Care Issues

Care News

MDCH-HAPIS Documents

New Resource: Michigan Go Local
Wayne State University's Shiffman Medical Library staff has put together a tremendous new resource for locating HIV/AIDS related services in Michigan on the Internet. Linked through the National Library of Medicine (NLM), the Michigan Go Local resource is part of a large National Institutes of Health project and is connected to Medline Plus.

Benefits

• HIV/AIDS BENEFIT INFORMATION SUMMARY
  GENERAL GUIDELINES  from the Michigan Department of Human Services - September 2007
   

CARE Act

• New Website for Technical Resources

Drugs

• Drug Assistance Program DAP
• Drug Warnings
• Guides to Side Effects
• Report hoaxes to CDC

Treatment

• HIV Medications: When to Start and What to Take
• Adherence issues
• Care for Infants & Children
• Clinical Trials
• Hospital Care Comparison
• Treatment Guidelines

MDCH-HAPIS Documents

• Draft-MDCH-HAPIS Ryan White Treatment Modernization Act Part B and D Quality Improvement Indicators for Contract year 2007-2008 IMPLEMENTATION PLAN
• Title II CARE Needs Assessment: Executive Summary; FINAL Report; Appendices
• 2006 HIV/AIDS Continuum of Care Comprehensive Plan
• 2006 Michigan SCSN Statewide Coordinated Statement of Need
• For complete information on MDCH-DHWDC-HAPIS Care Programs see the new MDCH website at www.michigan.gov/hivstd
   

Medical

• Medical Research News
• Medical Conferences
• Medical jargon explained
• Physicians Desk Reference

PWA Issues

• Advisory Group to MDCH
• Advocacy - Michigan Positive Action Coalition (MIPOZ)
• Ask 'The Body'
• Case Management
• Confidentiality Issues
• Drug Assistance Programs: DAP
• Dental Care 
• Documentation
• Hospice
• Housing
• Insurance Issues
• Medicaid -Managed Care
• Medicare
• Mental Health
• Nutrition and HIV
• Nursing Homes
• Patient's HIPAA Privacy Notice
• Project H.O.P.E. and  Returning to Work
• Patient Advocacy
• Social Security Benefits
• Support Groups listing provided by FRIENDS Alliance
• On-line User Friendly Manual for PWAs
in  SE-MI

See also Research News and Resources  resources for PLWHA

The (former) Michigan Persons Living with HIV/AIDS Needs Task Force Web site has a wealth of resources and information for PLWH/As, their caregivers and case managers.

Physicians: Looking for assistance with HIV patient treatment? See Resources in the Medical and Clinical section.

If you're caring for an HIV-positive child, one of the important decisions you'll make will be choosing a doctor and a program that will provide the best care. The National Pediatric and Family HIV Resource Center offers some tips on how to get the best care possible for HIV-positive children.

Frequently asked questions and answers concerning pediatric AIDS, from The National Pediatric and Family HIV Resource Center.

www.thebody.com/nphrc/questions/contents.html

Case Management

See the current DHWDC Case Management Training Schedule

PWA Confidentiality

"Shut UP! Project"

This was a project of the former MAX (Michigan Advocates Exchange) that was invented to distribute materials describing the HIV confidentiality law around the state, to allow people to deal with violations of their privacy. That project died when MAX closed. "Shut Up Project" actually had three tools: (1) the "Shut Up" article for people living with HIV that explained their rights and responsibilities, (2) the "Shut Up" cards with a summary of the confidentiality law on one side and MAX's contact info on the other, and (3) the "Shut Up" letter that could be sent by anybody to anybody else with a big mouth. I've done some updating.

Former MAX ED Kendra Kleber, JD announced on February 8, "The 'Shut Up' article has been updated, and it is still a great introduction to legal rights for a person living with HIV. The 'Shut Up' letter has morphed into another article, this one targeted at the 'blabber.' It has a completely different tone from the old version, and now is an explanation of the confidentiality law for somebody with no background. The 'Shut Up' card is gone."

These new articles will be posted on Kleber's website www.positiveoutlook.org, on a new "Shut Up!" section. Each article is just two pages, which means that you could print them double-sided to save paper.


Kleber now has a private practice, Kendra S. Kleber & Associates PLLC, supporting the self-sufficiency, independence and quality of life of people living with HIV/AIDS
by providing those who are disabled and unable to work with creative and effective legal representation on claims for Social Security disability benefits, nationwide. You may contact her at P.O. Box 1960, Royal Oak, Michigan 48068-1960
248-591-0301 248-548-7909 (fax); kkleber@positiveoutlook.org 


 

Dental Care for PLWH/A

Michigan Dental Care Program

See the MDCH web site for more information on this program www.michigan.gov/hivstd  direct link:

http://www.michigan.gov/mdch/0,1607,7-132-2940_2955_2982_46000_46001-45691--,00.html

Other Programs in Michigan

There are several places in Michigan where individuals with HIV/AIDS can receive subsidized dental care. The University of Michigan Dental School is one place that all clients pay on an ability to pay basis and identification as HIV positive is not necessary for treatment. Individuals or case managers may call (734) 763-6933. The HIV/AIDS Resource Center in Ypsilanti, (734) 572-9355, is now the fiduciary for this service at U of M for clients in Regions 1 -8 seeking dental care. 

Also, the University of Detroit-Mercy has a clinic specifically for persons with HIV/AIDS who live in the Metro-Detroit area. Clients must have confirmed positive on an HIV test. Most are referred by physicians but some do come in on their own. The clinic has a leading edge professional staff for AIDS dental care.

HIVDENT Visit this site for information on oral manifestations of HIV disease (with photos), treatment, infection control and post-exposure protocol.

DENTAL HEALTH AND HIV

Why is dental care important for people living with HIV? Terry Wilder explains why, in AIDS Survival News.

www.thebody.com/asp/dec00/dental.html

Got questions about dental health and HIV? Ask The Body's online expert, Dr. David Reznik. www.thebody.com/cgi/oralans.html

Guide on Housing and the CARE Act

HOPWA

Administration of Michigan's Housing Opportunities for Persons With AIDS program has changed from the Division of HIV/AIDS -STD to the Bureau of Community Living, Children and Families, directed by Virginia Harmon.

Hospital Care

New information provides consumers with standardized assessments of the care that nearly 4,200 hospitals across the country provide to all adult patients, based on valid and reliable measures that have been shown to reflect quality of care. Hospital Compare is available on the Internet at www.hospitalcompare.hhs.gov  or www.medicare.gov . Consumers without web access can call 1-800-MEDICARE (1-800-633-4227) to get the same information on hospital quality.

Hospice Care

Hospice Advantage provides comprehensive, compassionate care and comfort to people living with a terminal illness.   Everyone deserves to live in comfort and dignity throughout their lives.  Hospice Care helps ensure that those with a life-limiting illness live everyday to its fullest, by tending to their physical, emotional and spiritual needs.  Care is provided at home, in hospitals, nursing homes and other residential facilities. All of us at Hospice Advantage believe strongly in our mission of helping patients and their families, and we’re committed to ensuring that end of life is free from pain and other symptoms so that their remaining time is as rewarding as possible.
Michigan offices in Bay City, Detroit, Flint, Milford, Sheboygan, and Lansing see
www.hospiceadvantage.net

INSURANCE INFORMATION

Online Health Insurance Portability and Accountability Act  http://www.mihivnews.com/resource_national.htm#HIPPA

Insurance Information Institute
http://www.iii.org/home.html

Offers answers to consumers' questions on all types of insurance and provides an archive of insurance related news.

Insurance Assistance Program

The Michigan Insurance Assistance Program enables individuals with HIV/AIDS to continue health insurance coverage where in many cases the insurance would have lapsed because of economic hardships. This program has insured that the relationship and care that a client has had with his/her physician be allowed to continue with no sudden changes or disruption.  Also see DAP, for information on Michigan's Drug Assistance Program.

FIA announces a new enhancement to the Insurance Assistance Program (IAP)-Plus

The State of Michigan Family Independence Agency (FIA) and MDCH-HAPIS are now collaborating to offer this new program for HIV positive people who have a COBRA or a group policy that offers prescription benefit coverage. 

The IAP-Plus requirements include:

• COBRA or group insurance with prescription coverage
• HIV + verified by a physician
• Michigan resident
• Monthly income of less than 300% of federal poverty level (FPL) -- if over, a client may complete a Special Request Form - considered on a case-by-case basis. Starting 10/1/00 the monthly income will be raised to 450% of FPL.
• Must not be eligible for any other employer sponsored health insurance policy.
• Must not be eligible for Medicaid.
• No asset limitation.

IAP Requirements include:

• COBRA, Group, Individual, conversion, or Medicare Supplement Policy. May or may not have prescription coverage.
• HIV +, Disability Requirements, verified by a doctor
• Monthly income up to 200% FPL
• Asset limit up to $10,000

There is one application for both programs.

* You can find the application published at: www.michigan.gov/dhs-forms

Please call the Insurance Assistance Program Kelly Esser at (313) 456-3882

Insurance Portability

Online Health Insurance Portability and Accountability Act  http://www.mihivnews.com/resource_national.htm#HIPPA

From: The Private Health Insurance Group (PHIG) at The Health Care
Financing Administration (HCFA)

Help consumers find out how their health coverage is affected by life
events such as:  job changes, marriage, divorce, birth, adoption or death. Online help to answer health coverage questions is now available!
Are you aware of the Federal health coverage protections under the Health Insurance Portability and Accountability Act of 1996 (HIPAA)?
If you field client or employee questions about: pre-existing conditions,
special enrollment, certificates of creditable coverage, or how to cope
with the denial or loss of health coverage, a welcome new tool has arrived.
A confidential, free, easy-to-use, 24-hour-a-day, Internet-based tool
called HIPAA OnLine helps answer consumer questions rapidly and accurately on the Federal health coverage protections provided by HIPAA. HIPAA OnLine responds directly to individual concerns about health coverage by guiding users through a series of questions that often lead to local resources for more information.
To request a CD, click on the Help icon on the HIPAA OnLine Web page or send an e-mail to hipaacd@saic.com (quantities are limited).

Additional Resources
HCFA is making another information product available.  "Protecting Your
Health Insurance Coverage" is a 45 page booklet outlining five key steps
that consumers can take to understand their Federal health coverage
protections under HIPAA. You may order single hard copies by calling
1-800-633-4227.  For 2-100 hard copies, fax your request to 1-410-786-4786.  For more than 100 hard copies, fax your request to 1-410-786-1905. In addition, the Georgetown University Health Policy Center also offers a user-friendly, widely-praised, interactive, state-specific HIPPA site at www.healthinsuranceinfo.net .

MEDICAID

Final Rules on Medicaid Beneficiary Protections Published

from the Kaiser HIV/AIDS Report 1/19/01

HHS published new regulations in the Federal Register requiring "greater patient protections" for beneficiaries enrolled in Medicaid managed care plans. The regulations, which will be enforced by HCFA, implement provisions of the 1997 BBA, and will take effect 90 days after publication. The rules include strengthened beneficiary protections and new provisions "designed to protect the rights of otherwise vulnerable" Medicaid beneficiaries. HHS says that among the "most important improvements" are increased protections for those with special needs. Published regulations for Medicaid managed care plans include the following:

Quality Care: States will be required to assure continued care access for Medicaid beneficiaries who have "ongoing health care needs" and switch from fee-for-service to a managed care plan, from one health plan to another or from a health plan to fee-for service. In addition, states and participating plans must identify beneficiaries with "special health care needs" and "assess the quality and appropriateness" of their care.

Health Assessment: Medicaid managed care plans must provide expedited health assessments to beneficiaries "at risk of having special health care needs" or to those who already have special health care needs.

Health Plan Marketing: Medicaid managed care plans must provide consumers with "comprehensive, easy-to-understand information" about heath plans and offer "most" beneficiaries a choice between at least two "qualified" health plans. States must also approve health plan marketing materials used to enroll and re-enroll Medicaid beneficiaries, and plans are restricted from engaging in "door-to-door, telephone and other forms of 'cold call' marketing."

Emergency Services: Medicaid managed care plans are required to cover emergency health care service costs "wherever and whenever the need for such services arises." Plans "are prohibited" from requiring prior approval for emergency services or from requiring beneficiaries to obtain care at "approved facilities." Emergency services are "based on a 'prudent layperson' standard that requires payment in situations where the beneficiary reasonably assumes that he or she is in an emergency situation."

Reimbursement: States are required to set managed care capitation rates that are "actuarially sound." The new regulations omit the "generally outdated regulatory ceiling on what states may pay managed care plans." An HHS release notes that this provision is "particularly important," as "more state Medicaid programs include people with chronic illnesses and disabilities in managed care" who require more expensive care. This provision implements a "new approach" to regulating capitation payments, and will have a 60-day comment period.

Access to Care: Female beneficiaries may have "direct access" to a woman's health specialist within a health plan's provider network for routine and preventive health care services. Also, beneficiaries will be allowed to obtain a second opinion from a "qualified" health professional.

Patient-Provider Communication: Medicare managed care plans may not impose restrictions, such as "gag rules" that interfere with patient-provider communications.

Network Adequacy: Plans must "assure" that they maintain the capacity to serve the "expected enrollment" in their service area.

Grievance Systems: Managed care plans must implement a system to address appeals and grievances, and all grievances must be resolved in "state established time frames" not exceeding 90 days. Resolution of appeals must occur "in accordance with medical needs," and not later than 30 days. "Expedited" time-frames of no more than 72 hours are required for certain grievances and appeals."

Fulfilling a Promise

These regulations "fulfil[l]" President Clinton's promise to "extend a Patients' Bill of Rights to all Americans enrolled in public health care programs," the HHS release states. Outgoing HHS Secretary Donna Shalala added, "Managed care provides the promise of better coordinated health care at a more reasonable cost. But all Americans -- whether they are in Medicare, Medicaid or private health plans -- deserve the basic protections that a Patients' Bill of Rights provides" (HHS release, 1/18)

Medicaid to Managed Care

See new Federal Guidelines

See The Managed Care in Michigan 2001 Review

AIDS Action has on line publications
including: Mgd Care and HIV/AIDS, a guide for CBO's; Stigma and HIV Prevention; Medicaid/Medicare Dual Eligibility for people with HIV/AIDS
http://www.aidsaction.org/communications/publications/index.html

Interactive Tools on Medicaid
From the Kaiser Commission on Medicaid and the Uninsured

The Kaiser Commission on Medicaid and the Uninsured presents the State Medicaid Fact Sheets and the Medicaid Benefits Online Database, two interactive tools featuring the latest key data, information and services provided for each state’s Medicaid program. Both tools allow for easy access to the data which can then be printed, saved and emailed.

STATE MEDICAID FACT SHEETS
http://cme.kff.org/Key=9643.z0.C.C.NxKlpp

Michigan: http://www.kff.org/mfs/medicaid.jsp?r1=MI&r2=US

This new interactive online tool provides the latest key data for each state’s Medicaid program and the population it serves, allowing for easy comparisons of one state to any other state or to the nation as a whole, on a selection of important indicators. Utilizing the latest Medicaid data from the Kaiser Commission on Medicaid and the Uninsured and drawn directly from Kaiser's continuously updated site for state health data, statehealthfacts.org, this tool provides figures and tables that can be easily printed as customized fact sheets, emailed or saved.


MEDICAID BENEFITS ONLINE DATABASE
http://cme.kff.org/Key=9643.z0.H.C.NmhmxT 

Michigan: http://kff.org/medicaid/benefits/state.jsp?nt=on&cat=0&yr=0&st=23

This interactive tool provides easy access to information on services provided by each state's Medicaid program. The database contains Medicaid benefits survey data from 2003 and 2004 with information about benefits covered, limits, co-payments and reimbursement methodologies for the 50 states, the District of Columbia and the Territories.

The tool allows for searches by state or service and permits comparisons between 2003 and 2004 information. Customized searches and the options of printing, emailing or saving search results are also available.



Fact Sheets: Getting the Best Out of Managed Care

These illustrated fact sheets are designed for a general audience and are available in English and Spanish versions. The files are
available in Word, HTML, and PDF (Adobe Acrobat) formats.

Feel free to print out these documents and reproduce them. The PDF files are the best suited for reproduction.

The Center for Health Care Strategies (CHCS), in Lawrenceville, NJ,
provided funding for "Making Sense of Managed Care Quality Information for Consumers with Special Needs." This project was made possible through a separate grant to CHCS by The Robert Wood Johnson Foundation.

Fact Sheet 1: How can this information help me? (¿Cómo puede ayudarme esta información?)

Fact Sheet 2: Understanding Quality Measures (Comprenda las Medidas de Evaluación de la Calidad)

Fact Sheet 3: Figuring Out Which Health Care Plan Meets Your Needs
(Determine qué Plan de Atención de Salud Responde a sus Necesidades)

Fact Sheet 4: Report Cards (Boletas de Calificaciones)

Fact Sheet 5: Consumer Surveys (Encuestas de Consumidores)

Michigan is currently switching its Medicaid system over to managed care. For more information on managed care and medicaid to managed care background please see the John Hopkins website.

A company called Maximus has been contracted by the Michigan Department of Community Health to enroll Medicaid participants in the new managed care system. The program operated by Maximus, called Michigan Enrolls, will assist individuals in making this transition.

If you need help with reading, writing, hearing, etc., under the Americans with Disabilities Act, you are invited to make your needs known to Michigan Enrolls.

Michigan Enrolls can:

• Tell you which doctors, pharmacies and hospitals are part of each health plan.
• Give you information to help you choose a primary provider.
• Answer questions you may have about how to get medical services through your health plan.
• And, enroll you in the health plan you choose.
  

If you are a medicaid client living in southeastern Michigan, you should have received the managed care health plan information.

If you have any questions, you may call Michigan Enrolls at:

1-888-ENROLLS (1-888-367-6557 or

TTY: 1-888-263-5897. This call is free.

Most people who get Medicaid must choose a health plan. If you do not choose a plan, Michigan Enrolls will choose one for you.

There are five ways to enroll in a health plan:

1. Call: Michigan Enrolls at one of the above numbers.

2. Mail: The enrollment form that has been/will be sent to you.

3. Go to a community meeting.

4. Visit an enrollment office.

5. Ask for a home visit, if it is difficult for you to leave your home.

Medicare

• View claim status (excluding Part D claims),
• Order a duplicate Medicare Summary Notice (MSN) or replacement Medicare card,
• View eligibility, entitlement and preventive services information,
• View enrollment information including prescription drug plans,
• View or modify your drug list and pharmacy information,
• View address of record with Medicare and Part B deductible status, and
• Access online forms, publications and messages sent to you by CMS.

Mental health

Winter 2007 Issue of "Mental Health AIDS" Includes Tool Box on Posttraumatic Growth of HIV Infected Individuals

Biopsychosocial therapy involves assessing an individual patient's biological, psychological, and social condition to help determine treatment. Mental Health AIDS is a quarterly biopsychosocial research update on HIV and mental health sponsored by the Center for Mental Health Services (CMHS) of the Substance Abuse and Mental Health Services Administration (SAMHSA). This publication is provided free of charge through the SAMHSA Web site in both PDF and HTML formats.

The Winter 2007 issue features the From Surviving to Thriving: HIV-Associated Posttraumatic Growth tool box, which summarizes recent research on posttraumatic growth (PTG) and HIV. Emotional trauma related to HIV infection, including depression, anxiety, fear, helplessness, and guilt, may lead to positive changes in relationship and life priorities, health behaviors, and outlook on life in some individuals with HIV infection (and in some cases, their caregivers). The toolbox includes suggestions for clinicians on how to incorporate principles of PTG into psychotherapy treatment for trauma survivors. AIDSinfo At-a-Glance: Volume Issue No. 52
 

Nutrition and HIV

AIDS Education and Training Center’s Health Care and HIV: Nutritional Guide for Providers and Clients

ABCNews.com/Healthology Press (12.14.01)::Meredith Liss, MA, RD,
CDN, New York Presbyterian Hospital, Weill Cornell
     Use of highly active antiretroviral therapy (HAART) to treat
HIV disease has improved immune status for those people who have
access to the drugs and can tolerate them. However, maintaining a
good physical appearance and overall health continue to be
significant concerns for most patients.
     People with HIV must contend with body composition changes
that include wasting syndrome and fat redistribution syndrome as
well as metabolic changes such as elevated levels of cholesterol,
triglycerides and blood sugars. While many of these conditions
require medication, developing a healthy diet and exercise
program can make a great difference in longevity and the quality
of life.
     Good nutrition should be taken seriously as co-therapy for
HIV. Diet recommendations include a high protein diet to fight
wasting syndrome; a heart healthy, low saturated fat diet to keep
cholesterol levels within proper limits; and a diet high in whole
grains and low in sugar to maintain adequate blood sugar and
triglyceride levels. Also included should be 1-2 multi-vitamins
with minerals to insure that micronutrient needs are met...
    
     To reduce cholesterol levels, decrease intake of foods high
in saturated fat like red meat, poultry skin, whole and 2 percent
milk, cheese, butter, coconut and palm oils.
     One of the causes of weight loss in HIV infection is not
being able to eat enough calories. You may find that you get
hungry and when you sit down to eat, you become full too fast.
There are some medical causes of early fullness but a pattern of
small, frequent meals of six or more a day will probably help a
great deal. Also, high calorie, high protein shakes of ice cream,
yogurt, milk, fruits, peanut butter, wheat germ and fruit nectars
or canned supplements that can be purchased at local drug stores
and supermarkets are highly recommended as meal alternatives.
     Exercise is safe and does not weaken the immune system. It
is important to prevent or fight the loss of muscle mass and to
offset the effects of the fat redistribution syndrome.

Nursing Homes

Patient's HIPAA Privacy Notice

This resource has "information on every conceivable medication, and the search engine on this site will return results that are even just close to what you've entered. That means that if you have the spelling remotely close, you can probably find what you need.

Use this, for instance, to double-check the spelling and purpose of medications when filling out a Social Security disability application.."


http://www.healthsquare.com/drugmain.htm


Kendra S. Kleber, JD
President, Director of Legal Services
Michigan Advocates Exchange, Inc.
 

Project H.O.P.E.

DETROIT - POWER OF WORK SUPPORT GROUP. The Power of Work (POW) Support Group continues to meet every other Thursday at Goodwill Industries, 3111 Grand River, Detroit, MI from 5:30pm-7:30pm. This group’s focus is to learn to live again with HIV/AIDS while exploring options of returning to work, school or training. Participants are asked to bring a dish to share with the group. For more information, contact Rick Jones at 313-964-3900 ext. 423. Project HOPE (HIV Opportunities for Pursuing Employment) has partnered with Goodwill Industries of Greater Detroit. They have hired a full time Vocational Services Coordinator and are in the process of applying for new grants to help with the return to work issues for people living with HIV.

For more information or to find out how returning to work will affect your benefits, call Ken Pape at the Family Independence Agency, (313) 456-1678, to schedule an appointment for benefits counseling.

 

Return to Work Incentive

Biggest change in HIV benefits since passage of the Ryan White Act in 1990.

The Ticket to Work and Work Incentives Improvement Act of 1999 has numerous, complex provisions affecting SSDI, SSI, Medicare, Medicaid, return-to-work and vocational rehabilitation services for disabled persons. It offers states a set of interrelated options for enhanced Medicaid coverage of disabled persons who work. It limits---but does not fully eliminate---the threat of being found "no longer disabled" for those patients in remission who are work ready or are already actually working. AIDS agencies and even businesses can now get federal funding for return-to-work, benefits counseling and vocational rehabilitation services. Click here for the full article by Tom Mcormick

ON SOCIAL SECURITY

If you are on disability and considering starting a business or working on your own, you should know that Social Security's regulations favor self-employment. Learn the details from AIDS Project Los Angeles.

www.thebody.com/apla/nov00/work.html

TUITION FOR DISABLED

Tuition tips for the disabled: A crash course in scoring financial aid for college while you are on disability.

www.thebody.com/apla/nov00/benefits.html

Social Security Benefits On-line

Guide to HIV/AIDS-Related Social Security Benefits Now Available
View Social Security Administration Publications online at http://www.socialsecurity.gov/pubs/englist.html

Did you know people living with HIV/AIDS (PLWH/A) can qualify for certain disability benefits from the Social Security Administration (SSA)? If not, then you need to read the SSA publication, Social Security Benefits for People Living with HIV/AIDS. The booklet describes how PLWH/A can apply for benefits under two SSA programs: Social Security Disability Insurance (SSDI) and Supplemental Security Income (SSI), and covers the following topics:

Benefits You May Be Able to Get; What We Mean by Disabled; How to File for Benefits; What We Will Ask; How We Make a Decision on Your Claim; How You Can Help Speed up Your Claim; What We Are Doing to Help You Get Benefits Faster; What Will Happen If You Go Back to Work

 

Documentation for Benefits

There are a few documents that people absolutely need to have at some point in their lives -- a birth certificate may be the best example, but marriage or death certificates, and perhaps a divorce decree, could be other essential documents. The fact is that in order to apply for Social Security benefits (and for a number of other reasons) you will probably need at least one of these documents, either the original or a copy certified by the state that issued it. Figuring out where to go to find the certified copies you need could be confusing -- until now. With this online resource you can find the addresses and phone numbers of the issuing offices as well as the fees for the documents you need. So even a person born in Alabama, married n California, divorced in Utah and retired in Florida can find everything he or she needs at the link below.
http://www.socialsecurity.gov/vitalstats.html

Treatment Guidelines

National Treatment Guidelines
http://www.aidsinfo.nih.gov

Also AmFar Treatment Directory

Guides to Side-Effects

The National Minority AIDS Council NMAC has published the Patient's Guide to HIV Medicines and Guidelines for Their Use, a pamphlet meant to make topics such as HIV/AIDS and combination therapy more understandable to non-medical persons.

Also, see AIDSmeds.com's Currently Approved Drugs for HIV: A Comparative Chart http://www.aidsmeds.com/lessons/DrugChart.htm

Drug Warnings

FDA To Review Safety of GSK, BMS Antiretrovirals Abacavir, Didanosine
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=51205

FDA HIV/AIDS Update - Updates to Prezista (darunavir) tablets labeling
(3/11/08)

Updates have been made to Prezista (darunavir) tablets labeling to reflect significant new risk information. Changes have been made to the CLINICAL PHARMACOLOGY section to include data from 6 pharmacokinetic, drug interaction Phase 1 trials, and to the WARNINGS, PRECAUTIONS AND ADVERSE REACTIONS sections of the package insert to include hepatotoxicity information. Other updates include those made to PRECAUTIONS, updates to DOSAGE AND ADMINISTRATION, and changes to Table 11 to include information regarding a potential drug-drug interaction with rosuvastatin.

In the WARNINGS section, the following has been added:

"Hepatotoxicity
Drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) has been reported with PREZISTA/rtv. During the clinical development program (N=3063), hepatitis has been reported in 0.5% of patients receiving combination therapy with PREZISTA/rtv. Patients with preexisting liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities including severe hepatic adverse events.

Post-marketing cases of liver injury, including some fatalities, have been reported. These have generally occurred in patients with advanced HIV-1 disease taking multiple concomitant medications, having co-morbidities including hepatitis B or C co-infection, and/or developing immune reconstitution syndrome. A causal relationship with PREZISTA/rtv therapy has not been established.

Appropriate laboratory testing should be conducted prior to initiating therapy with PREZISTA/rtv and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases, especially during the first several months of PREZISTA/rtv treatment.

If there is evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients on PREZISTA/rtv, interruption or discontinuation of treatment must be considered."

The PRECAUTIONS section has been changed to read as follows:

"Patients with co-existing conditions
Hepatic Impairment: No dose adjustment of PREZISTA/rtv is necessary for patients with either mild or moderate hepatic impairment. There are no pharmacokinetic or safety data available for subjects with severe hepatic impairment, therefore, PREZISTA/rtv is not recommended for use in patients with severe hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics in Adults, Special Populations, Hepatic Impairment and DOSAGE AND ADMINISTRATION)."

Table 11, Established and Other Potentially Significant Drug Interactions, has been modified, under HMG-CoA Reductase Inhibitors, to include rosuvastatin, indicating increased concentration of rosuvastatin, with the following clinical comment: "Use the lowest possible dose of atorvastatin, pravastatin or rosuvastatin with careful monitoring, or consider other HMG-CoA reductase inhibitors such as fluvastatin in combination with PREZISTA/rtv."

The following sentence has been added to the CLINICAL PHARMACOLOGY section, under Absorption and Bioavailabilty: "In vivo data suggests that darunavir/ritonavir is an inhibitor of the p-glycoprotein (p-gp) transporters."

The following has been added under: Special Populations
"Hepatic Impairment: Darunavir is primarily metabolized by the liver. The steady-state pharmacokinetic parameters of darunavir were similar after multiple dose co-administration of PREZISTA/rtv 600/100 mg b.i.d. to subjects with normal hepatic function (n=16), mild hepatic impairment (Child-Pugh Class A, n=8), and moderate hepatic impairment (Child-Pugh Class B, n=8). The effect of severe hepatic impairment on the pharmacokinetics of darunavir has not been evaluated (see PRECAUTIONS, Patients with co-existing conditions, Hepatic Impairment and DOSAGE AND ADMINISTRATION)."

In addition, there are updates to Table 4: Drug Interactions Pharmacokinetic Parameters for Darunavir in the Presence of Co-administered Drugs, and Table 5: Drug Interactions: Pharmacokinetic Parameters for Co-administered Drugs in the Presence of Darunavir/Ritonavir.

The last paragraph of the ADVERSE REACTIONS section now reads: "Patients co-infected with hepatitis B and/or hepatitis C virus: In subjects co-infected with hepatitis B or C virus receiving PREZISTA/rtv, the incidence of adverse events and clinical chemistry abnormalities was not higher than in subjects receiving PREZISTA/rtv who were not co-infected, except for increased hepatic enzymes (see WARNINGS, Hepatotoxicity). The pharmacokinetic exposure in co-infected subjects was comparable to that in subjects without co-infection."

In addition, the following has been added:

"Additional adverse reactions identified in clinical studies, occurring in less than 1% of the patients, are listed below by body system:

Hepatobiliary System: acute hepatitis, cytolytic hepatitis, hepatotoxicity, hyperbilirubinemia

Skin and Appendages: erythema multiforme, Stevens-Johnson Syndrome
[this duplicate information was deleted from the Skin and Appendages section under the treatment-emergent adverse events occurring in less than 2% of de novo subjects]"

Changes were also made to DOSAGE AND ADMINISTRATION, to include the following: "Hepatic Impairment: No dose adjustment is required in patients with mild or moderate hepatic impairment. There are no data regarding the use of PREZISTA/rtv when co-administered to subjects with severe hepatic impairment; therefore, PREZISTA/rtv is not recommended for use in patients with severe hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics in Adults, Special Populations, Hepatic Impairment and PRECAUTIONS, Patients with co-existing conditions, Hepatic Impairment)."

FDA, Pfizer Warn of Possible Carcinogen in Antiretroviral Treatment Viracept
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=47404

FDA Issues Warning for BMS Hepatitis B Drug Entecavir
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=46965

Abbott, FDA Warn About Possible Overdose of Antiretroviral Kaletra in Children
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=46879
 

July 22, 2007 Celsentri (Maraviroc) Interaction Warning
Based on a recent drug interaction study, Pfizer is warning that the dose of Celsentri (maraviroc) needs to be altered if the drug is combined with Tibotec’s etravirine and/or Prezista. POZ Update

BARCLUDE may increase the chance of HIV resistance to HIV medication
FDA-HIV-AIDS Digest - 18 Jul 2007 to 25 Jul 2007 (#2007-22)

FDA approved revised labeling on July 24, 2007 for BARACLUDE (entecavir) 0.5 mg and 1.0 mg Film-Coated Tablets, and BARACLUDE (entecavir) 0.05 mg/mL Oral Solution for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. The amended label includes safety information related to the use of entecavir (ETV) in patients with human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfection who are not receiving simultaneous highly active antiretroviral therapy (HAART).  Specifically, a recommendation against the use of BARACLUDE in HIV/HBV co-infected patients who are not also receiving adequate therapy for their HIV were added to the Boxed Warnings and the WARNINGS sections of the label. Corresponding changes were made to PRECAUTIONS: Information for Patients section, and in the Patient Information (also referred to as the Patient Package Insert).

Added to the Boxed Warning: Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if BARACLUDE is used to treat chronic hepatitis B virus infection in patients with HIV infection that is not being treated. Therapy with BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART). See WARNINGS: Co-infection with HIV.

Added to WARNINGS section/ Co-infection with HIV: BARCLUDE has not been evaluated in HIV/HBV co-infected patients who were not simultaneously receiving effective HIV treatment. Limited clinical experience suggests there is a potential for the development to resistance HIV nucleoside reverse transcriptase inhibitors if BARCLUDE is used to treat chronic hepatitis B virus infection in patients with HIV infection that is not being treated. (see MICROBIOLOGY: Antiviral Activity, Antiviral Activity against HIV). Therefore, therapy with BARCLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART). Before initiating BARCLUDE therapy, HIV antibody testing should be offered to all patients. BARACLUDE has not been studied as a treatment for HIV infection and is not recommended for this use.

Added to PRECAUTIONS/Information for Patients: Patients should be offered HIV antibody testing before starting BARCLUDE therapy. They should be informed that if they have HIV infection and are not receiving effective HIV treatment, BARCLUDE may increase the chance of HIV resistance to HIV medication (see WARNINGS: Co-infection with HIV). 

Added to Patient Information: If you have or get HIV (human immunodeficiency virus) infection be sure to discuss your treatment with your doctor. If you are taking BARCLUDE to treat chronic hepatitis B and are not taking medicines for your HIV at the same time, some HIV treatments that you take in the future may be less likely to work. You are advised to get an HIV test before you start taking BARCLUDE and anytime after that when there is a chance you were exposed to HIV. BARCLUDE will not help your HIV infection.
 

FDA Reports Apparent Combivir Bottle Tampering
AIDSinfo At-A-Glance Volume 3 Issue 15
On Monday, April 9, 2007, the FDA reported on an isolated incident of apparent label tampering involving counterfeit Combivir (lamivudine/zidovudine) labels. The incident occurred at one pharmacy in California, with no reports of similar incidents elsewhere in the United States.

Specifically, a bottle falsely labeled as Combivir actually contained 300 milligram tablets of Ziagen (abacavir sulfate). In some patients, abacavir sulfate has caused a severe allergic reaction sometimes resulting in death. Patients prescribed Combivir may not be advised about this allergic reaction. Legitimate Combivir bottles contain tablets of 150 milligrams of lamivudine and 300 milligrams of zidovudine. The counterfeit labels have been identified as Lot No. 6ZP9760, with expiration dates of April 2009 and April 2010.

It is recommended that pharmacy professionals and patients closely examine the contents of all Combivir bottles. Combivir is a white, capsule-shaped tablet engraved with "GX FC3" on one side; the other side is plain. Ziagen is a yellow, capsule-shaped tablet engraved with "GX 623" on one face; the other side is plain. The FDA report about this incident includes pictures of Combivir and Ziagen for help distinguishing between the two tablets.

If you discover a Combivir bottle that does not contain Combivir tablets, call the GlaxoSmithKline Response Center at 1-888-825-5249 between 8:00 a.m. and 8:00 p.m. ET, Monday through Friday.Revised labeling for Baraclude (entecavir) re: HIV/HBC co-infected.

FDA and Bristol-Myers Squibb are notifying healthcare professionals of revisions to the MICROBIOLOGY/Antiviral Activity and INDICATIONS AND USAGE/Description of Clinical Studies/Special Populations sections of the prescribing information for Baraclude (entecavir), a nucleoside analog used in the treatment of chronic hepatitis B virus (HBV).

The revised labeling is the result of a case report in which a human immunodeficiency virus (HIV) variant containing the M184V resistance substitution was documented during Baraclude treatment for HBV infection in an HIV/HBV co-infected patient who was not simultaneously receiving highly active antiretroviral therapy (HAART).

Current treatment guidelines recommend Baraclude as an option for treatment of HBV in the HIV/HBV co-infected adult patient who does not qualify for HAART.

Healthcare professionals are advised that when considering therapy with Baraclude in an HIV/HBV co-infected patient not receiving HAART, the risk of developing HIV resistance cannot be excluded based on current information.

You can read the manufacturer's Dear Healthcare Provider Letter at: http://www.fda.gov/medwatch/safety/2007/Baraclude_DHCP_02-2007.pdf

The revised labeling can be found at: http://www.fda.gov/medwatch/safety/2007/Baraclude_PI.pdf


 

Study regarding depression, anxiety and stress among patients taking Sustiva.
http://www.medscape.com/viewarticle/550461?src=mp
To access the article, click on this Web address. This article notification service provided by http://www.medscape.com
 

FDA List Serve (1/23/07) - Important update to Sustiva package insert
The Sustiva (efavirenz) package insert has been updated to include drug-drug interaction information regarding coadministration of efavirenz with rifampin, diltiazem, itraconazole, voriconazole, atorvastatin, pravastatin, simvastatin, pimozide and bepridil.

The Clinical Pharmacology section (Tables 1 and 2 ) were revised to include the results of drug-drug interactions studies with diltiazem, itraconazole, voriconazole, atorvastatin, pravastatin, and simvastatin.

The CONTRAINIDCATION section was revised to state Sustiva should not be administered concurrently with bepridil, pimozide and standard doses of voriconazole.

The PRECAUTION: Drug Interaction section (Tables 5 and 6) were updated to include information regarding coadministration of efavirenz with rifampin, diltiazem (and other calcium channel blockers), itraconazole, ketoconazole, voriconazole, pimozide and bepridil.

The Dosing and Administration section was updated to include dosing information for the co administration of efavirenz and voriconazole. Specifically, if Sustiva is coadministered with voriconazole, the voriconazole maintenance dose should be increased to 400 mg every 12 hours and the SUSTIVA dose should be decreased to 300 mg once daily using the capsule formulation (three 100-mg capsules or one 200-mg and one 100-mg capsule). SUSTIVA tablets should not be broken. FDA-HIV-AIDS Digest - 23 Jan 2007 to 31 Jan 2007 (#2007-2)

FDA List Serve (1/31/07) - Important changes to Fuzeon product labeling

Important additions have been made to the Fuzeon (enfuvirtide) for injection product label to include a description of nerve bundle pain, hematoma, and cautionary wording regarding Biojector use in patients with coagulopathy. The changes add language to the Precautions, Adverse Reactions, and Dosage and Administration sections of the Physician's Insert (PI), as well as corresponding changes to the Patient's Package Insert (PPI), to provide additional safety information regarding the use of the Biojector 2000 to administer Fuzeon as follows:

1. The following section was added under PRECAUTIONS:

Administration with Biojector(r) 2000

Nerve pain (neuralgia and/or paresthesia) lasting up to 6 months associated with administration at anatomical sites where large nerves course close to the skin, bruising and hematomas (see ADVERSE REACTIONS) have occurred with use of the Biojector 2000 needle-free device for administration of FUZEON. Patients receiving anticoagulants or persons with hemophilia, or other coagulation disorders, may have a higher risk of postinjection bleeding.


2. The following bullet was added under PRECAUTIONS, Information for Patients

section:

* Patients and caregivers should be instructed on the preferred anatomical sites for administration (upper arm, abdomen, anterior thigh). FUZEON should not be injected near any anatomical areas where large nerves course close to the skin, such as near the elbow, knee, groin or the inferior or medial sections of the buttocks, skin abnormalities, including directly over a blood vessel, into moles, scar tissue, bruises, or near the navel, surgical scars,

tattoos or burn sites.


3. The following paragraph was added under ADVERSE REACTIONS, Local

Injection Site Reactions section:

Biojector 2000 Needle-Free Device

Adverse events associated with the use of the Biojector 2000 needle-free device for administration of FUZEON have included: nerve pain (neuralgia and/or paresthesia) lasting up to 6 months associated with administration at anatomical sites where large nerves course close to the skin, bruising and hematomas (see Error! Reference source not found.).


4. The following section under DOSAGE AND ADMINISTRATION changed from:

Adults

The recommended dose of FUZEON is 90 mg (1 mL) twice daily injected subcutaneously into the upper arm, anterior thigh or abdomen. Each injection should be given at a site different from the preceding injection site, and only where there is no current injection site reaction from an earlier dose. FUZEON should not be injected into moles, scar tissue, bruises or the navel. Additional detailed information regarding the administration of FUZEON is described in the FUZEON Injection Instructions.

to:

Adults

The recommended dose of FUZEON is 90 mg (1 mL) twice daily injected subcutaneously into the upper arm, anterior thigh or abdomen. Each injection should be given at a site different from the preceding injection site, and only where there is no current injection site reaction from an earlier dose. FUZEON should not be injected near any anatomical areas where large nerves course close to the skin, such as near the elbow, knee, groin or the inferior or medial section of the buttocks, skin abnormalities, including directly over a blood vessel, into moles, scar tissue, bruises, or near the navel, surgical scars, tattoos or burn sites. Additional detailed information regarding the administration of FUZEON is described in the FUZEON Injection Instructions.


5. The second to last paragraph under Subcutaneous Administration now reads:

The reconstituted solution should be injected subcutaneously in the upper arm, abdomen or anterior thigh. The injection should be given at a site different from the preceding injection site and only where there is no current injection site reaction. Also, do not inject near any anatomical areas where large nerves course close to the skin, such as near the elbow, knee, groin or the inferior or medial sections of the buttocks, skin abnormalities, including directly over a blood vessel, into moles, scar tissue, bruises or near the navel, surgical scars, tattoos or burn sites. A vial is suitable for single use only; unused portions must be discarded (see FUZEON Injection Instructions).


6. The following was added under the HOW SUPPLIED section:

Biojector is a trademark of Bioject Medical Technologies, Inc. Patient Package Insert (compared to S-007 final printed labeling)


7. The following bullet under How should I use FUZEON? Section was changed from:

* Do not inject FUZEON in the same area as you did the time before. Do not inject FUZEON into the following areas: around the navel (belly button), scar tissue, a bruise or a mole, and where there is an injection site reaction.

To:

* Do not inject FUZEON in the same area as you did the time before. Do not inject FUZEON into the following areas: near the elbow, knee, groin, the lower or inner buttocks, directly over a blood vessel, around the navel (belly button), scar tissue, a bruise, a mole, a surgical scar, tattoo or burn site, or where there is an injection site reaction.


8. The following section was added under What are the possible side effects of

FUZEON?

Injection using Biojector(r) 2000

Shooting nerve pain and tingling lasting up to 6 months from injecting close to large nerves or near joints, and bruising and/or collections of blood under the skin have been reported with use of the Biojector 2000 needle-free device to inject FUZEON. If you are taking any blood thinners, or have hemophilia or any other bleeding disorder, you may be at higher risk of bruising or bleeding after using the Biojector.


9. The following sentence was added under the Changes since the last version of this

leaflet section:

Clarification of appropriate injection sites for FUZEON and addition of side effects when injecting with Biojector 2000 needle-free device.


10. The following statement was added to the last page:

Biojector is a trademark of Bioject Medical Technologies, Inc.

You can access the complete, revised label on the Daily Med site, at http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=2705#nlm42232-9

Fuzeon is a distributed by Roche Pharmaceuticals.

 

FDA Public Health Advisory for Nevirapine (Viramune)
1/19/05
The Food and Drug Administration (FDA) is issuing a  public health advisory to inform health care providers and patients about recent safety-related changes to the nevirapine (Viramune) label (package insert) and about appropriate use of HIV triple combination therapy containing nevirapine, which is one treatment option in the United States and which is increasingly being used globally.  The nevirapine label has been revised several times over the last two years to include more information on liver toxicity associated with long term nevirapine use.  The Indications and Usage section of the Viramune label now recommends against starting nevirapine treatment in women with CD4+cell counts greater than 250 cells/mm³ unless benefits clearly outweigh risks.  This recommendation is based on a higher observed risk of serious liver toxicity in patients with higher CD4 cell counts prior to initiation of therapy.  In addition, the revised label now includes a Medication Guide to inform patients about risks associated with nevirapine when used for the treatment of HIV.

Both clinically symptomatic and asymptomatic liver toxicity are observed with long term use of nevirapine in combination with other HIV drugs.  Asymptomatic liver toxicity is defined as increases in liver enzymes without any associated clinical signs or symptoms and is similar to that seen with other antiretroviral drugs.  Symptomatic liver toxicity is more common with nevirapine compared to other antiretroviral drugs.  Important information regarding symptomatic nevirapine liver toxicity is summarized below:

• Symptomatic nevirapine liver toxicity consists of elevated liver enzymes plus at least one symptom, which is typically rash but may include flu-like symptoms or fever.  The severity of symptomatic liver toxicity ranges from mild symptoms with liver enzyme abnormalities to rapidly occurring liver failure and death.
• Symptomatic nevirapine liver toxicity typically occurs after only a few weeks of dosing and may progress to liver failure despite monitoring of laboratory tests, which is not characteristic of other antiretrovirals. 
• Females and patients with higher CD4+ cell counts are at increased risk of liver toxicity.  Females have a three fold higher risk of symptomatic nevirapine liver toxicity than males, and females with CD4+ cell counts > 250 cells/mm³ have a 12 fold higher risk of symptomatic liver toxicity than females with CD4+ cell counts < 250 (11% vs. 0.9%).  Males with CD4+ cell counts > 400 cells/mm³ have a three fold higher risk of symptomatic liver toxicity than males with CD4+ cell counts < 400 (6.3% vs. 2.3%).
• Nevirapine-related deaths due to symptomatic liver toxicity, including some in HIV-infected pregnant women, have been reported to FDA's Medwatch program.  Serious and fatal liver toxicity has not been reported after single doses of nevirapine.

• Triple antiretroviral regimens have been shown to have a large impact on the reduction of AIDS morbidity and mortality.  Triple antiretroviral drug regimens containing a protease inhibitor (PI) or a non-nucleoside reverse transcriptase inhibitor (NNRTI), such as nevirapine, are standard of care for HIV treatment and are needed to adequately and durably suppress virus. 
• Many options are needed for HIV-infected patients since resistance to antiretroviral drugs or to an entire antiretroviral class can develop.
• Symptomatic liver toxicity has not been reported with the use of single doses of nevirapine to the mother and to the child for prevention of perinatal HIV infection.
• Alternatives to nevirapine are limited by other toxicities, potential drug interactions, and by the risk of drug related birth defects if given to a female in the first trimester of pregnancy.
• Nevirapine liver toxicity is less frequent (<2% for both males and females with CD4+ cell counts <250 cells/mm³) when started in patients with lower CD4 counts.  Therefore, symptomatic liver toxicity in resource poor countries is likely to be much lower if World Health Organization standards are used for starting treatment.  The WHO recommends the initiation of ART treatment in patients with advanced disease or with CD4 counts < 200 cells/mm³.
• Nevirapine is chemically stable in environmental conditions where other antiretrovirals are not.
• Symptomatic liver toxicity has not been reported in HIV-infected children, and nevirapine is available in a liquid formulation while many other antiretrovirals are not.

Atazanavir, with or without ritonavir should not be coadministered with proton pump inhibitors

FDA List Serve (12/20/04)

Bristol-Meyers Squibb has issued a Dear Healthcare Provider letter regarding important new pharmacokinetic data concerning the coadministration of REYATAZ (atazanavir) and Norvir (ritonavir) with Prilosec (omeprazole). Omeprazole is a proton-pump inhibitor (PPI) for the treatment of acid-related diseases that works by suppressing gastric acid secretion.

The following observations were made from a randomized, open-label, multiple-dose drug interaction study.

A 76% reduction in atazanavir area under the concentration-time curve (AUC) and a 78% reduction in atazanavir trough plasma concentration (Cmin) were observed when REYATAZ/ritonavir 300/100 mg was coadministered with omeprazole 40 mg.

Based on the study results:
* DO NOT COADMINISTER REYATAZ OR REYATAZ/ritonavir with omeprazole due to the reduction in atazanavir exposure levels. This recommendation is consistent with the current REYATAZ U.S. Package Insert.
* It is not known whether the over-the-counter dose of omeprazole (20 mg once daily) would produce similar results; therefore, coadministration is not recommended.
* Increasing the REYATAZ/ritonavir dose to 400/100 mg in combination with omeprazole DID NOT result in REYATAZ exposures comparable to those observed with a regimen of REYATAZ/ritonavir 300/100 mg without omeprazole.
* Simultaneous administration of 8 ounces of cola given in an effort to decrease (acidify) gastric pH did not appear to affect this reduction.

Investigations regarding the potential drug interaction between REYATAZ (atazanavir sulfate) and H2-Receptor antagonists (another type of gastric medication) when coadministered are ongoing. Until data are available, clinicians should note the following statements from the REYATAZ Package Insert: "Reduced plasma concentrations of atazanavir are expected if H2-receptor antagonists are administered with REYATAZ (atazanavir sulfate). This may result in loss of therapeutic effect and development of resistance. To lessen the effect of H2 -receptor antagonists on atazanavir exposure, it is recommended that an H2-receptor antagonist and REYATAZ be administered as far apart as possible, preferably 12 hours apart."


 

“Antibiotic Can Trigger Cardiac Deaths”
Associated Press (09.09.04)::Linda A. Johnson
     The antibiotic erythromycin dramatically increases the risk of cardiac arrest, especially when it is taken with certain newer drugs, according to a new study published today. Erythromycin has been commonly prescribed for 50 years to treat numerous illnesses, including syphilis. CDC Summary

Atazanavir drug interaction with tenofovir

FDA List-serve 3.19.04

New drug interaction information has led to t in the CLINICAL PHARMACOLOGY section of the REYATAZ (atazanavir sulfate) label - tenofovir interaction studies.
The following information was added to the PRECAUTION: Drug Interaction section &#8211; Table 9: Established and Other Potentially Significant Drug Interactions. Specifically the following statement was included ·
Tenofovir decreases the AUC (area under the curve) and Cmin (minimum
concentration) of REYATAZ. When coadministered with tenofovir, it is
recommended that REYATAZ 300 mg is given with ritonavir 100 mg and
tenofovir 300 mg (all as a single daily dose with food). REYATAZ
without ritonavir should not be coadministered with tenofovir.
REYATAZ increases tenofovir concentrations. The mechanism of this interaction is unknown.
Higher tenofovir concentrations could potentiate tenofovir-associated
adverse events, including renal disorders. Patients receiving REYATAZ
and tenofovir should be monitored for tenofovir-associated adverse events.
The following information was added to the DOSAGE AND ADMINISTRATION section. · When coadministered with tenofovir, it is recommended that REYATAZ 300 mg is given with ritonavir 100 mg and tenofovir 300 mg (all as a single daily dose with food). REYATAZ without ritonavir should not be coadministered with tenofovir. Further, information regarding PDE5 inhibitors (sildenafil [Viagra], tadalafil [Cialis] and vardenafil [Levitra]) was added to the WARNINGS and PRECAUTION sections. The information included is consistent with the recently approved Invirase and Fortovase label. In addition, the patient package insert was revised to include information regarding tenofovir and PDE5 inhibitors (sildenafil, tadalafil, vardenafil).
 

"New Clarifications on Liver Dangers of Nevirapine (PDF)
Side effects of any drug can vary from individual to individual and from one gender to another. In a recent letter to healthcare providers, nevirapine (Viramune) producer Boehringer Ingelheim notes that the risk of severe liver damage is much higher for women, including pregnant women already receiving treatment for their HIV infection, whose CD4 counts are over 250. As with all medication-related issues, be sure to talk with your healthcare provider about any concerns you may have about using nevirapine." from What's New at The Body (2.4.04)
http://www.thebody.com/treat/pdfs/nevirapine_risk.pdf?m32h

IMPORTANT DRUG WARNING from Gilead Sciences, Inc
October 14, 2003

RE: High Rate of Virologic Failure in Patients with HIV Infection Treated With a Once- Daily Triple NRTI Regimen containing Didanosine, Lamivudine, and Tenofovir

Gilead Sciences, Inc (Gilead) today released a letter to health care professionals regarding a high rate of early virologic failure and
emergence of nucleoside reverse transcriptase inhibitor (NRTI) resistance associated mutations observed in a clinical study of HIV-infected treatment-naove patients receiving a once-daily triple NRTI regimen containing didanosine enteric coated beadlets (Videx EC, Bristol-Myers Squibb), lamivudine (Epivir, GlaxoSmithKline), and tenofovir disoproxil fumarate (Viread, Gilead).

These new data are consistent with the high rates of virologic failure observed in several recent clinical studies that have evaluated the use of triple NRTI regimens. Based on these results:

• 7 Tenofovir DF in combination with didanosine and lamivudine is not recommended when considering a new treatment regimen for therapy-naove or experienced patients with HIV infection. Patients currently on this regimen should be considered for treatment
  modification.
  

See the Project Inform article "Herbs, Supplements and HIV" http://www.projinf.org/fs/herbs.html

SPECIAL NOTICE TO THOSE USING ZERIT (stavudine, d4T). Changes have been made in the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT INFORMATION sections of the ZERITlabel to describe the occurrence of lactic acidosis and neuromuscular toxicity in patients using stavudine. A total of 25 patients with neuromuscular weakness resembling Guillian-Barre syndrome in association with lactic acidosis were reported to the FDA's Adverse Event Reporting System. In most cases, antiretroviral therapy was continued in the presence of symptoms that might have been due to lactic acidosis, such as abdominal pain, nausea, and fatigue, leading to death in six of the patients. Most of these patients (22 out of 25) were receiving antiretroviral combinations containing stavudine. Although causality has not been established, these findings were consistent with recent reports in peer-reviewed journals that the use of stavudine in antiretroviral combination therapy may increase the risk of lactic acidosis. Therefore, the stavudine label now includes a warning that its use may increase the risk of lactic acidosis, which represents a rare, but serious adverse event. The label now includes the symptoms of the newly described symptomatic hyperlactemia syndrome, and the recommendation for prompt suspension of all antiretroviral therapy in suspected cases of lactic acidosis with or without neuromuscular weakness. Permanent discontinuation of stavudine should be considered in confirmed cases of lactic acidosis. Please refer to the Zerit label for full prescribing information. A copy of the revised labeling is available at: http://www.fda.gov/cder/foi/label/2002/20412S017.pdf.

Garlic Supplements Can Impede HIV Medication
NIH News Release 12/05/01

Researchers have found garlic supplements can cause a potentially harmful side effect when combined with a type of medication to treat HIV/AIDS. Investigators from the National Institutes of Health (NIH) observed garlic supplements sharply reduced blood levels of the anti-HIV drug saquinavir. The study results appear this week in an on-line edition of Clinical Infectious Diseases ( http://www.journals.uchicago.edu/CID/journal/home.html ).

"In the presence of garlic supplements, blood concentrations of saquinavir decreased by about 50 percent among our study participants," explains the study's senior co-author Judith Falloon, M.D., an AIDS clinical researcher at the National Institute of Allergy and Infectious Diseases (NIAID). "We saw a definite, prolonged interaction. The clear implication is that doctors and patients should be cautious about using garlic supplements during HIV therapy," she says.

For the first three days of the study, nine healthy, HIV-negative volunteers received doses of saquinavir, part of a class of drugs called protease inhibitors that are effective at slowing the progression of HIV infection. The research team drew samples from the volunteers' blood to measure their baseline levels of the amount of saquinavir in the bloodstream.

Next, the volunteers took garlic caplets twice daily for three weeks. When the researchers again analyzed blood samples, the average overall levels of saquinavir had decreased 51 percent, and the average maximum concentrations had fallen 54 percent.

Even after a ten-day "wash-out" period with no garlic supplements, when the volunteers again used only the protease inhibitor for three days, their blood levels of saquinavir still averaged about 35 percent lower than the expected baseline amount.

The research paper's lead author was Stephen C. Piscitelli, Pharm D., formerly with the NIH Clinical Center Pharmacy Department and now the Associate Director of Clinical Pharmacology at Tibotec-Virco. Noting that some dietary supplements can cause detrimental interactions with medications, Dr. Piscitelli and his colleagues set out to investigate the effects of a number of herbal therapies. As Dr. Falloon explains, "We set out to learn more about these alternative medicine products because there simply was not a lot of clinical data available on them." In their first study, the team found a potentially dangerous interaction between the herbal remedy St. John's wort and the protease inhibitor indinavir.

Garlic became the next focus because of its reputation as a natural cholesterol fighter, which has made it particularly popular for patients whose cholesterol levels have risen due to a side effect from HIV medications. The research team also suspected a strong possibility of a drug interaction because both garlic and protease inhibitors share the same pathway into the body, a metabolic route known as the CYP450 enzyme system. Exactly how garlic supplements disrupt the uptake of saquinavir is still unclear.

Other questions remain as well, says Dr. Falloon. Usually, doctors prescribe saquinavir to be taken together with several anti-HIV drugs, and it is unknown how garlic supplements would affect such a combined drug regimen. "More research is needed in this area, but it's clear from this study that any patient using saquinavir as the sole protease inhibitor should avoid using garlic supplements," says Dr. Falloon.

NIAID and the Warren Grant Magnuson Clinical Center are components of NIH. NIAID supports basic and applied research to prevent, diagnose, and treat infectious and immune-mediated illnesses, including HIV/AIDS and other sexually transmitted diseases, tuberculosis, malaria, autoimmune disorders, asthma and allergies. The Clinical Center is the clinical research hospital for NIH. Through clinical research, physicians and scientists translate laboratory discoveries into better treatments, therapies and interventions to improve the nation's health.

###

Reference: Piscitelli, S. C., et al. The effect of garlic supplements on the pharmacokinetics of saquinavir. Clinical Infectious Diseases Electronic Edition (December 3, 2001).

"Increased Mitochondrial Toxicity with Ribavirin in HIV/HCV
Coinfection" - see Peer-Reviewed Journals.

"Euro Doctors Warned of HIV Drug Risks in Pregnancy"
Reuters Health Information Services (www.reutershealth.com)
(02/01/01)
     Physicians in Europe are being warned by the European Medicines
Evaluation Agency that pregnant women with HIV who take the
anti-AIDS drugs Zerit (stavudine) and Videx (didanosine) may
experience lactic acidosis, even to a fatal degree.  The disorder
occurs when the body is unable to process food into usable
energy, causing a build-up of acid in the body that can damage
vital organs.  The warning comes a month after a similar alert
from the Food and Drug Administration to U.S. doctors, with both
organizations noting the class of HIV drugs--called nucleoside
reverse transcriptase inhibitors--is not recommended for use
during pregnancy unless the benefits are much higher than the
risks.  The warning includes information about seven cases of
lactic acidosis, including three fatal cases, in pregnant women
taking the two drugs in combination.

Serostim Warning
Wall Street Journal (www.wsj.com) (01/23/01) P. A1
     The U.S. Food and Drug Administration is warning AIDS patients
about a fake version of the drug Serostim, one that is powdery
instead of caked.  The counterfeit drug carries the lot number
MNK612A with an expiration date of 08/02. See Michigan News.

ddI/d4T Combination Can Be Fatal for Pregnant Women

WASHINGTON (AP) - Three pregnant women with the AIDS virus recently died from a severe side effect caused by taking two AIDS drugs together, the government said Friday in warning pregnant women to try to avoid a combination of the drugs ddI and d4T.

Four other pregnant women suffered nonfatal cases of lactic acidosis, an emergency condition where acid builds up in the body and can seriously damage the liver or pancreas.

A class of older AIDS medicines called nucleoside analogs comes with warnings that such drugs occasionally cause lactic acidosis, and that women seem to be at higher risk than men.

But the recent deaths prompted the Food and Drug Administration to issue a special warning for pregnant women. Officials couldn't say why the problem seemed to suddenly arise, although it has become more common for HIV-infected women once restricted to a single drug during pregnancy to instead take multidrug combinations.

Bristol-Myers Squibb manufactures both drugs under the brand names Zerit and Videx, and wrote thousands of doctors Friday alerting them to the warning.

The FDA also has received two reports of pregnant women suffering lactic acidosis while taking a combination of the AIDS drugs d4T and 3TC, and one where the woman took ddI alone. The agency will investigate those cases.

As for ddI and d4T, the FDA says pregnant women should avoid taking those drugs together unless they have exhausted other treatment options. Women  using the combination should be closely monitored by HIV experts who can quickly take them off the drugs and begin emergency therapy if lactic acidosis arises, the FDA said.

The makers of the anti-HIV medication Viramune (nevirapine) have strengthened their warnings regarding the risk of hepatitis for people taking this medication.

More caution with Viraumune (nevirapine) -- detailed warnings from Community AIDS Treatment Information Exchange (CATIE)

Researchers at the National Institutes of Health Clinical Center have demonstrated that a widely used herbal product-St. John's wort-could significantly compromise the effectiveness of an antiviral drug often prescribed to treat HIV infection.

The findings are detailed in the Feb. 12 issue of The Lancet. "When St. John's wort and the protease inhibitor indinavir are taken together, the levels of indinavir in the blood drop dramatically," explained the study's principal investigator.

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