Publication of HPTN 052 Final Results: HIV Treatment Offers Durable Prevention of HIV Transmission in Serodiscordant Couples

The HIV Prevention Trials Network (HPTN) announced that the final results of the HPTN 052 study were published in the New England Journal of Medicine (NEJM). This pivotal study demonstrated that antiretroviral therapy (ART) for HIV infection provides durable and reliable protection against the sexual transmission of the virus from infected men and women to their HIV-uninfected sexual partners.

The final results showed a 93 percent reduction of HIV transmission when the HIV-infected person started ART when their immune system was relatively healthy. HIV transmission from HIV-infected study participants to their partners was not observed when viral replication in the treated individual was stably suppressed by ART.

“The HPTN 052 study confirms the urgent need to treat people for HIV infection as soon as it is diagnosed to protect their health and for public health,” said Myron S. Cohen, M.D., principal investigator for HPTN 052 and director of the Institute for Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill. “This study represents more than a decade of effort by a worldwide team of investigators, and the tremendous courage and generosity of more than 3,500 clinical trial participants.”

HPTN 052 began in 2005 and enrolled 1,763 HIV-serodiscordant couples – where one person was HIV infected and the other was not – at 13 sites in nine countries (Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, the United States, and Zimbabwe). The majority of the couples were heterosexual (97 percent). HIV-infected participants were assigned at random to start ART at the beginning of the study when their immune system was relatively healthy (called the “early” arm), or later in the study when they had immune system decline (called the “delayed” arm).

In 2011, interim study results demonstrated significant benefit of early ART, with a 96 percent reduction in HIV transmission from early ART compared to delayed ART. This finding was reported based on the recommendation of the study’s data safety and monitoring board; presented at the 6th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention in Rome, Italy; and published in NEJM.

All HIV-infected participants in the study were then offered ART and the study was continued until May 2015 to understand the magnitude and durability of “treatment as prevention”; 87 percent of the HIV-infected participants remained in the study for its 10-year duration.

The HPTN 052 results have helped to galvanize a worldwide commitment to a universal “treatment as prevention” strategy for combatting the HIV/AIDS epidemic, with ART offered to all HIV-infected people, regardless of CD4 cell count.

About HPTN 052

HPTN 052 was a randomized, controlled trial designed to evaluate the effectiveness of antiretroviral therapy (ART) to prevent the sexual transmission of HIV in serodiscordant couples. The trial was conducted by the HIV Prevention Trials Network (HPTN) and funded by the U.S., National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). Additional support was provided by the NIAID-funded AIDS Clinical Trials Group. The antiretroviral drugs used in the study were made available by Abbott Laboratories; Boehringer Ingelheim Pharmaceuticals, Inc.; Bristol-Myers Squibb; Gilead Sciences; GlaxoSmithKline; and Merck & Co., Inc.

Future Initiatives for the UNC CFAR HIV Clinical Cohort (UCHCC)

cfarlogoThe UNC-CFAR HIV/AIDS Clinical Cohort sponsors a bi-monthly meeting for discussing methods in Epidemiology, Biostatistics, and Infectious Diseases.

Future Initiatives for the UNC CFAR HIV Clinical Cohort (UCHCC)
A discussion of future pathways and areas of focus for research using the Cohort

Friday, December 19, 2014
1:30 – 3:30 pm
2127 Bioinformatics Building, UNC-CH Campus

Friday ID Conference: “Complications of HIV Infection: It’s Complicated”

PalellaThis talk is a part of our friday morning CFAR/IGHID Friday ID Conference Series.

“Complications of HIV Infection: It’s Complicated”
Frank Palella Jr. MD
Northwestern University, Chicago, IL

October 31, 2014
8:30 – 9:30 a.m.
1131 Bioinformatics
UNC Campus

Dr. Palella is the Potocsnak Chair of Medicine at Northwestern. His research focuses on the natural history, clinical outcomes, responses to therapy and complications of HIV disease. He wrote a landmark article documenting dramatic reductions in AIDS-associated deaths and opportunistic disease as a consequence of highly active antiretroviral therapy use. The article is the most cited in HIV/AIDS literature. He serves as the principal investigator or co-investigator of several studies, many funded by the National Institutes of Health and the Centers for Disease Control and Prevention. Palella has been on Northwestern’s faculty in the division of infectious diseases since 1992. He is a Northwestern alumnus, having completed his undergraduate degree, residency in internal medicine and fellowship in infectious diseases at Northwestern.

Special Note: This Friday Morning Conference event will be presented as an NCATEC training, and advance registration is requested. Register here.

For questions about registration or general questions about the NCATEC, please contact michele_bailey@med.unc.edu.

Friday ID Conference: Progress and Challenges in STI Research

King HolmesThis talk is a part of our friday morning CFAR/IGHID Friday ID Conference Series.

“Progress and Challenges in STI Research”
King Holmes, MD, PhD, FIDSA
Department of Global Health at University of Washington

September 19, 2014
8:30 – 9:30 a.m.
4th Floor Old Clinic, UNC-CH Campus

King K. Holmes MD, PhD, FIDSA, has dedicated 50 years to research on the epidemiology, diagnosis, and treatment and prevention of sexually transmitted infections. From 2006-2014, Dr. Holmes served as the first William H. Foege Chair of the Department of Global Health at the University of Washington, where he is Professor of Global Health and Medicine, and Adjunct Professor of Microbiology and Epidemiology. He also heads the Infectious Diseases Section at Harborview Medical Center. He founded and directs the UW Center for AIDS and STD, a WHO Collaborating Center.

Refreshments will be served.

Friday ID Conference: Power and Sample Size Boot Camp

Katie MollanThis week marks the start of the CFAR/IGHID Friday ID Conference Series for the 2014-2015 school year.

Power and Sample Size Boot Camp
Speakers: Michael Hudgens and Katie Mollan
UNC CFAR Biostatistics Core

September 5, 2014
8:30-9:30 a.m.
1131 Bioinformatics (first floor auditorium), UNC-CH Campus

The CFAR Biostatistics Core will present on power and sample size calculation using examples from HIV research. Topics will include an introduction to statistical power and related terminology, a discussion of the investigator and statistician roles in sample size calculation, and presentation of statistical software and brief formulas for sample size and power computation.

2014-2015 Friday ID Conference Series Begins

This week marks the start of the CFAR/IGHID Friday ID Conference Series for the 2014-2015 school year.

Power and Sample Size Boot Camp
Speakers: Michael Hudgens and Katie Mollan
UNC CFAR Biostatistics Core

September 5, 2014
8:30-9:30 a.m.
1131 Bioinformatics (first floor auditorium), UNC-CH Campus

The CFAR Biostatistics Core will present on power and sample size calculation using examples from HIV research. Topics will include an introduction to statistical power and related terminology, a discussion of the investigator and statistician roles in sample size calculation, and presentation of statistical software and brief formulas for sample size and power computation.

UNC CFAR partners with the clinical division of infectious diseases and the Institute for Global Health & Infectious Disease on a weekly conference series featuring distinguished clinicians and scientists from UNC, local universities, and other national and international institutions. The topics are varied and appeal to not only infectious disease specialists, but also professionals in epidemiology, public health, microbiology, biostatistics and other global health-related disciplines.

The conference takes place every Friday (September through May) from 8:30-9:30 a.m. in 1131 Bioinformatics (first floor auditorium) on the UNC campus. For more information, please contact the conference coordinator, Kathy James. To suggest a speaker, contact the faculty organizer, David Wohl.

For the current conference schedule, please click here.