SWORD Study Demonstrates Two-Drug Control of HIV

MedicalResearch.com Interview with:

Kati Vandermeulen Senior Director, Global Regulatory Leader and Compound Development Team Lead IDV Janssen

Kati Vandermeulen

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.
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Educating Religious Leaders Improves Uptake of Male Circumcision in Tanzania

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

Dr. Jennifer Downs

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.
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Ibalizumab Immunotherapy Decreased Viral Load In Resistant HIV

MedicalResearch.com Interview with:

Brinda Emu MD Assistant Professor of Medicine (Infectious Diseases Yale University New Haven, CT

Dr. Brinda Emu

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.

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African American Women Remain Disproportionately Affected By HIV

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.

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Does HAART Treatment for HIV Contribute To Rapid Rise in Syphilis Infections?

MedicalResearch.com Interview with:

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

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.

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Types of Myocardial Infarction Among HIV–Infected Individuals

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.

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Anti–HIV Drug Candidate Prevents Intestinal Inflammation

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).

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Dapivirine Vaginal Ring Helps Prevent HIV Infection in Women

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.

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Penn Takes First Step in Development of Antibodies to HIV and Cure

MedicalResearch.com Interview with:

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

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.

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Family-Centered Advanced Care Planning for Adolescents With HIV

MedicalResearch.com Interview with:

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

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.

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Ibalizumab Decreased Viral Load In Patients With Resistant HIV

MedicalResearch.com Interview with:

Jacob Lalezari, MD Quest Clinical Research San Francisco, CA

Dr. Jacob Lalezari

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. 

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EHRs Can Help Identify Patients Who May Benefit From HIV PrEP Medications

MedicalResearch.com Interview with:

Douglas Krakower, MD Infectious Disease Division Beth Israel Deaconess Medical Center Boston, MA,

Dr. Douglas Krakower

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.

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