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News Briefs
by Enid Vázquez
New Ziagen
warning
Ziagen
hypersensitivity
7th Conference on
Retrovirusesand Opportunistic Infections
Oral sex
CMV pills
Fewer deaths
Superinfection
Camps for kids
Treatment interruptions
St. John’s wort decreases
blood levels of HIV drugs
Effect of drugs on
infants
Anti-HIV drugs
= more risky business
San Francisco PEP
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New
Ziagen warning
How a cough can kill you:
when it’s part of an allergic reaction to the HIV med
Ziagen (abacavir). The Food and Drug Administration (FDA)
recently added respiratory problems such as cough, sore throat
and difficulty breathing to the warning on Ziagen’s label
(see the package insert—that folded up paper with the
small type). These symptoms are now recognized as signs that
a person may be having a hypersensitivity (allergic) reaction
to the drug. According to the FDA, “Deaths have been
reported in patients receiving Ziagen who were initially diagnosed
with an acute respiratory disease (pneumonia, bronchitis,
or flu-like illness) and who were later recognized to have
had a hypersensitivity reaction to abacavir that included
respiratory symptoms.” Ziagen manufacturer Glaxo Wellcome
reported that 11 deaths have occurred out of 1,000 people
who experienced hypersensitivity. More than 60,000 people
have taken the drug, the company reported.
The respiratory symptoms occurred
in one out of five people experiencing hypersensitivity (about
6% of all people on the drug). If hypersensitivity occurs,
Ziagen must be stopped permanently. Attempts to go back on
the drug (called “rechallenging”) lead to severe
illness and could cause death. Symptoms return within hours
and are more severe. Looking at 112 people who were re-challenged,
dangerously low blood pressure occurred in 24% and abnormally
fast heartbeat (tachycardia) occurred in 11%.
The most common signs
of Ziagen hypersensitivity are fever, malaise (discomfort,
as with the flu), rash, fatigue, and gastrointestinal problems
such as nausea, vomiting, diarrhea or stomach pain. As seen
from the FDA statement, misdiagnosis may occur. According
to Dr. Seth Hetherington, head of clinical research for Ziagen,
“The golden rule is: if you can’t tell the difference
between an acute illness and a hypersensitivity reaction,
you have to stop abacavir.” (See “Ziagen hypersensitivity”
below.)
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Ziagen
hypersensitivity
A review of hypersensitivity
(allergic reaction) to Ziagen (abacavir) by the drug’s
manufacturer noted that there were 1,015 cases among the 26,769
people taking it during studies or expanded access (before
it became available in pharmacies). More than 98% of people
had at least fever and/or rash, but 30% did not have rash
at all. Symptoms became more severe over several days. Early
symptoms tend to include fever, gastrointestinal problems
(such as stomach pain or diarrhea ?), or malaise (overall
feeling of discomfort, as with the flu). Rash was more common
later on. (See "New Ziagen warning"elsewhere
in News Briefs.) To report hypersensitivity cases, call the
manufacturer at (800) 270—0425 or the Food and Drug Administration
(FDA) at Medwatch, (800) 532–4440.
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7th
Conference on Retroviruses and Opportunistic Infections
This major HIV/AIDS conference
took place in San Francisco January 29-February 2. Some highlights
follow. Visit www.retrovirus.com for complete information.
Also see www.medscape.com,
www.thebody.com
and www.HIVandHepatitis.com
for summaries (in addition to other HIV magazines and newsletters).
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Oral
sex
New information on
oral sex drove people wild at the Retrovirus Conference. Basically,
researchers noted a higher than expected risk of HIV from
unprotected oral sex on a man–7.8%. However, critics
noted that people tend to lie about their risk factors. Then
again, the researchers said they eliminated lying and other
problems as much as possible. Moreover, they believe that
because people think oral sex has little or no risk of HIV,
they engage in it more often, thereby increasing their risk
through sheer number of contacts. Bottom line: unprotected
oral sex has always been a risk, but always much lower than
unprotected anal or vaginal sex.
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CMV
pills
French researchers urged
the U.S. Public Health Service (PHS) to change its guidelines
on opportunistic infections—those diseases that attack
when the immune system is weakened. The guidelines say that
prevention drugs for cytomegalovirus (CMV) can be stopped
for people whose T-cells go back above 200 for at least six
months—if they never had CMV. But for people who have
had an episode of CMV, it wasn’t sure whether or not
they could stop taking drugs used to prevent a second episode.
Therefore, now French doctors say that a review of an adequately
large number of people from European HIV studies show that
yes, these people too can stop taking prophylaxis for CMV.
CMV is a serious complication of AIDS often leading to loss
of vision, blindness or death. It occurs more commonly at
T-cell counts under 50.
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Fewer
deaths
Once again, fewer deaths
were found among people with HIV taking HAART (highly active
antiretroviral therapy). But French researchers noted that
mortality was still 8.7 times higher than in the general population.
Among people with HIV, women had a higher mortality rate.
There were also deaths from causes other than complications
of AIDS. Moreover, there were deaths in people who had undetectable
viral load (the level of HIV in their blood).
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Superinfection
It’s finally been documented:
two people with HIV can pass on a new HIV strain to each other.
So-called "superinfection" (from "super"
meaning one on top of the other, as in "superimpose")
was shown in this case because both men attended the same
medical clinic in Ottawa, Canada, so that blood samples could
be compared.
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Camps
for kids
The Lutheran Social Services
of the National Capital Area (LSS) seeks donations for a camp
for children with HIV who live in the D.C. area. The camp
will be run by Project Safe Haven, a non-profit organization
dedicated to improving the social well-being of children and
youth living with the virus, or affected by it. Donations
can be sent to Office of Stewardship, Lutheran Social Services,
4406 Georgia Avenue, NW, Washington, DC 20011. For more information,
call Danielle Walter at LSS, (202) 723—3000 ext. 291.
Camp Safe Haven operates a one-week camp in Martha’s
Vineyard every April, as well as other camps, mostly throughout
the East Coast. Call (508) 693-1767, write P.O. Box 24, Vineyard
Haven, MA 02568 or visit www.charityweb.net/safehaven.
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Treatment
interruptions
What used to be "stop-and-go"
therapy is now called "strategic treatment interruption,"
or STI, to emphasize the need to be careful. The strategy
arose primarily from information about the Berlin patient.
This man started therapy early in infection, then had to stop
for several weeks. He went back on treatment, but again had
to stop after a few weeks. Afterwards, he never again had
detectable viral load (HIV in the blood), despite never again
taking antiviral drugs. Can HIV drugs be used off-and-on as
a sort of vaccine against the virus? More studies are needed—don't
try this at home! Reseachers emphasize the need to use STI
under controlled, closely monitored studies only.
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St.
John's wort decreases blood levels of HIV drugs
The Food and Drug Administration
(FDA) in February issued a warning that St. John’s wort
has been found to lower blood levels of Crixivan (indinavir)
HIV protease inhibitor, and probably, therefore, other protease
inhibitors (Agenerase, saquinavir, Norvir, and Viracept) as
well as non-nucleoside reverse transcriptase inhibitors (Rescriptor,
Sustiva, and Viramune). The herb is used to relieve depression.
It should not be used by people taking any of these HIV medications
because it may cause the drugs to be ineffective.
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Effect
of drugs on infants
One study found that uninfected
children of HIV-positive moms still suffered some damage to
their immune systems. However, this may be because they were
effectively able to fight off HIV, which hurt their immune
cells in the process. The findings came from 19 infants who
had all been exposed to AZT to prevent infection and 42 older
children who had not been exposed to AZT (their average age
was around seven).
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Anti-HIV
drugs = more risky business
A study by the U.S. Centers
for Disease Control (CDC) and the University of California-San
Francisco found that people who believe HIV drugs can control
the virus are more likely to take greater risks of infection.
Comparing different risk groups, researchers found that 40%
of injection drug users were less concerned about becoming
infected, compared to 30% of heterosexuals who had attended
a clinic for treatment of sexually transmitted diseases (a
higher risk group than those not in need of STD services)
and 25% of MSM (men who have sex with men—thus called
to include men who do not identify as gay). For those same
groups, the percentage of people who reported being "less
careful" were 25%, 15% and 13%, respectively. The report
also noted that, "Of the 71% of MSM who had recent non-primary
partners, more of those who reported being less concerned
[about infection] had engaged in unprotected receptive anal
intercourse (65% vs. 41%), as had those who reported being
less careful (71% vs. 29%)." The researchers concluded
that "prevention programs should consider balancing risk
reduction and treatment information with improved knowledge
of the uncertainties of the long-term success of HAART [highly
active antiretroviral therapy]." Added the CDC in a press
release, "Many may not realize the complexity and toxicity
of these regimens." The results came from more than 600
people in each of the three groups. Overall—combining
the three risk groups—31% were less concerned about infection
and 17% (almost one in five people) were less careful about
sex or drug use.
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San
Francisco PEP
That’s post-exposure
prophylaxis, also known as “the morning after pill”
for HIV. (In reality, it’s usually many pills for many
weeks). The still often controversial program saw 401 people
in its first 16 months. One concern before the program started
was that the “worried well” would clog it up. These
are people who seek attention (sometimes obsessively) even
though they’re at low risk. Instead, PEP users tended
to have high risk. For example, 57% of gay men who entered
the program had had unprotected receptive anal sex. There
was an average of 33 hours between exposure and starting PEP—animal
studies suggest that PEP should begin within 36 hours. Most
people (88%) were given Combivir for 28 days. Combivir is
a combination of Retrovir (AZT) and Epivir (3TC), taken as
one tablet twice a day. The simplified regimen was completed
by 78% of participants.
There were no seroconversions
to HIV, but researchers stressed that the program cannot be
expected to reduce the rate of transmission in San Francisco,
estimated at 500 new infections a year. The program’s
main benefit, they say, is lowering future risk for participants,
thanks to appropriate counseling. A total of 12% of participants
came back for a second PEP within six months. The vast majority
of participants were unlikely to have multiple sex partners
and did not use the program as a way to have unsafe sex.
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