Trials seek to counter resistant HIV virus
Guardian Unlimited Education
Special report: Aids
Sarah Boseley, health editor
Monday March 26, 2001
The UK is to take part in an international trial to find how to com-
bat a possible resurgence of Aids in the west, as resistance grows to
the drugs given people who are HIV-positive.
While HIV/Aids spreads across Africa, complacency has grown in the US
and Europe because of the powerful if expensive medicines that are
But anti-retroviral drugs only suppress the virus; they cannot de-
stroy it or prevent others getting it. Because the virus is prone to
mutate, its resistance to some of the drugs used has steadily grown.
If patients do not rigidly comply with the treatment, taking exact
doses at precise times and sticking to dietary regimes, the virus mu-
tates, the treatment fails, and the patient may become sick.
A combination of three drugs, known as highly active anti-retroviral
therapy or Haart, is the norm. But with growing resistance to the
drugs in the west, a major trial called Optima (options in management
with anti-retrovirals) is to start in the UK, the US and Canada. It
will test whether using a cocktail of five or more drugs is an im-
provement on three. It will further examine whether there is any
benefit in taking a three-month total break from medication, to allow
recovery from side effects and see whether the virus resumes respond-
ing to the original drugs.
There are an estimated 30,000 people infected with HIV in the UK;
each year 2,500 more become HIV positive. Worryingly, it is thought
that between a tenth and a quarter of the latter are being infected
with a drug-resistant form.
"People are getting resistant virus from day one," said Mike Youle,
director of HIV clinical research at the Royal Free centre for HIV
medicine in London, who will be one of the investigators in the
trial. "I've had four in the last two weeks. Lads turn up on my door-
step thinking [the Aids crisis] is all over and they don't have to
worry about HIV, and they are inheriting resistant virus."
Very few now develop drug resistant HIV by not taking drugs properly.
"In the last year or so, things have become better in terms of being
able to take fewer pills and easier dietary requirements." But there
was an atmosphere of denial over drug resistance.
"We are very much in the situation with resistant strains that we
were with HIV in 1991-92, when everybody said it was in America but
not here," said Dr Youle. "Because it is not in our face constantly
that people are ill and dying, there is a belief the treatment will
last forever and there is no risk to the individual from catching
HIV. We are in a honeymoon period and I believe it is an extended
honeymoon period. What I'm concerned about is that people will ac-
quire resistant virus.
"There may be people - and we are already seeing cases of young peo-
ple with multi-drug resistant virus - coming to us sick and not able
to respond to standard combination therapy. It is not something we
can deal with effectively now."
Dr Youle's unit is funded by the medical research council, which is
running the UK end of Optima. Beginning in June, 1,700 patients will
be recruited to the trial, including 400 from the UK.
The difficulties of ensuring people get and take anti-retroviral
drugs properly so that drug-resistant virus does not spread has been
one argument advanced against provision of cheap Aids medicines in
Africa. But simpler forms of the drugs, including pills combining
more than one drug in a single dose, are becoming available. With the
advent of ever larger combinations of more powerful drugs in the
west, the moral pressure on pharmaceutical companies and western gov-
ernments to get at least basic medication to some of the millions who
are dying in Africa will become stronger.
Last week, the World Health Organisation and Unaids - the United Na-
tions organisation fighting the epidemic - met Cipla, the Indian com-
pany that manufactures generics (cheap copies of patented drugs).
They discussed Cipla's offer to provide a three-drug combination to
developing countries at GBP 400 a year per patient (or GBP 230 to
volunteer doctors of Medecins Sans Frontieres). The same combination
would cost GBP 7,000 to GBP 10,000 in the west.
The UN will consider whether to give the offer its approval. Although
Merck and Bristol Myers Squibb have dropped prices of brand-name
drugs to what they say is cost price or lower, they have not yet
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