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Results of the PENPACT 1 trial presented at the 18th International AIDS Conference
Results of the PENPACT 1 trial presented at the
18th International AIDS Conference
The PENPACT 1 trial suggests children infected with HIV
requiring treatment have a choice of antiretroviral combinations to
start with, and the timing of switching to 2nd line
treatment does not affect long-term viral load.
PENPACT
1 was a long-term trial run in collaboration between PENTA and
PATCG/IMPAACT that studied which 1st line antiretroviral
treatment (ART) children should start with, and when children
should switch to 2nd line ART.
In total, 263 children were randomised, 131 to
start with protease inhibitor (PI) based ART and 132 to start with
non-nucleoside reverse transcriptase (NNRTI) based ART.
Children were also randomised to either switch to 2nd
line ART if their viral load increased to 1,000 copies/ml on
1st line treatment (134 children), or to wait until the
viral load increased to 30,000 copies/ml before switching (129
children).
Overall, these children had excellent response
to treatment over a median of 5 years, and nearly three-quarters
were still on 1st line ART at the end of the
study. Children in the 30,000 group switched to
2nd line ART about a year later than those in the 1,000
group, resulting in fewer treatment switches in the high viral
switch group (23 vs 37 children).
The main result, measured at 4 years after
starting treatment, was that there was no difference in viral
response when comparing starting with PI or NNRTI based ART, OR
when comparing switching at 1,000 or 30,000 copies/ml.
In addition, staying on 1st line
treatment for an additional year did not result in any difference
in PI or NNRTI resistance which was similar in the early and late
switching groups. However, there was evidence that children
on NNRTI based ART were more likely to develop resistance to the
NRTI drugs (nucleoside reverse transcriptase inhibitors) if they
were in the 30,000 compared to the 1,000 viral load switch group.
This was not the case for PI based ART.
Children gained CD4 cells throughout the study
and very few had disease progression (no difference between
groups). There were also no differences in the number of
children experiencing side-effects on PI or NNRTI drugs.
In summary, children in this trial taking ART
for the first time had excellent results. If children have not been
exposed to an NNRTI to reduce mother-to-child transmission of HIV
infection, then either PI or NNRTI are equally good choices for
1st line treatment. Although routine viral load
testing may help identify children at risk of developing NRTI
resistance, it is unlikely to affect NNRTI resistance because this
occurs as soon as viral load becomes detectable.
For HIV infected children worldwide, the
PENPACT 1 trial sends a powerful message to start and continue
those requiring treatment on ART.
Download the
presentation.
