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In Memoriam

Posted March 2012

Ed Handelsman

Ed Handelsman, MD

It is with deep sadness that we announce the untimely and unexpected death of friend and colleague Ed Handelsman, MD (49).

Ed worked for the AIDS Institute for several years as Assistant Medical Director for Pediatrics. He was a caring, fun-loving, gentle man who dedicated his professional career to caring for children with HIV. He was a Professor of Pediatrics at SUNY Downstate and oversaw the care of children living with HIV in the clinic at Downstate for many years before joining the AIDS Institute part-time. After he left New York and the Institute, he moved on to NIAID where he oversaw clinical research related to ART for children with HIV. See Dr. Anthony Fauci’s tribute.

Ed was persistent and passionate in life. He was always concerned about children. He volunteered his time working at a summer camp for children with HIV each year, offering to them compassion, friendship, and superior care. His colleagues remember his knack for making people feel welcome and valued.

Ed was 49 — his life was all too short, but nonetheless filled with much reward. The world has lost a committed clinical scientist, and children with HIV have lost one of their fiercest advocates.

Guidelines Panels Honor Legacy of Dr. Ed Handelsman

Zale Bernstein

Zale Bernstein, MD

It is with great sorrow that we announce the passing of dear colleague and friend Dr. Zale Bernstein.

Dr. Bernstein finished his residency and Hematology and Oncology Fellowship at the University at Buffalo School of Medicine, and joined Roswell Park’s medical staff in June 1988, working with Dr. Kenneth Foon in Clinical Immunology. In 1990, he joined the division of Lymphoma/Myeloma in the Department of Medicine, a position he held to the present.

Dr. Bernstein was an independent thinker and was committed to caring for people living with HIV, even when he had no support to do so. He was a compassionate and caring physician who was dedicated to ensuring that patients received the care they needed. He is best remembered for his lifelong dedication to improving the quality of care – and breaking down barriers to care – for patients with hematologic malignancies, HIV and AIDS. Dr. Bernstein took a leadership role in establishing and directing Roswell Park’s Center for HIV-Related Malignancies. In 1996, the Center was designated an “AIDS Treatment Center” by the New York State Health Department, making it the first such center in the State to exclusively treat AIDS-related cancers.

A graduate of the George Washington University School of Medicine, Dr. Bernstein also served as the Chief of the Hematology-Oncology Section and as Medical Director of the Center for Cancer Care and Blood Diseases at Erie County Medical Center. He was a Professor of Clinical Medicine and the Program Director of the Fellowship in Hematology in the Department of Medicine at the University at Buffalo. In addition to his interest and expertise in HIV-related cancers, Dr. Bernstein was a specialist in the treatment of Gaucher’s disease, a rare hematologic disorder.

Dr. Bernstein is survived by his wife Barbara and two children, Rachel and Ezra.

 

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ALERT: Cephalosporin-Resistant Gonococcal Infections

Posted February 2012

Recent alerts, including a NYC DOHMH Health Alert, have issued to increase awareness of the emergence of cephalosporin-resistant gonococcal infections:

The Centers for Disease Control and Prevention (CDC) and NYSDOH are now recommending ceftriaxone 250 mg plus a single 1-g dose of azithromycin as the most effective treatment for uncomplicated gonorrhea.

 

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PEPline: 1-888-448-4911

Posted March 2007

PEPline: 1-888-448-4911

In collaboration with the National HIV/AIDS Clinicians’ Consultation Center (NCCC), the New York State Department of Health AIDS Institute offers the HIV Post-Exposure Prophylaxis Hotline (PEPline) for providers needing consultation with an HIV Specialist regarding the management of exposure to bloodborne pathogens. The PEPline operates 24 hours a day, 7 days a week. PEPline clinicians will assist callers in assessing of risk of the exposure, discuss the most recent New York State post-exposure prophylaxis guidelines, and review specific treatment and follow-up options.

PEPline:    1-888-448-4911
Hours:       24 hours/7 days a week

For more information about the National Clinicians’ Post-Exposure Prophylaxis Hotline, please visit the National HIV/AIDS Clinicians’ Consultation Center website at: http://www.nccc.ucsf.edu/about_nccc/pepline/

PEP-LINE HIV Post-Exposure Prophylaxis

To order copies of this poster, please email Terri Wilder at: twilder@chpnet.org


CEI PEP Card:

PEP Triage Protocol Card Front PEP Triage Protocol Card Back

To download a copy of the PEP card, please click here (PDF).

 

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New York State Strategic Plan for Elimination of Mother-to-Child Transmission of HIV

Posted May 2012

The AIDS Institute convened a New York State Advisory Panel for the Prevention of Perinatal HIV Transmission in November 2010. The Panel was composed of women living with HIV and 28 experts from all regions of the State with experience/expertise in the care of HIV-positive women, including pregnant women, HIV-exposed infants and HIV-positive children. Staff from NYS and NYC agencies and community-based organizations also attended. The major goal of the meeting was to develop recommendations to further eliminate MTCT in NYS. The Panel’s deliberations provided the content for the New York State Strategic Plan for Elimination of Mother-to-Child Transmission of HIV. They have also developed a companion document for the Plan. This User Guide provides background information, rationale, and possible action steps for each strategy under each of the Plan’s four goals. The Plan’s framework provides a flexible approach for diverse stakeholders to align their efforts in support of elimination of MTCT.

The Director of the AIDS Institute, Humberto Cruz, has issued this Dear Colleague letter.

NYS Strategic Plan for Elimination of MTCT of HIV

 

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New York State Medicaid Update: Apri 2012

Posted April 2012

Dear Medicaid Provider:

The Office of Health Insurance Programs of the New York State Department of Health has just approved the release of the April 2012 Medicaid Update (PDF).

New York State Medicaid Updates Archives

 

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New York State Medicaid Update: Special Edition on Health Homes April 2012

Posted April 2012

Dear Medicaid Provider:

The Office of Health Insurance Programs of the New York State Department of Health has approved the release of the April 2012 Medicaid Update Special Edition on Health Homes (PDF).

The Health Home program is a result of the efforts of the Medicaid Redesign Team (MRT), which was established by Governor Andrew Cuomo in January 2011 and charged with reducing costs while increasing quality and efficiency in New York’s Medicaid program. Health Homes will improve the health care provided to both Fee-for-Service (FFS) and Managed Care Plan (MCP) members of the Medicaid Program (who are medically needy) and will save money by reducing preventable hospitalizations, emergency room visits and unnecessary care. It is anticipated that at least 975,000 of the more than five million Medicaid members meet the Federal criteria for Health Homes. The Centers for Medicare and Medicaid Services (CMS) approved the State Plan Amendment (NYS Health Home SPA for Individuals with Chronic Conditions 11-56) for Phase I of the Health Home program on February 3, 2012, with an effective date of January 1, 2012.

New York State Medicaid Updates Archives

 

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Spotlight on Salzburg: Making Health Care Better in Low and Middle Income Economies

Posted April 2012

Salzburg Global Seminar: Making Health Care Better in Low and Middle Income Economies: What are the next steps and how do we get there?
Schloss Leopoldskron
Salzburg, AUSTRIA
April 22-27, 2012

Much of the conversation today on health systems improvement revolves around how to develop systems capable of continually improving. However, in spite of progress made, many low and middle income economies are not able to achieve this.

The Salzburg Global Seminar “Making Health Care Better in Low and Middle Income Economies: What are the next steps and how do we get there?” will bring together 60 global health leaders (at least two-thirds from low and middle income countries), with others representing key agencies involved in improving health care quality and safety, to discuss what has been accomplished to date and what can be done to take this effort to a new level over the coming 5-10 years.

While not everyone will be able to attend the seminar, everyone will be able to participate.

Thanks to a partnership between ISQua Knowledge and the Salzburg Global Seminar, you have the opportunity to contribute directly to the discussions at Salzburg. To contribute to the conversation, please click here.

For further details about the seminar, please click here.

To follow the daily activities and deliberations, please click here.

* To watch Dr. Agnes Binagwaho’s talk for the panel titled “Strengthening Leadership and Policy for Improving Care in Low and Middle Income Economies,” please click here.

Session 8 – Setting the Agenda for Learning
The participants were tasked with defining the components of the learning agenda and the mechanisms for collecting and disseminating that information.
To read more, please click here.

Session 7 – Sustaining Execution
This session described the current state and the inputs that are required to achieve QI integration into health systems.
To read more, please click here.

Session 6 – Strengthening Leadership & Policy
This session offered an important opportunity to drill down into the components of effective leadership specifically focused on its role in improving health care.
To read more, please click here.

Session 5 – Role of Quality Improvement (QI) in Health Systems Strengthening
This session attempted to describe conceptually why Health Systems Strengthening (HSS) is important and how it could be done by looking at a model developed by M Rashad Massoud of the Health Care Improvement Project and through case studies.
To read more, please click here.

Session 4 – Overcoming Issues of Confusion
This session aimed to clarify and prioritize issues of confusion that hinder or obstruct healthcare quality improvement efforts, outline priority actions and actors.
To read more, please click here.

Session 3 – Challenges Ahead
Increasingly, the concepts and approaches of quality improvement are contributing to better health outcomes in low and middle income countries. However, there are admittedly serious challenges that hinder or even obstruct progress.
To read more, please click here.

Session 2 – Journey to Date
This session focused on a discussion of what has been learned to date about improvement in health systems in LMICs and what remains to be learned.
To read more, please click here.

Session 1 – Introduction
An overview of the Salzburg Framework Paper, BMJ Editorial and the synthesis paper on the ISQua Knowledge discussion forum were presented. Click below to read a summary of highlights from the discussion.
To read more, please click here.

 

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Lexiva (Fosamprenavir) Dosing for Pediatric Patients Approved

Posted April 2012

FDA Approval for Lexiva (Fosamprenavir) Dosing for Pediatric Patients

On April 27, 2012, the FDA approved dosing recommendations for use of Lexiva (fosamprenavir) oral suspension in pediatric patients for the treatment of HIV-1 infection in pediatric patients from ≥4 weeks to <6 years of age.

The Lexiva label now includes dosing for pediatric patients aged at least 4 weeks to 18 years. The dosage of Lexiva should be calculated based on body weight (kg) and not exceed the recommended adult dose.

Twice daily dosage regimens by weight with ritonavir are as follows:

  • for protease inhibitor-naïve pediatric patients (greater than or equal to 4 weeks of age) and

  • for protease inhibitor-experienced pediatric patients greater than or equal to 6 months of age. (Lexiva plus ritonavir is not recommended for protease inhibitor experienced pediatric patients less than 6 month of age.)
Less than 11 kg:                                   Lexiva 45 mg/kg plus ritonavir 7 mg/kg
11 kg to less than 15 kg:                      Lexiva 30 mg/kg plus ritonavir 3 mg/kg
15 kg to less than 20 kg:                      Lexiva 23 mg/kg plus ritonavir 3 mg/kg
Greater than and equal to 20 kg:          Lexiva 18 mg/kg plus ritonavir 3 mg/kg

Alternatively, protease inhibitor naïve children 2 years of age and older can be administered Lexiva (without ritonavir) 30 mg/kg twice daily.

Lexiva should only be administered to infants born at 38 weeks gestation or greater and who have attained a post-natal age of 28 days.

For pediatric patients, pharmacokinetic and clinical data:

  • do not support once-daily dosing of LEXIVA alone or in combination with ritonavir

  • do not support administration of LEXIVA alone or in combination with ritonavir for protease inhibitor experienced children younger than 6 months of age

  • do not support twice-daily dosing of LEXIVA without ritonavir in pediatric patients younger than 2 years of age

Sections 6: Adverse Reactions, 8.4 Pediatric Use, 12.3 Pharmacokinetics and 14 Clinical Studies were updated to include safety and activity data from the three open label trials in pediatric subjects aged at least 4 weeks to 18 years.

The complete updated labeling will be posted soon to Drugs@FDA, on the FDA web site.
Lexiva is an HIV protease inhibitor manufactured by GlaxoSmithKline

 

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Intelence (Etravirine): Pediatric Dosing Recommendations and New Scored 25 mg Tablet for Pediatric Dosing

Posted March 2012

On March, 26, 2012, the Food and Drug Administration approved dosing recommendations for INTELENCE® (etravirine) for treatment-experienced pediatric patients 6 to 18 years of age and weighing at least 16 kg. In addition a new scored 25 mg tablet was approved for use in pediatric patients. Listed below are the major changes to the product labeling.

The Dosage and Administration section includes the following:

2.2 Pediatric Patients (6 years to less than 18 years of age)

The recommended dose of Intelence for pediatric patients 6 years to less than 18 years of age and weighing at least 16 kg is based on body weight not exceeding the recommended adult dose. Intelence tablet(s) should be taken orally, following a meal. The type of food does not affect the exposure to etravirine. The safety and efficacy of Intelence have not been established in children less than 6 years of age.

Healthcare professionals should pay special attention to the accurate dose selection of Intelence, the transcription of the medication order, the dispensing information and the dosing instructions to minimize the risk of medication errors, overdosing, and underdosing.

2.3 Method of Administration

Patients should be instructed to swallow the Intelence tablet(s) whole with a liquid such as water. Patients who are unable to swallow the Intelence tablet(s) whole may disperse the tablet(s) in a glass of water. The patient should be instructed to do the following:

  • place the tablet(s) in 5 ml (1 teaspoon) of water, or at least enough liquid to cover the medication,
  • stir well until the water looks milky,
    if desired, add more water or alternatively orange juice or milk (patients should not place the tablets in orange juice or milk without first adding water). The use of grapefruit juice or warm (greater than 40°C) or carbonated beverages should be avoided.

  • drink it immediately,
  • rinse the glass several times with water, orange juice, or milk and completely swallow the rinse each time to make sure the patient takes the entire dose.

6 ADVERSE REACTIONS

6.2 Clinical Trials Experience: Pediatric Subjects (6 years to less than 18 years of age)

The safety assessment in children and adolescents is based on the Week 24 analysis of the single-arm, Phase 2 trial TMC125-C213 in which 101 antiretroviral treatment-experienced HIV-1 infected subjects 6 years to less than 18 years of age and weighing at least 16 kg received Intelence in combination with other antiretroviral agents [see Clinical Studies (14.2)]. The frequency, type and severity of adverse drug reactions in pediatric subjects were comparable to those observed in adult subjects, except for rash which was observed more frequently in pediatric subjects. The most common adverse drug reactions in at least 2% of pediatric subjects were rash and diarrhea. Rash (greater than or equal to Grade 2) occurred in 15% of pediatric subjects. In the majority of cases, rash was mild to moderate, of macular/papular type, and occurred in the second week of therapy. Rash was self-limiting and generally resolved within 1 week on continued therapy. The discontinuation rate for rash was 4%. Rash including serious (Grade 3 or 4) events and discontinuations were more frequently observed in female subjects compared to male subjects.

8.4 Pediatric use

Treatment with Intelence is not recommended in children less than 6 years of age. The pharmacokinetics, safety, tolerability and efficacy of Intelence in children less than 6 years of age have not been established.

The safety, pharmacokinetic profile, and virologic and immunologic responses of Intelence were evaluated in treatment-experienced HIV-1-infected pediatric subjects 6 years to less than 18 years of age and weighing at least 16 kg. Frequency, type, and severity of adverse drug reactions in pediatric subjects were comparable to those observed in adults, except for rash.

14 CLINICAL STUDIES

14.2 Treatment-Experienced Pediatric Subjects (6 years to less than 18 years of age)

TMC125-C213, a single-arm, Phase 2 trial evaluating the pharmacokinetics, safety, tolerability, and efficacy of Intelence enrolled 101 antiretroviral treatment-experienced HIV-1 infected pediatric subjects 6 years to less than 18 years of age and weighing at least 16 kg. Subjects eligible for this trial were on an antiretroviral regimen with confirmed plasma HIV-1 RNA of at least 500 copies per mL and viral susceptibility to Intelence at screening.

The median baseline plasma HIV-1 RNA was 3.9 log10 copies per mL, and the median baseline CD4 cell count was 385 x 106 cells per mm3.

At Week 24, 52% of all pediatric subjects had HIV-1 RNA less than 50 copies per mL. The proportion of pediatric subjects with HIV-1 RNA less than 400 copies per mL was 67%. The mean CD4 cell count increase from baseline was 112 x 106 cells per mm3.

The complete updated labeling will be posted soon to Drugs@FDA, on the FDA web site.

Intelence is a non-nucleoside reverse transcriptase inhibitor (NNRTI) manufactured by Janssen Pharmaceuticals.

 

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FDA Safety Announcement: Updated Information on Drug Interactions Between Victrelis, an HCV Protease Inhibitor, and Certain HIV Protease Inhibitors

Posted May 2012

The U.S. Food and Drug Administration (FDA) has issued an updated safety announcement regarding drug interactions between boceprevir (Victrelis) and certain ritonavir-boosted HIV protease inhibitor drugs (atazanavir, darunavir, and lopinavir/ritonavir). Co-administration of boceprevir is not recommended with these ritonavir-boosted HIV agents because of possible reduced effectiveness of these medicines against both infections.

Patients should not stop taking any of their medicines without talking to their healthcare professional. Patients should contact their healthcare professional if they have any questions or concerns.

Healthcare professionals who have started patients infected with both chronic HCV and HIV on Victrelis and antiretroviral therapy containing a ritonavir-boosted protease inhibitor should closely monitor patients for HCV treatment response and for potential HCV and HIV virologic rebound.

For the FDA safety announcement, click here.

For the original FDA announcement for approval of Victrelis, click here.

 

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FDA Issues Safety Announcement About Interactions Between Certain HIV or Hepatitis C Drugs and Cholesterol-Lowering Statin Drugs

Posted March 2012

“The U.S. Food and Drug Administration (FDA) is issuing updated recommendations concerning drug-drug interactions between drugs for human immunodeficiency virus (HIV) or hepatitis C virus (HCV) known as protease inhibitors and certain cholesterol-lowering drugs known as statins. Protease inhibitors and statins taken together may raise the blood levels of statins and increase the risk for muscle injury (myopathy). The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure, which can be fatal.

“The labels for both the HIV protease inhibitors and the affected statins have been updated to contain consistent information about the drug-drug interactions. These labels also have been updated to include dosing recommendations for those statins that may safely be co-administered with HIV or HCV protease inhibitors … .

“Healthcare professionals should refer to the current drug labels for protease inhibitors and statins for the latest recommendations on prescribing these drugs.

“Patients should contact their healthcare professional if they have any questions or concerns about taking protease inhibitors and statins.”

More information is available:

 

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HRSA Announces Funding Availability to Support New Part C Programs Offering Early HIV Intervention Services

Posted May 2012

Ryan White HIV/AIDS Part C programs provide HIV primary medical care in the outpatient setting. The FY 2012 Part C Early Intervention Services: New Geographic Areas funding opportunity announcement, HRSA-12-171, will support between 5 and 10 new Part C programs in areas of the country where the HIV epidemic is increasing, demand for services has increased, and there are limited other services available.

Applicants must propose to provide a comprehensive continuum of outpatient HIV primary care services in the targeted area including HIV counseling, testing, and referral; medical evaluation and clinical care; other primary care services; and referrals to other health services.

Part C funded services should target 3 populations

  • newly diagnosed/identified persons with HIV infection,
  • previously diagnosed persons living with HIV/AIDS who have never been in care, and
  • persons living with HIV/AIDS who have dropped out of care.

Eligible Applicants

  • Organizations in the U.S. and U.S. territories that are not currently funded by Part C EIS
  • Public or nonprofit private entities, including
    • Federally qualified health centers
    • rural health clinics
    • family planning grantees
  • Organizations including State and local governments, their agencies, and Indian Tribes or tribal organizations with or without Federal recognition; as well as community-based and faith-based organizations.

Apply at Grants.gov by May 25, 2012

For more information, please visit http://www.hrsa.gov/grants/apply/assistance/partc/

 

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NYSDOH Letter Regarding New HIV Testing Algorithm

Posted January 2012

Dear Colleague,

The New York State Department of Health has issued a letter to provide important information about a new HIV testing algorithm that will impact the diagnosis and reporting of HIV infection. The letter provides background on the new algorithm and discusses the potential implications for clinical laboratories, clinicians and community-based organizations.

To download and view the letter, please click here (Adobe Acrobat).

Questions may be submitted to NYSDOH at hivtesting@health.state.ny.us.

Related NYS Clinical Guidelines:

 

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hivguidelines and Medscape: Care of the HIV-Infected Transgender Patient: Guideline and Commentary

Updated April 2012

Every few months Medscape features a New York State Department of Health AIDS Institute guideline along with commentary written by clinicians who work with the HIV Clinical Guidelines Program.

The most recent featured guideline is Care of the HIV-Infected Transgender Patient with commentary written by Dr L Jeannine Bookhardt-Murray.

To view the commentary and guideline on Medscape, please click on the following link: http://www.medscape.com/viewarticle/761434

To see the full series of hivguidelines that have posted on Medscape so far, please visit the Medscape website at: http://www.medscape.com/index/section_10155_0

hivguidelines and Medscape Archives

 

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Email Announcement Archives

Posted December 2009

The HIV Clinical Guidelines Program provides subscribers with email announcements of when new guidelines are posted and existing guidelines are updated.

hivguidelines email announcement archives

Subscribe to hivguidelines email announcements

 

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Please visit the Hot Topics Archive page.

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