The Bolger conference on PDE-5 inhibition and HIV risk: implications for health policy and prevention.
BACKGROUND
Recent reports have linked the use of phosphodiesterase type 5 (PDE-5) inhibitors with increased rates of high-risk sexual behavior and HIV transmission in some individuals.


OBJECTIVE
A National Institute of Mental Health (NIMH)-funded, multidisciplinary conference was convened to evaluate scientific research, clinical and ethical considerations, and public policy implications of this topic.


METHODS
Published and unpublished findings on effects of PDE-5 inhibitors on sexual behavior; published guidelines and management recommendations.


METHODS
Leading investigators in relevant disciplines (e.g., public health, epidemiology, medical ethics, urology, psychology) participated in a 2-day meeting, including representatives of government, scientific, and regulatory agencies (the Centers for Disease Control, Food and Drug Administration, NIMH, and the National Institute on Drug Abuse). Panelists provided critical reviews of substantive areas of research, followed by question and answer sessions on each topic. On the second day, working groups were convened to identify critical gaps and priorities in three major areas: (i) research and evaluation needs; (ii) prevention strategies and clinical management issues; and (iii) policy and prevention implications.


RESULTS
Research needs and priorities were categorized into four specific areas: (i) basic and clinical/laboratory research; (ii) epidemiology and risk factors; (iii) social-behavioral processes and interventions; and (iv) prevention/policy and educational needs. Identified gaps in the available data include populations at risk (e.g., risk among heterosexuals, risk profiles among subpopulations of men who have sex with men) and the specific role of PDE-5 inhibitors in HIV seroconversion. Specific areas of emphasis were the need for safer sex counseling, comprehensive sexually transmitted infection (STI) screening and follow-up when indicated, avoidance of potentially dangerous drug interactions, and potential benefits of testosterone replacement for HIV-positive men with decreased androgen and other symptoms of hypogonadism. Conclusions. A conference was convened on the topic of PDE-5 inhibition and HIV risk. This "white paper" summarizes the findings of the conference and recommendations for future research.
Rosen
Raymond C
RC
Department of Psychiatry, Robert Wood Johnson Medical School, Piscataway, NJ, and New England Research Institutes, Watertown, MA. Electronic address: rrosen@neriscience.com.
Catania
Joseph A
JA
Center for AIDS Prevention Studies, Department of Medicine, San Francisco, CA.
Ehrhardt
Anke A
AA
HIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute, Columbia University, New York, NY.
Burnett
Arthur L
AL
Department of Urology, The Johns Hopkins Hospital, Baltimore, MD.
Lue
Tom F
TF
Department of Urology, University of California, San Francisco, CA.
McKenna
Kevin
K
Departments of Physiology and Urology, Northwestern University Medical School, Chicago, IL.
Heiman
Julia R
JR
Kinsey Institute for Research in Sex, Gender and Reproduction, Indiana University, Bloomington, IN.
Schwarcz
Sandy
S
HIV/AIDS Statistics and Epidemiology, San Francisco Public Health Department, San Francisco, CA.
Ostrow
David G
DG
David Ostrow & Associates, Lakewood, IL.
Hirshfield
Sabina
S
Medical and Health Research Association, New York, NY.
Purcell
David W
DW
Prevention Research Branch, Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Fisher
William A
WA
Departments of Psychology and Obstetrics and Gynecology, University of Western Ontario, London, Ontario, Canada.
Stall
Ron
R
Department of Behavioral and Community Health Sciences, University of Pittsburgh, Pittsburgh, PA.
Halkitis
Perry N
PN
Center for Health, Identity, Behavior and Prevention Studies (CHIBPS), New York University, New York, NY.
Latini
David M
DM
Scott Department of Urology, Baylor College of Medicine, Houston, TX, USA.
Elford
Jonathan
J
City University, Institute of Health Sciences, UK.
Laumann
Edward O
EO
Department of Sociology, University of Chicago, Chicago, IL.
Sonenstein
Freya L
FL
Center for Adolescent Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.
Greenblatt
David J
DJ
Department of Pharmacology & Experimental Therapeutics, Tufts University, Boston, MA.
Kloner
Robert A
RA
Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Lee
Jay
J
Private Practice, Calgary Alberta, Canada.
Malebranche
David
D
Department of Medicine, Emory University, Atlanta, GA.
Janssen
Erick
E
Kinsey Institute for Research in Sex, Gender and Reproduction, Indiana University, Bloomington, IN.
Diaz
Rafael
R
Cesar Chavez Institute, San Francisco State University, San Francisco, CA.
Klausner
Jeffrey D
JD
STD Prevention and Control Services, San Francisco Department of Public Health, San Francisco, CA.
Caplan
Arthur L
AL
Center for Bioethics, University of Pennsylvania, Philadelphia, PA, USA.
Jackson
Graham
G
Saint Thomas Hospital, London, UK.
Shabsigh
Ridwan
R
Department of Urology, Columbia Presbyterian Medical Center, Columbia University, New York, NY.
Khalsa
Jag H
JH
Medical Consequences Branch, National Institute on Drug Abuse, Bethesda, MD.
Stoff
David M
DM
Center for Mental Health Research on AIDS, National Institute of Mental Health, Bethesda, MD, USA.
D015106:3',5'-Cyclic-GMP Phosphodiesterases / Q000037:antagonists & inhibitors*; D007172:Erectile Dysfunction / Q000188:drug therapy; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006291:Health Policy; D018451:Homosexuality, Male; D006801:Humans; D008297:Male; D011322:Primary Prevention / Q000458:organization & administration*; D012309:Risk-Taking; D012736:Sex Education / Q000458:organization & administration; D012725:Sexual Behavior; D012749:Sexually Transmitted Diseases / Q000517:prevention & control; D012955:Societies, Medical
D015106:3',5'-Cyclic-GMP Phosphodiesterases