Author Interviews, HIV, University of Michigan / 13.06.2018

MedicalResearch.com Interview with: Rogério M. Pinto, LCSW, Ph.D. Associate Professor Associate Dean for Research School of Social Work University of Michigan Ann Arbor, USA MedicalResearch.com: What is the background for this study? Response: This integrative review, published in the journal AIDS and Behavior, includes content from 47 peer-reviewed scholarly articles reporting multiple barriers to high-risk individuals trying to access pre-exposure prophylaxis (PrEP), the HIV drugs that reduce subsequent risk of infection. We found 31 potential solutions to 30 barriers at the patient, provider and health-system levels. In synthesizing this research from a multi-level perspective, based upon a socioecological model, our report contributes much-needed analysis to the rapidly expanding field of PrEP implementation research. At this stage in the scale-up of U.S. PrEP programs, it is important to systematically and comprehensively analyze and integrate knowledge about the successes of and the barriers to PrEP implementation. Our review provides a comprehensive analysis and informs the direction of PrEP implementation across a variety of settings. (more…)
Annals Internal Medicine, Author Interviews, Cancer Research, HIV, Infections / 12.06.2018

MedicalResearch.com Interview with: Lesley S. Park, PhD, MPH Instructor, Medicine- Primary Care and Population Health BioStanford Center for Population Health Sciences (PHS) Associate Director, Research and Data Strategy; Director, PHS Postdoctoral Fellowship Veterans Aging Cohort Study (VACS) Cancer Core Co-Director MedicalResearch.com: What is the background for this study? What are the main findings?  Response: As the population of persons living with HIV/AIDS is aging, the overall burden of cancer is substantial and increasing; however, we have much to learn about the potential cancer prevention benefits of antiretroviral treatment (ART). Our study is the first to examine the effects of prolonged periods of viral suppression and potential cancer prevention benefits. While prior randomized clinical trials (RCTs) and observational studies have examined viral suppression and cancer risk, they mostly were limited to small numbers of cancer outcomes or were only focused on few specific cancer types. Our study demonstrated a benefit of the prevention of cancer development in AIDS-defining cancers (non-Hodgkin lymphoma, Kaposi sarcoma), which was expected, but also in some non-AIDS-defining cancer types (lung, larynx, melanoma, leukemia).  (more…)
Author Interviews, HIV, Infections, OBGYNE / 12.06.2018

MedicalResearch.com Interview with: Manish Sagar, MD Infectious Disease Physician at Boston Medical Center Boston MA  MedicalResearch.com: What is the background for this study? Response: Women compromise the majority of new infections in the world and most of them acquire the virus after sexual exposure.  The goal of the study was to understand how HIV establishes initial infection in the female genital tract. We obtained discarded vaginal tissue and isolated cells present in the outermost layer that contact the virus during exposure. (more…)
Author Interviews, CDC, HIV, Sexual Health / 29.03.2018

MedicalResearch.com Interview with: Sonia Singh, PhD, Epidemiologist Division of HIV/AIDS Prevention CDC  MedicalResearch.com: What is the background for this study? What are the main findings? Response: HIV infection is a persistent health concern in the United States, particularly for people at high risk of infection such as gay and bisexual men. We used data from the National HIV Surveillance System to estimate HIV incidence and prevalence and the percentage of undiagnosed HIV infections overall and among gay and bisexual men. Estimated HIV incidence declined nearly 15% overall in the U.S. from an estimated 45,200 infections in 2008 to 38,500 in 2015. Estimated HIV incidence declined for both males (9%) and females (33%) over this period. Estimated HIV incidence declined 32% among heterosexuals, 42% among people who inject drugs and 20% among gay and bisexual men who also inject drugs. Estimated HIV incidence remained relatively stable among gay and bisexual men; however, it increased over 25% among Latino gay and bisexual men, almost 45% among gay and bisexual men ages 25 to 34 and 30% among gay and bisexual men ages 55 and older. The percentage of undiagnosed HIV infections decreased nearly 20%, from 18.1% in 2008 to 14.5% in 2015. The percentage of undiagnosed HIV infections among gay and bisexual men declined 21.6%, from 21.3% in 2008 to 16.7% in 2015. In 2015, the percentage of undiagnosed HIV infections was highest among gay and bisexual males ages 13-24 (52.2%) compared to other age groups and higher among Latino (20.1%) and African American (19.6%) gay and bisexual men, as well as Asian gay and bisexual men (20.5%), compared to white gay and bisexual men (11.9%). (more…)
Author Interviews, HIV, NYU, PLoS, Zika / 23.02.2018

MedicalResearch.com Interview with: Maite Sabalza Ph.D Post Doctoral Associate Department of Basic Science and Craniofacial Biology College of Dentistry, New York University New York, NY 10010 MedicalResearch.com: What is the background for this study? What are the main findings?  Response: With previous NIH funding we were able to develop an automated “dual assay” (able to detect both host antibodies and viral RNA) for HIV. In relatively short time, we were able to migrate those findings into the new assay for ZIKA Virus. (more…)
Author Interviews, HIV, NIH, PLoS / 18.01.2018

MedicalResearch.com Interview with: Tae-Wook Chun, Ph.D. National Institutes of Health Bethesda, MD 20892  MedicalResearch.com: What is the background for this study? What are the main findings? Response: While antiretroviral therapy (ART) has improved the clinical outcome for people living with HIV, persistence of viral reservoirs in the peripheral blood and lymphoid tissues remains a hurdle to complete eradication of virus and cure of the infection. We know the vast majority of people living with HIV will experience plasma viral rebound within weeks of cessation of therapy. Considering that current research on the treatment of people living with HIV has been heavily focused on developing strategies aimed at achieving sustained virologic remission in the absence of ART, it is of great interest to investigate whether treatment interruption results in expansion of the viral reservoir and/or damage to the immune system. Using data from a recently concluded trial that employed short-term analytical treatment interruption (ATI), we found that, as expected, HIV DNA increased in the CD4+ T cells of individuals living with HIV during the treatment interruption phase. However, the size of the HIV reservoirs as well as immune parameters returned to baseline 6–12 months after the participants resumed ART.  (more…)
Author Interviews, HIV, Infections, Lancet, STD / 12.12.2017

MedicalResearch.com Interview with: Professor Jean-Michel Molina MD Head of Department of Infectious Diseases, Hôpital Saint-Louis Paris France  MedicalResearch.com: What is the background for this study? What are the main findings? Response: There is a high rate of sexually transmitted infections (STIs) among Pre-exposure prophylaxis users and we wished to assess whether post-exposure prophylaxis (PEP) with doxycycline could reduce the incidence of sexually transmitted infections in this population. We have found indeed a high rate of STIs most of them (71%) being asymptomatic and warranting therefore systematic testing. Also PEP reduced the incidence of syphilis and chlamydiae infection by 70%, not for gonorrhea due to the high rate of detection in throat swabs without any impact of PEP. (more…)
Author Interviews, Cognitive Issues, Compliance, HIV, JAMA / 16.11.2017

MedicalResearch.com Interview with: Ryan Sanford, MEng Department of Neurology and Neurosurgery Montreal Neurological Institute McGill University, Montréal, Québec, Canada   MedicalResearch.com: What is the background for this study? What are the main findings? Response: With the introduction of combination antiretroviral therapy (cART) the outlook for HIV+ individuals has dramatically shifted from a fatal disease to a chronic manageable condition. However, HIV-associated neurocognitive disorders are still prevalent. The etiology of this dysfunction remains unknown. Previous work has reported progressive brain atrophy in HIV+ individuals with advanced disease and poor viral suppression, but it is unclear whether stable treatment and effective viral suppression can mitigate the progression of brain atrophy. To examine this issue, we followed well-treated HIV+ individuals with good viral suppression and well-matched controls, and assessed whether ongoing brain atrophy occurs over time. The main finding in this study was the HIV+ participants had reduced brain volumes and poorer cognitive performance compared to the control group, but the changes in brain volumes and cognitive performance were similar between the groups. (more…)
Author Interviews, Cost of Health Care, HIV, Lancet / 13.11.2017

MedicalResearch.com Interview with: Dr Valentina Cambiano PhD Institute for Global Health University College London London UK MedicalResearch.com: What is the background for this study? Response: Pre-Exposure Prophylaxis (PrEP) which involves the use of drugs, which are used to treat HIV, in people without HIV to prevent them from getting is a critical new advance in HIV prevention. It has been shown to reduce the risk of HIV infection by 86% and the benefits heavily out-weigh any concerns. However, introducing this intervention has a cost. When we started working on this study the National Health Services was discussing whether to introduce PrEP and if so for which populations. Unfortunately, at the moment NHS England is not providing Pre-exposure prophylaxis. However, a large study, the PrEP impact trial, funded by the NHS, has just started and this will provide PrEP to 10,000 people. (more…)
Author Interviews, Gender Differences, HIV, Sexual Health / 09.11.2017

MedicalResearch.com Interview with: Adrian Juarez, PhD, RN Assistant Professor The State University of New York School of Nursing Department of Family, Community and Health Systems Sciences Buffalo, New York 14214     MedicalResearch.com: What is the background for this study? Response: HIV testing is considered the initial component of HIV eradication strategies such as “seek, test, treat, and retain.” This study examines the characteristics of an urban, transgender population in western New York when volunteering for an HIV test. The use of an intersectional lens was observed in order to determine the level of influence of sexual partnership types, previous HIV and STD testing, substance use, housing status referral source and racial/gender identification on HIV testing. (more…)
Author Interviews, HIV, Mental Health Research, Pediatrics / 08.11.2017

MedicalResearch.com Interview with: Marcin Jankiewicz  University of Cape Town Cape Town, South AfricaMarcin Jankiewicz  University of Cape Town Cape Town, South Africa  MedicalResearch.com: What is the background for this study? Response: The Children with HIV Early Antiretroviral (CHER) trial, conducted in Cape Town and Soweto, was designed when there was uncertainty whether to start antiretroviral therapy (ART) as soon as HIV was diagnosed (below 12 weeks of age) or to wait until there was evidence of immuno-compromise and disease progression. Also, there were concerns about maintaining adherence, long-term toxicity and also resistance in the setting of few antiretroviral options. Early outcomes showed a decreased risk in childhood mortality in the early treatment arms compared to deferred treatment, becoming standard of care globally. The CHER cohort is one of the largest and best documented of children receiving ART within the first year of life. Also, age- and community-matched HIV exposed uninfected (HEU) and HIV unexposed (HU) uninfected infants were enrolled in parallel for a linked vaccine study. We therefore had an amazing opportunity to link with a neurodevelopmental sub-study in participants from Cape Town and apply sophisticated neuroimaging modalities that could link with clinical, virological and immunological characteristics. (more…)
Author Interviews, Cannabis, Cognitive Issues, HIV / 03.11.2017

MedicalResearch.com Interview with: Richard Saitz, MD, MPH, FACP, DFASAM Department of Community Health Sciences Boston University School of Public Health Clinical Addiction Research and Education (CARE) Unit Section of General Internal Medicine, Department of Medicin Boston University School of Medicine and Boston Medical Center Boston , Massachusetts MedicalResearch.com: What is the background for this study? What are the main findings? Response: Many people living with HIV infection use alcohol and other drugs including marijuana. People with HIV infection are also susceptible to cognitive dysfunction from many causes from HIV infection itself to aging. The main findings were that among people with HIV and substance use disorder, lifetime marijuana and alcohol use were not associated with cognitive dysfunction, likely due to competing risks.  But current marijuana use was associated with cognitive dysfunction. (more…)
Author Interviews, HIV, Infections / 06.10.2017

MedicalResearch.com Interview with: Paul M. Salcuni, MPH Department of Health and Mental Hygiene New York City MedicalResearch.com: What is the background for this study? What are the main findings? Response: NYC Health Department is committed to ensuring equitable access to HIV pre-exposure prophylaxis (PrEP) for all New Yorkers who are HIV-negative and may be exposed to HIV. We examined trends in PrEP prescribing by 602 ambulatory care practices in New York City from 2014 to 2016, as well as associated patient and practice factors, to inform our comprehensive scale-up efforts. For every 100,000 medical visits in the first three months of 2014, roughly 39 involved a patient being prescribed PrEP. In the second quarter of 2016, 419 of every 100,000 medical visits at those same practices involved a PrEP prescription. Despite this nine-fold increase overall, some groups of patients among these practices were less likely to be prescribed PrEP. Those groups include men of color, women, and people getting health care at smaller private practices or practices outside of the city center. (more…)
Author Interviews, Coffee, Gastrointestinal Disease, Hepatitis - Liver Disease / 03.10.2017

MedicalResearch.com Interview with: Patrizia Carrieri PhD INSERM U912 - ORS PACA IHU - Faculté de Médecine Marseille, France MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study is based on the longitudinal data of the French  ANRS HEPAVIH cohort of patients with HIV and Hepatitis C co-infection. This cohort was set up thanks to a collaboration between INSERM (National Institute of health and medical research) UMR912 in Marseille, the ISPED (public health and epidemiology institute) in Bordeaux and several hospital/university sites. Our INSERM team in Marseille is specialized in the study of the impact of behaviors on HIV and HCV outcomes, including mortality. We could think that HCV cure was enough to reduce mortality in HIV-HCV patients as the mortality risk was 80% lower in those who were cured of (i.e. who “cleared”) Hepatitis C thanks to treatment. However, our study showed that, even after HCV cure, sociobehavioral factors still matter: drinking at least 3 cups of coffee a day was associated with a 50% reduction in mortality risk as well as not smoking which was also associated with a reduced mortality risk. This association between elevated coffee intake and reduced mortality risk is probably due to the properties of polyphenols contained in coffee which can protect the liver and also reduce inflammation. (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…)
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).
(more…)
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).
(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, Cost of Health Care, HIV, Opiods, PLoS / 31.05.2017

MedicalResearch.com Interview with: Cora Bernard, MS, PhD candidate Pre-doctoral Student in Management Science and Enginnering Affiliate, Center for Health Policy and the Center for Primary Care and Outcomes Research Stanford Health Policy MedicalResearch.com: What is the background for this study? Response: The US opioid epidemic is leading to an increase in the US drug-injecting population, which also increases the risks of HIV transmission. It is critical to public health that the US invests in a coherent and cost-effective suite of HIV prevention programs. In our model-based analysis, we considered programs that have the potential both to prevent HIV and to improve long-term health outcomes for people who inject drugs. Specifically, we evaluated opioid agonist therapy, which reduces the frequency of injection; needle and syringe exchange programs, which reduce the frequency of injecting equipment sharing; enhanced HIV screening and antiretroviral therapy programs, which virally suppress individuals and decrease downstream transmission; and oral HIV pre-exposure prophylaxis (PrEP), which is taken by an uninfected individual and lowers the risk of infection. (more…)
Author Interviews, HIV, Pharmacology / 24.05.2017

MedicalResearch.com Interview with: Martin Markowitz MD Clinical Director and Staff Investigator Aaron Diamond AIDS Research Center Aaron Diamond Professor at The Rockefeller University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Cabotegravir ((CAB) is an inhibitor of HIV-1 integrase and is amenable to formulation in both oral and long acting injectable forms. In preclinical studies injectable CAB protected against low dose intrarectal challenge using an HIV-like virus in the rhesus macaque model. These results support the clinical development of CAB as prevention. This study was a first attempt to establish a dosing regimen and evaluate safety and acceptability of intramuscular injections of CAB. The study was a placebo controlled blinded study of approximately 120 subjects with a 5:1 randomization active/placebo. Subjects received 800mg CAB given as 2 2mL injections or placebo every 12 weeks for 3 injections after a 4 week safety lead in of oral therapy. Safety acceptability and PK were assessed. The main findings were that injections were associated with injection site reactions in the vast majority of participants that were mild to moderate and of short duration. Only 4 subjects who entered the injection phase discontinued due to injection intolerance. There were no additional safety signals and the participants considered the injections acceptable when asked to complete questionnaires. PK analysis found that despite modeling that suggested that the 800mg q 12 week dose would be adequate, this was not the case. More rapid uptake and release from the depot resulted in lower than anticipated drug levels at trough. Alternate dosing regimens are under study. Another finding is that there were participants (14%) who had detectable drug in plasma detected at 52 weeks after last injection suggesting the presence of a tail in some individuals. (more…)
Author Interviews, Infections, Vaccine Studies / 15.05.2017

MedicalResearch.com Interview with: AbivaxJean-Marc Steens, M.D. Chief Medical Officer of Abivax MedicalResearch.com: What is the background for this study? What are the main findings? Response: Antiretroviral therapy (ART) has had an enormous impact on the HIV pandemic since its introduction almost 20 years ago. Most patients treated with ART achieve undetectable or near undetectable plasma levels of the virus. This means that although HIV is controlled, it is not completely eliminated. The virus remains in the body, usually contained in dormant cells (known as the HIV reservoir) that are widely distributed, including to the central nervous system, the gut mucosa, the lymph nodes and other sites. If ART is stopped, the virus rebounds. The goal of any curative therapy would be to eliminate the virus or ensure there is sustained remission in the absence of ART, which until now have been unsuccessful. Abivax’s Phase 2 clinical study with ABX464 demonstrated, for the first time, a reduction in HIV reservoirs in chronically infected HIV patients as measured by total HIV DNA detected in peripheral blood mononuclear cells (PBMCs). In the ABX464-004 trial, 30 HIV patients received either ABX464 or matching placebo in addition to their current antiretroviral treatment over 28 days. The viral load at the start of the study was well controlled with boosted darunavir. After the 28-day treatment period, all treatments were interrupted until viral load rebound. Baseline and day 28 blood samples were taken to assess the potential effect of ABX464 on the HIV reservoir in PBMCs. Safety was the primary endpoint in the trial. ABX464 was well tolerated, with no severe adverse events in the treatment group. Amongst evaluable patients (4 placebo and 14 ABX464-treated patients), a reduction in viral DNA copies/mPBMCs was observed in 7/14 treated patients (mean change of -40%, ranging from -27% to -67%) and no responders were observed in the placebo group. Responders were defined as patients who had a decrease greater than 25% in total HIV DNA in PBMCs and a reduction of at least 50 copies. Total HIV DNA in PBMC has been validated as a widely accepted biomarker for measuring the HIV reservoir. Specifically, in untreated patients, total HIV DNA load influences the course of the infection and is therefore clinically relevant. In addition, a correlation exists between the pool of HIV-1 DNA and the replication-competent reservoir. (more…)
Author Interviews, CDC, OBGYNE, Pediatrics / 01.05.2017

MedicalResearch.com Interview with: Deborah L. Dee, PhD Division of Reproductive Health National Center for Chronic Disease Prevention and Health Promotion CDC MedicalResearch.com: What is the background for this study? Response: Although the national teen birth rate has dropped to a historic low (22.3 births per 1,000 females aged 15-19 years in 2015), many teens continue to have repeat births. Because repeat teen births are more likely than first teen births to be preterm and low birth weight, and giving birth more than once as a teenager can significantly limit a mother’s ability to attend school and obtain work experience, it’s important to assess patterns in repeat teen births and better understand contraceptive use within this population. (more…)
Author Interviews, HIV, JAMA, Pediatrics, Sexual Health / 25.04.2017

MedicalResearch.com Interview with: Robin Lin Miller, Ph.D. Professor, Ecological-Community Psychology Co-Director, MA in Program Evaluation Chair, Graduate Program in Ecological-Community Psychology Michigan State University East Lansing, MI 48824 MedicalResearch.com: What is the background for this study? Response: We wanted to identify promising strategies for providing access to HIV-testing for gay and bisexual male youth. We were especially interested in testing strategies to reach gay and bisexual male youth of color, as they bear a disproportionate burden of the HIV epidemic and are the least likely to be aware of their HIV status. We also wanted to explore approaches to successfully link these youth with HIV-negative test results to diverse HIV prevention services, including pre-exposure prophylaxis, when warranted. Although some argue that the ideal place to test adolescents and young adults is via emergency rooms and in routine medical care visits, we found that we were able test many more youth with previously undiagnosed HIV-infection through intensive, targeted community outreach efforts. We also tested a much higher proportion of young men of color through targeted outreach. (more…)
Author Interviews, Heart Disease, HIV, JAMA, Vanderbilt / 18.04.2017

MedicalResearch.com Interview with: Matthew S Freiberg, MD, MSc Associate Professor of Medicine, Division of Cardiovascular Medicine Vanderbilt Translational and Clinical Cardiovascular Research Center MedicalResearch.com: What is the background for this study? Response:  HIV infected people are living longer and are at risk for cardiovascular diseases. While acute myocardial infarction has been studied and the increased risk of Acute Myocardial Infarction (AMI) among HIV+ people compared to uninfected people is well documented, there are less data describing the risk of HIV and different types of heart failure, including reduced and preserved ejection fraction heart failure. Understanding more about the link between HIV and different types of HF is important because reduced and preserved ejection fraction heart failure differ with respect to underlying mechanism, treatment, and prognosis. Moreover, as cardiovascular care has improved, HIV infected people who experience an AMI are likely to survive but may live with a damaged heart. Understanding more about the link between HIV and heart failure may help providers and their patients prevent or reduce the impact of HF on the HIV community. (more…)
Author Interviews, Brigham & Women's - Harvard, HIV, Pediatrics / 28.03.2017

MedicalResearch.com Interview with: Anne M Neilan, MD,MPH Assistant in Medicine and Pediatrics Massachusetts General Hospital Instructor at Harvard Medical School Department: Medicine Service Division: Infectious Disease Department: Pediatric Service Massachusetts General Hospital Boston, MA 02114 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Adolescents infected with HIV – either at birth or later in life – experience poorer health outcomes compared to adults with HIV in nearly every respect. This study found that U.S. youth infected with HIV around the time of their birth are at higher risk throughout their adolescence and young adulthood for experiencing serious health problems, poor control of the HIV virus (having high levels of HIV virus in their bodies and fewer CD4 immune cells which protect the body from infection), or death. The study also found that among those with good HIV control, serious health problems are rare. By combining data from two large, long-term U.S. studies – the Pediatric HIV/AIDS Cohort Study (PHACS, www.phacsstudy.org) and the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT, www.impaactnetwork.org) Network – we were able to study the health of more than 1,400 perinatally HIV-infected children, adolescents and young adults ages 7 to 30 years between 2007 and 2015. The study found that youth ages 13 to 30 were most likely to have poor HIV control AIDS-related illnesses, and death compared to younger participants. Among 18 – 30 year-olds, the study found that poor control of the HIV virus – meaning higher levels of HIV virus and lower levels of CD4 immune cells which protect the body from infection –35 percent of the time, increasing the risk that these youth would stop responding to certain HIV medications and could transmit HIV to others. These findings are consistent with other U.S. and European reports. Despite being engaged in health care, the number of deaths among youth born with HIV in the U.S. is 6 to12 times higher than for youth without HIV of the same age, sex and race. Along with HIV-related health problems, the most commonly reported health conditions concerned mental health and brain and nervous system development. Many women in the study also had sexually transmitted infections, which was found to be associated with lower CD4 immune cell counts. This may suggest a biological mechanism or may reflect that patients who have difficulty with their medications are also engaging in more frequent risky sexual behaviors. (more…)
Author Interviews, CDC, HIV, Sexual Health / 23.03.2017

MedicalResearch.com Interview with: Qian An, PhD Epidemiologist/statistician Division of HIV/AIDS Prevention CDC MedicalResearch.com: What is the background for this study? Response: Since 2006, the Centers for Disease Control and Prevention (CDC) has recommended HIV testing for all persons aged 13-64 years old. Persons at high risk for HIV infection should be tested more frequently. Among sexually active men who have sex with men (MSM), repeat testing is recommended at least annually. An analysis in 2011 suggested that MSM might benefit from more frequent than annual testing.(1) Among non-MSM, repeat testing is recommended at least annually for persons at high risk, including persons who inject drugs (PWID) and their sex partners, those who have sex in exchange for money or drugs, heterosexuals who have had more than one sex partner since their most recent HIV test, and those whose partners are living with HIV.. Using statistical models based on renewal theory, we estimate the mean HIV inter-test interval (ITI) — meaning the average time period (in months) between two successive HIV tests — to describe temporal trends in HIV testing frequency among MSM, PWID and high-risk heterosexuals (HRH) and differences in testing frequency by age and race/ethnicity. A decrease in ITI means individuals are testing more frequently. (more…)
Author Interviews, HIV, Pharmacology / 20.02.2017

MedicalResearch.com Interview with: Kati Vandermeulen Senior Director, Global Regulatory Leader and Compound Development Team Lead IDV Janssen MedicalResearch.com: What is the background for this study? What are the main findings? Response:  SWORD is the first large trial program specifically conducted to look at the combination of dolutegravir and rilpivirine as a complete, two-drug antiretroviral regimen. Results of the two identical Phase III SWORD studies have been positive and demonstrate that the two-drug regimen of dolutegravir and rilpivirine is as effective, with comparable tolerability, to traditional three- or four-drug (integrase inhibitor-, non-nucleoside reverse transcriptase inhibitor-, or boosted protease inhibitor-based) antiretroviral regimens for the maintenance treatment of HIV. (more…)
Author Interviews, Global Health, HIV, Lancet / 19.02.2017

MedicalResearch.com Interview with: Jennifer A. Downs, M.D., Ph.D. Assistant Professor of Medicine and Microbiology & Immunology Department of Medicine Weill Cornell Medicine Center for Global Health New York, NY 10065 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Between 2002 and 2006, three large randomized controlled trials in sub-Saharan Africa demonstrated that male circumcision reduces new HIV infections in men by approximately 60%. Based on these findings, the World Health Organization recommended male circumcision as an HIV prevention strategy in countries with high levels of HIV and a low prevalence of male circumcision. This led to prioritization of 14 countries in Eastern and Southern Africa for massive scale-up of male circumcision beginning in 2011. In many of these countries, the uptake of male circumcision was lower than expected. In northwest Tanzania, where we work, there are a number of barriers to male circumcision. Some of these barriers are cultural, tribal, economic, and religious. We conducted focus group interviews in 2012 that showed that many Christian church leaders and church attenders in our region in Tanzania had major concerns about whether male circumcision was compatible with their religious beliefs. This led us to hypothesize that the uptake of male circumcision could be increased when religious leaders were taught about male circumcision, with the goal that they would then be equipped to discuss this issue with their congregations. (more…)