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Biotech / Medical : Procept (PRCT): 50% rise on high volume. Why?
PRCT 31.91+1.9%Nov 7 9:30 AM EST

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To: Douglas who wrote (255)9/29/1997 8:38:00 AM
From: Douglas   of 455
 
Maybe they will have a press release. The timing is great, with the Stockholders Meeting today.

Evolving HIV Treatments:
Advances and the Challenge of Adherence

September 27, 1997  4:00 pm - 8:00 pm

The Westin Harbour Castle

Toronto, Ontario

AGENDA

Saturday  September 27, 1997

4:00 pm - 4:45 pm Registration and Refreshment Break

4:45 pm - 5:00 pm Welcome and Introduction
Richard E. Chaisson, MD

5:00 pm - 5:30 pm Treatment Strategies: The Implications for Viral Load and Resistance Assays
John W. Mellors, MD

5:30 pm - 6:00 pm Practical Treatment Issues and Adherence: Challenges from the Clinic
Charles Flexner, MD

6:00 pm - 6:30 pm The New NIH HIV Guidelines
John G. Bartlett, MD

6:30 pm - 7:00 pm New Antiretroviral Therapies: Adherence Challenges and Strategies
Margaret A. Chesney, PhD

7:00 pm - 7:30 pm A Behavioral Approach for the Promotion of Adherence in Complicated Patient Populations
Glenn J. Treisman, MD, PhD

7:30 pm - 8:00 pm Questions and Answers
Moderator: Richard E. Chaisson, MD

8:00 pm Adjourn

FACULTY

John G. Bartlett, MD
Chief, Division of Infectious Diseases
Professor of Medicine
Johns Hopkins University School of Medicine
Baltimore, Maryland

Richard E. Chaisson, MD
Associate Professor of Medicine, Epidemiology,
and International Health
Johns Hopkins University
Baltimore, Maryland

Margaret A. Chesney, PhD
Professor, Department of Medicine
University of California at San Francisco
Co-Director, Center for AIDS Prevention Studies
University of California at San Francisco
San Francisco, California

Charles Flexner, MD
Associate Professor of Medicine, Pharmacology and
Molecular Sciences, and International Health
Johns Hopkins University
Baltimore, Maryland

John W. Mellors, MD
Director, HIV/AIDS Program
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania

Glenn J. Treisman, MD, PhD
Associate Professor of Psychiatry
Director, AIDS Psychiatry Service
Associate Professor of Medicine
Johns Hopkins University
Baltimore, Maryland

FACULTY DISCLOSURES

Faculty may have disclosed one or more of the following: grants; consulting role; speakers bureau member; stock
ownership; other special relationships with the program's commercial supporter.

Faculty members have provided the following information on sources of funding for research, consulting agreements, offices
in professional associations, financial interests and stock ownership.

John G. Bartlett, MD
Sources of Funding for Clinical Grants: NIH, HRSA

Consulting Agreements: None

Financial Interests/Stock Ownership: None

Positions Held in Professional Associations: President Elect - IDSA; Member - ATS, ASM, AAAS, ACP, ASP, AAP,
ASCI

Richard E. Chaisson, MD
Sources of Funding for Research: NIH, CDC, Robert Wood Johnson Foundation, Bristol-Myers Squibb Co., Abbott
Laboratories, Annie E. Casey Foundation

Consulting Agreements: Novartis, TAP Pharmaceuticals

Financial Interests/Stock Ownership: Merck and Co., Inc.

Positions Held in Professional Associations: Board of Directors - American Thoracic Society

Margaret A. Chesney, PhD
Sources of Funding for Research: NIH, CDC

Consulting Agreements: None

Financial Interests/Stock Ownership: None

Positions Held in Professional Associations: President - American Psychosomatic Society; President Elect - Academy of
Behavioral Medicine Research

Charles Flexner, MD
Sources of Funding for Research: NIAID, NCI, Abbott Pharmaceuticals, Agouron Pharmaceuticals, Hybridon, Inc.,
Merck and Co., Inc.

Consulting Agreements: Alza Corporation, << Procept>> , Inc., GelTex Pharmaceuticals, Inc.

Financial Interests/Stock Ownership: None

Positions Held in Professional Associations: Board of Directors - American Society for Clinical Pharmacology and
Therapeutics; American Federation for Medical Research; International Society for Antiviral Research

John W. Mellors, MD
Sources of Funding for Research: Merck and Co., Inc., Chiron Corporation, Abbott Laboratories, Inc.,
Bristol-Myers Squibb Co.

Consulting Agreements: Speaker's Bureau: Merck and Co., Inc., Glaxo Wellcome, Inc., Hoffman-LaRoche Laboratories,
Inc.

Financial Interests/Stock Ownership: None

Positions Held in Professional Associations: None

Glenn J. Treisman, MD, PhD
Sources of Funding for Research: NIH/Ryan White

Consulting Agreements: None

Financial Interests/Stock Ownership: None

Positions Held in Professional Associations: Member - APA, Maryland Psychiatric Association, American Association of
Directors of Psychiatric Residency Training, Johns Hopkins Medical Surgical Association

ACCREDITATION

Medical Education Collaborative (MEC), a non-profit education organization, is accredited by the Accreditation Council
for Continuing Medical Education (ACCME) to sponsor continuing medical education for physicians. MEC designates this
continuing medical education activity for a maximum of 3.25 hours in Category 1 credit toward the AMA Physician's
Recognition Award. Each physician should claim only those hours of credit that he/she actually spent in the educational
activity.

ACKNOWLEDGEMENT

"Evolving HIV Treatments: Advances and the Challenge of Adherence" is supported in part by an unrestricted educational
grant from Agouron Pharmaceuticals Inc.

Treatment Strategies:
The Implications for Viral Load and Resistance Assays

John W. Mellors, MD

(There was not information for Mellors, no copy, no slides - he didn't submit anything by the time we published the
handout)

Practical Treatment
Issues and Adherence: Challenges from the Clinic

Charles Flexner, MD

Objectives
1. Review lessons learned in the management of imperfect adherence, as it has affected other chronic illnesses such as
hypertension and epilepsy.

2. Discuss which approaches to the management of imperfect adherence have been most successful.

3. Describe the practical limitations of available methodologies for assessing adherence in the outpatient setting.

Narrative Summary
Imperfect adherence to prescribed medication regimens has been a medical fact of life since the dawn of man. What we
think we know about adherence is often based on inaccurate and imprecise estimands. Patient report, physician and nurse
assessment, and pill counts provide notoriously unreliable information. More recently, computerized electronic monitoring
devices such as MEMS’ caps have made it possible to quantify adherence. What we have learned from recent studies in
the treatment of chronic diseases such as hypertension and epilepsy is that: 1) imperfect adherence is the rule in medicine,
with fewer than 10% of patients taking all doses of medication as prescribed, and 20% to 30% of patients taking fewer than
50% of prescribed doses; 2) QD regimens promote adherence best, BID regimens are only marginally better than TID
regimens, and any medication prescribed more frequently than TID invites poor adherence; 3) most socioeconomic,
demographic, and diagnostic traits are poor discriminators of poor, moderate, or good adherence behavior.
Lessons learned from the treatment of hypertension suggest that imperfect adherence can be managed effectively by
recognizing the problem, counseling and educating the patient about the importance of good adherence, providing
environmental cues to habituate the taking of medicines, monitoring outcomes and providing feedback to reinforce success,
minimizing polypharmacy, using BID or QD regimens whenever possible, and using sustained-release formulations
whenever necessary.

Bibliography

Cramer JA, Mattson RH, Prevey ML, Scheyer RD, Ouellette VL. How often is medication taken as prescribed? A novel
assessment technique. JAMA. 1989;261:3273-3277.

Cramer JA and Spilker B, eds. Patient Compliance in Medical Practice and Clinical Trials. New York, NY: Raven Press
Ltd.; 1991.

Efron B, Feldman D. Compliance as an explanatory variable in clinical trials. J Am Stat Assoc. 1991;86:9-17.

Kasstrisios H, Flowers NT, Blaschke TF. Introducing medical students to medication noncompliance. Clin Pharmacol Ther.
1996;59:577-582.

Rudd P, Byyny RL, Zachary V, et al. The natural history of medication compliance in a drug trial: limitations of pill counts.
Clin Pharmacol Ther. 1989;46169-176.

Urquhart J. Ascertaining how much compliance is enough with outpatient antibiotic regimens. Postgrad Med.
1992;68(suppl 3):S49-59.

Vanhove GF, Schapiro JM, Winters MA, Merigan TC, Blaschke TF. Patient compliance and drug failure in protease
inhibitor monotherapy [letter]. JAMA. 1996;276:1955-1956.

Waterhouse DM, Calzone KA, Mele C, Brenner DE. Adherence to oral tamoxifen: a comparison of patient self-report, pill
counts, and microelectronic monitoring. J Clin Oncol. 1993;11:1189-1197.

(21 slides)

The New NIH HIV Guidelines

John G. Bartlett, MD

(Dr. Bartlett sent a reprint article to be scanned in to the handout, plus he had 7 slides)

A Behavioral Approach for the Promotion of Adherence
in Complicated Patient Populations

Glenn J. Treisman, MD, PhD

The AIDS epidemic has evolved radically since it was first identified. Initially, patients presented with opportunistic
infections and rapidly deteriorated. The development of tools to characterize HIV infection led to identification of risk
factors for infection and early detection of HIV. The resulting education and prevention campaign has altered the population
at risk, and the epidemic now affects an increasing population of patients with difficulty modifying risk behaviors. We have
reported high rates of psychiatric disorders in patients presenting for medical treatment of HIV. Identified psychiatric
disorders include high rates of mood disorders (20%), dementia (and other cognitive disturbances) (18%), adjustment
problems (20%), substance abuse (74%), and personality disorders, and less elevated rates of other psychiatric disorders.
We have found improved outcomes in a variety of clinical measures all correlate with measures of compliance with
treatment of psychiatric disorders.
The current phase of the epidemic has highlighted the difficulty associated with strict adherence to complex antiviral
regimens. Psychiatric disorders decrease compliance, and accurate identification of both psychiatric disorders and patient
personality features can be used to develop treatment plans that improve compliance over time. More importantly, because
antiretroviral medications provoke resistance when taken incorrectly, a treatment plan to improve compliance is life saving
and essential. A model for treatment planning for patients with substance abuse disorders, personality vulnerabilities, mood
and cognitive disorders, and adjustment disorders will be presented.

(Plus 57 scanned slides)
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