Low-Dose Drug Combo Safe in Kids with HIV (CME/CE)
A low-dose treatment regimen with lopinavir/ritonavir antiretroviral therapy appears to have similar efficacy with fewer adverse events than standard dosing in HIV-infected children, researchers said here.
In the intention-to-treat analysis, 89 of 101 children (88.1%) on the low-dose regimen achieved undetectable viral loads using the 50 copies/ml assay (P
=0.38) compared with 90 of 98 children treated with the standard dose of lopinavir/ritonavir (Kaletra), said Thanyawee Puthanakit, MD, from Chulalongkorn University in Bangkok, and colleagues.
"This study demonstrated non-inferiority in virologic efficacy of low dose compared to standard dose lopinavir/ritonavir tablets as maintenance therapy," she reported at the International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention.
In terms of adverse effects, the study showed that children treated with the lower dose of the protease inhibitor had significantly lower cholesterol levels. She said that 34.4% of children on the standard dose had cholesterol levels greater than 200 mg/dl at the end of the 48 week trial compared with 20.6% of children treated with the low-dose regimen (P
=0.03).
In addition, triglyceride levels greater than 150 mg/dl were observed among 60.4% of the children on the standard dosing regimen and in 44.3% of those on the low dose of lopinavir/ritonavir (P
=0.03), Puthanakit reported.
"This dosing regimen conferred adequate lopinavir blood level with reduced drug cost, and reduced potential long-term complications such as dyslipidemia," she said.
"Lopinavir/ritonavir is the most commonly used HIV regimen used in children," Puthanakit pointed out.
In the trial, which was conducted from December to June 2011, the children assigned to the standard, weight-based dose received an average of 284 mg/m2 twice daily. The children in the low-dose group received an average of 210 mg/m2. The lower dose represents about 70% of the recommended treatment dose in the U.S., Puthanakit said.
Of the 199 patients in the study, seven children in both arms were lost to follow-up.
The average age of the children was 13.2 years and their CD4-positive cell counts was 786 cells/mm3. All were on protease inhibitor regimens. The background nucleoside reverse transcriptase inhibitors included zidovudine and lamivudine; zidovudine and didanosine; lamivudine and tenofovir; lamivudine alone; and lamivudine and didanosine.
The study was devised as a way to deliver maintenance therapy for children whose HIV was well controlled, with all of the children at baseline having undetectable HIV plasma viral loads using the 50 copies/mm3.
Puthanakit noted that the study results could only be generalized to children with controlled, undetectable viral loads and should not, at this time, be expanded to include children with high viral loads who may just be beginning antiretroviral therapy.
Diana Gibb, MD, from the Medical Research Council Clinical Trials Unit in London also cautioned that the results "would not apply to the use of liquid lopinavir/ritonavir therapy since this study was done with tablets that have a higher bioavailability."
Puthanakit concurred, noting that her study did not include infants and young children who are treated with liquid formulations of the antiretroviral regimen.
The study was part of the long-standing HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT).
The study was funded by Thai governmental agencies.
Puthanakit and Gibb reported no conflicts of interest.
Primary source: International AIDS Society
Source reference:
Puthanakit T, et al "A randomized study comparing low dose versus standard dose lopinavir/ritonavir among HIV-infected children with virological suppression" IAS
2013; Abstract MOAB0101.
