Alzheimer's - Dementia, Author Interviews, Infections, Neurology, Parkinson's / 22.09.2017

MedicalResearch.com Interview with: Rima McLeod, M.D., F.A.C.P, F.I.D.S.A Professor of Ophthalmology and Visual Sciences,Pediatrics (Infectious Diseases), and The College, Director, Toxoplasmosis Center, Senior Fellow,Institute of Genomics, Genetics and Systems Biology, Member, Commitees on Immunology, and Molecular Medicine and Pathogenesis, Member Global Health Center, Affiliate CHeSS; Attending Physician, Chicago Medicine, The University of Chicago MedicalResearch.com: What is the background for this study? * One third of humans are infected lifelong with the brain-dwelling, protozoan parasite, Toxoplasma gondii. * Approximately fifteen million of these have congenital toxoplasmosis. * The parasite interconverts between slow-growing, encysted bradyzoites and rapid-growing tachyzoites. * In mice, T. gondii creates a chronic intra-neuronal infection and an inflammatory process. * Mice with acute and chronic infection have alterations in neurotransmitters, memory, seizures, and neurobehavior. * Some epidemiologic-serologic studies show associations between seropositivity for T. gondii and human neurologic diseases, for example, Parkinson’s and Alzheimer’s diseases. * Although neurobehavioral disease is associated with seropositivity, causality is unproven. * Serologic studies of humans with diverse genetics are not optimal to detect strong associations or directionality. * Epidemiologic associations also do not reveal parasite-modulated gene networks in human brain that could provide insights into how to cure and prevent resultant diseases. * We need integrative approaches to examine relationships between brain parasitism and other brain diseases, to provide a foundation to identify key pathways and molecules for drug and vaccine design * To address these problems, we considered two central questions: (i) If chronic brain parasitism associates with other neurologic diseases, what are they? And (ii) Which macromolecular networks are modulated by the parasite in human brain that lead to neuropathology which could underpin and facilitate design of treatments? * We hypothesized that a systems approach integrating multiple levels of host parasite interactions might resolve these questions. * To better understand what this parasite does to human brains, we performed a comprehensive systems analysis of the infected brain.  (more…)
Author Interviews, Infections, JAMA, OBGYNE, Surgical Research, Weight Research / 20.09.2017

MedicalResearch.com Interview with: Dr. Carri R. Warshak, MD Associate Professor of Obstetrics & Gynecology University of  Cincinnati MedicalResearch.com: What is the background for this study? Response: Cesarean deliveries are the most common major surgical procedure performed in the United States.  A common complication of cesarean section is wound infections that can include infections in the skin and incision site, or infections in the uterus itself after delivery.  These complications can lead to prolonged hospitalization after delivery for antibiotics and even further surgery in severe infections.  Often these wound complications lead to delayed healing, wound opening which can sometimes take several weeks to heal. Studies have demonstrated as many as 12% of women experience a surgical site infection after delivery. Obesity is a strong risk factor for increased surgical site infections.  Increasing maternal weight increases the risk of wound complications, with a two to five fold increase in risk, making surgical site infections and common and concerning complication of cesarean delivery in obese women. (more…)
Author Interviews, Emergency Care, Infections, Pediatrics, Technology / 19.09.2017

MedicalResearch.com Interview with: Prof. Alain Gervaix Head of the Emergency Division Department of Children and Adolescents University Hospitals of Geneva Switzerland MedicalResearch.com: What is the background for this study? Response: Many are familiar with the following ‘seemingly’ simple clinical dilemma that occurs on a daily basis across the world. A patient visits the doctor with a fever. Commonly, assigning a diagnosis comes down to deciding whether the infection is bacterial or viral. Accordingly, the doctor decides if to treat or not to treat with antibiotics. The problem is that bacterial and viral infections often present with very similar symptoms, causing uncertainty that leads to antibiotics being used, in many instances, when they are not needed. This antibiotic misuse contributes to the rise of antimicrobial resistance, one of the biggest health threats of the 21st century. Host biomarkers hold great promise as routine diagnostic tools that can assist doctors in making correct antibiotic treatment decisions, as they overcome key limitations of currently applied pathogen-based tests. Recently, a novel host-assay (ImmunoXpert™) for differentiating bacterial from viral infections was developed and validated to yield high sensitivity and specificity. The three-protein host-assay comprises tumor necrosis factor-related apoptosis-inducing ligand (TRAIL), Interferon gamma-induced protein-10 (IP-10) and C-reactive protein (CRP). (more…)
Author Interviews, Diabetes, Flu - Influenza, Genetic Research / 19.09.2017

MedicalResearch.com Interview with: Paz Lopez-Doriga Ruiz MD, PhD candidate Norwegian Institute of Public Health Department of Non Communicable Diseases OsloPaz Lopez-Doriga Ruiz MD, PhD candidate Norwegian Institute of Public Health Department of Non Communicable Diseases Oslo  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Some case reports have linked pandemic influenza to the development of type 1 diabetes. Other studies have suggested that also respiratory infections may contribute to type 1 diabetes risk.  Our findings supports a suggested role of respiratory infections in the etiology of type 1 diabetes and influenza virus could be a contributing factor to the development of clinical diabetes, due to stress and inflammation in predisposed individuals. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Infections, JAMA / 15.09.2017

MedicalResearch.com Interview with: Dr. Chanu Rhee MD, Assistant Professor Therapeutics Research and Infectious Disease Epidemiology Group Department of Population Medicine at Harvard Medical School / Harvard Pilgrim Health Care Institute Critical Care and Infectious Disease Physician Transplant/Oncology Infectious Disease service and Medical Intensive Care Unit at Brigham and Women’s Hospital  MedicalResearch.com: What is the background for this study? Response: Multiple studies suggest that the incidence of sepsis, the syndrome of life-threatening organ dysfunction caused by infection, is increasing over time, while mortality rates are decreasing.  However, reliably measuring sepsis incidence and trends is challenging because clinical diagnoses of sepsis are subjective and insurance claims data, the traditional method of surveillance, can be affected by changing diagnosis and coding practices over time. In this study, my colleagues and I estimated the current U.S. burden of sepsis and trends using clinical data from the electronic health record systems of a large number of diverse hospitals. The findings, published in JAMA, challenge the use of claims data for sepsis surveillance and suggest that clinical surveillance using electronic health record data provides more objective estimates of sepsis incidence and outcomes. (more…)
Author Interviews, Infections, NEJM / 14.09.2017

MedicalResearch.com Interview with: Susan E. Dorman, M.D Associate Professor of Medicine, Division of Infectious Diseases Johns Hopkins University School of Medicine, Baltimore MedicalResearch.com: What is the background for this study? What are the main findings? Response: Tuberculosis, also called “TB” is one of the top 10 causes of death worldwide, according to the World Health Organization.  TB is caused by bacteria called Mycobacterium tuberculosis.  In 2015, over 10 million people became sick from TB and 1.8 million people died from TB.  This is a lot of people – diagnosing and treating TB to improve their health is important.  Because TB usually involves the lungs, it can be passed from person to person through the air, and thus, diagnosing and treating TB is critical to  reduce the spread of TB.   Drug-resistant TB -- TB caused by bacteria that are resistant to commonly used TB antibiotics -- is a serious problem.  In 2015 an estimated 480,000 people had multidrug-resistant TB. We have been working to develop better, faster ways to diagnose TB and drug-resistant TB.  A new test was developed as a partnership between Rutgers University and Cepheid (Sunnyvale, CA), and development was supported by the US National Institutes of Health (NIH).  The new test was designed to detect Mycobacterium tuberculosis bacteria in sputum, and to simultaneously detect whether the bacteria are resistant to several of the main antibiotics (isoniazid, fluoroquinolones, and aminoglycosides) used to treat TB.  The test takes about two hours from sample to result. The NEJM article describes the results of a study that was undertaken in China and South Korea to understand how well the new test works, compared against gold standard tests. (more…)
Annals Internal Medicine, Author Interviews, Flu - Influenza, Merck, Technology / 11.09.2017

MedicalResearch.com Interview with: Jesse Papenburg, MD MSc FRCPC FRQS Clinical Research Scholar Assistant Professor of Pediatrics, McGill University Div. of Pediatric Infectious Diseases, Dept. of Microbiology Montreal Children’s Hospital Montreal, QC  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Influenza viruses cause yearly epidemics of acute respiratory illness affecting 5 to 30 percent of the population. Diagnosing influenza on the basis of only clinical symptoms is difficult because its manifestations vary and are nonspecific. Reverse transcriptase polymerase chain reaction (RT-PCR) is the gold standard for flu diagnosis, but these tests must be sent to a laboratory and have turnaround times that extend beyond the clinical encounter. Rapid and accurate diagnosis of influenza has the potential to improve patient outcomes and decrease health care costs. Since 2011, two novel classes of rapid influenza diagnostic assays i.e., with results available in <30 minutes, have been commercialized with claims of improved sensitivities based on technological improvements: 1) automated immunochromatographic antigen detection tests (digital immunoassays, DIAs) and 2) rapid nucleic acid amplification tests (NAATs). Our systematic review and meta-analysis synthesized the available evidence and compared the diagnostic accuracy of commercially available rapid tests for the detection of influenza A and B infection:
  • Overall, the rapid tests displayed very high specificities (≥98%). Physicians can therefore diagnose influenza with confidence on the basis of a positive RIDT, DIA, or rapid NAAT result.
  • The pooled sensitivities for DIAs (80.0% for influenza A and 76.8% for influenza B) and rapid NAATs (91.6% for influenza A and 95.4% for influenza B) are markedly higher than those for RIDTs (54.4% for influenza A and 53.2% for influenza B).
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Author Interviews, CDC, Infections, Vaccine Studies / 08.09.2017

MedicalResearch.com Interview with: Cristina V. Cardemil, M.D., M.P.H. Pediatrics, Primary Care, Public Health Centers for Disease Control and Prevention Atlanta, GA 30333  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The effect of a third dose of the measles–mumps–rubella (MMR) vaccine in stemming a mumps outbreak is unknown. During an outbreak among vaccinated students at the University of Iowa, health officials implemented a widespread MMR vaccine campaign. We evaluated the effectiveness of a third dose of MMR vaccine in preventing mumps cases during the outbreak, and assessed for waning immunity. Of 20,496 university students enrolled in the 2015-16 academic year, 259 developed mumps. Prior to the outbreak, 98.1% of students had received two or more doses of MMR vaccine. During the outbreak, 4,783 students received a third dose. The attack rate was lower among students who received a third dose of MMR vs. 2-dose recipients (6.7 vs. 14.5 per 1,000, respectively). Students had at least nine times greater risk of getting mumps if they received their second dose of MMR 13 years or more prior to the outbreak. Individuals who received a third MMR vaccine dose had a 78% lower risk for mumps than individuals who had received only two doses. This study demonstrates a lower risk of mumps in 3-dose MMR vaccine recipients, suggesting the MMR vaccine dose campaign prevented cases and may have helped stop the spread of the outbreak. Waning immunity likely contributed to the spread of the outbreak. (more…)
Author Interviews, Brain Cancer - Brain Tumors, Zika / 07.09.2017

MedicalResearch.com Interview with: Milan G. Chheda, MD Assistant Professor Department of Medicine Oncology Division Molecular Oncology Department of Neurology Washington University School of Medicine in St. Louis MedicalResearch.com: What is the background for this study? What are the main findings? Response: Glioblastoma is an extremely aggressive brain tumor. Most patients die in less than two years. A longstanding challenge has been killing tumor cells that are inherently resistant to our current therapies (radiation and chemotherapy). These cells, called cancer stem cells, are extremely hardy. A longstanding dream of oncologists has been to devise a way to find them and kill them. The public health epidemic in 2015 made Zhe Zhu, post-doctoral fellow in Jeremy Rich’s lab, wonder whether Zika virus could work on cancer stem cells, that share properties with stem cells in fetal brain. Zika virus doesn’t cause significant problems in adults. We took a lesson from nature and tested Zika virus. (more…)
Author Interviews, Infections, JAMA / 05.09.2017

MedicalResearch.com Interview with: Cinnamon S. Bloss, Ph.D. Associate Professor, Department of Psychiatry Department of Family Medicine and Public Health Division of Health Policy University of California, San Diego MedicalResearch.com: What is the background for this study? Response: In 2016, the FDA invited public comments on a draft environmental assessment for a proposed field trial of a genetically modified (GM) mosquito designed to suppress wild-type Aedes aegypti mosquitoes. The preliminary finding from the environmental assessment indicated the trial would be unlikely to adversely affect the environment in Key Haven, Florida, the proposed trial site. We assessed public response to this trial based on the content of public comments submitted to the FDA by requesting comment transcripts through the Freedom of Information Act. (more…)
Author Interviews, Dermatology, Infections / 02.09.2017

MedicalResearch.com Interview with: Kyle T. Amber, MD Department of Dermatology UC Irvine Health Irvine, CA 92697  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Patients with autoimmune blistering diseases often requires significant immunosuppression in order to control their diseases. Pneumocystis pneumonia is an opportunistic infection that occurs in immunocompromised patients.  This study was borne out of my observation that most European experts in the treatment of autoimmune blistering disease did not give routine prophylaxis for pneumocystis. Among American dermatologists, there was far more disagreement. This was a collaborative effort of several international tertiary care centers. We demonstrated that the incidence of pneumocystis in 801 patients with autoimmune blistering disease was only 0.1%, which fell well below previous recommendations in the literature suggesting an incidence of 3.5% in order to justify prophylaxis. (more…)
Author Interviews, Cancer Research, HIV, JAMA / 29.08.2017

MedicalResearch.com Interview with: Fahad Mukhtar MD MPH Department of Epidemiology and Biostatistics College of Public Health University of South Florida, Tampa MedicalResearch.com: What is the background for this study? What are the main findings? Response: Studies done in the 80s and 90s showed that patients with Kaposi sarcoma may be at risk of having secondary tumors. As a result of changes that have taken place in the demographics of patients affected with HIV/AIDS as well as Kaposi’s sarcoma, we hypothesized that tumors that follow Kaposi sarcoma might have also changed. We analyzed the incidence of second tumors developing after Kaposi sarcoma using the Surveillance Epidemiology and End Result (SEER) data. Our result indicated that the incidence of secondary tumors following Kaposi sarcoma have decreased after the emergence of antiretroviral therapy. However, we observed a significantly higher than expected number of cancer of the anus, liver, tongue, penis lymphomas, and acute lymphocytic leukemia developing in patients with Kaposi sarcoma in the era of antiretroviral therapy. (more…)
Author Interviews, Cancer Research, Cost of Health Care, HPV, University Texas / 25.08.2017

MedicalResearch.com Interview with: David R. Lairson, PhD Professor of health economics Department of Management, Policy, and Community Health The University of Texas Health Science Center at Houston (UTHealth) School of Public Health MedicalResearch.com: What is the background for this study? What are the main findings? Response: The study of oropharyngeal cancer treatment cost was initiated by the Head and Neck Cancer Surgery Department at the University of Texas MD Anderson Cancer Center as part of a larger study of the economic and health consequences of human papillomavirus (HPV) related conditions in Texas.  State specific information is required for policy-makers to consider future investments in cancer prevention based on HPV immunization and cancer screening.  The cost estimates at $140,000 per case for the first two years of treatment are substantially higher than previous estimates.  They indicate the potential savings associated with cancer prevention and partially justify increased investment in immunization efforts. (more…)
Author Interviews, Cancer Research, Gastrointestinal Disease, Infections, Nature, Stem Cells / 20.08.2017

MedicalResearch.com Interview with: Michael Sigal PhD Clinical scientist of the Charité -- Universitätsmedizin Berlin Investigator at the Max Planck Institute for Infection Biology  MedicalResearch.com: What is the background for this study? What are the main findings? Response: We have previously found that H. pylori can colonize gastric glands and that in colonized glands the epithelial turnover was increased. We wanted to characterize the mechanisms that control the gland turnover in the stomach. We found that Axin2, a classic Wnt target gene, marks two different subpopulations of cells with stem cell properties, one of which is Lgr5-positive and the other one Lgr5-negative. Both populations are affected by Rspondin 3, that is produced in myofibroblasts right beneath the stem cell compartment. Rspondin is crucial for stem cell signaling and knockout of Rspondin 3 in myofibroblasts results in loss of Lgr5 and Axin2 expression. Once we increased the bioavailability of Rspondin, that now could also interact with cells outside of the stem cell compartment, we noticed that the number of Axin2 positive stem cells dramatically increased. Of interest, only Lgr5-negative cells expanded in number and proliferate more, while the Lgr5-positive cells remained silenced. Infection with Helicobacter pylori leads to an expansion of Axin2-positive cells which is driven by increased expression of Rspondin3. Expansion of the long lived stem cell pool could be an explanation for how H. pylori infection increases the risk for gastric cancer. (more…)
Author Interviews, CDC, Infections, Ophthalmology, Pediatrics / 18.08.2017

MedicalResearch.com Interview with: Dr. Jennifer R. Cope MD Medical Officer Division of Foodborne, Waterborne, and Environmental Diseases National Center for Emerging and Zoonotic Infectious Diseases CDC MedicalResearch.com: What is the background for this study? What are the main findings? Response: Wearing contact lenses can increase your chances of getting a severe eye infection. Eye infections can lead to serious problems, including blindness. All contact lens wearers can help prevent serious eye infections by correctly wearing and caring for their contact lenses. Eighty-one percent of young adults, 85% of adolescents, and 88% of older adults regularly did at least one risky behavior related to their contact lenses. The most frequently reported risk behaviors in adolescents were not visiting an eye doctor as least annually, sleeping or napping in lenses, and swimming in lenses. Among young adults and older adults, the most frequently reported risk behaviors were replacing lenses at intervals longer than those prescribed, replacing lens storage cases at intervals longer than those recommended, swimming in lenses, and sleeping or napping in lenses. (more…)
Author Interviews, Cancer Research, CMAJ, HPV, Vaccine Studies / 14.08.2017

MedicalResearch.com Interview with: Steven Habbous MSc, PhD candidate Ontario Cancer Institute Scarborough, Ontario, Canada MedicalResearch.com: What is the background for this study? Response: Human papillomavirus (HPV) is a strong risk factor for oropharyngeal cancers (a subset of head and neck cancers). Because HPV-related oropharyngeal cancers generally respond well to treatment and may be prevented through HPV vaccination, it is critical to be able to accurately estimate the incidence and prevalence of this disease. Only recently, however, has testing for HPV become routine at most cancer centres across Canada.  As a result, attempts to estimate the growth of HPV-related oropharyngeal cancer over time may be inaccurate. (more…)
Author Interviews, Flu - Influenza, Kaiser Permanente, Merck, NEJM, Vaccine Studies / 10.08.2017

MedicalResearch.com Interview with: Michael Jackson  PhD, MPH Kaiser Permanente Washington Health Research Institute (KPWHRI) principal investigator for the United States Influenza Vaccine Effectiveness Network  MedicalResearch.com: What is the background for this study?
  • Response: Each year, Kaiser Permanente Washington is one of five sites across the country that participate in the United States Influenza Vaccine Effectiveness Network. The Network reports its early interim results in the MMWRand presents additional interim results to the Advisory Committee on Immunization Practices (ACIP). This New England Journal of Medicine publication is an update of those interim results.
  • The findings in this New England Journal of Medicine are special because prior randomized controlled trials indicated that the nasal spray vaccine (FluMist)—also called live attenuated influenza vaccine (LAIV)—would work well to protect children and teens from the flu, whereas in actual practice we found that the flu shot worked much better, particularly against the predominant strain, A(H1N1)pdm09.
  • The nasal spray vaccine was first seen to be less effective for young children than the flu shot in 2013-2014 for the A(H1N1)pdm09 virus strain. In response, the A(H1N1)pdm09 virus strain used in the nasal spray vaccine was changed for the 2015-2016 influenza season. The 2016/17 season was the first since 2015-2016 to be dominated by the A(H1N1)pdm09 virus, making this our first opportunity to evaluate the updated nasal spray vaccine.
  • The Influenza Vaccine Effectiveness Network evaluated the impact of this change as part of our estimates of influenza vaccine effectiveness in 2015-2016. Preliminary findings from this study were presented to the ACIP in June 2016, which led to the nasal spray vaccine not being recommended in 2016-2017 in the US, although the nasal spray vaccine remains licensed in the US. In 2016-2017, the LAIV A(H1N1)pdm09 vaccine strain was unchanged from 2015-2016.
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Annals Internal Medicine, Author Interviews, CDC, HIV / 09.08.2017

MedicalResearch.com Interview with: Dr. Nicole Crepaz PhD Behavioral Scientist Division of HIV/AIDS Prevention CDC MedicalResearch.com: What is the background for this study? Response: The most common measure of viral suppression in clinical and surveillance studies is the most recent viral load in past 12 months. This single-value measure does not capture the viral load dynamics over time. We examined durable viral suppression, never virally suppressed, and cumulative HIV burden (measured in the viremia copy-year) to help us better understand viral suppression and transmission risk potential. (more…)
Author Interviews, CDC, Gender Differences, HIV / 07.08.2017

MedicalResearch.com Interview with: Dr. Tiffany Aholou Behavioral Scientist Division of HIV/AIDS Prevention CDC MedicalResearch.com: What is the background for this study? Response: Women accounted for 24% of people living with HIV in the United States at the end of 2013 and 19% of HIV diagnoses in 2014. Of these diagnoses, 78% were among black women and Latinas. HIV diagnoses among women are overwhelmingly attributed to heterosexual contact with a person known to have, or to be at high risk for, HIV infection. Of note, new HIV diagnoses among US women declined 40% over a 10 year period (2005-2014), yet we continue to see significant racial/ethnic disparities due largely to a complex web of demographic, individual, social and contextual factors with the environment that enables HIV risk behaviors to occur. While the decline in new HIV diagnoses among US women is noteworthy, in our review of the literature, we found research studies that specifically focus on women and HIV from a domestic perspective were scarce. To fill this gap and sharpen our understanding about sexual behaviors that are associated with heterosexual transmission of HIV, this study used data from three cycles of the National Survey of Family Growth (2006-2008, 2008-2010, and 2011-2013) to examine HIV-related sexual risk and protective behaviors - concurrent sex partnerships, non-monogamous sex partners, and condom use at either last vaginal sex or anal sex similar to what you might of seen on websites such as fulltube xxx - among sexually active women aged 18-44 years by race/ethnicity and over time. (more…)
Author Interviews, HIV, J&J-Janssen, Merck, Pharmacology / 26.07.2017

MedicalResearch.com Interview with: Dr. Kathleen Squires MD Professor and Director of Infectious Diseases Thomas Jefferson University Philadelphia, PA  MedicalResearch.com: What is the background for this study? What are the main findings?
  • The pivotal Phase 3 DRIVE-AHEAD study evaluated the safety and efficacy of a once-daily, single tablet, fixed-dose combination containing doravirine, an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV-1 infection, compared to a fixed-dose combination containing efavirenz.
    • After 48 weeks of treatment, 84 percent of the 364 treatment-naïve patients taking once-daily DOR/3TC/TDF achieved levels of HIV-1 RNA <50 copies/mL compared to 81 percent of the 364 patients taking once-daily EFV/FTC/TDF, with an estimated treatment difference of 3.5 percent.
    • Increases in mean CD4+ T-cell counts from baseline for the DOR/3TC/TDF and EFV/FTC/TDF groups were 198 and 188 cells/mm3, respectively, with an estimated treatment difference of 10.1.
    • In addition, comparable efficacy was observed across both treatment groups among individuals with high viral load (HIV-1 RNA >100,000 copies/mL) at baseline, which consisted of 69 patients in the DOR/3TC/TDF group and 73 patients in the EFV/FTC/TDF group (Observed Failure approach).
      • Of those patients with a high viral load (HIV-1 RNA >100,000 copies/mL) at baseline, 81 percent in the DOR/3TC/TDF group and 81 percent in the EFV/FTC/TDF group achieved the study’s primary endpoint of <50 copies/mL of HIV-1 RNA, with a treatment difference of 1.0 percent.
    • The study also met its primary safety endpoint, showing that treatment with DOR/3TC/TDF resulted in fewer patients reporting events of several pre-specified neuropsychiatric adverse events compared to EFV/FTC/TDF by Week 48, including dizziness (8.8 percent versus 37.1 percent); sleep disorders and disturbances (12.1 percent versus 25.5 percent); and inability to think clearly or concentrate (4.4 percent versus 8.2 percent).
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Author Interviews, HIV, Merck, Pharmacology / 25.07.2017

MedicalResearch.com Interview with: Dr. Pedro Cahn Chief of the infectious disease unit at Juan A. Fernandez Hospital Buenos Aires, Argentina, and ONCEMRK lead study investigator MedicalResearch.com: What is the background for this study? What are the main findings? The ONCEMRK Phase 3 study was conducted to evaluate the efficacy and safety of once-daily ISENTRESS (raltegravir) HD 1200 mg (given as two 600 mg oral tablets) compared to twice daily raltegravir 400 mg, each in combination therapy with emtricitabine plus tenofovir disoproxil fumarate in previously untreated adults with HIV-1 infection with levels of HIV-1 RNA ≥ 1,000 copies/mL.
  • Week 96 data showed:
    • 5 percent of the 531 patients taking once-daily raltegravir 1200 mg (2 x 600 mg) achieved viral suppression of less than 40 copies/mL of HIV-1 RNA, compared to 80.1 percent of the 266 patients taking twice-daily raltegravir 400 mg, both in combination therapy with emtricitabine plus tenofovir disoproxil fumarate, with a treatment difference of 1.4 percent.
    • Increases in CD4+T-cell counts from baseline were comparable for the two treatment regimens, with an average increase of 261.6 cells/mm3 for once-daily raltegravir (1200 mg) and 262.2 cells/mm3 for twice-daily raltegravir (400 mg).
    • Efficacy was consistent across a variety of patient populations, including those with high viral load at baseline (HIV-1 RNA >100,000 copies/mL).
    • Treatment-emergent viral mutations leading to any drug resistance were detected in less than 1 percent of patients in both treatment arms, with 4/531 (0.8 percent) in the once-daily raltegravir (1200 mg) treatment arm, and 2/266 (0.8 percent) in the twice-daily raltegravir (400 mg) treatment arm through 96 weeks.
    • The rate of discontinuation of therapy due to adverse events through 96 weeks was low (1.3 percent in patients receiving once-daily raltegravir (1200 mg) and 2.3 percent in patients receiving twice-daily raltegravir (400 mg).
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Author Interviews, Infections, JAMA, Pediatrics, Respiratory, Vitamin D / 18.07.2017

MedicalResearch.com Interview with: Jonathon Maguire MD MSc FRCPC Scientist, Li Ka Shing Knowledge Institute Staff Pediatrician, Department of Pediatrics, St. Michael’s Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: Vitamin D has been hypothesized as being protective of seasonal viral upper respiratory tract infections.  In this randomized clinical trial, high dose wintertime vitamin D supplementation (2000 IU/day) was compared with standard-dose vitamin D supplementation (400 IU/day) among 703 children.  The number of laboratory confirmed viral upper respiratory tract infections was not statistically different between groups. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Dermatology, HIV, JAMA, Kaiser Permanente, Merck / 13.07.2017

MedicalResearch.com Interview with: Maryam M. Asgari, MD, MPH Department of Dermatology Massachusetts General Hospital, Department of Population Medicine Harvard Medical School, Boston, Massachusetts Division of Research, Kaiser Permanente Northern California, Oakland MedicalResearch.com: What is the background for this study? What are the main findings? Response: Nonmelanoma skin cancer – defined as basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) – is a common malignant condition, affecting more than 2 million Americans every year. BCCs are more common than SCCs among individuals with healthy immune systems, while SCCs are more predominate than BCCs among people who are immunocompromised. We examined how laboratory markers used to evaluate HIV disease progression may be associated with subsequent nonmelanoma skin cancer risk in white patients previously diagnosed with at least one such cancer from 1996 to 2008.  We measured CD4 count, viral load and subsequent nonmelanoma skin cancer. The study included 455 participants with HIV and 1,952 without HIV. All were members of the Kaiser Permanente Northern California health care plan. (more…)
Author Interviews, Infections, Lancet, STD, Vaccine Studies / 11.07.2017

MedicalResearch.com Interview with: Helen Petousis-Harris. BSc, PhD Senior Lecturer, Dept General Practice and Primary Health Care Academic Head, Immunisation Research and Vaccinology Immunisation Advisory Centre School of Population Health, Faculty of Medical and Health Sciences University of Auckland MedicalResearch.com: What is the background for this study? What are the main findings? Response: Early thinking came from two quarters. One, the observation that the NZ OMV vaccine appeared broadly protective – beyond the clone it was based on and two, the observation of graphs depicting annual number of cases from both Cuba and NZ. There is nothing to suggest other types of meningococcal vaccine have had any effect on gonorrhoea so we are interested in the OMV vaccines. This led to the hypothesis that as these two Neisseria species are related the meningococcal OMV in the form of a vaccine may offer some kind of cross protection. To explore this possibility we conducted a case-control study that compared the vaccination status of cases (gonorrhoea) and controls (Clamydia). We found that the cases with gonorrhoea were less likely to be vaccinated than the controls and after we controlled for confounders – ethnicity, SE deprivation, age we found a vaccine effectiveness of 31%. (more…)
Author Interviews, Emory, Flu - Influenza, Lancet, Technology, Vaccine Studies / 28.06.2017

MedicalResearch.com Interview with: Dr Nadine G Rouphael MD Associate Professor of Medicine, Emory University Director of the VTEU and HIPC networks at the Hope Clinic of the Emory Vaccine Center Decatur GA 30030, USA MedicalResearch.com: What is the background for this new technology and study? What are the main findings? Response: Different groups including a group of researchers at Georgia Tech have been working on the microneedle technology for more than 20 years. The dissolvable microneedle patches are already used in several cosmetic products and drugs. However, vaccination with microneedle patches has been studied mostly in animals. Our phase 1 trial published this week in The Lancet showed that vaccination with the microneedle patches was safe, with no related serious adverse events reported. Local skin reactions to the patches were mostly mild itching and faint redness that lasted two to three days. No new chronic medical illnesses or influenza-like illnesses were reported with either the patch or the injection groups. Antibody responses generated by the vaccine, as measured through analysis of blood samples, were similar in the groups vaccinated using patches and those receiving intramuscular injection, and these immune responses were still present after six months. When asked after immunization, more than 70 percent of patch recipients reported they would prefer patch vaccination over injection or intranasal vaccination for future vaccinations. (more…)
Author Interviews, CDC, Lyme / 23.06.2017

MedicalResearch.com Interview with: Dr. Christina Nelson, MD MPH Medical epidemiologist, Division of Vector-Borne Diseases CDC  MedicalResearch.com: What is the background for this study? Response: Patients who are given a diagnosis of “chronic Lyme disease” have been offered a variety of treatments that have not been shown to be effective.  Many patients are treated with prolonged courses of antibiotics (for months or years), which have not been shown to provide substantial long-term benefit to patients.  Anecdotal reports about adverse outcomes associated with these treatments for chronic Lyme disease are common, but there have not been systematic efforts to collect data about the frequency of these events. MedicalResearch.com: Why is the diagnosis of 'Chronic Lyme Disease' so common? Response: The term “chronic Lyme disease” (CLD) has been used to describe people with different illnesses. While the term is sometimes used to describe illness in patients with Lyme disease, in many occasions it has been used to describe symptoms in people who have no evidence of a current or past infection with Lyme disease.  Because of the confusion in how the term CLD is employed, experts in this field do not support its use. (more…)
Author Interviews, Dermatology, Infections / 22.06.2017

MedicalResearch.com Interview with: Dr. Sue Cammarata, MD Chief Medical Officer Melinta Therapeutics MedicalResearch.com:   Would you explain what is meant by MRSA? Response: MRSA is methicillin-resistant Staphylococcus aureus, a type of staph bacteria that is  resistant to many antibiotics. MRSA is noted by the CDC as one of the top 18 drug-resistant bacteria threats to the United States.  (from CDC https://www.cdc.gov/drugresistance/biggest_threats.html  )  MedicalResearch.com:   Why is infection with MRSA so serious? Response:  MRSA can cause skin infections, lung infection and other issues. If left untreated, MRSA infections can become severe and cause sepsis - a life-threatening reaction to severe infection in the body - and even death.  MRSA can also cause major issues, such as bloodstream infections, pneumonia and surgical site infections in a healthcare setting, such as a hospital or nursing home. “Resistance to first-line drugs to treat infections caused by Staphlylococcus aureus—a common cause of severe infections in health facilities and the community—is widespread. People with MRSA (methicillin-resistant Staphylococcus aureus) are estimated to be 64% more likely to die than people with a non-resistant form of the infection.”  (quote from WHO website http://www.who.int/mediacentre/factsheets/fs194/en/  )   (more…)
Author Interviews, Infections / 22.06.2017

MedicalResearch.com Interview with: Deborah Linder, DVM, MS, DACVN Research assistant professor Cummings School of Veterinary Medicine Tufts University and Associate director of the Tufts Institute for Human-Animal Interaction MedicalResearch.com: What is the background for this study? Response: In our experience with our own therapy animal program, Tufts Paws for People, we have seen facilities and organizations put animals and people at risk by not following rigorous health and safety policies, and this certainly was confirmed by the results of our study. Lax health and safety policies typically aren’t intentional but occur as a result of enthusiasm for therapy animal programs without being aware of potential risks and what questions to ask. Also, it’s not just obvious problems that can occur, such as bites or allergies. It also can be an animal spreading infections due to diet or inadequate grooming, or unwanted stress on the animal. (more…)
Author Interviews, Dermatology, HPV, PLoS / 22.06.2017

MedicalResearch.com Interview with: Prof. Dr. med. Sigrun Smola Institute of Virology, Saarland University Homburg/Saar, Germany MedicalResearch.com: What is the background for this study? Response: Non-melanoma skin cancer (NMSC), the most common cancer in humans, is caused by UV-irradiation. The potential co-factor role of cutaneous genus beta-human papillomaviruses (beta-HPV) in skin carcinogenesis, particularly in immunosuppressed patients, has become a major field of interest. However, the underlying mechanisms were unclear. The skin has natural mechanisms providing protection against UV-induced damage. One important factor suppressing UV-induced skin carcinogenesis is the transcription factor C/EBPα belonging to the CCAAT/enhancer binding protein family. C/EBPα can induce cellular differentiation and is regarded as a tumor suppressor in various tissues. When C/EBPα expression is blocked in these tissues, tumorigenesis is enhanced. Another important factor is the microRNA-203. It has been shown to control “stemness” in normal skin by suppressing a factor called p63. In many tumors miR-203 expression is shut off releasing this “brake”. In our study we demonstrate that cutaneous beta-HPV interferes with both protective factors providing an explanation how cutaneous beta-HPV enhances the susceptibility to UV-induced carcinogenesis. Moreover, we provide evidence that these viruses regulate miR-203 via C/EBPα. We have investigated this mechanism in Epidermodysplasia verruciformis (EV) patients that serve as a human model disease for studying the biology of genus beta-HPVs. They are highly susceptible to persistent genus beta-HPV infection, such as HPV8, and have an increased risk to develop non-melanoma skin cancer at sun-exposed sites. (more…)
Author Interviews, Flu - Influenza, NEJM, Vaccine Studies / 22.06.2017

MedicalResearch.com Interview with: Lisa M. Dunkle, M.D. Chief Medical Officer Protein Sciences Corporation 1000 Research Parkway Meriden, CT MedicalResearch.com: What is the background for this study? What are the main findings? Response: The first and only recombinant protein influenza vaccine (RIV, Flublok) was approved in 2013 as a trivalent formulation for use in adults 18 years of age and older. This approval was based on demonstration of clinical efficacy (full approval) in adults 18-49 years of age and accelerated approval was granted for adults 50 years of age and older. Two clinical trials were conducted in 2014-2015 with RIV4 (Flublok Quadrivalent), of which the trial reported in the current NEJM is one. These studies supported full approval of Flublok in adults 50 years of age and older and approval of Flublok Quadrivalent in all adults 18 years of age and older. The second trial of immunogenicity of Flublok Quadrivalent in adults 18-49 years of age will be the subject of another publication in the near future. The main findings of the current trial are well summarized in the Conclusion of the Abstract: “RIV4 provided better protection than standard-dose IIV4 against confirmed influenza-like illness in older adults.” Additionally, the recombinant vaccine (RIV4, Flublok Quadrivalent) demonstrated significantly less injection site pain and tenderness following vaccination. Based on the characteristics of the study participants, one can conclude that RIV4 is safe and effective in most individuals with underlying chronic diseases (more…)