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MedicalResearch.com specializes in exclusive interviews with medical researchers from major and specialty journals and presenters at health care meetings.
Learn directly from the researchers as they discuss the ideas behind their investigations and their plans for future studies. Over 7830 interviews to date!

Once-Daily, Fixed-Dose Combination Tablet Containing Doravirine Achieved HIV-1 Viral Suppression

MedicalResearch.com Interview with:

Dr. Kathleen Squires MD Professor and Director of Infectious Diseases Thomas Jefferson University Philadelphia, PA 

Dr. Squires

Dr. Kathleen Squires MD
Professor and Director of Infectious Diseases
Thomas Jefferson University
Philadelphia, PA 

MedicalResearch.com: What is the background for this study? What are the main findings?

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

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ONCEMRK Study: Once Daily Raltegravir In Combination With Other Antivirals Effective For Some HIV Patients

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

Dr. Pedro Cah

Dr. Pedro Cahn
Chief of the infectious disease unit at Juan A. Fernandez Hospital
Buenos Aires, Argentina, and
ONCEMRK lead study investigator

MedicalResearch.com: What is the background for this study? What are the main findings?

The ONCEMRK Phase 3 study was conducted to evaluate the efficacy and safety of once-daily ISENTRESS (raltegravir) HD 1200 mg (given as two 600 mg oral tablets) compared to twice daily raltegravir 400 mg, each in combination therapy with emtricitabine plus tenofovir disoproxil fumarate in previously untreated adults with HIV-1 infection with levels of HIV-1 RNA ≥ 1,000 copies/mL.

  • Week 96 data showed:
    • 5 percent of the 531 patients taking once-daily raltegravir 1200 mg (2 x 600 mg) achieved viral suppression of less than 40 copies/mL of HIV-1 RNA, compared to 80.1 percent of the 266 patients taking twice-daily raltegravir 400 mg, both in combination therapy with emtricitabine plus tenofovir disoproxil fumarate, with a treatment difference of 1.4 percent.
    • Increases in CD4+T-cell counts from baseline were comparable for the two treatment regimens, with an average increase of 261.6 cells/mm3 for once-daily raltegravir (1200 mg) and 262.2 cells/mm3 for twice-daily raltegravir (400 mg).
    • Efficacy was consistent across a variety of patient populations, including those with high viral load at baseline (HIV-1 RNA >100,000 copies/mL).
    • Treatment-emergent viral mutations leading to any drug resistance were detected in less than 1 percent of patients in both treatment arms, with 4/531 (0.8 percent) in the once-daily raltegravir (1200 mg) treatment arm, and 2/266 (0.8 percent) in the twice-daily raltegravir (400 mg) treatment arm through 96 weeks.
    • The rate of discontinuation of therapy due to adverse events through 96 weeks was low (1.3 percent in patients receiving once-daily raltegravir (1200 mg) and 2.3 percent in patients receiving twice-daily raltegravir (400 mg).

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Chronic Traumatic Encephalopathy Found In Brains of Nearly All NFL Players Examined

MedicalResearch.com Interview with:

Daniel H. Daneshvar, M.D., Ph.D. Chronic Traumatic Encephalopathy Center Team Up Against Concussions | Founder Boston University

Dr. Daneshvar

Daniel H. Daneshvar, M.D., Ph.D.
Chronic Traumatic Encephalopathy Center
Team Up Against Concussions | Founder
Boston University 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Chronic traumatic encephalopathy (CTE) is a neurodegenerative disease associated with repetitive head impacts. CTE was first described in JAMA in 1928. In the 99 years since, just over 100 cases of CTE have been described in the world’s literature.

This study nearly doubles the number of reported cases of CTE, with 177 cases of CTE in football players. Of note, 110 of the 111 athletes who played in the NFL had CTE. This study represents the largest and the most methodologically rigorous description of a series of patients with CTE ever published. Such a richness of data regarding the clinical and pathological features of CTE has never been previously compiled. As such, this study represents an important advance to the medical literature and an enormous scientific advance in our understanding of  chronic traumatic encephalopathy.

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Unregulated Direct-to-Consumer Treatment Centers Provide Stem Cells for Patients With Heart Failure

MedicalResearch.com Interview with:

Dr. Paul J. Hauptman, MD Professor of Internal Medicine Division of Cardiology Assistant Dean, Clinical and Translational  Research Saint Louis University School of Medicine St. Louis MO 63110-0250

Dr. Hauptman

Dr. Paul J. Hauptman, MD
Professor of Internal Medicine
Division of Cardiology
Assistant Dean, Clinical and Translational  Research
Saint Louis University School of Medicine
St. Louis MO 63110-0250 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: A publication in 2016 by Leigh Turner from the University of Minnesota in 2016 shed light on the proliferation of stem cell centers or “businesses” that offer non FDA approved treatments, described as “stem cell therapy” for a variety of conditions. We opted to evaluate sites that claimed to treat heart failure. We collected data on type of infusion, need for a medical evaluation, board certification status of the center physician, cost and other factors. Self reported patient volumes were very variable. Most centers/businesses claimed to use autologous stem cells; a number offered ancillary treatment (i.e. vitamin infusions and hyperbaric oxygen); only one appeared to have a board-certified cardiologist involved. The costs were high for single infusions (mean price of $7694, SD 2737 for autologous cells; slightly less for allogeneic cells). Efficacy claims made during telephone calls with the centers were highly positive.

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Sex and Ethnicity Data Missing From Many FDA Medical Device Approval Reports

MedicalResearch.com Interview with:

Sanket Dhruva, MD, MHS, FACC Cardiology, VA Connecticut Healthcare System Robert Wood Johnson Foundation Clinical Scholar Yale University

Dr. Dhruva

Sanket Dhruva, MD, MHS, FACC
Cardiology, VA Connecticut Healthcare System
Robert Wood Johnson Foundation Clinical Scholar
Yale University

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: In 2012, Congress passed the Food & Drug Administration (FDA) Safety and Innovation Act, with the goal of increasing enrollment and availability of data in important patient groups such as the elderly, women, and racial and ethnic minorities. In 2014, as mandated by the legislation, the FDA released an Action Plan to address these issues. This Action Plan included the goal of increasing the transparency by posting demographic information of pivotal (or key) clinical trials used to support approval decisions.

We examined how often these data were available in 2015 for all studies used to support approval of all original high-risk medical devices approved in the calendar year following the FDA Action Plan. Examples of these medical devices include stents, bone grafts, heart valves, and spinal cord stimulators. We wanted to understand if age, sex, and race and ethnicity data were available and if the results of clinical studies supporting these medical devices were analyzed to assess if there were differences in safety and effectiveness by these important demographic factors.

Our main findings are that FDA Summaries publicly reported age for 65% of study populations, sex for 66%, and race and/or ethnicity for 51%. Analyses to assess if demographic factors may have impacted device safety and effectiveness were only conducted by age for 9%, by sex for 17%, and by race for 4% of clinical studies.

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Trying Statins Again After Adverse Effect Linked To Lower Risk of Heart Attack

MedicalResearch.com Interview with:

Alexander Turchin, MD,MS Director of Quality in Diabetes Associate Professor, Harvard Medical School Brigham and Women's Hospital Boston, MA

Dr. Turchin

Alexander TurchinMD,MS
Director of Quality in Diabetes
Associate Professor, Harvard Medical School
Brigham and Women’s Hospital
Boston, MA

MedicalResearch.com: What is the background for this study?

Response: Cardiovascular disease is the # 1 cause of death in the U.S. and worldwide. Statins are some of the most effective medications available for prevention of cardiovascular events.

However, many patients stop statins, frequently because of adverse reactions. In our study we aimed to assess the risk-benefit balance of trying a statin again after experiencing an adverse reaction.

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Iris Freckles Are A Potential Biomarker for Chronic Sun Damage

MedicalResearch.com Interview with:

Iris Freckles Credit: © Africa Studio / Fotolia

Iris Freckles
Credit: © Africa Studio / Fotolia

Dr.med.univ. Christoph Schwab
Departement of Ophthalmology
Medical University of Graz
Graz, Austria 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Knowledge about risk factors and/or pathways involved in pathogenesis is from special importance in order of preventing diseases.

The role of sunlight in several eye diseases is unclear. In our study we found a close relation between sun light exposure – evaluated by a full body skin examination and a personal questionnaire – and iris freckles. Therefore we suggest the presence of iris freckles as a novel biomarker indicating high ocular sun exposure.

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Diet Rich in Anti-Inflammatory Foods May Help Preserve Brain Function

MedicalResearch.com Interview with:
Yian Gu, PhD
Assistant Professor of Neuropsychology (in Neurology and
Taub Institute for Research on Alzheimer’s Disease and the Aging Brain)
Columbia University Medical Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We have previously shown that elderly individuals who consume healthier diet (certain foods, nutrients, and dietary patterns) have larger brain volume, better cognition, and lower risk of developing Alzheimer’s disease.

The current study aimed to examine the biological mechanisms for the relationship between diet and brain/cognitive health

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Small Cell Lung Cancers Form Chemotherapy-Resistant Circulating Tumor Spheres

MedicalResearch.com Interview with:

Prof. Gerhard Hamilton Department of Obstetrics and Gynecology Medical University of Vienna 

Prof. Hamilton

Prof. Gerhard Hamilton
Department of Obstetrics and Gynecology
Medical University of Vienna

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Small cell lung cancer (SCLC) is a highly aggressive tumor (15 % of all lung cancers) mainly of patients with high tobacco consumption which shows an extremely poor survival (< 5% 2-year survival rate). Unfortunately the
low survival rates of advanced SCLC cases has not improved significantly during the last decades, with platinum drugs/etoposide and topotecan employed for first- and second-line chemotherapy, respectively. All kinds of new chemotherapeutics, targeted drugs and immunotherapies either failed or resulted in prolongation of survival of several months at best. SCLC responds well to first-line therapy but relapses within a short time as chemoradioresistant tumor. The failure of hundreds of registered studies seem to be linked to the lack of knowledge of the mechanism of resistance of SCLCs and proper ways to reverse the refractoriness.

Small cell lung cancer is distinguished by excessive numbers of circulating tumor cells (CTCs) in advanced stages. CTCs contain the founder of metastasis and seem to constitute a highly chemoresistant cell population. Thus, we ware able to establish a panel of permanent CTC lines in vitro for the first time (8 SCLC lines so far from blood samples). Although CTCs were considered to be chemoresistant we detected that they are chemosensitive in vitro in form of single cell suspensions. However, all CTC lines developed spontaneously into large multicellular aggregates, termed tumorospheres, which grow up to 1-2 mm in size and exhibit high chemoradioresistance due to limited drug perfusion as well as content of quiescent and hypoxic cells. Resistance to irradiation seems to be caused by lack of oxygen, such limiting the generation of oxygen radicals. High resistance mediated by the occurrence of tumorospheres easily explains the failure of a large number of drugs – if one is not able to achieve a sufficient concentration of a drug in cancer cells and the cells are quiescent, the respective compounds will not be able to destroy the target cells, regardless of their chemical nature.

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Duration of Dual Anti-Platelet Therapy After Cardiac Stenting Needs To Be Personalized

MedicalResearch.com Interview with:
Abhishek Sharma MD and

Division of Cardiovascular Medicine State University
New York Downstate Medical Center
Dr.Sahil Agarwal M.B.B.S., M.D.
Division of Cardiology
St. Luke’s University Health Network
Bethlehem, Pennsylvania

MedicalResearch.com: What is the background for this study? 

Response: Prior randomized control trials (RCTs) and meta-analysis of these trials which have attempted to compare differences in outcomes between strategies of short (S) (3-6 months) and longer (L) (12-30 months) durations of dual anti-platelet therapy (DAPT) after drug eluting stents (DES) implantation have reported conflicting results. In general, the events rates in these studies were small, affecting statistical power. To overcome this limitation, we conducted an updated meta-analysis to compare the efficacy and safety of strategies of S-DAPT versus L-DAPT strategy after DES implantation by restricting inclusion to randomized studies with follow-up durations of 24 months or longer.

The current meta-analysis is the first to compare outcomes between S-DAPT and L-DAPT in a meta-analysis restricted to trials with patient follow-up of 24 months or longer. We found no significant difference in the rates of mortality or of stent thrombosis with S-DAPT or L-DAPT. S-DAPT was associated with significantly lower risk of major bleeding but slightly higher risk of future myocardial infarctions.

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