Medical Research Council Press Release
MRC 59/09
EMBARGOED UNTIL 00.001 (GMT)
WEDNESDAY, 9 DECEMBER 2009
Thousands more could be treated for
HIV in Africa if expensive routine lab tests are
dropped.
A third more people could be successfully
treated for HIV in Africa if expensive lab tests, routinely used
for monitoring side effects, are abandoned, according to the
‘Development of Anti-Retroviral Therapy in Africa (DART)’
clinical trial funded by the Medical Research Council. A
video about this study can be viewed on
the MRC
You Tube channel.
Anti-retroviral treatment (ART) is the main
type of treatment for HIV or AIDS and involves patients taking
drugs every day for the rest of their lives. It is not a cure, but
it can stop people from becoming ill for many years. The aim of ART
is to keep the amount of HIV in the body at a low level. This helps
to stop any weakening of the immune system and allows it to recover
from any damage that HIV might have caused already.
In the biggest trial of HIV therapy to date in
Africa,
published today in The Lancet, 3,316 people who had not
previously had ART took part. All had severe or advanced HIV
infection and had been assessed for ART eligibility using clinical
staging and laboratory tests including CD4 cell count (a measure of
how well the body’s immune system, which is damaged by HIV, is
working). The trial began six years ago in Uganda and Zimbabwe when
treatment for people with HIV was starting to become more widely
available. The report concluded that ART can be delivered safely,
without routine laboratory monitoring for toxic effects, but
differences in the progression of the disease suggested monitoring
CD4-cell count from the second year of treatment. The survival rate
in the DART trial is amongst the best reported from any trial, ART
programme or study in Africa.
Professor Diana Gibb, co-principal
investigator of the study from the Medical Research Council
said:
‘‘The survival of people who took part in the
trial was remarkable; without treatment only about 10% of
HIV-infected African people like those in DART would be expected to
survive for five years. In DART, 87% of those receiving treatment
without routine blood test monitoring were still alive and well
after five years, only 3 percentage points less than in the group
that had routine blood test monitoring. For health policy-makers in
Africa, DART provides evidence that more people could be treated
for the same amount of money by not using routine laboratory tests.
This would substantially reduce the number of people dying with
serious disease due to HIV infection.’’
Dr P Mugenyi from co-principal investigator
the Joint Clinical Research Centre (JCRC) in Uganda said:
“At least 5 million people still need ART
treatment urgently and we know resources are limited. DART
results suggest ART can be delivered safely and effectively by
trained and supervised health workers in remote communities where
routine laboratory services are not available.
Professor James Hakim co-principal
investigator from Zimbabwe University said;
“The evidence from the DART trial will be of
value to low income or resource poor countries that are
prioritising ART access over investment in expensive laboratory
facilities.”
Professor Heiner Grosskurth, co-investigator
from the MRC/Uganda Virus Research Institute Uganda Research Unit
on AIDS, Entebbe said:
‘‘The DART trial is an example of how working
in partnership can deliver excellent results by sharing expertise
and resources. Along the way, this collaboration between
publically-funded researchers and industry has also helped to
develop research capacity in Africa.’’
Co-principal investigator Professor Charles
Gilks of Imperial College London and now UNAIDS, noted that:
“DART has been a landmark trial in Africa in
many ways, not only in the numbers involved and its length, but for
the way the patient communities were involved and engaged.”
DART participants were randomly allocated to
one of two groups. In one group doctors were given results of
regular 3-monthly blood tests to check for ART drug side-effects
and measure the CD4 cell count. The second group had the same ART
and regular blood tests, but results of safety tests were only
given to doctors if they were seriously abnormal and CD4 counts
were never seen. People in both groups received free medical care
and diagnostic tests for any illness throughout the trial.
The results show that 90% of people having
routine lab tests were alive after five years compared to 87% in
the group having tests only if clinically needed. 78% and 72% of
people in the two groups respectively developed no new AIDS
illnesses. These differences appeared to be the result of earlier
switching to a different combination of ART in the lab-monitoring
group. No difference in the occurrence of side effects caused
by ART was found between the two groups.
See also:
Lancet comment, BBC,
DART
film,
Independent, Aidsmap.
Ends
Notes to editors:
- For further information or to arrange an interview with any of
the scientist involved in the project, please contact the MRC Press
Office on 0207 670 6011 or press.office@headoffice.mrc.ac.uk
- DART was sponsored and funded by the UK Medical Research
Council. Further funding was provided by the UK Department for
International Development and the Rockefeller Foundation.
Antiretroviral drugs given to trial participants were donated by
GlaxoSmithKline, Gilead Sciences, Abbott Laboratories and
Boehringer Ingelheim. These pharmaceutical companies also provided
funding for some of the sub-studies that were part of the DART
trial.
- For almost 100 years the Medical Research Council has improved
the health of people in the UK and around the world by supporting
the highest quality science. The MRC invests in world-class
scientists. It has produced 29 Nobel Prize winners and sustains a
flourishing environment for internationally recognised research.
The MRC focuses on making an impact and provides the financial
muscle and scientific expertise behind medical breakthroughs,
including one of the first antibiotics penicillin, the structure of
DNA and the lethal link between smoking and cancer. Today MRC
funded scientists tackle research into the major health challenges
of the 21st century. http://www.mrc.ac.uk/
- Scientists and health care workers from Africa and the UK
collaborated closely to run the trial. Healthcare and research
centres in Uganda were the Joint Clinical Research Centre, Kampala,
the Infectious Diseases Institute at Mulago Hospital, Kampala and
the MRC/Uganda Virus Research Institute Uganda Research Unit on
AIDS, Entebbe. In Zimbabwe, researchers were based at the
University of Zimbabwe Medical School Clinical Research Centre,
Harare. The MRC Clinical Trials Unit in London provided overall
coordination and the secretariat was provided by the International
HIV Clinical Trials Research Management Office at Imperial College
London.
- As the DART trial centres are key centres for ART treatment,
most patients are staying at the same clinical centre for their
ongoing clinical care, unless for practical reasons they wish to be
transferred (e.g. to a health centre nearer to where they
live). All participants will continue to receive ART free of
charge and most will stay on the same regimen they were taking at
the end of the study. All the information from the trial, including
all their CD4 results have been summarised for each participant at
the end of the trial and shared with the participants and their
health carers. Some participants will have the opportunity to enrol
in other ART studies if they wish to.
