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HIV Treatment at High CD4 Counts Protects Against Both AIDS and Non-AIDS Events in the START Study: Overall and in Subgroup Analyses

July 20, 2015

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Clinical Events by Geographical Region

Earlier treatment had better outcomes in both high and low/middle income countries, although there were differences in the type of events by geographical region. Most of the TB cases (16/20) were in Africa and most of the cancers (22/27) and cardiovascular events (19/26) occurred in Australia, Europe, Israel and the US.


Subgroup Analysis Consistently Support Earlier Treatment

Another unexpected outcome from START was the consistency for the primary endpoint results in sub-group analysis for baseline demographics and other risk factors of serious events, all favouring the early treatment arm.

The expectation that events would only occur in the groups at highest risk and that lowest risk groups would be protected from events was not supported by the results.

This included analysis by age, sex, race, geographic regions, smoking status, cardiovascular risk or baseline CD4 and viral load. Even when 95%CI for the HR crossed 1.0 for several parameters (highest CD4 and CHD risk and lowest VL), none of the p-values for the interaction approached significance. See Table 3.


Table 3: Hazard Rates (HR) for Primary End Point by Subgroup
  HR in favour of early ART p for interaction
Age  

0.98

<35
>35
0.47
0.42
 
Sex   0.38
Male
Female
0.47
0.31
 
Race   0.65
Black
White
Other
0.57 *
0.40
0.37
 
Region   0.55
High income
Low/middle income
0.39
0.48
 
Baseline CD4   0.71
<600
600-800
>800
0.28
0.50
0.56 *
 
Baseline viral load  

0.25

<5,000
5,000-30,000
>30,000
0.66 *
0.38
0.37
 
Smoker   0.93
Yes
No
0.43
0.44
 
10 year CHD Framingham risk   0.56
<0.8
0.8 to 3.6
>3.6
0.46 *
0.39
0.50
 

* Individual 95% CI crossed 1.0 for these subgroups p-value for trend remained not statistically significant.


Comment

START has produced a dataset that defines level of risk for not using ART, irrespective of any individual decision to start treatment. The level of confidence for doctors recommending early ART will now increase, even if the scale up issues for universal treatment when global coverage hasn't yet met this based on CD4 thresholds of 500 or even 350.

Earlier treatment was already recommended in guidelines due to the impact that ART has on dramatically reducing the risk of onward transmission. However, START demonstrates the key missing evidence that this approach also produces clinical benefits for the person taking treatment.

These results are expected to change treatment guidelines globally, with UK BHIVA guidelines already removing CD4 threshold as a criteria for ART and an early announcement at IAS 2015 that WHO will also recommend treatment for all HIV positive people. [6, 7]

Continued follow up for all participants continues until 2017.

Simon Collins is a community representative on the Community Advisory Board (CAB) for the START study.


References

  1. Lundgren J et al, The START study: design, conduct and main results. The Strategic Timing of AntiRetroviral Treatment (START) study: results and their implications. IAS 2015, Session MOSY03.
  2. IAS members meeting.
  3. Lundgren J et al. Initiation of antiretroviral therapy in early asymptomatic infection. NEJM (20 July 2015). DOI: 10.1056/NEJMoa1506816
  4. Annual DSMB open reports 2009 - 2015.
    https://insight.ccbr.umn.edu/start/index.php?
  5. HIV Medicine supplement.
  6. British HIV Association. Treatment of HIV-1 positive adults with antiretroviral therapy. DRAFT guidelines for comment. (July 2015).
  7. Hirnschall G. WHO Global HIV Guidelines: How innovations in policy and implementation can pave the way to achieving 90-90-90. UN 90-90-90 Target workshop: lessons from the field.18 July 2015. Vancouver.
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This article was provided by HIV i-Base. It is a part of the publication HIV Treatment Bulletin. Visit HIV i-Base's website to find out more about their activities, publications and services.
 


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