AIDS TREATMENT NEWS Issue #358, January 12, 2001
phone 800-TREAT-1-2

CONTENTS

** AIDS Treatment Fact Sheets: Interview with Bob Munk, New
Mexico AIDS InfoNet
Widely regarded as the best collection of single-page AIDS
fact sheets, these cover over 100 treatment-related topics;
each is available in both English and Spanish, and is
changed as necessary to remain current.

** Urgent, United Nations AIDS Session, Deadline
February 1, Email Input Any Time
Nonprofits and businesses must apply by February 1 to be
accredited to participate in person in consultations
leading up to this important U.N. session in June. You can
also participate through a special email discussion group,
regardless of the February 1 deadline -- but earlier is
better, as critical preliminary meetings start in
February.

** Nevirapine Warning on Post-Exposure Prophylaxis
Nevirapine should not be used to prevent infection after
HIV exposure, except in unusual circumstances, due to the
risk of side effects. This warning does not affect its use
in HIV treatment, or in prevention of mother to child
transmission.

** d4T plus ddI: Warning for Pregnant Women
New data suggests that pregnant women may be at increased
risk of lactic acidosis from the combination of d4T and
ddI.


***** AIDS TREATMENT NEWS New Philadelphia Contacts

AIDS TREATMENT NEWS has moved to Philadelphia, and is now
being published with Philadelphia FIGHT. Editorial policies
will not change; John S. James is still editor and
publisher, and remains in complete control of the content.
This move frees us from the administrative work of
maintaining a separate office, and gives us daily contact
with an AIDS service provider running a nonprofit clinic,
Federally funded HIV/AIDS treatment research, and many
education and outreach programs.

Our new address is AIDS Treatment News, Philadelphia FIGHT,
1233 Locust St., 5th floor, Philadelphia, PA 19107. We will
keep our toll-free number, 800-TREAT-1-2; we can also be
reached at the same phone at 215-546-3776. Our new fax
number is 215-985-4952, but email is preferred as faxes may
not reach us while traveling.

We are keeping our email address, aidsnews@...

Because of the move, the first issues of 2001 will be
delayed. And our annual overview article, traditionally
published in the first issue of each year, has been
postponed.

John S. James, AIDS Treatment News


***** AIDS Treatment Fact Sheets: Interview with Bob Munk,
New Mexico AIDS InfoNet

by John S. James

In the three years since it started, the New Mexico AIDS
InfoNet has become widely recognized as perhaps the best
overall collection of single-page fact sheets on AIDS
treatment information. It now maintains over 100 of them,
each in English and Spanish. Topics include background on
HIV and AIDS, blood tests and what they mean, using
HIV/AIDS services, all approved antiretroviral treatments,
many opportunistic infections and their therapies,
alternative/complementary treatments, a separate section on
treatment side effects, and HIV prevention. All are in non-
technical language, and all are available on the Web
(http://www.aidsinfonet.org) plus two printable formats for
clients who may not have computer access. As with other
fact sheets, each one can be read separately as needed;
they do not need to be used in any sequence.

While this project was specifically designed to meet the
needs of clients of AIDS service organizations in New
Mexico, it has a national and international constituency as
well, with currently about half of the Web use coming from
outside the United States. It also provides a model for
presenting certain kinds of information effectively, either
online or off.

Bob Munk, a well-known AIDS activist, started this project
and has written most of the material. AIDS TREATMENT NEWS
interviewed him on December 23, 2000. [JSJ]

* * *

Interview with Bob Munk, New Mexico AIDS InfoNet

JSJ: Why did you first decide to write your own fact
sheets, instead of using existing ones?

Munk: We had to meet specific needs of clients in New
Mexico. It is a large and very rural state, so most clients
tend to be far away from AIDS service organizations. And it
was hard to get information in Spanish, which many prefer
because it is their native language.

We looked at existing fact sheets to see if they could meet
our needs. There were some good ones, but any particular
set had deficiencies. Most had a very limited range of
topics; most had no information at all about any
alternative or complementary therapies, which are of
serious interest to many clients in New Mexico.

Many were badly out of date--for example, a saquinavir fact
sheet in 1998 that said that saquinavir was the only
approved protease inhibitor, or a CMV fact sheet that did
not mention the existence of the intravitreal implants.
Others had a reading level that was too complex; on the
Flesch-Kincaid reading scale they came out at the 11th or
12th grade level. [For writers who want to test their own
documents, Flesch-Kincaid software is available within the
spelling checker of recent versions of Microsoft WORD.]

Another problem with some of the sites is that they might
issue multiple reports on a single topic--such as an
initial writeup, and then later an update when a new
treatment was approved. So the user had to be able to go to
their Web site and identify the different pieces and put
them together, first reading the obsolete report and then
the updates.

In consultation with front-line people--the case managers
of the AIDS service organizations in New Mexico--we agreed
to aim for an 8th grade reading level in a single-page (one
side) fact sheet. We don't consider 8th grade level "low
literacy." But we have heard from our case managers that
when they have a low-literacy client, if they have an
opportunity to sit down and discuss the information, the
fact sheet works as a memory aid to help the client
remember the discussion. The case managers believe that 8th
grade is a useful reading level. I'm not aware of other
fact sheets written at the same or lower level. The U.S.
Centers for Disease Control has some booklets that they
consider low literacy, but I find them almost insulting; I
don't know how well low-literacy clients receive them.

It's totally appropriate to have a wide range of reading
levels, including material that is much more complex or
technical. But service organizations need to be aware of
the range of resources available and try to match them to
the client. There is nothing wrong with a more technical
writeup, as long as the client can digest it. And there is
no reason that everyone with HIV should have a comfortable
familiarity with complex medical terminology.

When we realized there was no set of fact sheets we could
just pick up and use, that we would have to develop our
own, we worked with the case managers to determine the
higher priority topics--which were basic diagnostic tests,
HIV medications, and opportunistic infections.

We also did a survey of New Mexico HIV service providers
and clients. We found that only about 40% of AIDS service
providers had access to the Internet; clearly the figure
for clients would be lower than that. So we knew from the
outset that we had to structure the project for hard-copy
printout. In working with our advisory board we came up
with the format we use: a single sheet with three columns
of text, which is the most readable and user friendly.

Fact Sheets Available Now

JSJ: Recently I counted 114 fact sheets on your site. Could
you summarize the main categories for our readers?

Munk: In the Background Information section we have 11 fact
sheets, including what is AIDS, HIV antibody testing,
several fact sheets on understanding your lab results, and
one on the drug approval process. The web site Background
section also has several links on AIDS epidemiology and
statistics.

We have five fact sheets on prevention topics, including
post-exposure prophylaxis [what to do if you have just been
exposed to HIV].

A section on HIV services includes how to begin, choosing a
doctor, telling others you are HIV positive, participating
in a clinical trial, and how to spot HIV/AIDS fraud.

There are 12 sheets on New Mexico programs--the only ones
which are specific to New Mexico--and the Web site has
links to four Federal programs.

Antiretroviral drugs are covered in several sections. A
general category includes several fact sheets on new drugs
being developed, a chart of drug names and manufacturers,
official treatment guidelines (it will need to be changed
when the new guidelines are released in January), T-cell
tests, viral load tests, resistance tests, the HIV life
cycle, adherence (compliance), and treatment interruptions.

There are also fact sheets on each of the 15 antiretroviral
drugs now approved in the U.S. These are categorized by
drug class: nucleoside analogs, non-nucleoside reverse
transcriptase inhibitors, and protease inhibitors. (There
are also fact sheets for Combivir and Trizivir, which
combine two or three approved antiretrovirals in one pill,
to reduce the number of pills that must be taken each day.)

The "Treatment: Opportunistic Infections" has 24 fact
sheets covering many of the most common opportunistic
infections, and some of the drugs used to treat them.

We have a new section on treatment side effects, including
fatigue, body shape changes, diarrhea, mitochondrial
toxicity, and bone problems.

A "Treatment: Special Topics" section currently has eight
fact sheets on nutrition, vitamins and minerals, drug
interactions, women and HIV, pregnancy and HIV, immune
restoration, hydroxyurea, and interleukin-2 (IL-2).

And the alternative and complementary section has an
overview, Chinese acupuncture, Chinese herbalism, Native
American traditional healing, cat's claw, DHEA, DNCB,
echinacea, essiac, hypericin (St. John's Wort), marijuana,
and silymarin (milk thistle). More will be added.

Our site also includes a huge collection of links to
HIV/AIDS Web sites, over 500 of them by categories. We do
not evaluate or describe these sites, but each month we
verify that each one still exists.

JSJ: Where do you get the information for the fact sheets?

Munk: I scan the email lists, such as AEGIS
(http://www.aegis.org), the daily CDC HIV/STD/TB Prevention
News Update (available through AEGIS, or at
http://www.cdcnpin.org/services/listserv.htm), and
treatment discussion groups, and attend AIDS treatment
conferences. When there is news important enough to go into
a one-page sheet, I revise ours if necessary.

What Should Be in a Fact Sheet or Web Page?

JSJ: What do you believe should be included in each fact
sheet or Web page?

Munk: There are different Internet guides to creating good
material. Some ideas of what should be on Web sites are
fairly consistent.

* There should be a way to find out who is writing the
material, and what are the sources. Our site has
information about me, and about the AIDS Education and
Training Center, where our project is based.

* A site should state whether the material is reviewed by
somebody. Is it just posted, or checked by experts first?

* Each page should have a date on it. Ideally it will be
clear whether that was the date the material was originally
written, the date it was posted, or the date it was last
reviewed and/or updated. Often there is no date; sometimes
you just get a date on a page, and do not know which it
represents.

* For HIV treatment information, the Web site ought to
disclose the sponsorship or source of funding for the
project. Readers should know whether a site is sponsored by
pharmaceutical companies or a single company. On my site I
do not list specific percentages, but we have governmental
funding and corporate funding, and the corporate funding is
from many different firms. If I were looking at a treatment
site, I would feel more comfortable if it had many sponsors
than if it had a single corporate sponsor.

* It helps to have an introductory page stating the purpose
of the Web site. If it's in conjunction with a commercial
venture, that's good to know. If it's educational, that's
also worth knowing.

* A site should be easy to navigate. People should be able
to get in, get what they want, and get out, quickly. And
particularly in a rural area, many people do not have high-
speed access; our site is deliberately not flashy; it has
low graphic content, so pages load quickly.

* None of our pages is terribly long. And we break each
page into sections, and group the section headers at the
top of each page. So as soon as the screen appears, the
reader knows what's below on that page.

* And to make use of the capabilities of the Internet, we
try to cross-link our fact sheets as much as possible. If a
fact sheet on antiretroviral therapy talks about T-cell
counts, T-cell count wording will be linked to the fact
sheet on T-cell tests. If it talks about viral load, it
will link to the viral load fact sheet. If it talks about
specific drugs we have fact sheets on, it will link to
those fact sheets.

* Mechanism for feedback: Is there a way to contact the
site to make comments or ask questions? We have that on
each page.

* Each Web site should have a privacy statement. Ours
states that the logging software records each visit
(including what country you are from, what browser you are
using, and which pages you visit) but does not link this
information to an individual person.

I also have an email update mechanism so that people who
want to be informed of changes get a monthly email from me,
saying what has been changed on the site, so they can go to
the Web and get the new version. If people send me their
email address for this list, I do not disclose it to
anybody at any time for any purpose.

When people use a search engine to look for a particular
topic, they may come into a site several levels down in its
hierarchy. So Web users need to educate themselves about
trying to find the main page for the site. For treatment
information, people need to figure out which sites they
trust. So if you use a search engine and come upon a fact
sheet you like, try to find the main entry page of the Web
site, and educate yourself about the stated purpose of the
site, who reviews the material, who sponsors it, and so on.

JSJ: It's a good idea to have a link to the main page, at
the bottom of every page of the site.

Munk: We have just put that in.

For more information on how to judge medical Web sites, see
Criteria for Assessing the Quality of Health Information on
the Internet, a work in progress, currently 55 pages, at:
http://hitiweb.mitretek.org/docs/criteria.html

The New Mexico AIDS InfoNet

JSJ: How did the New Mexico AIDS InfoNet begin?

Munk: Within New Mexico the HIV/AIDS services are organized
in a managed-care type of model. There are four primary
agencies that serve the entire state. So if we could make
sure that those four agencies (and particularly the case
managers of those agencies) had Internet access, and knew
how to reach treatment information in a form they could
readily print it out and distribute to clients, we would
have a useful resource.

What seemed ideal was to use the Internet not only as a way
of delivering information to the end user, but to leverage
the delivery of information, since the Internet is an ideal
way to update information quickly, and make it available to
people spread over a large area. From the beginning we
wanted have the material in a form that could be printed
*off* the Internet by agencies, and given to clients.
Currently our materials are used in this way by a number of
AIDS service organizations and clinics.

The New Mexico AIDS InfoNet started in 1997, when the state
director of HIV/AIDS services noticed an announcement for a
National Library of Medicine grant for electronic
information. A group of us then met about the needs in New
Mexico. Our first application was turned down. But I
decided to go ahead and start the project anyway, because
it seemed that it would have huge advantages for New
Mexico.

The project began in a statewide, state-funded services
planning agency. That agency lost its major contract at the
middle of 1998, so then the AIDS InfoNet project moved over
and affiliated with the AIDS Education and Training Center
at the University of New Mexico (a satellite of the
Mountain Plains AETC out of Denver). I attached the project
to them, so it's not a separate 501(c)3. We do not get
financial support from the university. We get a certain
amount of support from the National Library of Medicine; we
went back the following year and were successful, and have
been funded twice more by them. We also have a contract
with the New Mexico Department of Health; and in addition
we get a fair amount of support from pharmaceutical
companies.

Our first home on the Internet was University of California
San Francisco's HIV InSite (http://hivinsite.ucsf.edu/);
they hosted our materials until we could set up our own Web
site. We launched ours on January 1 1998, and have
maintained it since then.

From the beginning of our Web site, each document was
created in three formats: a Web page (HTML); a Microsoft
Word document, and Adobe Acrobat format (.pdf). So persons
with either Microsoft Word or Adobe Acrobat could print the
fact sheets in their original format.

To make our own operation more efficient we do not provide
hard copy. There are a few special circumstances, for
example if someone is incarcerated and has no other access.
We may first try to identify a local AIDS service
organization, and make sure that they know about the New
Mexico AIDS InfoNet, and how to download and print our fact
sheets--and that a potential client needs them.

We have also made our materials available at no charge
through other HIV/AIDS Web sites, including AEGIS,
AIDS.org/Immunet, The Body, Medscape, the National Minority
AIDS Council, and University of California San Francisco's
HIV InSite.

JSJ: I'm impressed that you cover
mainstream/pharmaceutical, nutritional, and
alternative/complementary treatments in the same context.

Munk: Our advisory group felt strongly about that.
Everybody knows that many people with HIV and AIDS are
looking to alternative and complementary therapies as part
of their program. Yet almost all sites providing AIDS
treatment information--unless they were strictly focused on
alternative and complementary--made people go to different
sources to get information on Western approaches, and on
alternative/complementary approaches. We thought there was
no reason for that; if we could build trust and credibility
for a source of treatment information, why not also provide
information on alternative and complementary topics along
with the mainstream ones?

Clearly we are not cheerleaders for any of the herbal
substances, etc.; we take a research-based approach in what
we put in the fact sheets. And they are reviewed by the
Physician Administrator of the Infectious Disease Bureau of
the New Mexico Department of Health. So we do not praise
something like Cats Claw or Essiac, when there is no
research to support it. We try to put out a balanced fact
sheet, that says this is what has been researched, this is
what people are saying but it has not been supported by
research, and these are the downsides that people are
talking about as potential adverse effects, or that have
been documented in clinical research.

JSJ: When you look at anything on the Web, you realize it's
there for a reason. And then the question is, what reason?
And with many alternative sites, you have no way of knowing
if the reason is one you can trust. Is it only that
somebody wants to make money? Or that someone is a fanatic
for a particular remedy? This is true for mainstream sites
as well, but at least there are more checks and balances.

Munk: With many of the alternative/complementary
treatments, especially the supplements, often the only
place you can get information is somebody who is trying to
sell you the product. DAAIR (Direct Access Alternative
Information Resources, http://www.daair.org) does a very
good job providing information.

International Use

JSJ: What international interest are you finding?

Munk: About 50% of our Web site visits are from outside the
U.S. That's something we did not expect. It's a huge bonus
with the Internet--once you put information there, people
can use it from around the world. The primary access from
outside the U.S. has very consistently been from Mexico,
Peru, Argentina, Spain, and the UK.

People often ask is which version of Spanish we use. The
fact sheets are written in English and translated into
Spanish. They get a final edit by a native Spanish speaker
from Northern Mexico. People from other Spanish-speaking
countries have told us that while there may be some
differences in usage here and there, they basically have no
problems understanding the concepts.

JSJ: Perhaps the focus on simple language helps.

Munk: Actually that cuts the opposite way. If you are using
technical language, the words are identical all over the
world; with scientific terminology there is no regional
variation. And often with non-technical language I am using
colloquial wording, which is more susceptible to regional
differences. But it has not proved to be a problem. I have
not had any complaints; and people have requested the
updates from Spain, Peru, Argentina, and other countries.


***** Urgent, United Nations AIDS Session, Deadline
February 1, Email Input Any Time

Civil society throughout the world (including nonprofits
and businesses, especially in developing countries) has
been invited to participate in a United Nations General
Assembly Special Session on HIV and AIDS, June 25-27, 2001.
If your organization wants to send an accredited
representative, then unfortunately the deadline to apply to
be accredited is February 1 -- and the announcement and
instructions went out less than two weeks before this
deadline. But anybody can participate online, through an
email discussion group which you can join at any time.

* For more information about the special session, including
background, and how to apply to be accredited, see
http://www.unaids.org; also see http://www.hdnet.org
(Health and Development Networks, which "has been
commissioned by UNAIDS to help ensure that NGO and
community voices are channeled, in a transparent way, into
the UN General Assembly special session on HIV/AIDS").

* Another possible way to participate in person is through
the official delegation of your government (which might not
be subject to the February 1 deadline).

* Also, some nonprofit organizations already have official
status at the United Nations, and your group might be able
to work through them.

* To join the online discussion group at any time, send an
email to: break-the-silence@...

Comment

We have heard unofficially that although the United Nations
session itself is in June, the content is likely to be
mostly set by then, so the most important times for
participation will be earlier, especially February 26 -
March 2, and April 23 - 27, which are informal
consultations for government delegates; these meetings will
take place in New York. Accredited (and possibly other)
civil society organizations might or might not be able to
address the delegates at these consultations. Whether or
not your organization applies by the deadline and is
accredited, if you have information or issues you want
considered at this session, it makes sense to submit them
to the online discussion group as soon as possible, so that
they can be considered at the February 26 - March 2
consultation.

The online discussion group may be the most important way
for civil society to participate. It is certainly the most
accessible.


***** Nevirapine Warning on Post-Exposure Prophylaxis

HIV-negative persons taking antiretrovirals for
postexposure prophylaxis--prevention of infection
immediately after a needlestick or sexual exposure to HIV--
should avoid using nevirapine except in unusual situations,
according to recommendations published in the January 5
MMWR (Morbidity and Mortality Weekly Report) by the U.S.
Centers for Disease Control and Prevention (CDC).
Nevirapine has not been officially recommended for this
use, but physicians have used it because of its rapid
action and success in preventing mother to infant
transmission.

These recommendations do *not* affect use of nevirapine for
preventing mother-to-child transmission, where only a
single dose is used for the mother and the infant. They
also do not affect the use of this drug for treating HIV
infection.

The CDC published the following questions and answers about
the current knowledge of the safety of this drug:

"Occupational Postexposure Prophylaxis

"Q1: What is postexposure prophylaxis? Is it effective?

"A1: Postexposure prophylaxis (PEP) refers to using certain
drugs called antiretrovirals, or a combination of these
drugs, in an attempt to reduce the risk of HIV infection
for health care workers following an exposure to the blood
or body fluids of a patient with HIV. One study of health
care workers who took AZT for PEP after a needlestick
injury found an 81 percent reduction in HIV infection.

"Q2: Does CDC recommend nevirapine for PEP?

"A2: Nevirapine has not been recommended for PEP use and
has previously been associated with instances of serious
skin conditions, liver damage, and death when used for
treating HIV-infected individuals.

"Q3: Should the drug ever be used for PEP? Are there any
situations when the benefits of nevirapine for PEP outweigh
the risks?

"A3: The only possible exception would be if an individual
is exposed to HIV from a patient with known drug resistance
to all other available antiretrovirals. In this case,
consultation with an antiviral expert would be recommended,
and a thorough review of potential risks and benefits would
be necessary. After this review, if the exposed individual
decided to take nevirapine as part of his or her PEP,
she/he would need to be monitored closely for serious side
effects, including those reported in today s MMWR, and the
dose regimen should be followed as recommended by the
manufacturer.

"Q4: What are CDC recommendations regarding the use of PEP?

"A4: PEP is not recommended for all types of occupational
exposures to HIV. Because most occupational exposures do
not lead to HIV infection, the chance of possible serious
side effects (toxicity) from any of the drugs used to
prevent infection may be much greater than the chance of
HIV infection from such exposures. Both risk of infection
and possible side effects of drugs should be carefully
considered when deciding whether to prescribe PEP.
Exposures with a lower infection risk may not be worth the
risk of side effects associated with these drugs.

"For those deciding to take PEP, the US Public Health
Service (USPHS) recommends a four-week course of two drugs
(zidovudine and lamivudine) for most HIV exposures, or
zidovudine and lamivudine plus a protease inhibitor
(indinavir or nelfinavir) for exposures that may pose a
greater risk for transmitting HIV (such as those involving
a larger volume of blood or those involving a source
patient with advanced HIV disease). Differences in side
effects associated with the use of these drugs and the
possibility of drug resistance in the source patient may
influence which drug is selected in a specific situation.

"Determining which drugs and how many drugs to use or when
to change a treatment regimen should be guided by published
recommendations and the judgment of the treating physician.
Whenever possible, consulting an expert with experience in
the use of antiviral drugs is advised, especially if a
recommended drug is not available, if the source patient's
virus is likely to be resistant to one or more recommended
drugs, or if the drugs are poorly tolerated.

"Q5: Are there adverse side effects for the drugs
recommended for PEP?

"A5: All of the antiretroviral drugs for HIV have been
associated with side effects. The most common side effects
include upset stomach (nausea, vomiting, diarrhea),
tiredness, or headache. The few serious side effects that
have been reported in health-care workers using combination
postexposure treatment have included kidney stones,
hepatitis, and suppressed blood cell production. Protease
inhibitors (indinavir and nelfinavir) may interact with
other medicines and cause serious side effects and should
not be used in combination with certain drugs.

"Preventing Perinatal HIV Transmission

"Q1: Given these findings, does CDC still recommend
nevirapine for prevention of perinatal HIV transmission?
How do we know it is safe?

"A1: These findings relate to multiple doses of nevirapine
given as prophylaxis over several weeks and do not apply to
the use of a single dose of nevirapine given to mothers and
infants to prevent perinatal transmission of HIV. Current
USPHS perinatal antiretroviral recommendations include use
of nevirapine as one of the options for HIV-infected
pregnant women presenting in labor who are not tested for
HIV during their pregnancy. Recent UNAIDS/WHO
recommendations, based on both safety and efficacy, include
single-dose nevirapine to mothers and infants as one of the
options for prevention of mother-to-child HIV transmission
in developing countries.

"Treating Advanced HIV Disease

"Q1: Given these findings, does CDC still recommend
nevirapine as an option for treatment of HIV-infected
individuals?

"A1: With regard to treatment of HIV-infected individuals
with advanced disease, physicians should be aware that the
severe hepatotoxicity has been described in patients
receiving nevirapine as part of combination antiretroviral
drug regimens, although this complication appears to be
uncommon. The manufacturer's package insert contains a box
warning about this adverse effect, and current
antiretroviral guidelines list hepatotoxicity as a
potential adverse effect of nevirapine. Physicians should
weigh the potential benefits versus risks when prescribing
nevirapine, as well as all other medications, for HIV-
infected persons.

"Q2: Why does CDC recommend nevirapine for HIV-infected
individuals, but does not recommend the drug for PEP?

"A2: Individuals occupationally exposed to HIV have an
extremely small chance of becoming infected with HIV
without any PEP at all (about one in 300 for a needlestick
or cut exposure to HIV-infected blood). Thus, the risk of
serious side effects, including life-threatening liver
damage, to an otherwise healthy person must be weighed
carefully against the likelihood of the individual becoming
infected. Also, there are many effective alternative drugs
available for PEP.

" A patient with advanced HIV disease often develops
resistance to antiretrovirals and many of these drugs may
no longer be effective in fighting the virus. Thus, the
potential benefits of nevirapine for an infected
individual, for whom there may be no other options, may
outweigh the risk of adverse side effects.

"For Additional Information

"Guidelines for postexposure prophylaxis, the use of
antiretrovirals in HIV-infected adults and adolescents, and
interventions to reduce perinatal HIV transmission can be
found at: http://www.cdc.gov/hiv/treatment.htm "


***** d4T plus ddI: Warning for Pregnant Women

On January 5 the FDA and Bristol Myers Squibb warned
healthcare professionals about cases of lactic acidosis,
which can be fatal, in pregnant women using d4T (Zerit(R))
plus ddI (Videx(R)) as part of a combination regimen. The
FDA "talk paper" is reproduced here; Bristol Myers Squibb
sent a more technical letter to physicians, pharmacists,
and other medical professionals.

"FDA/Bristol Myers Squibb Issues Caution for HIV
Combination Therapy with Zerit and Videx in Pregnant Women

"FDA and Bristol Myers Squibb are warning health care
professionals that pregnant women may be at increased risk
of fatal lactic acidosis when prescribed the combination of
the HIV drugs stavudine (Zerit) and didanosine (Videx or
Videx EC) with other antiretroviral agents.

"Lactic acidosis occurs when cells of the body are unable
to convert food into usable energy. As a result, excess
acid accumulates in the body and vital organs such as the
liver or pancreas may be damaged. Severe lactic acidosis is
an infrequent, but well-described complication of the class
of HIV drugs known as nucleoside analogues. Pancreatitis is
also a well-described complication of Videx and Zerit.

"This new warning follows three reported cases of fatal
lactic acidosis, with or without pancreatitis, that
occurred in pregnant women taking Zerit and Videx in
combination with other drugs used to treat HIV. Two of the
cases were reported from ongoing clinical trials of an
investigational HIV drug, and one was identified through
worldwide post marketing surveillance. In addition FDA has
received several nonfatal reports of lactic acidosis, with
and without pancreatitis, occurring in pregnant women
receiving only Videx and Zerit. Although data have
suggested that women may be at increased risk for the
development of lactic acidosis and liver toxicity, it is
unclear whether pregnancy potentiates these known side
effects.

"On January 5, 2001, Bristol Myers Squibb issued a letter
to alert health care professionals to the potential
increased risk of lactic acidosis and liver damage in
pregnant women treated with the combination of Zerit and
Videx. Bristol Myers Squibb recommends that the combination
of the two drugs should be prescribed for pregnant women
only when the potential benefit clearly outweighs the
potential risk. One situation where the benefit may
outweigh the risk is the use of didanosine plus stavudine
in women who have exhausted other treatment options. The
letter points out that decisions about using the drugs for
pregnant women should be made by health care professionals
experienced in treating HIV infection.

"Because of these reports, the FDA will strengthen the
existing black box warnings to include this new prescribing
information. Women who are prescribed the combination drug
therapy should be closely monitored for clinical or
laboratory signs of lactic acidosis and liver damage. This
syndrome may develop abruptly, and in the absence of
abnormal laboratory values in the weeks preceding its
development. Therefore, it is imperative that healthcare
providers maintain a high index of suspicion when
monitoring these patients. Healthcare providers are
encouraged to report any adverse events related to
stavudine and didanosine to Bristol Myers Squibb Company
(800-426-7644). Reports may be submitted to FDA by
telephone (800-FDA-1088), fax (800-FDA-0178), online at
http://www.fda.gov/medwatch/ or by mail to: MedWatch (HF-2),
Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857."


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