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Short course of treatment for people with
recent HIV infection slows damage to immune
system: results from the SPARTAC study
A 48 week course of antiretroviral medication taken in the early stages of
HIV infection slows the damage to the immune system and delays the need
for long term therapy by 65 weeks. These are the results of SPARTAC (Short
Pulse Anti-Retroviral Therapy at HIV Seroconversion); the largest randomised
controlled trial ever undertaken in recent HIV infection. The study ran
between 2003 and 2011 across eight countries. This leaflet tells you more
about the study, the results and what they mean.
www.imperial.ac.uk/medicine/spartac
How HIV is currently treated?
Scientists and doctors are always looking for better ways to treat people living with
HIV. HIV is a virus that affects a person’s immune system by killing the CD4 cells that
help to protect the body against illnesses. During early infection, HIV spreads quickly
and over time the virus will destroy enough CD4 cells for the immune system to fail.
According to current standards of care, anti-HIV treatment, called anti-retroviral
therapy (ART), is not usually prescribed until late stage disease, once biological tests
(CD4 count) show that the immune system is failing. Once a person starts ART it is a
long-term commitment for life. ART must be taken every single day, is expensive and
can have side effects.
Why is SPARTAC important?
Improve current management of recent HIV infection
Although doctors and scientists know how to manage late stage HIV infection, there
is still a lot of research to be done to understand how to best manage the very early
stages of HIV infection.
The SPARTAC study aimed to test two new possible treatment strategies for early
HIV infection: could giving people recently infected with HIV a short period of 12 or
48 weeks of ART delay the need to starting long-term ART? A significant delay would
shorten the overall time a person has to take ART in their lifetime.
Robust evidence to inform treatment
guidelines
There are no conclusive current national and
international guidelines on how to treat recent HIV
infection as there is no strong evidence on which
to base recommendations. The SPARTAC study was
conducted in resource-limited and resource-rich
settings amongst men and women, and designed to
provide robust results.
SPARTAC enrolled participants from
Australia, Brazil, Italy, Ireland, Spain, South
AFrica, Uganda and the UK.
How were the participants chosen?
Woman picking up medicines at an
HIV clinic, Masaka, Uganda.
→
The SPARTAC team recruited enough
participants to ensure that, if there
really was a benefit of early treatment,
then we would be able to detect it. 366
adults – mainly heterosexual women
and men who have sex with men –
took part from 35 clinical sites in 8
countries. Only people with confirmed
recent HIV infection (laboratory
evidence of recent infection or a
negative HIV test up to 6 months
before a positive one) were eligible
to participate. All those eligible were
fully informed about what it meant to
be part of the study before deciding
to enrol. All participants had access
to treatment according to national
treatment guidelines in case they
needed it.
How was the clinical trial run?
SPARTAC participants were allocated into one of three treatment strategy groups
randomly, like the roll of dice. The three groups were:
•
a short-course of ART for 12 weeks;
•
a short-course of ART for 48 weeks;
•
no early ART (the current standard of care for people recently infected with HIV).
The SPARTAC team followed up participants for an average of 4 years, regularly
measuring the number of CD4 cells and the amount of virus in the blood. The team
compared how the 3 groups fared in terms of how long it took before the participants
had to start long-term treatment, which is usually when the CD4 count falls below
350 cells per mm3 of blood. As soon as CD4 counts fell below 350 cells per mm3
blood, long-term treatment was offered.
Participants with
recent HIV infection
(within 6 months)
Randomisation
(like the roll of dice)
No early ART
(123 people)
12 weeks of treatment
(120 people)
People who needed
treatment straight away
were not eligible to
join and were treated
outside of the trial
48 weeks of treatment
(123 people)
CD4 cell count confirmed below 350 cells per mm3 blood, or
started long-term treatment
What did the results show?
SPARTAC is the largest clinical randomised trial to have looked at treatment in recent
HIV infection and enrolled both men and women in resource-poor and resource-rich
settings. Collecting measurements over an average period of 4 years has allowed
the SPARTAC team to obtain robust evidence on the impact a short course of ART in
recent HIV infection has on the progression of HIV disease, compared to participants
who received the current standard of care of no early treatment.
Summary
Giving people recently infected with HIV 48 weeks of treatment had some
advantages, compared to no early treatment:
•
It delayed the time to needing long-term treatment, though not much longer
than the time already spent on 48 weeks of treatment (average of 65 weeks).
•
Overall the group had healthier immune systems (an average of 138 more CD4
cells per mm3 blood) and lower amounts of virus in the blood.
•
These advantages were greater the closer the 48 weeks of treatment was started
to the time of HIV infection.
There was no effect found in giving people recently infected with HIV 12 weeks of
treatment, compared to no early treatment. There was no evidence of harm of early
treatment in terms of deaths, adverse events and the effectiveness of long-term
treatment later on.
What’s the science behind these findings?
More research is needed to understand why 48 weeks of treatment given to
participants recently infected with HIV had certain advantages. Our findings suggest
that it may be due to 48 weeks of treatment reducing the amount of hidden virus in
the body (viral reservoir size).
HIV attacks the
immune system and
can stay hidden in certain
cells that fight infection.
When these cells are activated
HIV is released.
What do the results mean for HIV treatment?
The SPARTAC results contribute to scientific research looking for better ways to treat
people with recent HIV infection. 48 weeks of treatment during this stage of infection
could be an option.
Informing treatment guidelines: benefits versus costs
The benefits found in giving 48 weeks of treatment early in HIV infection will have to
be considered against the extra financial and strategic cost of increased testing and
treatment. However, doctors, healthworkers and patients should be aware of the
SPARTAC clinical trial findings and may wish to consider the option of 48 weeks of
treatment given at recent infection if appropriate.
Preventing the spread of HIV
National and international guidelines are supporting a more proactive approach to
HIV testing in order to put in place proven strategies to reduce the risk of further
transmission of HIV. Recent HIV infection is estimated to be responsible for 30% of
new HIV transmissions. People who have recently become infected with HIV often
don’t know it (symptoms are rare) and have very high levels of virus in their blood,
making them especially high risk to pass on the virus to their partners.
The lower amounts of virus in the body
seen in the group taking 48 weeks of
treatment could be a more cost effective
and manageable way to significantly reduce
the risk of passing on the virus compared to
other prevention strategies. The additional
individual benefits - a healthier immune
system and delay in starting long-term ART
- is unique in HIV prevention strategies and
could be more important in resource-poor
countries where people with HIV are often
co-infected with tuberculosis. The SPARTAC
team plan to look at this more closely.
“Prevention represents the
very best investment that
any government can make. It
can yield significant savings
by avoiding future treatment
costs.”
UK Lords Select Committee on
HIV and AIDS, 2011
More research is needed
SPARTAC has thrown up more questions on what the best strategy is for treating
people recently infected with HIV:
Treat as close to the time of infection as possible?
The SPARTAC results suggest a greater benefit of 48 weeks of early treatment the
closer the treatment was started to the time of HIV infection. The participants who
were enrolled closer to the time of HIV infection tended to have faster declines in
the number of CD4 cells, indicating greater damage to their immune systems, if
they did not receive treatment. It was amongst this group that the 48 weeks of early
treatment appeared to have a bigger benefit in delaying the need to start long-term
treatment. However, we are not sure why these people were coming to see a clinician
so early after infection – it may be that they felt unwell.
More research focusing on people in the very early stages of infection, a challenging
group to identify, needs to be done to confirm this observation.
Start long-term treatment earlier?
Although previous studies have shown that treating a person with early stage HIV
infection reduces the risk of this person infecting a sexual partner, more research
needs to be done to see if giving people in the early stages of HIV infection life-long
treatment is beneficial to the individual. ART has side effects and must be taken every
day to prevent the virus from mutating and becoming resistant to the medicines,
so the potential benefits of taking early treatment must be weighed against these
disadvantages.
Does 48 weeks of early treatment have long-term benefits?
The higher numbers of CD4 cells and lower amount of virus in the blood of the
participants given 48 weeks of early treatment are promising but more research
needs to be done to see whether these benefits are maintained and keep people
well in the years ahead. The SPARTAC team plan to do this by continuing to follow up
participants that took part in the SPARTAC study.
Find out more
To find out more about SPARTAC send us an email or visit our website for a
comprehensive set of FAQs and video interviews with SPARTAC participants and staff.
[email protected]
www.imperial.ac.uk/medicine/spartac
→ Watch our online films Experiences from the SPARTAC clinical trial and When to
start? HIV treatment’s unanswered question on our website.
The SPARTAC clinical trial was an international
collaboration by leading research and academic
institutions. Thank you to all SPARTAC staff and
volunteers. Thank you to the Wellcome Trust for funding
the SPARTAC study and Abbott Laboratories for donating
lopinavir/ritonavir for use in the SPARTAC study.
Printed 2011. Front page image credit: Frank Herdolt.