From April 2011,
the preferred first- and second-line drug regimens for HIV-positive people in London are changing. The
change in prescribing practice will not initially affect people on current regimens
but will be applied to new patients and to those who need to change to a
second-line protease inhibitor-based regimen.
The two primary
changes are:
- The preferred
first-line regimen will change from tenofovir + FTC + efavirenz to abacavir +
3TC + efavirenz. What this means in practice is that, instead of taking one pill
a day (the combination pill Atripla),
most new patients will take two (Kivexa
[3TC + abacavir] plus Sustiva
[efavirenz]).
- If patients
have to start on or switch to a protease inhibitor (PI)-based regimen, the PI
initially prescribed will be atazanavir (Reyataz).
Some patients taking ‘old-fashioned’ PIs may be offered a change to atazanavir.
These changes
are due to a new two-year purchasing agreement between the London HIV Consortium
(LHC) and the drug companies. The LHC represents the majority of London’s hospital and primary care trusts and, since 47%
of people with HIV accessing care in England
live in London,
has considerable negotiating power when it comes to the prices paid for drugs.
Although a
maximum ‘list price’ is set by each country for drugs licensed in Europe, an
aspect of HIV care that gets little scrutiny is that NHS bodies – ranging from
individual trusts to large consortia like the LHC – negotiate their own deals with
each drug supplier. The LHC has managed over the years, due to its economic
position, to pay about 25% below list price for antiretrovirals.
This year,
however, primary care trusts in London
told the LHC and HIV prescribers that their budget would not grow this year.
This meant that hospitals needed to save £9 million on drugs in order to
accommodate other HIV patient and clinic costs and not to lose services.
This excluded other cost-saving measures like home
delivery (which is cheaper because it does not attract VAT). Although the
overall HIV spend has not been cut, the number of patients continues to
increase, (a 5.3% increase in 2009 in London),
and thus the amount spent on drugs had to come down.
Although in
terms of cost per lives saved, HIV treatment is a cost-effective intervention,
its sheer cost to the NHS these days is staggering: with a higher HIV
prevalence than the rest of the country, 19% of the entire London NHS drugs
budget in 2009 was spent on antiretrovirals, and 29% of the budget for
specialist conditions.
The changes are
based on current clinical practice and no patient will be forced to take a drug
with significant side-effects or which is detrimental to their quality of life.
They are also in accordance with the most recent treatment guidelines issued by
the British HIV Association (BHIVA),1 although these guidelines are
now three years old (new ones are planned for later this year).
They are,
however, bound to cause some controversy. The biggest area of concern surrounds
the use of abacavir and conflicting evidence about an increased risk of heart
attack.2,3,4,5 The difference may be due to the fact that large
cohort studies like D:A:D may miss a factor that impacted on both health and
choice of drug regimen.
There is also some
evidence – again disputed – that abacavir may not be as potent as tenofovir in
suppressing HIV in patients with a high viral load (see News in Brief).6,7
Because of these
concerns, tenofovir instead of abacavir will be prescribed to patients with a
viral load over 100,000 copies/ml or with a high heart attack risk score.
Does having to
take two pills a day impact on adherence or health? One study last year found a
difference between one- and two-pill regimens, but this has not been found in other
studies.8
Atazanavir does
not raise blood lipids (fats) as much as other protease inhibitors and is taken
as one capsule, once a day. It has been linked to kidney stones in a few
patients and can cause a harmless but sometimes marked form of jaundice;
darunavir (Prezista) is recommended
as the alternative for people who cannot tolerate atazanavir or have resistance
to it.
The purchasing
agreement has been signed by London’s
lead HIV consultants and holds until April 2013. It can be changed if new
clinical evidence comes along that changes prescription guidelines, but it
cannot now be altered if a company makes a new price offer.
The LHC, and its
parent body the London Specialised Commissioning Group, can withhold all or
part of the HIV drugs budget from any clinic seen to fail to achieve the cost
savings expected, though commissioners stressed that this was a "final
resort", and would be seeking to work in partnership with clinics to meet
the requirements of the agreement.
For more
information on these prescribing changes, see: http://i-base.info/home/changes-to-hiv-drug-prescribing-in-london/.