|
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
Drugs
Treatment
MDCH-HAPIS
Documents
Medical
PWA Issues
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.
Adherence Video
The Michigan adherence work group has produced a video to assist physicians in
discussing the issues of drug adherence. The video is available by calling the MI AIDS Hotline 1-800-872-2437.
Also, AIDS
Partnership Michigan has developed one of the first drug programs in the country
to help clients achieve full adherence to complex drug regimens. The program
also established mechanisms for monitoring possible side effects of the drugs as
well as aspects of the patient's daily life.
TREATMENT ADHERENCE: FAMILY SUPPORT HELPS HIV PATIENTS STICK TO DRUG REGIMEN
Kaiser HIV/AIDS Report (4/14) Self-confidence and support from family and friends help HIV patients keep up with their complicated drug regimens, according to a study in the March issue of Health Psychology. Researchers from the Medical College of Wisconsin interviewed 72 men and women taking highly active antiretroviral therapy, finding that "those who lacked social support or weren't confident that they could manage their drug regimen were less likely to comply with their treatment." Study author Dr. Sheryl Catz of the Wisconsin university said, "The results suggest that patients taking HIV medications should be regularly monitored to identify any barriers to (taking their drugs on schedule)." Such comprehensive care "means giving patients easy access to an 'interdisciplinary team' of doctors, nurses, social workers, psychologists and dieticians," she added (Reuters Health, 4/12).
Ask 'The Body'
Your HIV Questions Answered, FREE!
Ever wish you could ask an HIV specialist a question anytime you wanted, anonymously and from the privacy of your home? Wish no longer! At the Body Pro's "Ask the Experts" forums, you can ask whatever's on your mind, and one of their top HIV health professionals will answer -- free of charge! You can also search through our massive archive of previously asked questions on everything from starting treatment to mental health to having a baby when you're HIV positive.
http://www.thebody.com/experts.shtml
HIV Medications: When to Start and What to
Take
Order this booklet from The Body
http://www.thebody.com/content/art12718.html
Got a question specifically about starting HIV treatment? Meet Dr. Gerald Pierone, Jr., The Body's newest expert and the founder of an AIDS research and treatment center in Fort Pierce, Fla. He joins Drs. David Wohl and Ben Young to provide you with the answers to your treatment questions.
http://www.thebody.com/Forums/AIDS/Starting/index.html
CARE Act
New TARGET Web Site Centralizes Ryan White CARE Act
Technical Resources
The TARGET (Technical Assitance Resources, Guidance, Education and Training)
Center Web site and Help Desk are resources that centralize an array of
technical assistance resources for Ryan White CARE Act grantees and HIV/AIDS
Bureau (HAB) staff. The Help Desk is available online or via phone at:
301-443-0067. TARGET resources include those developed by the Health Resources
and Services Administration (HRSA) HAB as well as other grantees:
Best Practices Technical Assistance Library
Links to CARE Act Grantees
Online and Phone Help Desk
Check out the TARGET Web site today!
http://careacttarget.org/
AIDSinfo At-a-Glance: Volume Issue No. 52
Care for Children and
Infants
Caring for an HIV-Positive Child
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.
www.thebody.com/nphrc/wellcare.html
FAQ on Pediatric AIDS
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
Clinical Trials
AIDSinfo The HIV/AIDS Clinical Trials Information
Service (ACTIS) and the HIV/AIDS Treatment Information Service
(ATIS) merged into AIDSinfo. This provides quick and easy access to wide-ranging federal
resources on HIV/AIDS clinical research, HIV treatment and
prevention, and medical practice guidelines for health care
providers and consumers. For more information, visit
www.AIDSinfo.nih.gov.
NIH UNVEILS 'CONSUMER FRIENDLY' CLINICAL TRIALS WEB SITE In March, NIH launched
http://clinicaltrials.gov/
-- its "consumer-friendly" database of more than 4,000 federal and private medical studies, including those on HIV/AIDS. The database includes information about the location of clinical trials, their design, criteria for participation, and in many cases, further information about the disease and treatment under study. (NIH release, 2/29).
This Little Medication Goes to Market, But This Little Med Stays
Home
How does a new HIV medication get approved in the United States? How long
does the approval process take, and what factors can make or break a prospective
drug? Tim Horn of ACRIA Update offers this in-depth explanation of the many
steps that must be taken before a prescription drug can be sold in the United
States. Web highlight rom What's New at the Body (10/26/04)
http://www.thebody.com/cria/fall04/fda_approval.html?m70h
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
"Housing is Health Care," a new HRSA/HAB guide on implementing the
Bureau's housing policy regarding use of CARE Act funds for housing-related services,
explains the flexibility of HAB Policy 99-02 (Use of CARE Act Funds for Housing Referral Services and Short-term or Emergency Housing Needs). It
outlines three implementation areas: housing categories to use in allocations and applications; record keeping and documentation; and
funding/program changes. Case studies on integrating housing funds under
the CARE Act and HOPWA (Housing Opportunities for People with AIDS) are also featured. Additional resources in the guide include a history of HIV/AIDS
housing in the U.S.; planning under the CARE Act and HOPWA; a statement from HAB Administrator Dr. Joseph O'Neill on the role of housing in a changing
epidemic; and technical resources available on housing.
The guide, produced in partnership with AIDS Housing of Washington, can be obtained from the HAB web site "Tools" page at: http://hab.hrsa.gov
(go to the "Select a Topic" pop up menu and click on "Homelessness
and HIV") or the HRSA Information Center at 1-888-ASK-HRSA.
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
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.
* Please make new copies of the application for your use and destroy all
outdated copies you may have.
* No old applications will be accepted after June 30, 2007. No exceptions!
* 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)
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
Feds allow Medicare participants to access records on line.
-
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.
http://www.mymedicare.gov/
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
HHS Web Site Allows Consumers To Compare
Nation's 17,000 Nursing Homes
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=14570
Patient Advocacy
Deciphering Medical Terminology
Sometimes HIV specialists, HIV caseworkers -- even some HIVers --
talk about the virus with words that seem impossible to understand:
"pharmacokinetics," "co-formulation," "sequencing." Here's a list of
some of the most often-used HIV-related terms and their definitions.
http://www.thebody.com/pw/glossary.html
Guide to Side Effects
Drugs used to treat HIV and AIDS can be a double-edged sword. While they
may do a good job of controlling HIV and treating AIDS-related
diseases,
they are also associated with problems of their own: side
effects.
Community Research Initiative on AIDS has put together a handy little
booklet on side effects and how to make sense of standard
treatments and
complementary therapies to manage them.
www.thebody.com/cria/sideeffects/contents.html
"Fight AIDS at Home," www.fightaidsathome.or,
uses existing connections on the
Internet to link personal computers to a network that compares anti-AIDS drugs against genetic variations to find the best one.
Downloadable software from Entropia allows personal computers to help evaluate AIDS drugs. The software, called
AutoDock, runs
when the computer is not processing other data. Users should be aware of their privacy needs and research the project before
taking part.
New List Serve
There is a new list serve available for Case Managers, Social Workers, Nurse
Managers, Dieticians, Nutrition Managers, and other related fields.
The same
staff that is overseeing the HIV-Doc and HIV-Law list will also take on
this list. The list manager is ezmlmis.
The email address is socwkr@lists.boygeniuse.com
To subscribe send an EMPTY email message to:
socwkr-subscribe@lists.boygenius.com
You will get a response message that you have to reply to, and you will be
all set.
NEW PATIENT PROTECTIONS IN MEDICAID MANAGED CARE
RULE
HCFA reports those enrolled in Medicaid managed care plans will have greater
patient protections under new regulations published in the January 19, 2001
Federal Register (Volume 66, Number 13, Pages 6227-6426)
http://www.hhs.gov/news/press/2001pres/20010118.html
Social Security Cost-of-Living Raises
Cost-of-living adjustments for 2001 announced by Social Security; for the details: www.thebody.com/apla/jan01/cola.html
The new poverty levels for 2001 have just been
announced
These are used for eligibility for the Medicaid, CHIP, WIC, food stamp,
school lunch and the programs which pay Medicare premiums for those who are
slightly "too rich" for Medicaid (QMB, SLMB, QI [I], QI [II] and QDWI),
as
well as a host of other state-run programs.
For the 48 states and DC, the one person level is $8590 ($715.83 monthly);
add $3020 yearly ($251.66 monthly) for each additional family member.
Patient's HIPAA Privacy Notice
Since HIPAA took effect on April 14, 2003, each of your health care providers (including dentists) should have provided you with a Privacy Notice. If you read it, you would discover the ways that the HCP will "use" your protected health information WITHOUT asking your permission.
More on this subject.
Physician's Desk Reference (PDR)
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.
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
Another Guide to Social Security Benefits for People
Living with HIV/AIDS
Per Kendra Kleber: A new
document from the Social Security Administration (SSA), "Social Security
Benefits for People Living with HIV/AIDS," describes how people living with
HIV/AIDS can apply for benefits under two SSA programs: Social Security
Disability Insurance (SSDI) and Supplemental Security Income (SSI).
The document covers: eligibility for benefits; disability definitions; how to
file for benefits; questions asked during the eligibility process; how
eligibility determinations are made; how to expedite processing of claims; and
what happens if recipients return to work. This new document replaces another
SSA publication geared toward PLWH, "A Guide to Social Security and SSI
Disability Benefits for People with HIV Infection," which has been discontinued
and is no longer available.
To view the document go to:
http://www.ssa.gov/pubs/10019.pdf
.
A Better Guide to HIV/AIDS-Related Social Security Benefits
According to Kendra S. Kleber JD, of the law office of Kendra S. Kleber &
Associates, the Social Security Administration is currently revising the rules
used to evaluate disability benefits claims based on HIV/AIDS. The rules have
been in place since 1995, but will soon incorporate clearer guidance about the
impact of many manifestations of HIV infection that were not known before HAART.
The guidebook "Social Security Secrets," written by Kleber for people disabled
by HIV/AIDS and originally made available by Michigan Advocates Exchange (MAX),
explains the disability benefits programs and strategies for supporting a
benefits claim. The book is available at
www.positiveoutlook.org .
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
Community Research Initiative on AIDS has put together a handy little
booklet on side effects and how to make sense of standard
treatments and
complementary therapies to manage them.
www.thebody.com/cria/sideeffects/contents.html
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 List Serve 3/31 -
Important Information About Sustiva (efavirenz)
and Pregnancy
Bristol-Myers Squibb Company would like to make
clinicians who are caring for HIV-1-infected patients aware of important new
information in the SUSTIVA Package Insert regarding pregnancy.
The pregnancy category for SUSTIVA has been changed from
Category C (Risk of Fetal Harm Cannot Be Ruled Out) to Category D (Positive
Evidence of Fetal Risk). This change is a result
of four retrospective reports of neural tube defects in infants born to women
with first trimester exposure to SUSTIVA including three cases of
meningomyelocele and one Dandy Walker Syndrome. As
SUSTIVA may cause fetal harm when administered during the first trimester to a
pregnant woman, pregnancy should be avoided in women receiving SUSTIVA.
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.
In spite of the potential for serious and life-threatening liver toxicity and
skin rashes with nevirapine, there are multiple reasons why nevirapine remains
an important part of an HIV treatment regimen for many HIV-infected
individuals world-wide. These reasons include:
- 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.
In conclusion, the seriousness of the underlying disease must be considered as
part of the risk benefit analysis when treating HIV-infected patients. HIV
infection will progress to AIDS and death if untreated. Treatment with
combination antiretroviral drugs, including nevirapine, can slow clinical
progression and may delay the development of AIDS or death for years. Health
care providers should weigh the benefits and risks associated with nevirapine
use before prescribing nevirapine for the treatment of their HIV-infected
patients.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Jeffrey Murray
Division of Antiviral Drug Products
Food and Drug Administration
An archive of past list serve announcements is available on the FDA web site
at
http://www.fda.gov/oashi/aids/listserve/archive.html
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 – 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.
On the Net: http://www.fda.gov
VIRAMUNE WARNINGS
The makers of the anti-HIV medication Viramune (nevirapine) have
strengthened their warnings regarding the risk of hepatitis for people taking
this medication.
www.thebody.com/step/ezine_121500/viramune.html
More caution with Viraumune (nevirapine) -- detailed warnings from
Community AIDS Treatment Information Exchange (CATIE)
www.thebody.com/catie/nevirapine.html
"Glaxo AIDS Drug Gets FDA Approval, With Strong Warning"
Wall Street Journal (www.wsj.com) (11/16/00) P. B2
The U.S. Food and Drug Administration (FDA) has approved a
combination drug for the treatment of HIV, but the agency has
warned that about 5 percent of patients trying the pill could
undergo a severe, possibly fatal if untreated, allergic reaction.
Called Trizivir, Glaxo Wellcome's combination of AZT, 3TC, and
Ziagen (abacavir) reduces the number of pills needed in an HIV
regimen from four to two. Trizivir will reach the market in
December, according to Glaxo, at a price of $26.60 per day. The
FDA's warning stems from the fact that about 5 percent of people
taking Ziagen experience serious allergic reactions, so patients
trying the new drug combination also have that same risk.
Glaxo notifies physicians about fatal reactions to
HIV treatment Ziagen
By Steve Mitchell
WASHINGTON, Aug 01 (Reuters Health) - Glaxo Wellcome has issued a "Dear
Health Professional" letter notifying physicians of recent cases of fatal
hypersensitivity reactions in patients reintroduced to the company's nucleoside
analogue reverse transcriptase inhibitor Ziagen (abacavir).
"Recent reports indicate that severe or fatal hypersensitivity reactions
can occur within hours after Ziagen reintroduction in patients who have no
identified history or unrecognized symptoms of hypersensitivity to abacavir
therapy," Glaxo said in the letter.
A Glaxo spokesperson told Reuters Health that the purpose of the letter was
to reemphasize to physicians the need for determining why a patient has stopped
taking abacavir. "If hypersensitivity can't be ruled out, then they must
not start back on abacavir," the spokesperson commented.
Symptoms indicative of hypersensitivity include fever, skin rash,fatigue,
vomiting, diarrhea or abdominal pain.
Glaxo noted that "most of these hypersensitivity reactions were
indistinguishable from hypersensitivity reactions associated with abacavir
rechallenge: short time to onset, increased severity of symptoms, and poor
outcome (including death)."
The company added that "severe or fatal hypersensitivity reactions
[also] occurred upon reintroduction when abacavir was discontinued for reasons
unrelated to symptoms of hypersensitivity." Glaxo said that "in some
cases, symptoms consistent with hypersensitivity may have been present before
abacavir was discontinued, but may have been attributed to other medical
conditions."
The Glaxo spokesperson said that in two cases, the patients were running out
of medication, which could be the reason they stopped taking it.
Physicians are advised not to reintroduce Ziagen to patients who discontinued
the drug because of hypersensitivity. "If symptoms consistent with
hypersensitivity are not identified, reintroduction should be undertaken with
caution," Glaxo said.
"Patients should be made aware," the company added, "that a
hypersensitivity reaction can occur upon reintroduction of abacavir, and that
reintroduction should be undertaken only if medical care can be readily accessed
by the patient and others."
Since Ziagen was approved in 1998, labeling has included a warning of the
potential for fatal hypersensitivity reactions. In January, labeling was revised
to include a warning about fatal hypersensitivity reactions to Ziagen in
patients presenting with respiratory symptoms.
"EU Medicines Agency Issue Warning on AIDS Drug"
Fox News Online www.foxnews.com (04/19/00)
The European Medicines Evaluation Agency (EMEA) has
released a warning about the AIDS drug Viramune following
reports of possibly deadly side effects. The European Union's
drug administration issued a statement last week which said that
special care must be taken in the first two months of using the
drug. The agency noted that some patients taking the drug had
experienced severe skin and liver reactions and some had died.
Patients with previous liver problems should not use the drug,
the EMEA said.
"FDA Links 70 Deaths to Heartburn Drug"
Washington Post (www.washingtonpost.com) (01/25/00) P. A1;Kaufman, MarcThe Food
and Drug Administration (FDA) announced new warnings
to doctors for patients taking Propulsid, a popular drug for
nighttime heartburn, after 70 deaths and 270 adverse reactions
were reviewed. The FDA said that patients with heart conditions
and other risk factors need to be tested by their doctors before
taking the Propulsid--also known under the generic name
cisapride--is made by Johnson & Johnson's Janssen Pharmaceutica.
Spokesmen for Janssen said that the number of adverse reactions
was low, considering the fact that some 30 million prescriptions
have been filled for the drug since it was introduced in 1993.
The new warnings include notices about adverse reactions when the
drug is combined with other drugs, including antibiotics like
erythromycin, all protease inhibitors used to fight HIV and AIDS,
and a class of antidepressants that includes Elavil and Serzone.
STUDY DEMONSTRATES DANGEROUS INTERACTION BETWEEN ST. JOHN'S WORT AND
INDINAVIR
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.
Tell Your Doctor About Herbal Supplements
Herbs can be potent medicines, and may interact with other drugs or cause complications during surgery, which is why it is crucial to discuss your herbal treatments with your doctor.
Read more at (the former Surgeon General) Dr. Koop's website http://www.drkoop.com/news/stories/may/herbal.html?nl=dkc&dt=060800
Report Health Rumors to the CDC
The Centers for Disease Control and Prevention has developed
a Web site, www.cdc.gov/hoax_rumors.htm,
to dispel concerns
about new diseases or drug safety scares that travel the
Internet. Mostly spread by concerned people who pass e-mail
messages about health issues to their friends, the good
intentions of Web users have a tendency to create an "urban
legend," or completely false safety scare. They range from
non-existent food contamination to date-rape drugs that exist
only in the mind of the message creator, or HIV-infected needles
stuck into movie theater seats. After receiving 250 phone calls
and 500 e-mails per week for just one hoax, the CDC opted to
create its informational Web site to combat the myths. According
to CDC spokesman Tom Skinner, "So many of the hoaxes used the CDC
as a supporting voice of authority in their messages, so we
decided to make a formal response."
User Friendly Manual for PWAs
The highly regarded USER FRIENDLY MANUAL for people living with HIV/AIDS has been updated. This is the indispensable handbook for
PWA/Hs, their friends & care providers.
PWH/A Reference Guide
Copies of the PWH/A Reference Guide are now available on CD-ROM. CD’s
may be picked up at the MAPP office at 429 Livernois, Ferndale, MI during normal
business hours.
- Medical & Health Information
- Basic Needs (Food, Housing, Employments
- Benefits (Social Security, Medical Insurance, Legal)
- Counseling & Support Services
- Internet Resources & much more . . .
The USER FRIENDLY MANUAL is also a directory of addresses & phone
numbers to many metropolitan Detroit area organizations of HIV/AIDS services.
|