Children with HIV experienced good long-term outcomes on multiple treatment regimens

PENPACT-1 (PENTA 9/PACTG 390) Study Team. Lancet Infect Dis. 2011;11:273-283.

Switching treatment regimens at different viral load points yielded similar outcomes in a cohort of children with HIV, according to study results.

Researchers conducted a study to determine the long-term outcome of protease inhibitor (PI) and non-nucleoside reverse transcriptase inhibitor (NNRTI) first-line antiretroviral therapy and viral load switch criteria in children. The primary endpoint was change in viral load between baseline and 4 years as evaluated in an intention-to-treat analysis.

The treatment regimens were as follows:

PI and switch to second-line at 1,000 copies/mL (PI-low; n=66)
PI and switch to second line at 30,000 copies/mL (PI-higher; n=65)
NNRTI and switch at 1,000 copies/mL (NNRTI-low; n=68)
NNRTI and switch at 30,000 copies/mL (NNRTI-higher; n=67)

Results indicated that the median reductions in viral load were -3.16 log¹⁰ copies/mL for children in the PI group and -3.31 log¹⁰ copies/mL for NNRTIs, resulting in a difference of -0.15 log¹⁰ copies/mL (95% CI, -0.41 to 0.11).

Switching at a lower viral load yielded a mean reduction in viral load of -3.26 log¹⁰ copies/mL compared with a reduction of -3.20 log¹⁰ copies/mL for switching at a higher viral load count. This amounted to a difference of 0.06 log¹⁰ copies/mL (95% CI, -0.20 to 0.32).

Resistance was uncommon in the PI group. No increase in NRTI resistance was observed between the PI-higher and PI-low groups. NNRTI resistance was selected early during viral rebound, according to the results.

Children in the NNRTI-higher group accumulated about 10% more mutations than children in the NNRTI-low group.

New CDC stage-C events were observed in nine children. Sixty children had grade 3-4 adverse events. These events were balanced across the study arms.

The trial was conducted between Sept. 25, 2002, and Sept. 7, 2005. The median follow-up duration was 5 years (interquartile range, 4.2-6.0).

Of the 266 children randomly assigned initially, 71% were receiving first-line ART by the end of the trial.

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