearch.com: What is the background for this study? Response: As vector-borne diseases pose an increasing public health threat to communities in South Florida and elsewhere, a new study led by public health researchers at the University of Miami Miller School of Medicine has revealed that ornamental bromeliad plants contribute to breeding of the Aedes aegypti mosquito—a key culprit for the Zika outbreak that hit Miami-Dade County and other areas of Florida and the Americas in 2016. In addition to Zika, bites from the Aedes aegypti mosquito can cause dengue, yellow fever and chikungunya. Zika has been linked to microcephaly and other birth defects in unborn babies when pregnant women contract the disease. The family of diseases linked to the Aedes aegypti can cause other severe symptoms. Yellow fever can be fatal. (more…)
Author Interviews, Infections, OBGYNE, Pediatrics, Vaccine Studies / 17.06.2018

MedicalResearch.com Interview with: Sylvia Becker-Dreps, MD MPH Associate Professor, Department of Family Medicine Associate Director, Office of International Activities (Latin America Focus) Director, UNC Program in Nicaragua University of North Carolina at Chapel Hill Chapel Hill, NC 27599-7595 MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Pertussis (or whooping cough) is a respiratory infection caused by bacteria. It has been becoming more common in the US over the past two decades. Infants are more likely to be hospitalized and die of the disease. They are especially vulnerable in the first months of life because they have not yet had time to complete the DTaP vaccine series themselves. (Currently, infants receive 3 doses of DTaP at 2,4, and 6 months of age.) Immunizing mothers allows the mothers to pass antibodies against pertussis through the placenta and provide passive immunity to infants early in life. In early 2013, the CDC recommended that pregnant women receive a Tdap vaccine in every pregnancy. That recommendation was based on studies of the immune response to the vaccine, not real cases of pertussis. Our study examined clinical cases of pertussis in over 675,000 infants throughout the US. We found that in the first six months of life, infants of vaccinated mothers (those that received Tdap during pregnancy) had 75% less pertussis hospitalizations and 50% less pertussis cases overall.  (more…)
Author Interviews, Hand Washing, Infections, MRSA, Pediatrics / 15.06.2018

MedicalResearch.com Interview with: “Bart Infant” by Bart Everson is licensed under CC BY 2.0Gwen M. Westerling, BSN, RN, CIC Infection Preventionist Helen DeVos Children's Hospital MedicalResearch.com: What is the background for this study? Response: The setting of this study is a Level III Neonatal Intensive Care Unit (NICU) with 106 beds. In 2016, an increase in Hospital Acquired Infections (HAI) was noted in the Neonatal Intensive Care Unit (NICU) caused by Staphylococcus aureus (SA) through diligent Infection Prevention Surveillance. When we reviewed the literature we found the SA is a common skin colonizer and can be a problem for neonates with immature skin and immune systems. Staphylococcus aureus is easily transmitted through direct contact with skin, the contaminated hands of health care workers, the environment and equipment. We also found one study that listed skin to skin care as a risk factor for acquisition of SA. Before we saw the increase in infections some process changes occurred in our NICU that included increased skin to skin care, meaningful touch between neonates and parents, and two person staff care. We hypothesized that the process changes were exposing neonates to increased amounts of Staphylococcus aureus and contributing to the increase in infections. (more…)
Author Interviews, HIV, University of Michigan / 13.06.2018

MedicalResearch.com Interview with: Rogério M. Pinto, LCSW, Ph.D. Associate Professor Associate Dean for Research School of Social Work University of Michigan Ann Arbor, USA MedicalResearch.com: What is the background for this study? Response: This integrative review, published in the journal AIDS and Behavior, includes content from 47 peer-reviewed scholarly articles reporting multiple barriers to high-risk individuals trying to access pre-exposure prophylaxis (PrEP), the HIV drugs that reduce subsequent risk of infection. We found 31 potential solutions to 30 barriers at the patient, provider and health-system levels. In synthesizing this research from a multi-level perspective, based upon a socioecological model, our report contributes much-needed analysis to the rapidly expanding field of PrEP implementation research. At this stage in the scale-up of U.S. PrEP programs, it is important to systematically and comprehensively analyze and integrate knowledge about the successes of and the barriers to PrEP implementation. Our review provides a comprehensive analysis and informs the direction of PrEP implementation across a variety of settings. (more…)