Author Interviews, HIV, Immunotherapy / 17.02.2017

MedicalResearch.com Interview with: [caption id="attachment_32115" align="alignleft" width="149"]Brinda Emu MD Assistant Professor of Medicine (Infectious Diseases Yale University New Haven, CT Dr. Brinda Emu[/caption] Brinda Emu MD Assistant Professor of Medicine (Infectious Diseases Yale University New Haven, CT  MedicalResearch.com: What is the background for this study? Response: Ibalizumab is a fully humanized monoclonal antibody that targets the CD4 receptor.  This Phase III registrational study enrolled individuals with HIV infection that harbor high levels of multi-drug resistance, with limited treatment options.  At IDWeek in October, 2016, data was presented that demonstrated patients experienced a significant decrease in viral load after receiving a single loading dose of ibalizumab 2,000 mg intravenously (IV) in addition to their failing antiretroviral therapies (ART) (or no therapy). Seven days after this loading dose, 83% of patients achieved a ≥ 0.5 log10 decrease from baseline compared with 3% during the seven-day control period .These results were statistically significant (p<0.0001). At CROI, additional data on the Week 24 results from this study are now presented.
Author Interviews, CDC, Gender Differences, HIV, Race/Ethnic Diversity / 09.02.2017

MedicalResearch.com Interview with: Donna Hubbard McCree, PhD MPH, RPh Association Director for Health Equity/Division of HIV/AIDS Prevention Centers for Disease Control and Prevention  MedicalResearch.com: What is the background for this study? What are the main findings? Response: HIV diagnosis rates among women declined 40% between 2005 and 2014 with the largest decline, 42%, occurring in black women. However, in 2015 black women represented 61% of HIV diagnoses among women. Our goal in this analysis was to determine whether the decline resulted in a decrease in the disparities among African American, Hispanic and white women between 2010 and 2014. There is currently not a standard method for measuring HIV-related disparity. However, for this analysis we used three different measures – the absolute rate difference (the difference between the group with the lowest rate and the group with the highest rate); 2) the diagnosis disparity ratio (the ratio of the difference between the group rate and the overall population rate to the overall rate); and 3) the Index of Disparity (the average of the differences between rates for specific groups and the total rate divided by the total rate, expressed as a percentage). The absolute rate difference between black women and white women decreased annually, from 36.9 in 2010 to 28.3 in 2014. The diagnosis disparity ratio for black women compared to the total population decreased from 1.7 in 2010 to 1.2 in 2014. The Index of Disparity increased during 2010–2011, and then decreased each year during 2012–2014. Although disparities still exist, these findings indicate improvement.
Author Interviews, BMJ, HIV, STD / 17.01.2017

MedicalResearch.com Interview with: [caption id="attachment_31241" align="alignleft" width="200"]Michael Rekart, MD, DTM&H Clinical Professor, Medicine and Global Health The University of British Columbia .... On behalf of my co-authors Dr. Michael Rekart[/caption] Michael Rekart, MD, DTM&H Clinical Professor, Medicine and Global Health The University of British Columbia .... On behalf of my co-authors MedicalResearch.com: What is the background for this study? Response: The background for this study is the observation that new syphilis cases over the last decade in British Columbia, Canada, have been escalating more rapidly than anyone could have predicted and that syphilis incidence has outpaced the incidence of other sexually transmitted diseases (STDs), including gonorrhea and chlamydia. This unexpected increase in syphilis has been almost wholly concentrated in men who have sex with men (MSM). Most of these MSM are HIV-1 infected and many are taking highly active antiretroviral therapy (HAART). In fact, the expansion in HAART coverage in MSM parallels the growth in syphilis in the same population. In addition, my co-authors and I had serious doubts as to whether 'treatment optimism', the generally accepted explanation for this phenomenon, was robust enough to account for such a dramatic increase in new syphilis cases. Treatment optimism posits that HAART availability and effectiveness have led to the perception in both HIV-1-infected and HIV-1-uninfected individuals that HIV-1 transmission has become much less likely, and the effects of HIV-1 infection less deadly. This is expected to result in increased sexual risk-taking, especially unprotected anal intercourse, leading to more non-HIV-1 STDs, including gonorrhea, chlamydia and syphilis.
Author Interviews, Heart Disease, HIV / 05.01.2017

MedicalResearch.com Interview with: Heidi M. Crane MD, MPH Associate Professor of Medicine Associate Director Clinical Epidemiology and Health Services Research Core Center for AIDS Research University of Washington MedicalResearch.com: What is the background for this study? What are the main findings? Response: Studies have suggested that rates of myocardial infarction (MI) are higher in those with HIV, likely for a variety of reasons. However, prior studies have not been able to distinguish MIs by type. The Universal Definition of MI has been recommended by cardiology societies and classifies MIs into types with Type 1 MIs resulting spontaneously from atherosclerotic plaque instability and Type 2 MIs occurring secondary to causes other than atherosclerotic plaque rupture, including hypotension, hypoxia, and stimulant induced spasm resulting in increased oxygen demand or decreased supply. Understanding MI types is likely important as they may indicate a different prognosis and need for different prevention approaches.
Author Interviews, Gastrointestinal Disease, HIV, Inflammation / 15.12.2016

MedicalResearch.com Interview with: Prof. Jamal Tazi Director, Institute for Molecular Genetics CNRS and University of Montpellier and Executive Committee Member ABIVAX MedicalResearch.com: What is the background for this study? Response: Its long been established that people with HIV, even those treated successfully with antiretroviral treatment, exhibit significantly higher levels of chronic inflammation than HIV-negative people. The causes of this inflammation are many – ongoing viral replication, often in the so-called viral reservoirs, leaky gut syndrome, concomitant viral infections (eg CMV, hepatitis etc).
Author Interviews, HIV, NEJM / 03.12.2016

MedicalResearch.com Interview with: Ms. Neliëtte Van Niekerk M.Com and Dr. Annalene Nel M.B., Ch.B., Ph.D. From International Partnership for Microbicides Silver Spring, MD MedicalResearch.com: What is the background for this study? What are the main findings? Response: Existing prevention methods have not done enough to stop the alarming rates of infection among women and girls, especially in sub-Saharan Africa, where young women are at least twice as likely to have HIV as young men. Rates of new infections among women aged 15-24 were more than four times greater than that of men the same age, and this age group accounted for 25 percent of new infections in South Africa. To provide women with more prevention options, the nonprofit International Partnership for Microbicides (IPM) developed a vaginal ring that contains an antiretroviral drug called dapivirine. Women insert the ring themselves and replace it every month. The Ring Study was a Phase III clinical trial that assessed the safety and long-term efficacy of the monthly dapivirine ring among nearly 2,000 women in South Africa and Uganda. We found that the ring reduced the risk of HIV-1 infection in about one-third of the women in the trial, and it was safe, with no difference in adverse effects between the active and placebo ring groups.
Author Interviews, HIV, NEJM, University of Pennsylvania / 24.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29950" align="alignleft" width="148"]Katharine J Bar, MD Assistant Professor of Medicine Attending Physician, Infectious Diseases, Hospital of the University of Pennsylvania Physician, International Travel Medicine, Perelman Center for Advanced Medicine Director, Penn CFAR Viral and Molecular Core Dr. Katharine J Bar[/caption] Katharine J Bar, MD Assistant Professor of Medicine Attending Physician, Infectious Diseases, Hospital of the University of Pennsylvania Physician, International Travel Medicine, Perelman Center for Advanced Medicine Director, Penn CFAR Viral and Molecular Core MedicalResearch.com: What is the background for this study? What are the main findings? Response: The passive administration of monoclonal antibodies has revolutionized many fields of medicine. Anti-HIV monoclonal antibodies are being explored as components of novel therapeutic and curative strategies, as they can both neutralize free virus and kill virus-infected cells. We sought to determine whether passive administration of an anti-HIV monoclonal antibody, VRC01, to chronically HIV-infected individuals on antiretroviral medications (ART) would be safe and well tolerated and could delay virus rebound after discontinuation of their ART.
Author Interviews, End of Life Care, HIV, Pediatrics, Pediatrics / 03.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29351" align="alignleft" width="176"]Maureen E. Lyon PhD Division of Adolescent and Young Adult Medicine, Center for Translational Science/Children’s Research Institute, Children’s National The George Washington University School of Medicine and Health Sciences Washington, District of Columbia Dr. Maureen E. Lyon[/caption] Maureen E. Lyon PhD Division of Adolescent and Young Adult Medicine, Center for Translational Science/Children’s Research Institute, Children’s National The George Washington University School of Medicine and Health Sciences Washington, District of Columbia MedicalResearch.com: What is the background for this study? Response: Despite policy recommendations to include adolescents with chronic and life-limiting conditions in decision-making about their own end-of-life care, barriers continue in clinical practice, including fear of distressing vulnerable adolescents and providers’ beliefs that these conversations are potentially harmful.
Author Interviews, HIV, Immunotherapy / 02.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29241" align="alignleft" width="168"]Jacob Lalezari, MD Quest Clinical Research San Francisco, CA Dr. Jacob Lalezari[/caption] Jacob Lalezari, MD Quest Clinical Research San Francisco, CA  MedicalResearch.com: What is the background for this study? What are the main findings?
  • Tremendous strides have been made since HIV-1 was first discovered 35 years ago. However, while many HIV patients can control the infection with currently-approved therapies, there is an urgent need for new treatments that can address viruses that are resistant to multiple antiretroviral treatment classes. With people starting treatments earlier and staying on them longer, some patients also face long-term safety and tolerability issues associated with current therapies.
  • Thousands of people are infected with HIV-1 with resistance to three classes of antiretroviral therapy (ART), and are in dire need of treatment. There are limited or no treatment options available for these patients.
  • As multi-drug resistant (MDR) HIV can be transmitted, it is imperative that it be controlled in order to prevent it from becoming a larger problem. It is important to not only focus on the patient being treated but also consider those they could infect.
  • Ibalizumab is the first biologic long-acting investigational ART to show efficacy in patients in just seven days. The Phase III TMB-301 results showed that patients with MDR HIV-1 and with limited treatment options experienced a significant decrease in viral load after receiving a loading dose of ibalizumab (2,000 mg intravenously) in addition to their failing ART therapies.
    •  A total of 40 patients were enrolled in the study.
    • Seven days after the loading dose, 83% of patients achieved a ≥ 0.5 log10 decrease from baseline compared with 3% during the seven-day control period.
    • These results were statistically significant (p<0.0001). Moreover, during that same period, 60% achieved a decrease of ≥1.0 log10.
    • The average viral load decrease for the total population was 1.1 log10
    • There were no treatment-related serious adverse events or discontinuations reported during the initial seven-day treatment period. 
Author Interviews, Beth Israel Deaconess, Electronic Records, HIV / 31.10.2016

MedicalResearch.com Interview with: [caption id="attachment_29293" align="alignleft" width="120"]Douglas Krakower, MD Infectious Disease Division Beth Israel Deaconess Medical Center Boston, MA, Dr. Douglas Krakower[/caption] Douglas Krakower, MD Infectious Disease Division Beth Israel Deaconess Medical Center Boston, MA, MedicalResearch.com: What is the background for this study? What are the main findings? Response: There are 45,000 new HIV infections in the US annually, so effective HIV prevention strategies are needed. HIV pre-exposure prophylaxis (PrEP), whereby a person who is HIV-uninfected uses an HIV treatment medication on a daily basis to protect themselves from becoming infected with HIV, is over 90% effective when taken with high adherence. The Centers for Disease Control and Prevention estimates that there are 1.2 million Americans who are likely to benefit from using PrEP. However, only 80,000 persons have been prescribed PrEP. One of the barriers to implementing PrEP is that clinicians face challenges with identifying persons who are most likely to benefit from PrEP, given infrequent sexual health history assessments during routine clinical care. We thus sought to develop an automated algorithm that uses structured data from electronic health records (EHRs) to identify patients who are most likely to benefit from using PrEP. Our methods included extracting potentially relevant EHR data for patients with incident HIV and without HIV from nearly a decade of EHR data from a large ambulatory practice in Massachusetts. We then used machine learning algorithms to predict HIV infection in those with incident HIV and those without HIV. We found that some algorithms could offer clinically useful predictive power to identify persons who were more likely to become infected with HIV as compared to controls. When we applied these algorithms to the general population and identified a subset of about 1% of the population with risk scores above an inflection point in the total distribution of risk scores; these persons may be appropriate for HIV testing and/or discussions about PrEP.
Author Interviews, HIV, Pediatrics, PLoS / 28.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28422" align="alignleft" width="145"]Kenneth K. Mugwanya MBChB, MS Department of Epidemiology andDepartment of Global Health University of Washington, Seattle, Washington, USA Division of Disease Control, School of Public Health Makerere University Kampala, Uganda Dr. Kenneth K. Mugwanya[/caption] Kenneth K. Mugwanya MBChB, MS Department of Epidemiology andDepartment of Global Health University of Washington, Seattle, Washington, USA Division of Disease Control, School of Public Health Makerere University Kampala, Uganda MedicalResearch.com: What is the background for this study? What are the main findings? Response: Women living in regions with high HIV prevalence are at high risk of HIV acquisition in pregnancy and postpartum because they infrequently use condoms, do not know their partner's HIV status, and have biologic changes or changes in their partner's sexual partnerships that increase susceptibility. Moreover, acute HIV infection during pregnancy or breastfeeding period is associated with high rates of mother-to child HIV transmission because of high circulating level of HIV virus in blood. Oral antiretroviral pre-exposure prophylaxis (PrEP) is a powerful HIV prevention strategy recommended by both the World Health organization and US Centers for Diseases Control and Prevention. PrEP is an attractive prevention strategy for women as it can be used discreetly and independent of sexual partners. However, there is limited research about the safety of PrEP in HIV-uninfected pregnant or breastfeeding mothers and their infants.
Author Interviews, HIV, Infections, STD / 16.09.2016

MedicalResearch.com Interview with: Noah Kojima David Geffen School of Medicine University of California Los Angeles, California MedicalResearch.com: What is the background for this study? What are the main findings? Response: One of the most exciting new methods to prevent human immunodeficiency virus (HIV) type 1 infection is through the use of chemical pre-exposure prophylaxis (PrEP), which has been shown to be safe and effective in randomized-controlled trials and “real world” studies among men who have sex with men (MSM). However, reports of high incidence of sexually transmitted infections (STIs) and condomless sex in PrEP trials has led clinicians and public health advocates to be concerned that the use of PrEP for HIV might lead to higher STI incidence due to increased sexual risk behavior. We found that PrEP for HIV infection is associated with increased risk of STI acquisition among MSM in a meta-analysis of prior studies.
Author Interviews, Depression, Heart Disease, HIV, Vanderbilt / 25.08.2016

MedicalResearch.com Interview with: Matthew S Freiberg, MD, MSc Cardiovascular Medicine Division, Vanderbilt University School of Medicine Tennessee Valley Geriatric Research Education and Clinical Center, Nashville  TN Tasneem Khambaty, PhD Department of Psychology, University of Miami, Coral Gables, Florida Jesse C. Stewart, PhD Department of Psychology, Indiana University–Purdue University , Indianapolis, Indianapolis MedicalResearch.com: What is the background for this study? Response: Due to highly effective antiretroviral therapy, people with HIV are living longer. Unfortunately, these HIV-infected individuals remain at a higher risk for other chronic diseases, with cardiovascular disease (CVD) being one of the leading cause of death in this population. In the general population, depressive disorders, such as major depressive disorder (MDD) and dysthymic disorder, are associated with increased risk of new-onset CVD. Given that roughly 24-40% of HIV-infected individuals have a depressive disorder, we examined whether MDD and dysthymic disorder are also associated with an increased risk of new-onset CVD in people with HIV.
Author Interviews, HIV / 22.07.2016

MedicalResearch.com Interview with: [caption id="attachment_26421" align="alignleft" width="175"]Zhe Yuan MS. MS. PhD Candidate Nebraska Center for Virology University of Nebraska-Lincoln Dr. Zhe Yuan[/caption] Zhe Yuan MS. MS. PhD Candidate Nebraska Center for Virology University of Nebraska-Lincoln MedicalResearch.com: What is the background for this study? Response: AIDS causes millions of infections and deaths each year. Human immunodeficiency virus (HIV) is the cause of this detrimental disease of humans. Just like Ebola and Zika, AIDS is also a zoonotic disease at the beginning. For the origins of HIV, people believed that HIV originated from simian immunodeficiency virus from wild chimpanzees (SIVcpz). But until now, there has been no direct in vivo evidence for this assumption. Further, people cannot explain why only certain SIVcpz strains are thought to be the ancestors of already discovered HIV strains in humans. There is also a need to clarify what transmission risks might exist for those SIVcpz strains that have not already been found to infect humans. The answers to these questions are essential for a better understanding of cross-species transmission and predicting the likelihood of additional cross-species transmission events of SIV into humans.
Author Interviews, CDC, HIV, Sexual Health, Technology / 15.06.2016

MedicalResearch.com Interview with: [caption id="attachment_25221" align="alignleft" width="172"]Dr. James M. Smith Ph.D Laboratory Branch, Division of HIV/AIDS Prevention Centers for Disease Control and Prevention Atlanta, Georgia Dr. James M. Smith[/caption] Dr. James M. Smith Ph.D Laboratory Branch, Division of HIV/AIDS Prevention Centers for Disease Control and Prevention Atlanta, Georgia MedicalResearch.com: What is the background for this study? Dr. Smith: Our laboratory has been developing a macaque model for testing drug release, safety and efficacy of intravaginal rings (IVR) for preexposure prophylaxis (PrEP) against HIV for several years. The initial studies involved both matrix rings, where the drug is dispersed in the silicone matrix of the device, and reservoir rings, which are essentially a polymer tube filled with drug. In collaboration with the Oak Crest Institute of Science and Auritec Pharmaceuticals, Inc., we began testing a new type of intravaginal ring, the pod-IVR. In this innovative design the ring itself is a scaffold that contains compressed polymer-coated drug tablets, or pods, within the ring. Each pod is separate, allowing for a customizable release rate for each drug by varying the number and diameter of the drug release ports for each individual pod. The macaque pod-IVR can accommodate up to six pods whereas the human pod-IVR can accommodate up to 10 pods. The IVR design was developed to allow the delivery of drug combinations and for simple, cost-effective manufacturing.
Author Interviews, Hematology, HIV, Stem Cells, Transplantation / 15.06.2016

MedicalResearch.com Interview with: [caption id="attachment_25218" align="alignleft" width="120"]Joseph Alvarnas, MD Associate clinical professor Department of hematology and Director of value-based analytics City of Hope National Medical Center Duarte, CA Dr. Joseph Alvarnas[/caption] Joseph Alvarnas, MD Associate clinical professor Department of hematology and Director of value-based analytics City of Hope National Medical Center Duarte, CA MedicalResearch.com: What is the background for this study? Dr. Alvarnas: Patients with HIV infection have a significantly increased risk of non-Hodgkin lymphoma and Hodgkin lymphoma. Prior to the availability of effective anti-retroviral therapy, HIV-infected patients with lymphoma had very poor treatment outcomes. Following the availability of effective anti-HIV therapy, patient outcomes for HIV-infected patients now parallel those of non-infected patients. Historically, however, HIV infection has been used as a criterion for not offering patients autologous blood stem cell transplantation outside of centers with unique expertise. The purpose of this trial was to evaluate outcomes, complication rates, and immunological reconstitution of HIV-infected patients following autologous blood stem cell transplantation.
Abuse and Neglect, Author Interviews, Heart Disease, HIV, JAMA / 31.05.2016

MedicalResearch.com Interview with: [caption id="attachment_24761" align="alignleft" width="120"]Steven Grinspoon, MD Professor of Medicine, Harvard Medical School MGH Endowed Chair in Neuroendocrinology and Metabolism Director, MGH Program in Nutritional Metabolism and Nutrition Obesity Research Center at Harvard MGH Boston, MA 02114 Dr. Steven Kyle Grinspoon[/caption] Steven Grinspoon, MD Professor of Medicine, Harvard Medical School MGH Endowed Chair in Neuroendocrinology and Metabolism Director, MGH Program in Nutritional Metabolism and Nutrition Obesity Research Center at Harvard MGH Boston, MA 02114 MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Grinspoon: Numerous epidemiologic studies have shown that people living with HIV face a 1.5 to 2-fold increased risk of heart attack, or myocardial infarction, as compared to individuals without the virus. Mechanisms underlying the increased risk of myocardial infarction in HIV are incompletely understood. It is possible that among people living with HIV, increased systemic immune activation fuels arterial inflammation. Arterial inflammation may, in turn, promote the development of high-risk morphology coronary atherosclerotic plaque, which is liable to rupture and result in myocardial infarction. For people diagnosed with HIV, the overall health benefits of immediate antiretroviral therapy (ART) are clear. However, the effects of newly-initiated antiretroviral therapy on arterial inflammation have not previously been studied. In this study, we set out to assess among a cohort of treatment-naive HIV-infected subjects, the effects of newly-initiated ART with a contemporary regimen on both immune function and arterial inflammation. We found that among treatment-naive HIV-infected individuals without clinical cardiovascular disease, newly initiated combined antiretroviral therapy has discordant effects to restore immune function without reducing the degree of arterial inflammation.
Author Interviews, HIV, University of Pennsylvania / 06.05.2016

MedicalResearch.com Interview with: [caption id="attachment_24043" align="alignleft" width="200"]Robert Bonacci MPH, MD Candidate’16 University of Pennsylvania School of Medicine Robert Bonacci[/caption] Robert Bonacci MPH, MD Candidate’16  University of Pennsylvania School of Medicine MedicalResearch.com: What is the background for this study? Response: During the mid-2000’s, the HIV incidence rate stubbornly persisted around 50,000 infections per year. Responding to this trend, President Obama released the first comprehensive US National HIV/AIDS Strategy (NHAS) in 2010. The NHAS hoped to spur a more coordinated national response and set ambitious targets for reducing HIV incidence (25 percent) and the transmission rate (30 percent), among other goals, by 2015. To evaluate whether the U.S. achieved the NHAS goals by 2015, we used mathematical models drawing on data from the U.S. Centers for Disease Control and Prevention (CDC) on HIV prevalence and mortality for 2007 to 2012, and our own previously published incidence estimates from 2008-2012. Changes seen from 2010 through 2012 were extrapolated for the time period 2013 through 2015.
Author Interviews, Hepatitis - Liver Disease, HIV, JAMA, Vaccine Studies / 13.04.2016

MedicalResearch.com Interview with: [caption id="attachment_23342" align="alignleft" width="160"]Odile Launay MD, PhD Paris Descartes University Assistance Publique Hôpitaux de Paris, Cochin Hospital Dr. Odile Launay[/caption] Odile Launay MD, PhD Paris Descartes University Assistance Publique Hôpitaux de Paris, Cochin Hospital  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Launay: In patients with HIV infection, responses to standard HBV vaccination regimens remain suboptimal compared with responses in HIV seonegative individuals. We previously reported that alternative regimens (a 4 injection IMdouble dose regimen and a 4 injection intradermal low dose regimen) improve antibody response compared with the standard HBV vaccination regimen (ANRS HB03 VIHVAC-B study). Further precision on the duration of response achieved with alternative HBV vaccination regimes was needed. We report in this paper the results from the follow-up of the study. The results of this study show that the 4 dose IM regimen induces higher seroconversion rate but also higher long term seroprotection in HIV infected patients
Author Interviews, Emory, HIV / 01.03.2016

MedicalResearch.com Interview with: [caption id="attachment_22226" align="alignleft" width="202"]Dr. Igho Ofotokun MD MSc Division of Infectious Diseases, Department of Medicine Emory University School of Medicine, Atlanta, Georgia Grady Healthcare System, Atlanta, Georgia Dr. Igho Ofotukun[/caption] Dr. Igho Ofotokun MD MSc Division of Infectious Diseases, Department of Medicine Emory University School of Medicine, Atlanta, Georgia Grady Healthcare System, Atlanta, Georgia MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Ofotokun:  This work is focused on preventing further bone loss in HIV-infected patients and thus reducing the risk of future bone fractures. HIV infection is associated with a state of enhanced bone loss. HIV treatment with highly active antiretroviral therapy (HAART) further worsens rather than improve bone loss. Almost all HAART regimens that have been examined have been associated with bone loss. The consequence of this skeletal assualt is markedly elevated fracture prevalence among individuals living with HIV across a wide age range. It turns that the predominance of HAART associated bone loss occur within the first year of initiating therapy. In this study, we administered a single dose of 5 mg IV zoledronic acid, a long-acting bisphosphonate at the same time of HAART initiation to prevent HAART associated bone loss. At this dose, zoledronic acid prevented enhance bone resorption in all participants and completely blunted bone mineral density loss over the 48 weeks study follow up period.
Author Interviews, HIV / 26.02.2016

MedicalResearch.com Interview with: [caption id="attachment_22087" align="alignleft" width="200"]Wim Parys MD Global Head R&D Global Public Health Janssen Dr. Wim Parys[/caption] Wim Parys MD Global Head R&D Global Public Health Janssen  Medical Research: What is the background for this study? What are the main findings? Dr. Parys: In collaboration with ViiV Healthcare, we are working to develop the first long acting all-injectable combination regimen of Janssen’s rilpivirine and ViiV’s cabotegravir. Yesterday, we have announced promising Phase 2b data of this combination regimen which when given together every 4 or 8 weeks was able to maintain viral suppression with similar efficacy to a daily oral regimen of three HIV medicines. The results show that the combination met its primary endpoint at week 32. The study will now continue in its randomized controlled design for another 64 weeks enabling us to assess longer term outcomes. In parallel to this we will work to initiate the next stages of clinical development.
Author Interviews, Global Health, HIV, NEJM, OBGYNE / 22.02.2016

MedicalResearch.com Interview with: [caption id="attachment_21920" align="alignleft" width="200"]Jared Baeten, MD PhD Vice Chair, Department of Global Health Professor, Departments of Global Health, Medicine, and Epidemiology Co-Director, International Clinical Research Center University of Washington Dr. Jaret Baeten[/caption] Jared Baeten, MD PhD Vice Chair, Department of Global Health Professor, Departments of Global Health, Medicine, and Epidemiology Co-Director, International Clinical Research Center University of Washington MedicalResearch.com: What is the background for this studies? Dr. Baeten: Women account for nearly 60 percent of adults with HIV in sub-Saharan Africa, where unprotected heterosexual sex is the primary driver of the epidemic. While several studies have shown that antiretroviral medications (ARVs) are highly effective in preventing HIV, other studies – such as VOICE and FACTS 001 – suggest that for young, at-risk women in Africa, ARVs delivered as a vaginal gel or as a tablet may not be acceptable. Products must be used to be effective, and that was not the case for most of the participants in previous studies. Medical Research: What was the aim of ASPIRE and The Ring Study? Dr. Baeten: As Phase III clinical trials, ASPIRE and The Ring Study were designed to determine whether a vaginal ring containing an antiretroviral (ARV) drug called dapivirine is safe and effective in protecting women against HIV when used for a month at a time. These trials also sought to determine whether women find the vaginal ring practical and easy to use. As sister studies, ASPIRE and The Ring Study were designed as the centerpiece of a broader licensure program to provide the strength of evidence to support potential licensure of the dapivirine vaginal ring for preventing HIV in women. Because at least two Phase III efficacy trials are usually needed for a product to be considered for regulatory approval, ASPIRE and The Ring Study were conducted in parallel to accelerate the timeline to the ring’s potential approval.
Author Interviews, CDC, HIV / 21.02.2016

MedicalResearch.com Interview with: [caption id="attachment_21878" align="alignleft" width="158"]Martin Hoenigl, MD Postdoctoral Fellow AntiViral Research Center, Department of Medicine University of California, San Diego Dr. Martin Hoenigl[/caption] Martin Hoenigl, MD Postdoctoral Fellow AntiViral Research Center, Department of Medicine University of California, San Diego Medical Research: What is the background for this study? Response: The detection of acute HIV infection (AHI) is critical to HIV prevention and treatment strategies. Many field-based testing programs rely on point-of-care HIV antibody testing, which will reliably identify persons with established infection, but fail to detect persons with AHI. In many of these programs additional tests for AHI are only performed / recommended in persons presenting with signs and symptoms consistent with an acute retroviral syndrome (ARS). These signs and symptoms are unspecific and include fatigue, headache, pharyngitis, skin rash, GI symptoms, night sweats and others. However, the proportion of persons with acute HIV infection presenting symptomatic for their diagnostic test remains unknown. The objective of our study was therefore to determine the proportion of persons with acute HIV infection presenting with signs and symptoms consistent with ARS for HIV screening. Medical Research: What are the main findings? Response: We analyzed signs and symptoms in 90 patients diagnosed with acute HIV infection in a community-based program in San Diego that offered universal HIV-1 nucleic acid amplification testing, independent of signs and symptoms. Forty-seven (52%) patients reported ongoing signs or symptoms consistent with ARS on the day of NAT screening. Another 25 (28%) reported signs or symptoms that had occurred during the 14 days before testing, but had resolved by the testing date. Another 12 (13%) reported signs and symptoms that started after the diagnostic test. Only 6/90 (7%) reported no signs and symptoms consistent with ARS. As a secondary finding, viral loads were significantly higher (p=0.001) in the 72 individuals reporting signs and symptoms consistent with ARS before or at the time of NAT screening compared to the 18 participants who did not report signs and symptoms at their diagnostic test. Most frequently reported ARS signs and symptoms included fever, myalgia, fatigue and headache.
Addiction, Author Interviews, HIV / 16.02.2016

MedicalResearch.com Interview with: [caption id="attachment_21665" align="alignleft" width="200"]Pedro Mateu-Gelabert, Ph. D. Principal Investigator National Development Research Institutes, Inc. New York, NY 10010 Dr. Pedro Mateu-Gelabert[/caption] Pedro Mateu-Gelabert, Ph. D. Principal Investigator National Development Research Institutes, Inc. New York, NY 10010  Medical Research: What is the background for this study? What are the main findings? Dr. Mateu-Gelabert: Heroin production in Colombia increased dramatically in recent decades, and some studies point to an increase in local heroin consumption since the mid-1990s. Despite this rapid increase, little is known about the effects of these activities on heroin injection within Colombia. One of the biggest concerns surrounding heroin injection is the potential spread of HIV through drug user networks. Medical Research: What should clinicians and patients take away from your report? Dr. Mateu-Gelabert: The key take home message in the paper is that a widespread early implementation of harm reduction services (e.g. opioid substitution therapy, HIV testing, syringe exchange programs)  can prevent HIV among young PWID (People Who Inject Drugs) before it rapidly spreads within drug injection networks. Reducing HIV among young drug injectors could prevent the spread of HIV from PWID to the general population.
Author Interviews, CDC, JAMA / 16.02.2016

MedicalResearch.com Interview with: [caption id="attachment_21651" align="alignleft" width="147"]Philip J. Peters, M.D. HIV Testing and Biomedical Interventions Activity Lead Epidemiology Branch CDC’s Division of HIV/AIDS Prevention Dr. Phillip Peters[/caption] Philip J. Peters, M.D. HIV Testing and Biomedical Interventions Activity Lead Epidemiology Branch CDC’s Division of HIV/AIDS Prevention Medical Research: What is the background for this study? What are the main findings? Dr. Peters:  Acute HIV infection contributes disproportionately to HIV transmission and identifying individuals with acute HIV infection is critical to prevent further HIV transmission, as diagnosis can lead to several effective HIV prevention interventions. Acute HIV infection can be diagnosed with assays that detect either HIV RNA (the reference standard) or the p24 antigen (an HIV core protein), which are both detectable early after HIV infection and before an antibody response develops. HIV immunoassays that detect both the p24 antigen and anti-HIV antibody (fourth generation antigen/antibody [Ag/Ab] combination immunoassays) are currently being implemented as the initial screening test in the 2014 CDC and American Public Health Laboratories (APHL) recommended HIV diagnostic algorithm. In a prospective study we evaluated the performance of an HIV Ag/Ab combination assay to detect acute HIV infection compared with pooled HIV RNA testing in a high-prevalence population. All participants were first screened with a rapid HIV test to detect established HIV infection (antibody detectable).  All participants with a negative rapid HIV test result were then screened for acute HIV infection with an HIV Ag/Ab combination assay (index test) and pooled HIV-1 RNA testing.  HIV RNA testing was the reference standard, with positive reference standard result defined as detectable HIV-1 RNA on an individual RNA test. Among 86,836 participants with complete test results (median age, 29 years; 75.0% male; 51.8% men who have sex with men), acute HIV infection was diagnosed in 168 (0.19%). Acute HIV infection was detected in 134 (0.15%) participants with HIV Ag/Ab combination testing (acute HIV infection sensitivity, 79.8%) and in 164 (0.19%) with pooled HIV RNA testing (sensitivity, 97.6%; sensitivity comparison, p<0.001). Overall HIV Ag/Ab combination testing detected 82% of acute HIV infections detectable by pooled HIV RNA testing. Compared with rapid HIV testing alone (which detected established HIV infection), HIV Ag/Ab combination testing increased the relative HIV diagnostic yield (both established and acute HIV infections) by 10.4% and pooled HIV RNA testing increased the relative HIV diagnostic yield by 12.4%.
Author Interviews, CDC, HIV, Sexual Health / 12.02.2016

MedicalResearch.com Interview with: [caption id="attachment_21546" align="alignleft" width="141"]Laura Kann, PhD Chief of the School-Based Surveillance Branch (SBSB) Division of Adolescent and School Health (DASH). CDC Dr. Laura Kann[/caption] Laura Kann, PhD Chief of the School-Based Surveillance Branch (SBSB) Division of Adolescent and School Health (DASH). CDC  Medical Research: What is the background for this study? Dr. Kann:  Young persons aged 13–24 years accounted for an estimated 22% of all new diagnoses of human immunodeficiency virus (HIV) infection in the United States in 2014. Most new HIV diagnoses among youths occur among males who have sex with males (MSM). Among all MSM, young black MSM accounted for the largest number of new HIV diagnoses in 2014 (4,398 among blacks, 1,834 among Hispanics, and 1,366 among whites).  Although other studies have examined HIV-related risk behaviors among MSM, less is known about MSM aged <18 years. Medical Research: What are the main findings? Dr. Kann:  Among male students who had sexual contact with males, black students had a significantly lower prevalence than white students of drinking five or more drinks of alcohol in a row; ever using inhalants, heroin, ecstasy, or prescription drugs without a doctor’s prescription; and drinking alcohol or using drugs before last sexual intercourse. Black students also had a significantly lower prevalence than Hispanic students of drinking five or more drinks of alcohol in a row and ever using cocaine, inhalants, methamphetamines, ecstasy, or steroids without a doctor’s prescription.  However, among male students who had sexual contact with males, black students had a significantly higher prevalence than white students of ever having had sexual intercourse and using a condom during last sexual intercourse; black students also had a higher prevalence than Hispanic students of ever having sexual intercourse.
Author Interviews, HIV, Social Issues, Yale / 10.02.2016

MedicalResearch.com Interview with: [caption id="attachment_21438" align="alignleft" width="191"]Kristina Marie Talbert-Slagle, PhD Lecturer in Epidemiology (Microbial Diseases) and in Public Health (Health Policy); Senior Scientific Officer, Yale Global Health Leadership Institute Yale School of Public Health Dr. Talbert-Slagle[/caption] Kristina Marie Talbert-Slagle, PhD Lecturer in Epidemiology (Microbial Diseases) and in Public Health (Health Policy); Senior Scientific Officer, Yale Global Health Leadership Institute Yale School of Public Health Medical Research: What is the background for this study? What are the main findings? Dr. Talbert-Slagle: The interest for this study originally came as a result of work done by Elizabeth Bradley, PhD, co-author of The American Health Care Paradox.  In the book, Dr. Bradley compared spending rates of social services to health care services between the U.S. and other countries and found that while the U.S. invested more money in health care services than any other country we had worse health outcomes.  By contrast, countries that spent more on social services per dollar spent on health care had better outcomes. We applied that same idea to AIDS.  There are still more than 50,000 cases of HIV/AIDS diagnosed in the U.S. each year.  Although many medical advances have been made in treatment and prevention of this infection, we were curious as to why rates of HIV/AIDS have remained stagnate.  We wanted to explore how spending relates to differences in case rates among the states and found a significant difference among states regarding social service and public health spending related to HIV/AIDS.  We looked at all 50 states’ spending habits over the past 10 years and discovered that states that invested more money in social services such as education, housing, and nutrition per person in poverty had significantly lower rates of HIV/AIDS deaths.
Author Interviews, Compliance, HIV, Lancet / 03.02.2016

MedicalResearch.com Interview with: [caption id="attachment_21259" align="alignleft" width="134"]Dr Marcel Yotebieng, PhD Department of Epidemiology Ohio State University, 304 Cunz Hall Columbus, OH Dr. Marcel Yotenbieng[/caption] Dr Marcel Yotebieng, PhD Department of Epidemiology Ohio State University, 304 Cunz Hall Columbus, OH Medical Research: What is the background for this study? What are the main findings? Response: With the current World Health Organization recommended treatment for the prevention of mother-to-child HIV transmission (PMTCT), the risk of transmission of HIV from an infected mother to her baby can be cut from 35-45% to less than 5% in breastfeeding population and <1% in non-breastfeeding population. But in sub-Saharan Africa where over 90% of HIV-infected pregnant women worldwide live, transportation costs and opportunity costs to attend regular clinic visits (to collect drugs) have been identified as important barriers to PMTCT. The provision of economic incentives has the potential to help women overcome these economic barriers. In addition, by creating immediate rewards that “nudge” individuals towards positive health behaviors, financial incentives can also address psychological barriers to health-seeking behavior of HIV-infected pregnant and breastfeeding women. This is the first study to use small cash incentives to encourage women to attend clinic visit and received available PMTCT care. We found that, among newly diagnosed HIV-infected women, small, incremental cash incentives resulted in increased retention along the  prevention of mother-to-child HIV transmission cascade and uptake of available services.
Author Interviews, HIV, PLoS / 26.01.2016

[caption id="attachment_21005" align="alignleft" width="200"]Julian Falutz, MD Director, HIV Metabolic Clinic MUHC, Coordinator of Chronic Viral Illness Service, HIV and Aging Clinic McGill University Health Center Dr. Julian Falutz[/caption] MedicalResearch.com Interview with: Julian Falutz, MD Director, HIV Metabolic Clinic MUHC, Coordinator of Chronic Viral Illness Service, HIV and Aging Clinic McGill University Health Center Medical Research: What is the background for this study? What are the main findings? Dr. Falutz: The long-term use of antiretroviral therapy (ART) in HIV-infected patients is associated with body composition changes, including visceral adipose tissue (VAT) accumulation. HIV-infected patients with excess VAT may be at increased risk of type 2 diabetes, cardiovascular diseases, and mortality. Tesamorelin is a synthetic analog of human growth hormone-releasing factor, also known as growth hormone-releasing hormone (GHRH), which is indicated for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The objectives of our paper were to 1) evaluate the utility of patient characteristics and validated disease-risk scores, including indicator variables for the metabolic syndrome and the Framingham Risk Score (FRS), as predictors of  visceral adipose tissue reduction during tesamorelin therapy, and 2) to explore the characteristics of patients who reached a threshold of VAT <140 cm2, a level associated with lower risk of adverse health outcomes, after 6 months of treatment with tesamorelin. The basis of the report was a pooled analysis of the two pivotal, randomized Phase 3 trials of tesamorelin in 806 HIV-infected patients with excess abdominal fat. Our results indicate that presence of metabolic syndrome, high triglycerides, and white race are associated with a greater likelihood of responding to 6 months of tesamorelin treatment. The most robust response appears to be in subjects with VAT above 140 cm2, as well as those in the overweight range for body mass index (BMI) measures.
Author Interviews, HIV / 05.01.2016

  [caption id="attachment_20435" align="alignleft" width="150"]Dr. Christina Polyak MD MPH Acting Instructor with the University of Washington Clinical research physician at the U.S. Military HIV Research Program Walter Reed Army Institute of Research at WRAIR Bethesda, MD 20817 Medical Research: What is the background for this study? What are the main findings? Dr. Polyak: Today, 35 million people are infected with HIV, the virus that causes AIDS. Cotrimoxazole (CTX) is low-cost and widely utilized broad spectrum antibiotic used to prevent opportunistic infections in patients with HIV. CTX prophylaxis is recommended by the World Health Organization (WHO) for HIV infected adults in settings with high infectious disease prevalence. In these settings, the threshold for CTX discontinuation is undefined. We designed a study to determine whether CTX discontinuation was non-inferior to continued CTX-prophylaxis in decreasing morbidity in adults with evidence of immune reconstitution (CD4 >350 and 18 months on ART). Our findings show that combined morbidity/mortality was significantly higher in the CTX discontinuation arm (RR=2.27, 95% CI 1.52-3.38;p<0.001), driven by malaria morbidity. This suggests that CTX discontinuation among ART-treated, immune-reconstituted adults in malaria-endemic regions resulted in increased incidence of malaria but not pneumonia or diarrhea. These data helped inform and support the 2014 WHO CTX guidelines. Medical Research: What should clinicians and patients take away from your report? Dr. Polyak: CTX discontinuation among ART-treated adults in a region with endemic malaria resulted in increased incidence of clinical malaria but not pneumonia or diarrhea. The implications are broad and our results suggest that CTX prophylaxis should continue in regions with endemic malaria. Medical Research: What recommendations do you have for future research as a result of this study? Dr. Polyak: Understanding the burden of malaria, pneumonia and diarrhea in the HIV-uninfected community would be prudent to compare background rates of disease. Citation: Cotrimoxazole Prophylaxis Discontinuation among Antiretroviral-Treated HIV-1-Infected Adults in Kenya: A Randomized Non-inferiority Trial Christina S. Polyak ,Krista Yuhas, Benson Singa, Monica Khaemba, Judd Walson, Barbra A. Richardson,Grace John-Stewart Published: January 5, 2016 DOI: 10.1371/journal.pmed.1001934 Dr. Christina Polyak[/caption] MedicalResearch.com Interview with: Dr. Christina Polyak MD MPH Acting Instructor with the University of Washington Clinical research physician at the U.S. Military HIV Research Program Walter Reed Army Institute of Research at WRAIR Bethesda, MD  20817 Medical Research: What is the background for this study? What are the main findings? Dr. Polyak:    Today, 35 million people are infected with HIV, the virus that causes AIDS.   (CTX)  is low-cost and widely utilized broad spectrum antibiotic used to prevent opportunistic infections in patients with HIV.  CTX prophylaxis is recommended by the World Health Organization (WHO) for HIV infected adults in settings with high infectious disease prevalence.   In these settings, the threshold for CTX discontinuation is undefined.  We designed a study to determine whether CTX discontinuation was non-inferior to continued CTX-prophylaxis in decreasing morbidity in adults with evidence of immune reconstitution (CD4 >350 and 18 months on ART).  Our findings show that combined morbidity/mortality was significantly higher in the CTX discontinuation arm (RR=2.27, 95% CI 1.52-3.38;p<0.001), driven by malaria morbidity.   This suggests that CTX discontinuation among ART-treated, immune-reconstituted adults in malaria-endemic regions resulted in increased incidence of malaria but not pneumonia or diarrhea.  These data helped inform and support the 2014 WHO CTX guidelines.