An average figure for viral load or CD4+ count at the start of therapy tends to smooth over differences in a large group where people have varying cell counts and viral loads. Thus, sub-group analyses -- which look at sub-groups of people who have low CD4+ counts or high viral loads and analyses trends within these groups -- are important. Below are some of these sub-group analyses.
The CD4+ count that some participants had at the start of the study (baseline) appeared to influence their subsequent response to the study regimens. For instance, there were 123 participants whose CD4+ count at the start of the study was less than 200 cells/ml. Below are the proportions whose treatment failed:
In contrast, among 682 participants who entered the study with a CD4+ count greater than 200 cells/ml, below is how their treatment failures were distributed:
Rates of treatment failure among 275 participants who had a baseline viral load greater than 100,000 copies/ml were distributed as follows:
Rates of treatment failure among participants whose baseline viral load was less than 100,000 copies/ml were distributed as follows:
At the start of the study about 5% of participants had a viral load greater than 500,000 copies/ml.
Among participants whose dual therapy regimens failed, four of five entered the study with a viral load "much greater" than 500,000 copies/ml. Analysis of their blood samples after treatment failure occurred found that in four of these five participants, HIV with mutations that allowed it to resist the effect of integrase inhibitors -- the class to which raltegravir belongs -- was present.
None of the safety differences between study regimens were statistically significant.
Serious adverse events (SAEs) -- these could be side effects, complications related to HIV or other causes -- are always recorded in a clinical trial and then later analysed to determine if the study drugs played any role in their formation.
Here is the overall distribution of SAEs:
Here is the distribution of deaths that occurred during the study:
Very serious events were distributed as follows:
Less than 1% of participants taking either study regimen had abnormal changes in fatty substances in the blood -- cholesterol and triglycerides. Overall, there were no significant differences between regimens in the important ratio of total cholesterol to HDL-cholesterol.
There was a small but statistically significant decrease in kidney health (as assessed by using eGFR -- estimated glomerular filtration rate) among triple-therapy users: eGFR increased by about 4 units. This is in contrast to an increase of 1 unit in eGFR seen among participants taking dual therapy.
These clinically insignificant changes were maintained for 96 weeks and underscore the overall safety of both study regimens for the kidneys.
According to the study researchers, a regimen of twice-daily raltegravir together with once-daily boosted darunavir was "well-tolerated" and had similar effectiveness as triple therapy with boosted darunavir. However, among participants who entered the study with less than 200 cells/ml, dual therapy with boosted darunavir and raltegravir was inferior to triple therapy.
Overall, the researchers found the safety of both regimens to be similar. They concluded by stating that the combination of raltegravir + boosted darunavir represents an alternative option (to boosted darunavir + Truvada) for first-line therapy, particularly in patients who have more than 200 CD4+ cells/ml.
Although the results from NEAT are interesting, it is important to note that leading treatment guidelines, such as ones produced by the DHHS, do not recommend initiating HIV with simplified regimens.
Raffi F, Babiker AG, Richert L, et al. First-line raltegravir + darunavir-ritonavir is non-inferior to tenofovir-emtricitabine + darunavir-ritonavir: The NEAT 001/ANRS 143 randomized trial. In: Program and abstracts of the 21st Conference on Retroviruses and Opportunistic Infections, 3-6 March 2014. Abstract 84LB.
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