Robert Fieldhouse reports from - the Third International
Aids Society Conference, Rio de Janeiro
New and improved lopinavir on the way
A new tablet version of the protease inhibitor lopinavir-ritonavir (Kaletra),
with fewer side effects, will become more widely available in the UK within
the next year. The new formulation can be taken with or without food, requires
no refrigeration and entails taking four pills rather than six. It should
be ready for license in Europe early next year.Drug levels of the new Meltrex
tablet were consistently higher than those seen with the current orange capsules,
a study in 141 HIV negative volunteers found. Yet side effects were actually
lower than those commonly reported with the old capsule; diarrhoea in particular
was less frequent. Meanwhile, the longest ever follow-up in a clinical trial
of people receiving lopinavir-ritonavir showed continued benefit to the therapy
after six years. Of 100 people living with HIV who started therapy with the
nucleoside analogues d4T, 3TC and the protease inhibitor lopinavir-ritonavir,
63 remained on the same therapy six years later. All but one had maintained
a viral load below 50 copies. The average CD4 rise over the six year period
was 528 cells.
WePe16.7B04, WeOa0206*
Can efavirenz be
taken in the morning?
A
new study suggests some people who find taking efavirenz (Sustiva) at night
difficult because of side effects, may be able to switch to morning dosing.
The NNRTI efavirenz is a once-daily pill usually taken in the evening as it
can cause a range of central nervous system side effects such as tiredness
or dizziness. A group of 49 people with HIV taking efavirenz once a day at
night for at least one month were recruited to switch to morning dosing. After
four weeks, participants chose if they wanted to continue taking efavirenz
in the morning or return to evening dosing. Half wanted to change back, citing
reasons such as feeling dizzy, ‘drunk’ or unable to concentrate
during the day. Half coped well with morning dosing and reported sleeping
better, having fewer strange dreams and finding it easier to remember to take
the pills in the morning. Morning dosing of efavirenz may be particularly
attractive for people whose other tablets are taken once-daily. If sleep disturbance
is an issue for you with efavirenz, discuss morning dosing with your doctor.
WePe12.3C03*
Growth hormone may
boost CD4 count
Treatment with a man-made human growth hormone may increase key immune
cells, even among people whose CD4 counts have failed to rise significantly
with antiretroviral drugs (HAART). Human growth hormone has been shown to
increase overall weight and lean body mass in people with HIV-related wasting.But
a new study suggests it can also boost the CD4 T-cells that co-ordinate the
immune system.Researchers recruited 60 people with HIV who had been on HAART
for at least one year. Trial participants had an undetectable viral load,
but their CD4 counts had failed to rise above 350 cells.
Half the group took a 1.5mg human growth hormone injection daily for 48 weeks,
while the other half received only HAART for 24 weeks but then injected 3mg
of the growth hormone daily from weeks 24 until 48. Both groups saw similar
overall increases in CD4 cell counts (over 50 cells over the 48 weeks) but
the group taking the lower dose required treatment for longer. The thymus
(where T-cells are produced) increased in size in 14 people taking the hormone.
It is still unknown whether these positive effects continue after human growth
hormone is discontinued.
TuOa0203*
Acupuncture reduces
digestive side effects
A small study in people living with HIV currently taking HAART has suggested
that acupuncture may reduce side effects such as nausea, vomiting, loss of
appetite and weight as well as bowel disturbances. Previous studies have shown
the benefits of acupuncture to reduce digestive side effects of medications
used in cancer chemotherapy or anaesthesia. Side effects are a major barrier
to consistent treatment taking.
In total, 52 participants were treated with acupuncture at four symptom-specific
sites for three weeks and then at four nearby comparison points for a further
three weeks. Participants had to keep a daily diary to record their treatment
adherence and the symptoms they were experiencing.
Acupuncture treatment at the specific sites was more effective at reducing
bloating, flatulence, abdominal cramps and improving loss of appetite and
weight loss. Additionally, people who had previously reported less than optimal
adherence reported improvements over the course of the study. The acupuncture
treatment was well tolerated and a larger study is planned to see if these
findings can be confirmed in a larger, more diverse population of people
living with HIV. WePe8.2C01*
Restylane SubQ for
facial wasting
A
study has reported benefits to using a non-animal stabilized hyaluronic acid
(NASHA) product called Restylane SubQ for the treatment of facial wasting
among people with HIV. It contains larger granules than previous NASHA products
and can be injected in larger amounts and into deeper skin layers. Ten white
men living with HIV were included in the small study; six had a second treatment
after four weeks. The effects of Restylane were measured by ultrasound. After
six weeks all participants classified their appearance as very much improved
or moderately approved, though three patients reported visible lumps under
the skin and one experienced a reactivation of facial herpes zoster. Lumps
occurred less frequently when less than 2ml gel was injected. TuPe2.4CO2*
Cholesterol linked
to erection dysfunction
US
researchers have conducted the first research among men living with HIV to
evaluate the possible link between elevated cholesterol levels, the use of
cholesterol-lowering drugs and erectile dysfunction.
Just under a third of 196 men with HIV (28.5 per cent) reported erectile dysfunction,
while 56 per cent had abnormal lipid levels, 35 per cent had high total cholesterol,
28 per cent high LDL or ‘bad’ cholesterol and 36 per cent low
HDL or ‘good’ cholesterol. In addition, 47 per cent had elevated
triglycerides. One in five was using lipid-lowering drugs. Researchers found
that each five year increase in age elevated the risk of erectile dysfunction,
while each 5mg increase in HDL ‘good’ cholesterol decreased the
risk. Clearly, strategies that increase HDL cholesterol may help to delay
the development of erectile dysfunction among men with HIV. TuPe2.5C01*
Tipranavir approval
in Europe this autumn
The experimental protease inhibitor tipranavir took one step closer to approval
last month, when it received a ‘positive opinion’ from the Committee
for Medicinal Products for Human Use in London.
This is seen as a recommendation to the European Commission that approval
should be granted, most likely in the autumn. The new drug will be indicated
for highly pre-treated adults with virus resistant to multiple protease inhibitors.
In this group, tipranavir boosted with ritonavir provides superior viral load
reduction and CD4 cell count increase compared with the protease inhibitors
currently available. The best results were achieved in people who used tipranavir
together with the fusion inhibitor T-20. 
“The increasing prevalence of HIV drug resistance underlines the need
for medications like tipranavir that help patients who have become resistant
to current treatment options,” said Professor Adriano Lazzarin of the
Clinic of Infectious Diseases, San Raffaele Vita-Salute University, Milan,
Italy.
“These data provide additional evidence that tipranavir is an effective
and much needed
HIV therapy,” he concluded.
WePe6.3C07*
Superior response
to tenofovir at 48 weeks
People with HIV starting therapy with tenofovir, FTC and efavirenz
are more likely to still be on treatment with an undetectable viral load at
48 weeks than those who start with Combivir and efavirenz, according to a
new study. Side effects of Combivir were the main reason people discontinued
treatment in the first year. Researchers also found that people who received
tenofovir, FTC and efavirenz were less likely to
develop limb fat loss and blood fat increases. CD4 counts rose by an average
of 190 cells among those treated with the tenofovir
combination. WeOa0202*
Facial fat begins
to return after drug switch
New
data from the UK-based RAVE study, in which people receiving d4T or AZT who
had experienced body fat loss and switched to tenofovir or abacavir, demonstrates
that lost facial fat begins to return in the first 48 weeks after switching.
Forty-seven people with HIV who had experienced facial fat loss had 3-D facial
laser scans as they switched their meds and then 48 weeks later. Areas over
the forehead and cheeks were compared at these two time points. The majority
of participants were white men in their early 40s who had been taking therapy
for an average of three years. Around 85 per cent had self-identified facial
fat loss.
Researchers identified a significant link between limb fat gain and the restoration
of facial cheek volume. A similar rate of facial fat restoration occurred
in people who switched to either tenofovir or abacavir.
medical notes
Resistant HIV no more virulent
People who are infected with a resistant strain of HIV appear no more likely
to progress rapidly to Aids than those who acquire fully drug-sensitive virus,
according to a new study that collates information on drug resistance from
18 countries across Europe. Seventy-eight people with a drug-resistant HIV
strain were compared to people with drug-sensitive virus. CD4 and viral load
in both groups were similar at the outset and researchers failed to show any
greater disease progression over 18 months among those with resistant virus.
WeOaLB0101*
Trial shows link to protective effect of circumcision
A trial looking at the protective effects of circumcision proved so convincing
it was halted to offer male participants the chance to be circumcised. The
first controlled trial of circumcision among young South Africans showed a
65 per cent reduction in the rate of heterosexual acquisition of HIV. Researchers
recruited over 3,000 healthy 18-to-24-year-old men from Orange Farm, where
31.6 per cent of the population are HIV positive. The men were randomised
to have their foreskin removed or to remain uncircumcised and were followed
up at three, 12, and 21 months. During visits, participants were counselled
about condom use and safer sexual practices and tested for HIV. In the uncircumcised
group 51 men became HIV positive during the follow-up, compared with 18 of
the circumcised men. Longer-term follow up will help determine if the protective
effect is maintained.
TuOa0402*
Sexual dysfunction common among HIV positive women
Research carried out at London’s St Mary’s hospital has found
high rates of sexual dysfunction among women with HIV. Thirty four women were
included in the study, 30 of them of black African origin. Over half (56 per
cent) reported sexual problems in the previous 12 months, including lack of
desire, pelvic pain, lack of orgasm, fear of sex and bacterial vaginosis.
Just under half (47 per cent) were not satisfied with the sex they were having,
expressing a bitterness towards men and being fearful of aggression from their
partners as well as disclosing their HIV status. MoPe10.7P01*
Anxiety decreases once HIV therapy begins
Brazilian researchers have assessed anxiety and depression among 296 people
living with HIV shortly before and four months after they started HAART. Whereas
over one third (38 per cent) reported anxiety before starting therapy, only
one in five (20 per cent) reported it four months after. Women and people
diagnosed for longer, as well as those who expressed disbelief at their diagnosis,
were more likely to be anxious before starting therapy. Rates of depression
did not change over the first four months of treatment, with 20 per cent of
participants at the start, and again at month four, reporting feeling depressed.
Again, women, people who were on a low income, in poor housing, and lacking
sexual partners and confidence were more likely to be depressed.
WEPe12.7C18*
One year trial into response to Kivexa/efavirenz
A new trial of the recently licensed fixed-dose combination of abacavir and
3TC (Kivexa) taken once daily with efavirenz has shown that 71 per cent of
patients attained a viral load below 50 copies at 48 weeks. In total, 169
people who were taking HIV therapy for the first time received this simple,
well tolerated combo. The average CD4 rise over 48 weeks was 130 cells. Suspected
abacavir hypersensitivity reaction occurred in 10 per cent (17/169) of individuals,
but only 11 people discontinued the drug because of it. WePe12.2C23*
Investigational NNRTI shows promise for treatment-experienced patients
Larger clinical trials of new NNRTI Reverset will begin recruiting later this
year after better than expected results in people who have already used drugs
from the NNRTI class. A six-month study to identify the optimal safe dose
of Reverset concluded 200mg proved the most potent; 54 per cent of treatment-experienced
patients taking this dose experienced a 90 per cent reduction in their viral
load after four months of therapy.
WeOaLB0103*
Get your thyroid tested if you are on HAART
Researchers from London’s Chelsea and Westminster Hospital have found
increased rates of over-active thyroid among people treated with protease
inhibitors and under-active thyroid among people treated with NNRTIs. They
recommend people on HAART get their thyroid function tested routinely.
TuPe2.3C09*
