Compiled by Robert Fieldhouse with reports from Gus Cairns
Whilst global media attention in recent weeks focused on the New York ‘supervirus’ story, a poster presentation at the Twelfth Retroviruses meeting describing what may be evidence of a man being cured of HIV with HIV therapy, received less media attention. Israeli researchers detailed the case of a man who had received three positive antibody tests for HIV and three viral load tests before he began HAART seven years ago with a high CD4 count (over 850 cells) and low viral load (about 4,000 copies). After three years on therapy he had another HIV test because he was going on a study of treatment interruptions, and this came back negative. He stopped treatment and for the last four years the most sensitive tests have found neither HIV antibodies nor virus in his blood. Studies are ongoing to find if his immune system has genuinely defeated the virus.
A new study has found that switching to either abacavir or tenofovir led to
limb fat gains over 48 weeks, and people treated with tenofovir also saw improvements
in blood fats.
The study led by Dr Graeme Moyle at the Chelsea and Westminster Hospital switched
105 people with lipodystrophy from d4T or AZT to tenofovir or abacavir.
Limb fat gains were similar among those treated with tenofovir or abacavir.
Switchers to tenofovir had gained 393g of limb fat after 48 weeks while those
who switched to abacavir gained 316g.
People treated with tenofovir got fewer side effects and more people had to
discontinue abacavir (15 per cent compared to six per cent of the tenofovir
group).
Six per cent of those treated with abacavir discontinued because of suspected
abacavir hypersensitivity reaction, whereas only one person stopped tenofovir
because of side effects.
Tenofovir’s clear advantage over abacavir was its ability to reduce
lipids. Both total cholesterol and LDL, or ‘bad’ cholesterol fell
with tenofovir but not with abacavir. Triglycerides also fell among those
receiving tenofovir but not with abacavir.
More people on tenofovir got ostepenia – decline in bone mineral loss
less severe than osteoporosis - but these declines were not regarded as clinically
significant.
• Next month PN interviews Dr Graeme Moyle.
European licensing authorities have given the green light to a new version
of the protease inhibitor saquinavir. The drug is now available in 500mg tablets
that can be taken as two tablets twice a day.
As with all protease inhibitors, saquinavir needs to be taken with a boosting
dose of another protease inhibitor, ritonavir.
When saquinavir was first licensed back in 1996, patients needed to take six
tablets three times a day. The drug was first re-formulated in 1998 as a soft
gel capsule but this new version will greatly simplify this protease inhibitor.
“With fewer tablets per day, saquinavir will become an excellent choice
for people living with HIV”, commented Dr Anton Pozniak from the Chelsea
and Westminster Hospital, in London.
“A reduced pill burden will provide patients with a more convenient
regimen of a well-tolerate
d HIV drug and encourage greater adherence,” he added.
The drug should be available in hospitals within the next couple of months.
Being pregnant more than doubles the HIV infection risk in women, a
Ugandan study has found.
The study found an infection rate among pregnant women of 2.7 per cent a year,
compared with 1.1 per cent among other women, suggesting they are more vulnerable
to catching the virus.
Rates of HIV infection among women with regular partners who were HIV positive
was much higher, almost double that in other women; 15 per cent a year in
pregnant women and 8.3 per cent in others.
The study looked at 3,134 pregnant women, 3,031 women who were breastfeeding
and 30,545 others between 1993 and 2003.
Pregnant women were tested when pregnancy was detected and again an average
of four months after giving birth; other women were tested every 10-12 months.
Having ruled out every other explanation for the doubling of the HIV rate
in pregnant women, Dr Ronald Gray, of Johns Hopkins University, said that
further study was needed to find out what raised the risk. Gus Cairns
Three trials in Africa have brought the HIV infection rate among newborn
babies down to below five per cent.
The trials in Ivory Coast, Mozambique and Botswana used various combinations
of AZT, 3TC and nevirapine to push rates down.
The lowest rate was in the Botswana trial which gave AZT to mothers from 34
weeks of pregnancy to delivery, and to the babies from birth to one month.
A single-dose of nevirapine was also given to the mother in labour, and to
the baby immediately after birth. The downside was that 44 per cent of the
mothers developed resistance to nevirapine.
In the French trial, which continued to give AZT/3TC treatment to mums for
three days after birth, nevirapine resistance occurred in just over one per
cent of cases.
Professor Charles Gilks, of the World Health Organisation (WHO), said they
would convene a special meeting to discuss whether to modify guidelines for
the prevention of mother-to-baby transmission of HIV in light of the new data.
Gus Cairns
Pegasys licensed for HIV-hep C co-infection
Pegasys, the pegylated interferon from Roche Pharmaceuticals, has received
European licensing approval for people co-infected with HIV and hepatitis
C.
Previously the drug was licensed solely for the treatment of people only infected
with hepatitis C. Approval followed in quick succession to a ‘Positive
Opinion’ delivered on the drug by the European Medicines Agency.
Approval is based on results of the APRICOT study, first presented in February
2004. This study showed 40 per cent of people co-infected with hepatitis C
and HIV treated with pegylated interferon and ribavirin got a sustained virological
response (SVR) six months after the completion of 48 weeks of treatment. SVR
means that you are most likely cured of hepatitis C.
A third of those with the hardest-to-treat type of hep C (genotype ) treated
with the new ‘pegylated’ interferon and ribavirin were cured six
months after stopping 48 weeks of treatment.
This is compared with one in ten with genotype 1 who were cured after being
treated with standard interferon and ribavirin.
Atazanavir-omeprazole interaction
Bristol Myers-Squibb has warned doctors not to prescribe omeprazole (Prilosec),
a proton pump inhibitor that inhibits gastric
acid secretion alongside its protease inhibitor atazanavir (even when taken
with ritonavir) since combining these drugs results in a dramatic reduction
in atazanavir levels.Further studies are looking at whether other kinds of
gastric acid drugs, specifically H2 blockers, have the same effect. If you
are taking H2 blockers
and atazanavir, current advice is to take them 12 hours apart.
Marijuana may help adherence
A couple of recent studies have shown that marijuana-use reduces levels of
treatment adherence. However, some people living with HIV report that smoking
dope actually improves their ability to stick to treatments. US researchers
enrolled 252 people living with HIV, over two thirds of whom were currently
using HAART. A quarter of those on treatment also used marijuana. Among those
with nausea, marijuana use was shown to improve adherence, whereas other recreational
drugs reduced it.
Entecavir effective in HIV-hepatitis B co-infection
Hepatitis B drug entecavir has been shown to lower hepatitis B viral load
in people co-infected with HIV and hep B.
The drug, which has no anti-HIV activity, has previously been shown to be
superior to treatment with lamivudine in people infected only with hepatitis
B.
Over 24 weeks, a third of people taking entecavir obtained a normal liver
function test. The trial enrolled 68 HBV/HIV co-infected people who were already
taking lamivudine, 88 per cent had already developed some resistance to lamivudine.
Needle-free T-20
Last month we carried a story stating that T-20 (Fuzeon), the first fusion
inhibitor which is currently taken by twice daily injection, may soon be available
needle-free. We would like to clarify that the needle-free device Biojector
is being developed by Bioject Medical Technologies Inc in the USA, not by
Roche Pharmaceuticals who produce T-20. There are no certainties that this
device will be available outside the US, or if it were, what the cost implications
would be. For the forseeable future people using T-20 will need to continue
using the safety syringes in the T-20 packs.
New BHIVA treatment guidelines on TB
Last month the British HIV Association published new guidelines on the treatment
of tuberculosis (TB) in people living with HIV. Publication co-incided with
International TB day. The panel recommended starting daily therapy with four-drugs:
rifampicin, isoniazid, pyrazinamide and ethambutol for at least two months,
followed by four months of pyrazinamide and ethambutol. The guidenlines also
include information on managing interactions between HIV drugs and TB meds.
They advise that people with CD4 counts above 200 should complete their TB
treatment before beginning HAART. The guidelines can be read in full at www.bhiva.org
Pegasys licensed to treat hepatitis B
The European Commission has approved the pegylated interferon Pegasys for
treatment of hepatitis B. In clinical trials, Pegasys has demonstrated its
effectiveness against both forms of the disease: HB e antigen-positive and
HB e antigen-negative chronic hepatitis B, and has demonstrated superior benefits
against the two leading medications used to treat hepatitis B today; lamivudine
and conventional interferon.
These results support the use of Pegasys as first line therapy for chronic
hepatitis B.
