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News Briefs
by Enid Vázquez
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Undetectable
cum?
Eat and walk for lipo
Birth defects
Viramune for pregnancy
Children’s seizures
Babies and ethics
Positive women and kidney problems
AIDS lawyers conference
HPV in men
HIV cocaine
CROI Update
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Undetectable
cum?
Not quite, according to a
report from the Center for AIDS Intervention Research of the
Medical College of Wisconsin, in Milwaukee. They conducted
a study with 44 HIV positive men. Of the guys who were undetectable
based on the standard blood test for viral load, half had
detectable HIV in their semen. This was true no matter what
their disease or treatment history. The report was published
in the December 10th, 2001 issue of AIDS Research and Human
Retroviruses.
Eat
and walk for lipo
No, it’s not a fundraiser.
Once again researchers are reporting that eating right and
exercising may help people with HIV-related lipodystrophy,
a syndrome of body fat and cholesterol changes that’s quite
common. In this report, an “intensive” diet and exercise program
helped a 44-year-old man. He had gained 30 pounds within two
and a half years of HIV therapy (which has been associated
with the changes). The fat on his arms and legs thinned, while
his belly greatly increased and he grew “breasts.” He was
able to lose 14 pounds and lower his cholesterol, plus cut
his visceral fat in half (which sits on the organs beneath
the abdominals) after four months. Visceral fat has been associated
with cardiovascular disease, among other serious illnesses.
Three times a week he did cardiovascular exercise and strength
training for 75 minutes and his daily diet consisted of at
least 25 grams of fiber, 15% protein, 30% fat, with the rest
of his calories from carbohydrates. The report was published
in the February issue of Clinical Infectious Diseases.
Birth
defects
Sustiva is not supposed to
be used by women hoping to become pregnant, because birth
defects were seen in studies with monkeys. Italian doctors
recently reported on birth defects in a baby born to a woman
who had taken Sustiva, in combination with Retrovir and Zerit
(two drugs that are not supposed to be used together because
of antagonistic effects). After her periods stopped and a
pregnancy test came back positive, she was switched to Epivir,
Zerit and Viracept. The baby was born with a large mass outside
its body near the base of its spine and had blockage of its
spinal cord fluid. These conditions can be fatal, but the
mass was successfully removed through surgery and the fluid
drained. Viral load testing found that, thankfully, the child
was negative for HIV. The case was reported in the medical
journal AIDS.
Viramune
for pregnancy
Don’t panic. News that Viramune’s
manufacturer was “pulling it” from consideration for FDA approval
in pregnancy may have given people the wrong impression. The
company was applying for a new “indication” for the HIV med.
An “indication” is what a drug is used for. In this case,
the new indication for Viramune would be to reduce the risk
of HIV transmission from a woman to her newborn. Research
shows the drug is highly effective and safe at doing this,
with only four doses around the time of labor (two for the
mom and two for the child). Those research results are still
valid. But the U.S. Food & Drug Administration (FDA) told
the company that this research was not conducted in the way
it needed to be in order to gain a new indication. Basically,
the paperwork wasn’t completely in order. For example, the
FDA did not find it acceptable that one study submitted for
the new indication used oral consent instead of written consent
for the participants in the trial. However, unnamed FDA officials
told the Washington Post that the issue was more than paperwork,
but wouldn’t comment further. Researchers from Johns Hopkins
University and the National Institute of Allergy and Infectious
Diseases, the organizations that conducted the Ugandan clinical
trial in question, told the Post that safety concerns are
not at issue. An application for the new indication is expected
to be re-submitted in the future after the questions are resolved.
Children’s
seizures
A report in The Lancet
medical journal noted a doubled risk of “febrile seizures”
in children born to mothers who had taken anti-HIV medications,
compared to positive moms who had not. The seizures occurred
with fever (which is what febrile means) between three to
18 months of age. The French researchers looked at 4,426 children.
The vast majority (4,072) were HIV negative. Most of them
(2,644) were exposed to treatment. Thirty children had a febrile
seizure, and 24 of them had been exposed to HIV medications
before, during or after birth. The seizures were little cause
for concern, and usually occurred only once. According to
the report, the longterm effect is unknown, and probably harmless,
but the children’s cognitive (brain) and behavioral development
should be monitored.
Babies
and ethics
Since 1994, the ethics guidelines
of the American Society for Reproductive Medicine have discouraged
fertility treatment for HIV positive people. But this year
the association has issued new ethics guidelines that say
positive people should no longer be dismissed from such services.
The society noted the success of HIV medications in cutting
transmission from mother to child, although the risk is not
down to zero. For positive men with negative women, sperm
washing and testing reduces risk, but more research is needed
in this area, according to the guidelines. Visit www.asrm.org.
Positive
women and kidney problems
Kidney damage or failure
in HIV positive women is most often correlated with having
hepatitis C, being of African descent, or T-cell count below
200. Co-infection with hep C is common among people with HIV.
Looking at the records of 2,057 women enrolled in the Women’s
Interagency HIV Study (WIHS), researchers found that 32% had
proteinuria at their initial evaluation. Protein in the urine
is a sign of kidney damage or disease. Black women had a doubled
risk for proteinuria. As for out-and-out kidney failure, risk
factors included low T-cell counts, falling albumin levels
(check your lab results), viral load above the detectable
level, increasing creatinine levels (see labs), and high blood
pressure, in that order. The findings were published in the
January 2002 issue of Kidney International.
AIDS
lawyers conference
The first-ever national gathering
of lawyers and other advocates involved in the day-to-day
representation of people with HIV is scheduled for May 17-19th
here in Chicago. Keynote speaker Bennett Klein, director of
the AIDS Law Project at Boston’s Gay and Lesbian Advocates
and Defenders, successfully argued the case of Bragdon v.
Abbott before the U.S. Supreme Court in 1998, which led to
the landmark ruling extending full protection of the American
with Disabilities Act to all individuals infected with HIV.
The wide range of topics to be covered include employment
discrimination, debtor-creditor issues, Social Security and
public benefits, insurance, immigration, criminal justice
and women’s issues. For more information, contact Michael
Pates at the American Bar Association’s AIDS Coordinating
Committee, at 1 (202) 662–1025 or e-mail at patesm@staff.abanet.org.
HPV
in men
Of the many types of human
papilloma virus (HPV), HPV-16 has been found to be associated
with half of all cervical cancer cases. The U.S. Centers for
Disease Control and Prevention (CDC) recently reported findings
on HPV-16 in men. Of 83 men who have sex with men (MSM), 38%
were infected with HPV-16, compared to 8% of heterosexual
men and 19% of women. How the infection relates to anal and
reproductive tract cancers is still unknown. The fact finding
continues. HPV rarely has symptoms, although it can cause
genital warts, which are easy to treat. Left untreated, the
infection can lead to infertility as well as to cancer. The
CDC made its report at the National STD Prevention Conference
in San Diego in March. CDC researchers also reported on increasing
rates of sexually transmitted diseases (STDs) among MSM, noting
that, “Together with past indications, these findings continue
to point to the danger of a possible resurgence in the HIV
epidemic in this population and the urgent need for expanded
prevention efforts.”
HIV
cocaine
A study of mice injected
with human cells found that cocaine doubled the number of
cells infected with HIV, and increased viral load by 200 to
300 fold, when compared to placebo (fake drug). Cocaine also
seemed to lower T-cells. How the drug is able to directly
affect the virus is not understood. Researchers said the amount
of cocaine given the mice was comparable to what people would
use. The study by University of California Los Angeles was
reported in the March 1 issue of The Journal of Infectious
Diseases.
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CROI Update
by Enid Vázquez
Some news from the 9th Conference
on Retroviruses and Opportunistic Infections (CROI), held
in February in Seattle.
Liver
transplants
A team of doctors found three
reasons why HIV positive people may die shortly after a liver
transplant: hepatitis C, HIV treatment intolerance and hemophilia.
They looked at 23 HIV positive people from around the world.
Of the seven people who died within a month after their transplant,
all had hep C. This compared to only a little over half of
the survivors (9 out of 16). Another difference was being
able to tolerate HIV medications following the transplant,
whether or not those medications were tolerated before the
operation. Here the difference was more stark: all of the
survivors, but none of the people who died, were able to tolerate
their HIV treatment. Also, hemophilia was associated with
a greater risk of death—five of the seven were hemophiliacs,
compared to only two of the 16 survivors. Survival at the
time of the report ranged from one month to 49 months, with
a median (half below, half above) of 15 months.
Hepatitis
B
The commonly used HIV
drug Epivir (3TC) is also used to treat hepatitis B. With
medications developing resistance after a while (they can
no longer fight off disease), can another hep B drug work
for people who develop Epivir resistance?
A small study of 35 people
co-infected with HIV and hepatitis B found that after a year
and a half, the majority continuously lowered their hep B
viral load when using 10 mg a day of adefovir. None of them
experienced a rise, and four of the people were able to clear
their hep B altogether. However, there were four drop-outs:
two for adverse events (diabetes and insomnia), one for “noncompliance,”
and one for personal reasons. Fibrosis and liver function
tests (ALT) also improved, along with liver inflammation in
14 people given biopsies. This study was conducted by adefovir’s
manufacturer, Gilead Sciences, and a hospital in Paris. One
HIV specialist said doctors will be saving adefovir for use
in people who are HIV negative.
Adefovir is an experimental
drug. It had earlier been tested for HIV therapy, but was
dropped when it became the first HIV med to fail to win FDA
approval. Kidney damage was associated with the drug, but
none was found in this study. The researchers noted that Epivir
resistance is found in 90% of the people who’ve used it for
four years. Epivir is also part of two other HIV drugs: Combivir
(Retrovir, Epivir) and Trizivir (Retrovir, Epivir, Ziagen).
More
hepatitis B
Gilead Sciences also makes
Viread (tenofovir), an HIV drug (the newest on the market)
that can also fight hepatitis B. In another study of co-infected
people, researchers found that Viread lowered hepatitis B
viral load, even in those who had developed drug resistance
to Epivir. Researchers looked at the 14 co-infected participants
in a Viread clinical trial. Twelve were given Viread and two
received placebo (fake medication). All of them had taken
Epivir at some point, and six remained on Epivir during the
study. Liver enzymes (ALT) normalized in two Viread patients,
and the hep cleared in another. Meanwhile, the hepatitis B
viral load increased in the two placebo participants. The
preliminary results came from 24 weeks of study. The report
noted that Epivir resistance occurs in approximately 15 to
32% of people taking it for one year.
Newborns
and lactic acidemia
We know that HIV medications
in pregnant women help reduce transmission of the virus to
the baby, and is quite safe, but the search for abnormalities
is still necessary. Here doctors looked at 25 HIV negative
infants whose moms used HAART (highly active anti-retroviral
therapy) during pregnancy. They found that 92% of the infants
(23 of them) had abnormally high levels of lactic acid, which
were normal by the time they reached six months of age. These
children had also received some Retrovir treatment (zidovudine,
AZT) after birth to prevent infection. Half of the infants
had also been exposed to cocaine, heroin or methadone in the
womb. Most of the mothers themselves (17) had normal lactate
levels by the end of their pregnancy.
The researchers looked at
lactic acid because of abnormal levels found in HIV positive
adults on therapy. Scientists are speculating that the nucleoside
analogs in particular (Retrovir, Zerit, Videx, Epivir, Ziagen,
Hivid, etc.) may be causing damage to the mitochrondria. These
are “powerplants” that live in our cells, converting oxygen,
fat and sugar into energy. It’s believed that mitochondrial
toxicity in adults is causing lactic acidemia, which in serious
cases can lead to death. However, these researchers noted
that as with adults, it’s unclear what effect the abnormal
levels of lactic acid had on the children.
TMC-125
If Sustiva or Viramune are
no longer guarding the body against HIV, there’s a promising
non-nucleoside analog on the horizon. The potential of TMC-125
is that it may work when the other two drugs fail. That’s
an option that’s needed in HIV therapy.
It’s known that low-level
drug resistance to one of the two older drugs will also lessen
the chance of the other one working. As reported before, TMC-125
seems to work in people who have developed resistance to the
two oldies. In this small study, 16 men substituted their
Sustiva or Viramune for 900 mg of TMC-125, taken twice a day
for one week. These guys already had high-level resistance
to the non-nukes, plus resistance mutations to protease inhibitors
and nucleoside analogs. At the end of the week, almost half
of them had a very significant drop in their viral load of
one log. Also, 75% of them had at least a half-log drop in
viral load, the smallest drop that can be considered a significant
benefit .
Other TMC-125 researchers
noted that TMC-125 by itself dropped people’s viral load as
much as a five-drug combination, again, after one week on
medication. These people were all taking HIV medication for
the first time, when treatment tends to have the best results.
The researchers compared the results of 12 people on TMC-125
with those of 13 people on the five-drug combo (Retrovir,
Epivir, Ziagen [probably taken as Trizivir, one tablet twice
a day], Viramune and Crixivan). The monotherapy group had
a median viral load drop of 1.8 logs compared to a 1.55 log
drop in the combo group. Bottom line: it’s a potent drug.
Changes in T-cells were not statistically significant. There
was a rise in both groups.
DPC–083
Like TMC-125, DPC-083 is
an experimental non-nucleoside that may work when the older
non-nukes no longer can. It’s made by the same company that
manufactures Sustiva, and is considered a “second-generation”
drug. The company switched failing Sustiva or Viramune with
DPC-083 in 51 people. These people had extensive non-nucleoside
resistance. Still, after eight weeks (not enough time to show
durability, but enough to show potential) the majority of
the participants (57%) had less than 400 viral load. They
had all started out with more than 1,000—which is still pretty
low. However, a goal of HIV is to have viral load below the
level of detection (400 or 50, using an ultra sensitive test).
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