Belly Chance
Dr Graeme Moyle talks to Robert Fieldhouse about an
exciting new drug for ‘protease paunch’
Most
attention at this year’s Conference on Retroviruses and Opportunistic
Infections (CROI) was on the large number of new HIV drugs on the horizon.
While it’s important we get ‘second-generation’ HIV drugs
it’s also vital we get more drugs to tackle side-effects caused by early
therapies like body fat changes.
If you took an early HAART combo you may have noticed your waist-hip ratio
getting too close for comfort and that you have developed a big belly. Your
doctor may have even mentioned VAT (visceral adipose [fat] tissue - not the
taxman).
In the early days, it was often called Crix belly because many people who
had the syndrome were taking indinavir (Crixivan) although protease inhibitors
may not be the only culprit. Till now there was little that could be done
about it, but now help may be at hand.
A new study in the UK is looking ar a drug called TH9507. The study is looking
at people with well controlled virus whose HIV therapy has left them with
central fat accumulation (a big belly).
How does it work?
TH9507 is a protein that stimulates the body to produce growth hormone naturally
rather than supplementing it with recombinant (man-made) growth hormone.
How does it differ from recombinant growth hormone?
It’s suggested TH9507 is less likely to interfere with your blood glucose
levels because it regulates human growth hormone secretion from the pituitary
gland rather than flooding the body with supplementary growth hormone that
can disrupt glucose regulation.
How much fat could I lose?
Previous studies in people living with HIV have found that it reduced visceral
fat by 20 per cent over six months.
Can a big belly affect my health?
Previous research suggests that if your belly gets bigger due to therapy you
are also more likely to develop ‘metabolic syndrome’, or abnormal
blood fats such as triglycerides and cholesterol. Reducing abdominal fat may
reduce your future risk of developing heart disease.
Any other benefits?
In the study recently presented at CROI, the lipid-lowering effect seen in
people on TH9507 was better than that in many people treated with lipid-lowering
drugs, despite TH9507 not being a lipid-lowering drug. It may also be safely
used by people with impaired glucose metabolism because it appears not to
mess it up .
There are likely to be three or four clinical trial sites in the
UK and the Chelsea and Westminster Hospital is one of them. Director of HIV
Research Strategy, Dr Graeme Moyle, talks about the trial.
RF: What’s involved?
GM: It’s a six-month study followed by a six-month
extension study. People have a 2:1 chance of getting active drug. At the end
of the active treatment period, the placebo group will get the active drug
and the active treatment group will be randomised to continue the treatment
or to stop.
RF: Why is it structured like this?
GM: This is to look at how long the effects persist versus
the effect achieved with maintenance therapy. Effectively everyone will get
therapy over the course of the year; it’s just some will get it sooner
and some will get it in a delayed manner.
RF: Who can take part?
GM: To enter the study you need a big belly but not be generally
fat and have well controlled HIV on treatment.
RF: Do you have to live in London?
GM: Absolutely not. I have people coming from as far as Birmingham.
RF: How can people get more information?
GM: If people are interested they can contact the research
nurses at the Chelsea and Westminster hospital. (chris.higgs@chelwest.nhs.uk)
If the study outcome is favourable, the manufacturer Theratechnologies will
seek approval for TH9507 to be used for the treatment of HIV-associated visceral
fat accumulation. Right now there’s nothing licensed in Europe for fat
gain on HAART, so you may be doing yourself and others a big favour by taking
part.
