Author Interviews, Primary Care, Respiratory, Telemedicine / 02.10.2018

MedicalResearch.com Interview with: [caption id="attachment_44849" align="alignleft" width="150"]Dr. Kathryn A. Martinez PhD MPH CanSORT Cancer Surveillance and Outcomes Research Team Cleveland Clinic Dr Martinez[/caption] Dr. Kathryn A. Martinez PhD MPH CanSORT Cancer Surveillance and Outcomes Research Team Cleveland Clinic MedicalResearch.com: What is the background for this study? What are the main findings? Response: Most upper respiratory infections are viral and therefore should not be treated with antibiotics. Despite this, physicians commonly prescribe them for these conditions. Patients often expect antibiotics for respiratory tract infections.  As a result, physicians may find it easier to give patients what they want rather than explain to them why antibiotics aren’t needed. We hypothesized it also might be more time consuming for physicians to explain to patients why they don’t need antibiotics, which creates a further incentive to prescribe them. To explore this potential phenomenon, we used data from a large direct to consumer telemedicine system to assess differences in medical encounter length by prescription outcome for patients diagnosed with respiratory tract infections. We found that encounters resulting in antibiotics were 0.33 minutes shorter than those that resulted in no prescriptions, supporting our hypothesis that prescribing an antibiotic takes less time than prescribing nothing.
Author Interviews, JAMA, Urinary Tract Infections, Urology, UT Southwestern / 02.10.2018

MedicalResearch.com Interview with: "Glass of Water" by Iwan Gabovitch is licensed under CC BY 2.0Professor Yair Lotan MD Chief of Urologic Oncology Holder of the Helen J. and Robert S. Strauss Professorship in Urology UT Southwestern Medical Center at Dallas Department of Urology Dallas, Texas 75390-9110  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Urinary tract infections are extremely common in women and many women experience recurrent episodes which impact their quality of life.  There are also many women who do not drink as much water as is recommended. This study found that in healthy women with recurrent UTIs who drink less than 1.5 liters per day, the additional intake of 1.5 liters of water daily reduced the risk of recurrent infections by nearly 50%. 
Author Interviews, Cancer Research, HPV, UCLA / 28.09.2018

MedicalResearch.com Interview with: [caption id="attachment_44899" align="alignleft" width="200"]Manon Eckhardt, PhD Gladstone Institutes Quantitative BioSciences Institute University of California San Francisco  Dr. Manon Eckhardt[/caption] Manon Eckhardt, PhD Gladstone Institutes The Quantitative Biosciences Institute University of California San Francisco  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Infection with Human Papillomavirus (HPV) causes 5% of all cancers worldwide, including cervical cancer and an increasing number of head and neck cancers. Most cancers are caused by mutations in genes, leading to the production of malfunctioning proteins that result in unconstrained cell division. However, certain viruses like HPV can cause cancer without introducing mutations. In this study, we compared cancers of the same type (i.e. head and neck) that are caused by either mutation or virus infection to identify important processes that are dysregulated in both subsets. We hypothesized that identifying which proteins the virus binds can lead the way to prioritize which of the proteins and cellular processes (pathways) that are affected in cancer cells are most important. To do this, we identified the complete set of human proteins that interact with HPV. We next determined genes that were more frequently mutated in non-viral cancers, and combined both data sets. The proteins we find to be both binding to HPV and mutated in non-viral cancers will be potential targets for new, more specific drug development, and help better understand the development of head and neck cancer. From the many pathways we identified in this study, we highlighted two pathways with further mechanistic studies: the oxidative stress response, which helps cancer cells survive, as well as a pathway that allows the cancer to spread to other parts of the body.
Author Interviews, CDC, Infections / 26.09.2018

MedicalResearch.com Interview with: "Siberian Husky Puppies 2013-05-25" by Jeffrey Beall is licensed under CC BY 2.0Mark Laughlin, DVM Veterinary Medical Officer CDC MedicalResearch.com: What is the background for this study? How common are Campylobacter infections?  How does a Campylobacter infection typically present?  Response: Campylobacter is one of the most common causes of diarrheal illness in the United States, causing an estimated 1.3 million illnesses each year. Most people with Campylobacter infection usually have diarrhea (often bloody), fever, and abdominal cramps. The diarrhea may be accompanied by nausea and vomiting. These symptoms usually start within 2 to 5 days after exposure and last about a week. Most illnesses from Campylobacter likely occur due to eating raw or undercooked poultry, or from eating something that touched raw or undercooked poultry. Some illnesses can occur from contact with contaminated water, contact with animals, or from drinking raw (unpasteurized) milk. Since 2009, 13 outbreaks of human Campylobacter infections linked to contact with dogs have been reported to CDC. These outbreaks account for a reported 47 illnesses and 2 hospitalizations.
Antibiotic Resistance, Author Interviews, Infections / 25.09.2018

MedicalResearch.com Interview with: "pseudomonas first bacteria to be patented. professor Chakrabarty" by adrigu is licensed under CC BY 2.0Dr Dorival Martins Department of Microbiology and Immunology Meakins-Christie Laboratories, Research Institute McGill University Health Centre Montreal Canada.  MedicalResearch.com: What is the background for this study? Response: Antibiotic tolerance, together with drug resistance, makes bacteria refractory to antibiotics and can cause treatment failure in subacute and chronic bacterial infections. Pseudomonas aeruginosa, a major health concern worldwide, can cause severe chronic infections that are refractory to antibiotic treatments due to tolerance. Since the discovery of new antibiotics has been drastically diminished over the last decades, overcoming tolerance could be a strategy to enhance the efficacy of currently available antibiotic treatments. However, very little is known about the mechanism of tolerance, even though this phenomenon has been observed over 60 years ago.
Author Interviews, Infections, Technology, Urinary Tract Infections / 24.09.2018

MedicalResearch.com Interview with: SMARTPHONE, M.D. A NEW APP TO DIAGNOSE URINARY TRACT INFECTIONS Michael J. Mahan PhD Professor, Microbiology and Molecular Genetics Dept of Molecular, Cellular, and Developmental Biology University of California, Santa Barbara, CA MedicalResearch.com: What is the background for this study? What are the main findings? Response: Urinary tract infections (UTIs) cause nearly 10 million doctor visits each year in the United States. Women are much more likely to have a UTI than men, and are particularly harmful to pregnant women and can cause miscarriage. Thus, there is a medical need for rapid, low-cost, on-site testing — particularly in resource-limited settings. We developed a new app that enables a smartphone to identify (ID) bacteria causing UTIs in just one hour — a fraction of the time and cost of clinical diagnostics.
Author Interviews, Cancer Research, Cost of Health Care, ENT, HPV, JAMA, Surgical Research / 18.09.2018

MedicalResearch.com Interview with: [caption id="attachment_44611" align="alignleft" width="133"]Richard B. Cannon, MD Division of Otolaryngology–Head and Neck Surgery School of Medicine University of Utah, Salt Lake City  Dr. Cannon[/caption] Richard B. Cannon, MD Division of Otolaryngology–Head and Neck Surgery School of Medicine University of Utah, Salt Lake City  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The Patient Protection and Affordable Care Act (ACA) is a nationwide effort to reduce the number of uninsured individuals in the United States and increase access to health care. This legislation is commonly debated and objective data is needed to evaluate its impact.  As a head and neck cancer surgeon, I sought to evaluate how the ACA had specifically influenced my patients.  Main findings below:     MedicalResearch.com: What should readers take away from your report? Response: This population-based study found an increase in the percentage of patients enrolled in Medicaid and private insurance and a large decrease in the rates of uninsured patients after implementation of the Patient Protection and Affordable Care Act (ACA).  This change was only seen in states that adopted the Medicaid expansion in 2014. The decrease in the rate of uninsured patients was significant, 6.2% before versus 3.0% after. Patients who were uninsured prior to the Patient Protection and Affordable Care Act had poorer survival outcomes.
Author Interviews, Infections, Kidney Disease / 18.09.2018

MedicalResearch.com Interview with: [caption id="attachment_44597" align="alignleft" width="182"]Ben Roediger PhD Head of the Skin Inflammation Group within Professor Wolfgang Weninger’s Immune Imaging Laboratory Centenary Institute, Faculty of Medicine and Health, The University of Sydney,  Camperdown,, Australia Dr. Roediger[/caption] Ben Roediger PhD Head of the Skin Inflammation Group within Professor Wolfgang Weninger’s Immune Imaging Laboratory Centenary Institute, Faculty of Medicine and Health, The University of Sydney, Camperdown,, Australia MedicalResearch.com: What is the background for this study? Response: We use several strains of mice for our research, including animals with immunodeficiencies. One of our lines started succumbing to kidney disease and we decided to investigate.
Author Interviews, Infections, Pulmonary Disease, Stanford / 15.09.2018

MedicalResearch.com Interview with: [caption id="attachment_44541" align="alignleft" width="200"]Stephen J Ruoss MD Professor, Stanford University, Medicine, Division of Pulmonary and Cfritical Care Medicine Stanford, California Dr. Ruoss[/caption] Stephen J Ruoss MD Professor, Stanford University, Medicine, Division of Pulmonary and Cfritical Care Medicine Stanford, California MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by an atypical mycobacterial infection?  Response: Our interest in undertaking this study stems from three important clinical observations and issues. First, the use of inhaled steroid medications for a broad variety of respiratory complaints and diseases is increasing, including in clinical circumstances where there isn’t much strong supportive evidence for benefit to patients from using inhaled steroids. The second observation is that steroids can and do alter immune system responses, and can increase the risk for some infections. There are already data from studying patients on inhaled steroids where the incidence of bacterial respiratory infections has increased, supporting the concerns for infection risk from inhaled steroids. And the third issue is that steroids can more specifically alter immune system function that helps combat mycobacterial infections, and this means that the risk for, and incidence of mycobacterial infections could be increased in patients treated with inhaled steroids. The best known mycobacterial infection is of course tuberculosis, but there are other mycobacteria, called nontuberculous mycobacterial (or atypical mycobacterial) that are broadly found in the environment, and some of those nontuberculous mycobacteria (NTM) can cause lung infections. So our hypothesis was that the use of inhaled steroids might be associated with an increased frequency of NTM infections, and we designed the study to explore that hypothesis.
Author Interviews, Cancer Research, Gastrointestinal Disease, Infections / 14.09.2018

MedicalResearch.com Interview with: [caption id="attachment_44516" align="alignleft" width="200"]Nina R. Salama. PhD Member Human Biology Division Member Public Health Sciences Division Affiliate Member Basic Sciences Division Dr. Penny E. Petersen Memorial Chair for Lymphoma Research  Director of Molecular and Cellular Biology (MCB) Graduate Program Fred Hutchinson Cancer Research Center Dr. Salama[/caption] Nina R. Salama. PhD Member Human Biology Division Member Public Health Sciences Division Affiliate Member Basic Sciences Division Dr. Penny E. Petersen Memorial Chair for Lymphoma Research Director of Molecular and Cellular Biology (MCB) Graduate Program Fred Hutchinson Cancer Research Center  MedicalResearch.com: What is the background for this study? What are the main findings? Response: We wanted to better understand why certain patients infected with H. pylori developed stomach cancer and how we could better identify them. H. pylori is one of the strongest risk factors for stomach cancer, but how much it predisposes individuals to gastric cancer varies around the world. Working closely with colleagues from Zhengzhou University, we ran tests on 49 samples from China and found that 91 percent of patients infected with the EPIYA D gene variant of H. pylori also had stomach cancer.
Author Interviews, Cost of Health Care, Global Health, Infections, Vaccine Studies / 13.09.2018

MedicalResearch.com Interview with: [caption id="attachment_44471" align="alignleft" width="200"] Measles[/caption] Veronica Toffolutti PhD Research Fellow in Health Economics Bocconi University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Austerity has been linked to several health damaging effects such as suicides, increase in unmet needs, disease outbreaks that affect vulnerable peoples such as malaria in Greece, HIV in Greece and Romania during the current economic crises or in the earlier economic crisis cuts in public health expenditure have been linked with diphtheria and TB. Europe is experiencing declining vaccination rates and resurgences in measles incidence rates. Italy appears to be particularly affected reporting the second largest number, second to Romania, of infection in Europe in 2017. Starting from the point that the primary reason for the outbreak in the decline in the measles vaccination we test the hypothesis that large budget reductions in public health spending were also a contributing factor. Using data on 20 Italian regions for the period 2000-2014 we found that each 1% reduction in the real per capita public health expenditure was associated with a decrease of 0.5 percentage points (95% CI: 0.36-0.65 percentage points) in MMR coverage, after adjusting for time and regional-specific time-trends. 
Author Interviews, Critical Care - Intensive Care - ICUs, Infections, JAMA / 12.09.2018

MedicalResearch.com Interview with: [caption id="attachment_44416" align="alignleft" width="200"]Patrick Harris FRACP Staff Specialist Microbiology | Pathology Queensland | Health Support Queensland Postdoctoral Research Fellow University of Queensland, UQ Centre for Clinical Research (Paterson Group) Dr. Harris[/caption] Patrick Harris FRACP Staff Specialist Microbiology | Pathology Queensland | Health Support Queensland Postdoctoral Research Fellow University of Queensland, UQ Centre for Clinical Research (Paterson Group MedicalResearch.com: What is the background for this study? Response: Increasingly, common bacterial pathogens such as E. coli or Klebsiella have acquired genes known as extended-spectrum beta-lactamases (ESBLs), which mediate resistance to many of our most important antibiotics. Despite their clinical importance, we have limited information derived from randomised clinical trials on the best antibiotic treatments for life-threatening infections caused by these ESBL-producers. We aimed to compare two readily available antibiotics, meropenem (a carbapenem drug, as the “standard of care”) and piperacillin-tazobactam (which may be an alternative to meropenem). Many ESBL-producing bacteria test susceptible to piperacillin-tazobactam in the laboratory, yet clinical efficacy has been uncertain.  Some observational studies have suggested that piperacillin-tazobactam may be effective against ESBL-producers, but the data have been contradictory.  The theory has been that piperacillin-tazobactam may be less likely to select for resistance to carbapenems - which, when it occurs, can result in infection with bacteria that are almost untreatable.
Author Interviews, JAMA, OBGYNE, STD, USPSTF / 09.09.2018

MedicalResearch.com Interview with: [caption id="attachment_44364" align="alignleft" width="170"]Melissa A. Simon, M.D., M.P.H. Member, U.S. Preventive Services Task Force George H. Gardner professor of clinical gynecology, Vice chair of clinical research Department of Obstetrics and Gynecology Professor of preventive medicine and medical social sciences Northwestern University Feinberg School of Medicine Dr. Simon[/caption] Melissa A. Simon, M.D., M.P.H. Member, U.S. Preventive Services Task Force George H. Gardner professor of clinical gynecology, Vice chair of clinical research Department of Obstetrics and Gynecology Professor of preventive medicine and medical social sciences Northwestern University Feinberg School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: The number of babies born with syphilis is increasing, mirroring the recent increase of syphilis among women. Syphilis infection passed from a pregnant woman to her baby, also known as congenital syphilis, can lead to serious health complications for the baby including premature birth, low birthweight, birth defects, and even death. The Task Force recommends that all pregnant women be screened for syphilis as early in pregnancy as possible to prevent congenital syphilis. 
Author Interviews, Gastrointestinal Disease, Infections, JAMA, Pediatrics, Vaccine Studies / 07.09.2018

MedicalResearch.com Interview with: [caption id="attachment_44279" align="alignleft" width="166"]Chuanxi Fu, MD.PhD. Professor of Epidemiology, School of Public Health Zhejiang Chinese Medical University Associate editor, Human Vaccines & Immunotherapeutics Dr. Chuanxi Fu[/caption] Chuanxi Fu, MD.PhD. Professor of Epidemiology, School of Public Health Zhejiang Chinese Medical University Associate editor, Human Vaccines & Immunotherapeutics  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Since 2000, the Lanzhou lamb rotavirus vaccine has been exclusively licensed in China for voluntary rotavirus gastroenteritis prevention, however, the effects of the vaccination on population health, including any indirect impact to unvaccinated individuals have not been evaluated. In the study enrolled 33 407 patients with rotavirus gastroenteritis from 2007 to 2015 seasons in southern China shows vaccination effects in which the median age at onset increased by 4 months, and onset, peak, and cessation of incidence were delayed. The incidence rate ratio among children younger than 4 years and among children ineligible for vaccination decreased as citywide vaccination coverage increased, and the adjusted odds ratio for rotavirus gastroenteritis among unvaccinated infants decreased in areas with higher vaccination coverage. 
Author Interviews, Heart Disease, Infections, JAMA / 27.08.2018

MedicalResearch.com Interview with: [caption id="attachment_44113" align="alignleft" width="200"]Sheep tick - vector for Coxiella burnetii, the cause of the disease known as Q fever CDC image Sheep tick - vector for Coxiella burnetii, the cause of the disease known as Q fever CDC image[/caption] Pr. Didier Raoult Directeur de l'IHU Méditerranée-Infection Marseille  MedicalResearch.com: What is the background for this study? What are the main findings? Response: This work represents the sum of data accumulated over several decades of studies on Q fever. Our reference center contacts each of the physicians in charge and ensures patient follow-up, which allows obtaining data, that is not comparable to those used automatically in databanks. Four people exclusively dedicated their time to manage these specific data on Q fever. The main data confirm the need to perform a cardiac ultrasound for all patients with Q fever and acute endocarditis (to detect valvulopathy) and to give a prophylactic treatment to avoid fixation on the heart in patients with valvulopathy. This work helps clarify the evolution of Q fever by eliminating the term of chronic Q fever, which is based on non-clinical elements, and defining persistent Q fever for which there is an identifiable focus of infection. Furthermore, this work makes it possible to recommend systematic detection of antiphospholipid antibodies in order to limit the risk of thrombosis and the risk of cardiac fixation.
Allergies, Author Interviews, CDC, Infections, Pediatrics / 25.08.2018

MedicalResearch.com Interview with: Maribeth C. Lovegrove, MPH Division of Healthcare Quality Promotion Centers for Disease Control and Prevention Atlanta, GA 30333). MedicalResearch.com: What is the background for this study? What are the main findings? Response: There has been a lot of recent attention on reducing unnecessary antibiotic prescribing in order to reduce antibiotic resistance (a longer-term harm).  However, antibiotic use also can lead to shorter-term harms like allergic reactions and other side effects.  With this analysis, we wanted to focus on the acute harms to individual pediatric patients from antibiotic use in order to help target prevention efforts.  Specifically, we used data from two national data sources to identify the antibiotics with the highest numbers of emergency department visits for adverse drug events and the highest rates of emergency department visits for adverse drug events (accounting for amount of antibiotic prescriptions dispensed) and to identify the pediatric patients with the highest risks.
Author Interviews, HIV, NEJM, Yale / 17.08.2018

MedicalResearch.com Interview with: [caption id="attachment_43945" align="alignleft" width="149"]Brinda Emu, MD Assistant Professor of Medicine (Infectious Diseases) Yale School of Medicine Dr. Emu[/caption] 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.
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.
Author Interviews, Cancer Research, Gastrointestinal Disease, HIV, JAMA / 05.08.2018

MedicalResearch.com Interview with: [caption id="attachment_43740" align="alignleft" width="200"]Barrett's Esophagus -wikipedia Barrett's Esophagus -wikipedia[/caption] 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.
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. 
Author Interviews, CDC, Infections / 26.07.2018

MedicalResearch.com Interview with: [caption id="attachment_43528" align="alignleft" width="200"]https://www.cdc.gov/salmonella/backyard-flocks-06-18/index.html Dr. Megin Nichols[/caption] 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.
Author Interviews, Flu - Influenza, Genentech / 26.07.2018

MedicalResearch.com Interview with: [caption id="attachment_43512" align="alignleft" width="200"]Mark Eisner MD MPH Vice President and Global Head of Respiratory Actemra, ID, and Metabolism Clinical Development at Genentech Professor of Clinical Medicine University of California, San Francisco Dr. Mark Eisner[/caption] 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.
Author Interviews, HIV, JAMA / 25.07.2018

MedicalResearch.com Interview with: [caption id="attachment_43405" align="alignleft" width="150"]Michael S. Saag, MD Professor,Division of Infectious Diseases UAB Dr. Saag[/caption] 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
Author Interviews, Global Health, HIV / 25.07.2018

MedicalResearch.com Interview with: [caption id="attachment_43466" align="alignleft" width="200"]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 Dr. Spiegelman[/caption] 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.
Author Interviews, Critical Care - Intensive Care - ICUs, Infections, JAMA, Pediatrics, University of Pittsburgh / 25.07.2018

MedicalResearch.com Interview with: [caption id="attachment_43386" align="alignleft" width="200"]Idris V.R. Evans, M.D.,MA Assistant Professor Department of Critical Care Medicine University of Pittsburgh Dr. Evans[/caption] 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. 
Author Interviews, Cancer Research, ENT, HPV / 25.07.2018

MedicalResearch.com Interview with: [caption id="attachment_43416" align="alignleft" width="200"]Eric Adjei Boakye, PhD, MA Saint Louis University Center for Health Outcomes Research (SLUCOR) St. Louis, Missouri Dr. Boakye[/caption] 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%).
Author Interviews, HIV, OBGYNE, Pediatrics, Pediatrics, STD / 24.07.2018

MedicalResearch.com Interview with: [caption id="attachment_43452" align="alignleft" width="135"]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 Dr. Goyal[/caption] 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.
Author Interviews, Biomarkers, Infections / 21.07.2018

MedicalResearch.com Interview with: [caption id="attachment_43348" align="alignleft" width="200"]David K. Hong, M.D. VP Medical Affairs and Clinical Development at Karius Dr. Hong[/caption] 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.
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.