What's New, Different, and Critical to Know in Management of HIV in 2012
Presented by the Johns Hopkins University School of Medicine.

ACKNOWLEDGEMENT
Supported by educational grants from Bristol-Myers Squibb, Boehringer Ingelheim Pharmaceuticals Inc, and Gilead Sciences, Inc

TUITION

Complimentary

DATE OF RELEASE/EXPIRATION
Enduring sessions will be available May 17, 2012 through May 16, 2013.

ESTIMATED TIME TO COMPLETE
Each activity will take approximately one hour to complete, for a total of 3 hours.

ACTIVITY DIRECTORS 
John G. Bartlett, MD, Professor of Medicine and Epidemiology, Division of Infectious Diseases, Johns Hopkins University School of Medicine and Paul Sax, MD, Director of the HIV Program and Division of Infectious Diseases Brigham & Women's Hospital

ACCREDITATION STATEMENT
The Johns Hopkins University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENTS
The Johns Hopkins University School of Medicine designates this enduring activity for a maximum of 3  AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

OTHER CREDITS
American Nurses Credentialing Center (ANCC) accepts AMA PRA Category 1 Credit™ from organizations accredited by the ACCME.

American Academy of Nurse Practitioners (AANP) accepts AMA PRA Category 1 Credit™ from organizations accredited by the ACCME.

American Academy of Physician Assistants (AAPA) accepts certificates of participation for educational activities certified for AMA PRA Category 1 Credit™ from organizations accredited by the ACCME. Physician assistants may receive a maximum of 3.0 hours credit for completing this program.

JOHNS HOPKINS STATEMENT OF RESPONSIBILITY
The Johns Hopkins University School of Medicine takes responsibility for the content, quality, and scientific integrity of this CME activity.

INTENDED AUDIENCE
The summit is planned to meet the CME needs of infectious disease specialists, HIV specialists, primary care physicians, internal medicine practitioners, pathologists, epidemiologists, obstetricians/gynecologists, and other healthcare providers caring for patients with HIV will constitute the primary audience for this event. The secondary audience may include nurses, nurse practitioners, physician assistants, and pharmacists.

PREREQUISITES
There are no prerequisites.

STATEMENT OF NEED
Highly active antiretroviral therapy (HAART) has improved dramatically over the past 15 years and is now more effective, less toxic, and easier to take than earlier treatment approaches. However, there is still room for improvement; and new treatment options and regimens are urgently needed. Since the pace of research in this area is rapid, it is challenging for medical professionals treating HIV/AIDS patients to stay abreast of recent developments and changes. In light of this, the following knowledge and practice gaps have been identified in the management of HIV infection and AIDS:

1. Due to the HAART complexities, many physicians may have limited knowledge about various treatment regimens. As a result, prescribing errors are common, especially among those not specializing in HIV management.
2. Selection of the optimal HAART regimen could be challenging and complicated by various patient factors.
3. There are controversies about the timing of the HAART initiation and the therapy selection; and many HIV experts believe that the treatment should start sooner. However, the current guidelines' update does not propose any changes.
4. Antiretrovirals may play a role in HIV prophylaxis. However, effective prophylaxis regimens are not yet firmly established or widely used by practicing physicians.
5. Some physicians choose to simplify HAART regimens to improve patients' adherence. However, this simplification may be accompanied by lost efficacy and increased viral resistance.

The need for this educational activity has been established according to ACCME standards by expert assessment of a wide range of sources, including in-depth review of relevant medical literature, analysis of available quality of care and practice gap studies, and expert opinion as reflected in the faculty members' choices of topics and content. The resulting educational activity will include fair and balanced information on relevant therapies, including efficacy and a discussion of adverse events if warranted. It will make use of clinical data that are as up-to-date as possible, including clinical trial results Infectious disease specialists, HIV specialists, primary care physicians, internal medicine practitioners, pathologists, epidemiologists, obstetricians/gynecologists, and other healthcare providers caring for patients with HIV will constitute the primary audience for this event. The secondary audience may include nurses, nurse practitioners, physician assistants, and pharmacists. Because of the accessibility of an online event, approximately 10% of the audience is expected to consist of healthcare professio recently presented at major U.S. and international meetings, such as the Conference on Retroviruses and Opportunistic Infections (CROI), the Infectious Diseases Society of America (IDSA) conference, the American Conference on the Treatment of HIV (ACTHIV), the International AIDS Society (IAS) annual meeting, the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), and the Tenth International Congress on Drug Therapy in HIV Infection. Important regional meetings will also be included. Content will include clinical data recently published in major peer-reviewed journals and input from acknowledged experts and clinicians experienced in the field of HIV/AIDS management.

LEARNING OBJECTIVES
After participating in this activity, the participant will demonstrate the ability to:

Choose appropriate HAARTs for treatment-native patients with HIV to meet individual needs.
Identify the best course of action for HIV patients failing on standard HAART
Apply changes incorporated in the recent guidelines' revision to clinical practice
Integrate new research data on prevention of HIV transmission
Describe strategies for improving compliance with HAART, including therapy simplification whenever appropriate
Incorporate newly approved ARTs to minimize resistance and improve tolerability

FULL DISCLOSURE POLICY AFFECTING CME ACTIVITES

As a provider approved by the Accreditation Council for Continuing Medical Education (ACCME), it is the policy of the Johns Hopkins University School of Medicine Office of Continuing Medical Education (OCME) to require signed disclosure of the existence of financial relationships with industry from any individual in a position to control the content of a CME activity sponsored by OCME. Members of the Planning Committee are required to disclose all relationships regardless of their relevance to the content of the activity. Faculty are required to disclose only those relationships that are relevant to their specific presentation. The following relationships have been reported for this activity:

FACULTY NAME AND LECTURE TITLE(S): RELATIONSHIP(S):
Paul Sax, MD

Highlights of CROI 2012: Meeting Highlights and Implications for HIV Management
Consultant - Abbott, Aileron, Bristol Myers Squib, Gilead, GlaxoSmithKline, Merck, Tibotec
Research Funding - Bristol Myers Squib, Gilead, Merck, GlaxoSmithKline, Tibotec
Calvin Cohen, MD

Highlights of CROI 2012: Meeting Highlights and Implications for HIV Management
Research Funding and Consultant - Gilead, Bristol Myers Squib, Merck, Janssen
David Wohl, MD

Immune Activation and Inflammation--What to Measure and What to Do About It?
Advisory Board - Gilead, Tibotec
Grant Support - Merck, GlaxoSmithKline
Joseph Eron, MD

The Immune Activation and Inflammation--What to Measure and What to Do About It?
Research Funding - Glaxo Smith Kline/ViiV, Bristol Myers Squibb, Tobira
Consultant
- Merck, Avexa, Bristol Myers Squibb, Glaxo Smith Kline/ViiV, Gilead, Tibotec, Tobira, Argos, LabCorp, Kainos Pharmaceutical
Pablo Tebas, MD

Novel Treatment Strategies for HIV/AIDS: NRTI Sparing, Monotherapies, and Eradication
Research Support: Merck, Gilead, Bristol-Myers Squibb, Vertex, Tibotec, Virxsys, Sangamo
Committee member - GlaxoSmithKline
Consultant - Merck
Ian Frank, MD

Novel Treatment Strategies for HIV/AIDS: NRTI Sparing, Monotherapies, and Eradication
Advisor- Gilead
Research Support- GlaxoSmithKline

No other faculty members have indicated that they have any financial interests or relationships with a commercial entity whose products or services are relevant to the content of their presentation(s).
PLANNER NAME AND LECTURE TITLE(S): RELATIONSHIP(S):
Paul Sax, MD Consultant - Abbott, Aileron, Bristol Myers Squib, Gilead, GlaxoSmithKline, Merck, Tibotec
Research Funding - Bristol Myers Squibb, Gilead, Merck, GlaxoSmithKline, Tibotec

No other planners have indicated that they have any financial interests or relationships with a commercial entity.

Note: Grants to investigators at The Johns Hopkins University are negotiated and administered by the institution which receives the grants, typically through the Office of Research Administration. Individual investigators who participate in the sponsored project(s) are not directly compensated by the sponsor, but may receive salary or other support from the institution to support their effort on the project(s).

OFF-LABEL PRODUCT DISCUSSION

The following speakers have disclosed that their presentation will reference unlabeled/unapproved uses of drugs or products:

NAME AND LECTURE TITLE(S) PRODUCT(S):
Paul Sax, MD

Highlights of CROI 2012: Meeting Highlights and Implications for HIV Management
Dolutegravir, simeprevir, GS 7340, ABT-450, ABT-333, GS-7977, Daclatasvir, Cobicistat
Calvin Cohen, MD

Highlights of CROI 2012: Meeting Highlights and Implications for HIV Management
Dolutegravir, simeprevir, GS 7340, ABT-450, ABT-333, GS-7977, Daclatasvir, Cobicistat
Pablo Tebas, MD

Novel Treatment Strategies for HIV/AIDS: NRTI Sparing, Monotherapies, and Eradication
Dr. Tebas will speak about antiretroviral drugs, which are approved for use in combination therapy, but not as a single agents. Dr. Tebas will also speak about gene therapy approaches, and strategies to drive expression of HIV from the latent reservoir, all of which is experimental. Nucleoside reverse transcriptase inhibitor sparing regimens are also experimental.

No other speakers have indicated that they will reference unlabeled/unapproved uses of drugs or products.

COURSE FORMAT
Enduring video sessions are one hour, and are a recorded version of the live event.

PRE AND POST TEST AND EVALUATION
Prior to and immediately after each presentation, participants will be presented with a series of multiple choice test questions. After each presentation participants will also be presented with an online activity evaluation. A CME certificate of credit will be issued upon successful completion, which includes a passing grade of 70% or more. Participants must document the amount of time they spent in the activity.

DISCLAIMER STATEMENT
The opinions and recommendations expressed by faculty and other experts whose input is included in this program are their own. Use of Johns Hopkins University School of Medicine name implies review of educational format design and approach. Please review the complete prescribing information of specific drugs or combination of drugs, including indications, contraindications, warnings and adverse effects before administering pharmacologic therapy to patients.

INTERNET CME POLICY

The Office of Continuing Medical Education (CME) at the Johns Hopkins University School of Medicine is committed to protecting the privacy of its members and customers. Johns Hopkins University SOM CME maintains its Internet site as an information resource and service for physicians, other health professionals and the public. Continuing Medical Education at the Johns Hopkins University School of Medicine will keep your personal and credit information confidential when you participate in a CME Internet based program. Your information will never be given to anyone outside of the Johns Hopkins University School of Medicine's CME program. CME collects only the information necessary to provide you with the services that you request..

HIPAA STATEMENT
CONFIDENTIALITY DISCLAIMER FOR CME CONFERENCE ATTENDEES

I certify that I am attending a Johns Hopkins University School of Medicine CME activity for accredited training and/or educational purposes.

I understand that while I am attending in this capacity, I may be exposed to "protected health information," as that term is defined and used in Hopkins policies and in the federal HIPAA privacy regulations (the "Privacy Regulations").  Protected health information is information about a person’s health or treatment that identifies the person.

I pledge and agree to use and disclose any of this protected health information only for the training and/or educational purposes of my visit and to keep the information confidential.

I understand that I may direct to the Johns Hopkins Privacy Officer any questions I have about my obligations under this Confidentiality Pledge or under any of the Hopkins policies and procedures and applicable laws and regulations related to confidentiality.  The contact information is:  Johns Hopkins Privacy Officer, telephone: 410-735-6509, e-mail: HIPAA@jhmi.edu.


“The Office of Continuing Medical Education at the Johns Hopkins University School of Medicine, as provider of this activity, has relayed information with the CME attendees/participants and certifies that the visitor is attending for training, education and/or observation purposes only.”

For CME Questions, please contact the CME Office

(410) 955-2959 or e-mail cmenet@jhmi.edu.

For CME Certificates, please call (410) 502-9634.

Johns Hopkins University School of Medicine  
Office of Continuing Medical Education Reviewed & Approved by:
Turner 20/720 General Counsel, Johns Hopkins Medicine (4/1/03)
Baltimore, Maryland 21205-2195 Updated 4/09

Opening a New Chapter in HCV: Focus on Successful Outcomes w/ HCV Protease Inhibitor Therapy
Presented by the Johns Hopkins University School of Medicine.

ACKNOWLEDGEMENT
Supported by educational grants from Abbott Laboratory Inc., Boehringer Ingelheim, Gilead Sciences and Merck & Co., Inc.

TUITION

Complimentary

DATE OF RELEASE/EXPIRATION
Enduring sessions will be available May 17, 2012, through May 16th, 2013

ESTIMATED TIME TO COMPLETE
Each activity will take one hour to complete, for a total of 4 hours.

ACTIVITY DIRECTORS 
John G. Bartlett, MD, Professor of Medicine and Epidemiology, Division of Infectious Diseases, Johns Hopkins University School of Medicine and Mark Sulkowski, MD, Associate Professor of Medicine Johns Hopkins University School of Medicine

ACCREDITATION STATEMENT
The Johns Hopkins University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENTS
The Johns Hopkins University School of Medicine designates this enduring activity for a maximum of 4 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

OTHER CREDITS
American Nurses Credentialing Center (ANCC) accepts AMA PRA Category 1 Credit™ from organizations accredited by the ACCME.

American Academy of Nurse Practitioners (AANP) accepts AMA PRA Category 1 Credit™ from organizations accredited by the ACCME.

American Academy of Physician Assistants (AAPA) accepts certificates of participation for educational activities certified for AMA PRA Category 1 Credit™ from organizations accredited by the ACCME. Physician assistants may receive a maximum of 4.0 hours credit for completing this program.

JOHNS HOPKINS STATEMENT OF RESPONSIBILITY
The Johns Hopkins University School of Medicine takes responsibility for the content, quality, and scientific integrity of this CME activity.

INTENDED AUDIENCE
The summit is planned to meet the CME needs of Infectious disease specialists, gastroenterologists, hepatologists, primary care clinicians, and those clinicians affiliated with correctional facilities, Veteran's Administration hospitals, and alcohol/drug rehabilitation centers. A number of secondary audiences of healthcare providers such as nurses, physician assistants, and pharmacists may also be interested in participating in the program.

PREREQUISITES
There are no prerequisites.

STATEMENT OF NEED
Hepatitis C virus (HCV) infection is the most common chronic blood-borne infection in the U.S.; approximately 3.2 million persons are chronically infected. Sixty to 70% of people newly infected with HCV typically are asymptomatic or have a mild clinical illness. Chronic HCV infection develops in 70%- 85% of HCV-infected persons; 60% - 70% of those chronically infected have evidence of active liver disease. The majority of infected people, however, might not be aware of their infection because they are not clinically ill. It should be noted that infected persons serve as a source of transmission to others and are at risk for chronic liver disease or other HCV-related chronic diseases decades after infection. Fortunately, there have been a number of critical developments in understanding virus function, which have led to new treatment. The following gaps in knowledge and performance have been identified among healthcare providers. Addressing these gaps will improve the standard of care of patients with HCV

Therapies currently constituting the standard of care do not provide sustained virologic response (SVR) in many patients, leading to a gap in physician confidence in making treatment decisions in patients infected with HCV, especially with genotype 1.
Due to severe side effects and uncertainty about SVR, many healthcare providers choose to postpone the treatment in mild HCV cases, which in many cases may not be the best course of action. • With new therapies just becoming available, there is a need to educate healthcare providers in integrating them into clinical practice.
HCV infection is often present in special populations (e.g., in those with liver fibrosis, renal insufficiency, or in illicit drug users), and clinicians need to understand additional challenges they face when providing care to these patients.
There is a sizable pool of patients coinfected with both HCV and HIV. Adverse effects of HAART may complicate management of these patients. Additionally, established HCV therapies are less effective in these populations.
• Healthcare professional need additional awareness and training to treat these patients successfully.

The need for this educational activity has been established according to ACCME standards by expert assessment of a wide range of sources, including in-depth review of relevant medical literature, analysis of available quality of care and practice gap studies, and expert opinion as reflected in the faculty members' choices of topics and content. The resulting educational activity will include fair and balanced information on relevant therapies, including efficacy and a discussion of adverse events if warranted. It will make use of clinical data that are as up-to-date as possible, including clinical trial results recently presented at major U.S. and international meetings, such as the Infectious Diseases Society of America (IDSA) conference, the American Association for the Study of Liver Diseases (AASLD) meeting, the American Gastroenterological Association (AGA) meeting, the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), and the European Association for the Study of the Liver (EASL) meeting, among others. Important regional meetings will also be included. Content will include clinical data recently published in major peer-reviewed journals and input from acknowledged experts and clinicians experienced in the field of hepatitis management.

LEARNING OBJECTIVES
After participating in this activity, the participant will demonstrate the ability to:

Identify patients who will most benefit from novel treatment options Describe the application of biomarkers to predict SVR in patients with HCV
Revise office-based management of HCV by applying timely interventions and increasing therapy adherence
Recognize special populations infected with HCV and successfully manage these challenging cases
Evaluate the dynamics of HCV/HIV co-infection and apply proper treatment to avoid side effects and maximize SVR

FULL DISCLOSURE POLICY AFFECTING CME ACTIVITES

As a provider approved by the Accreditation Council for Continuing Medical Education (ACCME), it is the policy of the Johns Hopkins University School of Medicine Office of Continuing Medical Education (OCME) to require signed disclosure of the existence of financial relationships with industry from any individual in a position to control the content of a CME activity sponsored by OCME. Members of the Planning Committee are required to disclose all relationships regardless of their relevance to the content of the activity. Faculty are required to disclose only those relationships that are relevant to their specific presentation. The following relationships have been reported for this activity:

FACULTY NAME AND LECTURE TITLE(S): RELATIONSHIP(S):
Charles Howell, MD

New Paradigms for the Treatment of Patients Infected with HCV Genotype 1: Peginterferon Alfa/Ribavirin Combined With HCV Protease Inhibitors
Consultant - Abbott, Aileron, Bristol Myers Squib, Gilead, GlaxoSmithKline, Merck, Tibotec
Research Funding - Bristol Myers Squib, Gilead, Merck, GlaxoSmithKline, Tibotec
Mark S. Sulkowski, MD

New Paradigms for the Treatment of Patients Infected with HCV Genotype 1: Peginterferon Alfa/Ribavirin Combined With HCV Protease Inhibitors
Research Funding - Roche, Merck, Gilead, Bristol-Myers Squibb, Vertex, Tibotec, Pharmasset, BIPI, Abbott
Consultant - Roche, Merck, Gilead, Bristol-Myers Squibb, BIPI, , Pharmasset
Andrew J. Muir, MD, MHS

Maximizing Success and Minimizing Risks: The Role of IL28B Testing and Hepatitis C Viral Kinetics
Research Funding - Abbott, BMS, Gilead, GSK, Intercept, Medtronic, Merck, Novartis, Pfizer, Pharmasset, Roche, Santaris, Scynexis, Vertex
Consultant - Achillion, BMS, Merck, Vertex
Rajender Reddy, MD

Successful Office-Based Management of Patients With HCV Protease Inhibitors and Peginterferon/Ribavirin
Consultant - Genentech-Roche, Merck, Gilead, Vertex, Janssen
Research Funding - Merck, Genentech-Roche, Bristol-Myers Squibb
Sanjeev Arora, MD

Successful Office-Based Management of Patients With HCV Protease Inhibitors and Peginterferon/Ribavirin
Research Support: ZymoGenetics, Genentech, Vertex, Tibotec, Gilead, Pharmasset
Mark S. Sulkowski, MD

Successful Office-Based Management of Patients With HCV Protease Inhibitors and Peginterferon/Ribavirin
Research Support- Roche, Merck, Gilead, Bristol-Myers Squibb, Vertex, Tibotec, Pharmasset, BIPI, Abbott
Consultant: Roche, Merck, Gilead, Bristol-Myers Squibb, BIPI, , Pharmasset
Rohit Talwani, MD

The Treatment of Challenging HCV-Infected Patients
Independent Speaker - Merck
Research Funding: Vertex
Mark S. Sulkowski, MD

The Treatment of Challenging HCV-Infected Patients
Research Funding- Roche, Merck, Gilead, Bristol-Myers Squibb, Vertex, Tibotec, Pharmasset, BIPI, Abbott
Consultant: Roche, Merck, Gilead, Bristol-Myers Squibb, BIPI, , Pharmasset

No other faculty members have indicated that they have any financial interests or relationships with a commercial entity whose products or services are relevant to the content of their presentation(s).
PLANNER NAME AND LECTURE TITLE(S): RELATIONSHIP(S):
Mark S. Sulkowski, MD
The Treatment of Challenging HCV-Infected Patients
Research Funding - Roche, Merck, Gilead, Bristol-Myers Squibb, Vertex, Tibotec, Pharmasset, BIPI, Abbott
Consultant
- Roche, Merck, Gilead, Bristol-Myers Squibb, BIPI, , Pharmasset

No other planners have indicated that they have any financial interests or relationships with a commercial entity.

Note: Grants to investigators at The Johns Hopkins University are negotiated and administered by the institution which receives the grants, typically through the Office of Research Administration. Individual investigators who participate in the sponsored project(s) are not directly compensated by the sponsor, but may receive salary or other support from the institution to support their effort on the project(s).

OFF-LABEL PRODUCT DISCUSSION

The following speakers have disclosed that their presentation will reference unlabeled/unapproved uses of drugs or products:

NAME AND LECTURE TITLE(S) PRODUCT(S):
Mark S. Sulkowski, MD

Successful Office-Based Management of Patients With HCV Protease Inhibitors and Peginterferon/Ribavirin
Telaprevir and Beceprivir
Andrew J. Muir, MD, MHS

Maximizing Success and Minimizing Risks: The Role of IL28B Testing and Hepatitis C Viral Kinetics
BI201335, BI207127
Charles Howell, MD

New Paradigms for the Treatment of Patients Infected with HCV Genotype 1: Peginterferon Alfa/Ribavirin Combined With HCV Protease Inhibitors
ABT-450, ACH-1625, GS 9451, MK-5172, VX-985, BI 207127, IDX375, A-831, PPI-461, CTS-1027, Danoprevir GS 9256, IDX320, Vaniprevir , ABT-333, ABT-072, ANA598, BMS-791325, Filibuvir, Tegobuvir , VX-759 VX-222, IDX184, RG7128, BMS-824393, CF102, BMS, 650032, BI 201335, TMC435, PSI-7977, BMS-790052

No other speakers have indicated that they will reference unlabeled/unapproved uses of drugs or products.

COURSE FORMAT
Enduring sessions are one hour and will be delivered in the form of recorded versions of the live webcasts at www.IDCareLive.com

PRE AND POST TEST AND EVALUATION
Prior to and immediately after each presentation, participants will be presented with a series of multiple choice test questions. After each presentation participants will also be presented with an online activity evaluation. A CME certificate of credit will be issued upon successful completion, which includes a passing grade of 70% or more. Participants must document the amount of time they spent in the activity.

DISCLAIMER STATEMENT
The opinions and recommendations expressed by faculty and other experts whose input is included in this program are their own. Use of Johns Hopkins University School of Medicine name implies review of educational format design and approach. Please review the complete prescribing information of specific drugs or combination of drugs, including indications, contraindications, warnings and adverse effects before administering pharmacologic therapy to patients.

INTERNET CME POLICY

The Office of Continuing Medical Education (CME) at the Johns Hopkins University School of Medicine is committed to protecting the privacy of its members and customers. Johns Hopkins University SOM CME maintains its Internet site as an information resource and service for physicians, other health professionals and the public. Continuing Medical Education at the Johns Hopkins University School of Medicine will keep your personal and credit information confidential when you participate in a CME Internet based program. Your information will never be given to anyone outside of the Johns Hopkins University School of Medicine's CME program. CME collects only the information necessary to provide you with the services that you request..

HIPAA STATEMENT
CONFIDENTIALITY DISCLAIMER FOR CME CONFERENCE ATTENDEES

I certify that I am attending a Johns Hopkins University School of Medicine CME activity for accredited training and/or educational purposes.

I understand that while I am attending in this capacity, I may be exposed to "protected health information," as that term is defined and used in Hopkins policies and in the federal HIPAA privacy regulations (the "Privacy Regulations").  Protected health information is information about a person’s health or treatment that identifies the person.

I pledge and agree to use and disclose any of this protected health information only for the training and/or educational purposes of my visit and to keep the information confidential.

I understand that I may direct to the Johns Hopkins Privacy Officer any questions I have about my obligations under this Confidentiality Pledge or under any of the Hopkins policies and procedures and applicable laws and regulations related to confidentiality.  The contact information is:  Johns Hopkins Privacy Officer, telephone: 410-735-6509, e-mail: HIPAA@jhmi.edu.


“The Office of Continuing Medical Education at the Johns Hopkins University School of Medicine, as provider of this activity, has relayed information with the CME attendees/participants and certifies that the visitor is attending for training, education and/or observation purposes only.”

For CME Questions, please contact the CME Office

(410) 955-2959 or e-mail cmenet@jhmi.edu.

For CME Certificates, please call (410) 502-9634.

Johns Hopkins University School of Medicine  
Office of Continuing Medical Education Reviewed & Approved by:
Turner 20/720 General Counsel, Johns Hopkins Medicine (4/1/03)
Baltimore, Maryland 21205-2195 Updated 4/09

Infectious Disease 2011 Congress

Top 10 Topics in Key Areas of Infectious Disease: A Snapshot of What's New, Important, and Changing

Presented by the Johns Hopkins University School of Medicine

ACKNOWLEDGEMENT
Supported by an educational grant from Cubist Pharmaceuticals, Abbott Labs, Astellas Pharma, and Gilead Sciences.

TUITION
Complimentary

DATE OF RELEASE/EXPIRATION
Live sessions will be available November 16, 2011 from 9:00 AM-1:00 PM (EST) and November 17, 2011 from 9:00 AM-3:00 PM (EST). Enduring sessions will be available online from November 17th 2011 through November 17th, 2012.

ESTIMATED TIME TO COMPLETE
Each activity will take approximately one hour to complete, for a total of 9 hours.

ACTIVITY DIRECTORS
John G. Bartlett, MD, Professor of Medicine and Epidemiology, Division of Infectious Diseases, Johns Hopkins University School of Medicine

ACCREDITATION STATEMENT
The Johns Hopkins University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENTS
Enduring activity: The Johns Hopkins University School of Medicine designates this live activity for a maximum of 7 AMA PRA Category 1 Credits?. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

OTHER CREDITS
American Nurses Credentialing Center (ANCC) accepts AMA PRA Category 1 Credit? from organizations accredited by the ACCME.

American Academy of Nurse Practitioners (AANP) accepts AMA PRA Category 1 Credit? from organizations accredited by the ACCME.

American Academy of Physician Assistants (AAPA) accepts certificates of participation for educational activities certified for AMA PRA Category 1 Credit? from organizations accredited by the ACCME. Physician assistants may receive a maximum of 7.0 hours credit for completing this program.

JOHNS HOPKINS STATEMENT OF RESPOSIBILITY
The Johns Hopkins University School of Medicine takes responsibility for the content, quality, and scientific integrity of this CME activity.

INTENDED AUDIENCE
The summit is planned to meet the CME needs of infectious disease specialists, hepatologists, primary care physicians, family and internal medicine practitioners, nurses, physician assistants, pharmacists and other healthcare professionals involved in caring for patients across the spectrum of infectious disease.

PREREQUISITES
There are no prerequisites.

STATEMENT OF NEED
Despite decades of progress, today's infectious disease practitioner faces a wide range of challenging clinical scenarios, caused by the continued rise in antimicrobial resistance, the increasing population of immunocompromised and older individuals, worldwide shifts in disease patterns, and many other factors. Among these challenges is consistent implementation of proven measures to reduce and eliminate healthcare-acquired infections (HAIs) that cause significant burden on healthcare systems and affected individuals. Both growing antimicrobial resistance and scarcity of new antimicrobial agents have added to these problems. Clinicians are also faced with complex guidelines and expert opinions that change frequently to reflect the high volume of clinical research in certain areas of infectious diseases. Viral infections, especially HIV, hepatitis B and C, and influenza, are particularly active areas, as are bacterial infections such MRSA, C. difficile, pneumococcal disease, and antibioticresistant infections in general. New prevention and HAART strategies to control HIV infection and novel approaches to the management of HCV offer opportunities but also significant challenges. Immunization guidelines for influenza and other infectious diseases change frequently as new vaccines are developed and introduced. As a result, physicians are often confused and patients who would benefit from vaccine application are suboptimally immunized. Also, the recently updated guidelines on sexually transmitted diseases strongly emphasizing education of persons at risk and the use of pre-exposure vaccinations need to be more broadly implemented. The rapid pace of research in these areas has made it difficult for busy, time-challenged clinicians to stay current with and incorporate new clinical paradigms and expert recommendations into their everyday practices effectively. Identified Practice Gaps in the Area of Infectious Diseases: 1. Suboptimal implementation of measures to control healthcare-acquired infections (see attachment 1: Expert Opinion - Trends in Infection Prevention and Control) 2. Limited treatment choices and insufficient knowledge to effectively manage growing antimicrobial resistance (see attachment 2: Recent Research - Drug Resistance Update) 3. Complexities of HAART and physicians' lack of familiarity often leading to prescribing errors (see attachment 3: Physician Survey - HAART Prescribing Errors) 4. Limited experience with new therapies to combat HCV infection (see attachment 4: Literature Review - Treat Now or Wait for New DAA in HCV) 5. Insufficient rates of influenza immunization among at-risk populations (see attachment 5: Medical Audit - Influenza Immunization Among Healthcare Workers) 6. Lack of time and resources to implement recommendations of updated guidelines on STD, especially in the area of patient/partner counseling and education (see attachment 6: Patient Survey - Patient and Partner Perspectives on Patient-Delivered Partner Screening). The need for this educational activity has been established according to ACCME standards by expert assessment of a wide range of sources, including in-depth review of relevant medical literature, analysis of available quality of care and practice gap studies, and expert opinion as reflected in the faculty members' choices of topics and content. The resulting educational activity will include fair and balanced information on relevant therapies, including efficacy, side effects, and a discussion of adverse events if warranted. It will make use of clinical data that are as up-to-date as possible, including clinical trial results recently presented at major U.S. meetings, such as the Infectious Diseases Society of America and the Interscience Conference on Antimicrobial Agents and Chemotherapy meetings, international meetings such as the International Symposium on HIV and Emerging Diseases and the European Association for the Study of the Liver annual meeting, and important regional meetings as well. Content will also include clinical data recently published in major peer-reviewed journals and input from acknowledged experts and experienced clinicians in the fields of infectious disease, hepatology, internal medicine and primary care.

LEARNING OBJECTIVES
After participating in this activity, the participant will demonstrate the ability to:

  • Identify appropriate therapies for antibiotic resistant bacterial infections based on patient and disease characteristics, local epidemiology, and expert recommendations
  • Integrate infection control procedures in their daily practices and consider implementing screening for antibiotic resistant pathogens on admission
  • Judiciously apply newly approved antibiotic agents to effectively eradicate resistant pathogens and improve patient outcomes
  • Recognize and better manage infections due to C. difficile
  • Incorporate new therapies and recommendations into current management practices for their patients with HIV
  • Implement new developments in the area of HCV management
  • Incorporate recent expert recommendations into immunization and treatment plans for influenza that are tailored to specific at-risk patient populations within their practices
  • Integrate current vaccination guidelines and schedules for adult and pediatric patients, with careful attention paid to recommendations for specific patient groups, such as the elderly and immunocompromised individuals
  • Assess and utilize new molecular diagnostic tests appropriately
  • Implement new guidelines on STD prevention and treatment

COURSE FORMAT
Live sessions are approximately one hour and will be delivered in the form of video webcasts with real-time Q&A from faculty at www.IDCareLive.com

PRE AND POST TEST AND EVALUATION
Prior to and immediately after each presentation, participants will be presented with a series of multiple choice test questions. After each presentation participants will also be presented with an online activity evaluation. A CME certificate of credit will be issued upon successful completion, which includes a passing grade of 70% or more. Participants must document the amount of time they spent in the activity.

DISCLAIMER STATEMENT
The opinions and recommendations expressed by faculty and other experts whose input is included in this program are their own. Use of Johns Hopkins University School of Medicine name implies review of educational format design and approach. Please review the complete prescribing information of specific drugs or combination of drugs, including indications, contraindications, warnings and adverse effects before administering pharmacologic therapy to patients.

INTERNET CME POLICY
The Office of Continuing Medical Education (CME) at the Johns Hopkins University School of Medicine is committed to protecting the privacy of its members and customers. Johns Hopkins University SOM CME maintains its Internet site as an information resource and service for physicians, other health professionals and the public. Continuing Medical Education at the Johns Hopkins University School of Medicine will keep your personal and credit information confidential when you participate in a CME Internet based program. Your information will never be given to anyone outside of the Johns Hopkins University School of Medicine's CME program. CME collects only the information necessary to provide you with the services that you request.

FULL DISCLOSURE POLICY AFFECTING CME ACTIVITES
As a provider approved by the Accreditation Council for Continuing Medical Education (ACCME), it is the policy of the Johns Hopkins University School of Medicine Office of Continuing Medical Education (OCME) to require signed disclosure of the existence of financial relationships with industry from any individual in a position to control the content of a CME activity sponsored by OCME.? Members of the Planning Committee are required to disclose all relationships regardless of their relevance to the content of the activity.? Faculty are required to disclose only those relationships that are relevant to their specific presentation.? The following relationships have been reported for this activity:

FACULTY NAME AND LECTURE TITLE(S):

RELATIONSHIP(S):

Mark Sulkowski, MD
Top 10 Developments in Hepatitis C

Grant: Roche, Merck, Vertex, Gilead, Janssen, Abbott, BMS, BIPI, Novartis, Pharmasset

Advisory Board: Roche, Merck, Vertex, Gilead, Janssen, Abbott, BMS, BIPI, Pharmasset

William Greenough, MD
Top 10 Observations in Clostridium Difficile

Advisor & Shareholder: CERA Products

Co-investigator: Merck & Co., Ventria

Safety Monitor: Sanofi

Neal Halsey, MD
Top 10 Vaccine Messages

Safety Monitor: Novartis, Merck & Co.

Advisory Committee: Pfizer

Grant: Merck & Co.

Trish Perl, MD
Current Trends in Infection Control

Grant: Merck & Co., Sage

Advisory Board: Pfizer

Paul Sax, MD
Hot Topics in AIDS/HIV

Consultant: Abbott, BMS, Gilead, GSK, Merck, Tibotec

Grant: BMS, Gilead, Merck, GSK, Tibotec

Daniel Kuritzkes, MD
Hot Topics in AIDS/HIV

Consultant: Abbott, Aileron, Avexa, BMS, Gilead, Merck, Pathogenica, Roche, Tobira, Vertex, ViiV, VIRxSYS, Virostatistics

Grant: Gilead, Merck & Co.

Honorarium: Roche

Edward Hook III, MD
New STD Guidelines From the CDC and Your Patient

Grant: Roche Molecular Diagnostics, Gen Probe, Becton Dickinson

Honorarium: Becton Dickinson

Employment/Salary: medhelp.org

Khalil Ghanem, MD
New STD Guidelines From the CDC and Your Patient

Honorarium: Becton Dickinson Diagnostics

Consultant: Cempra

No other faculty members have indicated that they have any financial interests or relationships with a commercial entity whose products or services are relevant to the content of their presentation(s).

No other planners have indicated that they have any financial interests or relationships with a commercial entity.

Note: Grants to investigators at The Johns Hopkins University are negotiated and administered by the institution which receives the grants, typically through the Office of Research Administration. Individual investigators who participate in the sponsored project(s) are not directly compensated by the sponsor, but may receive salary or other support from the institution to support their effort on the project(s).

OFF-LABEL PRODUCT DISCUSSION
The following speakers have disclosed that their presentation will reference unlabeled/unapproved uses of drugs or products:


NAME AND LECTURE TITLE(S)

PRODUCT(S):

John Bartlett, MD
Top 10 Observations in Clostridium Difficile

Toxoid A and B vaccines

Mark Sulkowski, MD
Top 10 Developments in Hepatitis C

teleprevir, boceprevir, PSI-7977, daclatasvir, BI1335, TMC435, TMC435, BI201335, ACH-1625, BMS-650032, BMS-791325, Danoprevir, GS-9256, GS-9451, ABT-450/r, Vaniprevir, GSK2336805, IDX320, MK-5172, VX-985, ACH-1095, ACH-2684, AVL-192, GNS-227, ABT-267, BMS-790052, GS-5885, AZD7295, PPI-461, ACH-2928, BMS-766, EDP-239, IDX380, IDX719, PPI-437, PPI-668, PPI-883, PPI-1301, IDX184, Mericitabine, PSI-7977, PSI-7851, RG7128, GS-6620, INX-08189, PSI-661, ABT-333, ABT-072, ANA598, BBI207127, Filibuvir, IDX375, Tegobuvir, VCH-916, VX-222, GSK2485852, VX-759, GS-9669, BILB 1941, IDN-6556, Alisporivir, NIM811, SCY-635, PEGylated interferon-?, GS-9620, ITX-5061, ITX4520, PRO206, REP 9C, SP-30

Daniel Kuritzkes, MD
Hot Topics in AIDS/HIV

elvitegravir, dolutegravir,

HIPAA STATEMENT

CONFIDENTIALITY DISCLAIMER FOR CME CONFERENCE ATTENDEES

I certify that I am attending a Johns Hopkins University School of Medicine CME activity for accredited training and/or educational purposes.

I understand that while I am attending in this capacity, I may be exposed to "protected health information," as that term is defined and used in Hopkins policies and in the federal HIPAA privacy regulations (the "Privacy Regulations"). Protected health information is information about a person's health or treatment that identifies the person.

I pledge and agree to use and disclose any of this protected health information only for the training and/or educational purposes of my visit and to keep the information confidential.

I understand that I may direct to the Johns Hopkins Privacy Officer any questions I have about my obligations under this Confidentiality Pledge or under any of the Hopkins policies and procedures and applicable laws and regulations related to confidentiality. The contact information is: Johns Hopkins Privacy Officer, telephone: 410-735-6509, e-mail: HIPAA@jhmi.edu.

"The Office of Continuing Medical Education at the Johns Hopkins University School of Medicine, as provider of this activity, has relayed information with the CME attendees/participants and certifies that the visitor is attending for training, education and/or observation purposes only."

For CME Questions, please contact the CME Office at (410) 955-2959 or e-mail cmenet@jhmi.edu.
For CME Certificates, please call (410) 502-9634.

Johns Hopkins University School of Medicine
Office of Continuing Medical Education
Turner 20/720 Rutland Avenue
Baltimore, Maryland 21205-2195

Reviewed & Approved by:
General Counsel, Johns Hopkins Medicine (4/1/03)
Updated 4/09

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Supported by educational grants from:

• Abbott Laboratories
• Bristol-Myers Squibb
• Boehringer Ingelheim, Inc.
• Gilead Sciences
• Merck & Co., Inc.