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| |  Double-Boosted Saquinavir/Lopinavir Combination Safe and Effective for Treatment-Resistant Children With AIDS: Presented at CROI By Maria Bishop BOSTON, MA -- February 7, 2008 -- Double-boosted saquinavir/lopinavir (SQV/LPV/r) demonstrated a significant increase in CD4 cell counts and a decline in viral loads at 96 weeks in children with AIDS who were resistant to non-nucleoside- and nucleoside reverse transcriptase inhibitors (NNRTIs/NRTIs), according to research presented here at the 15th Conference on Retroviruses and Opportunistic Infections (CROI). In this prospective study, 50 NNRTI/ NRTI pretreated Thai children from Bangkok (n = 20) and Khon Kaen (n = 30) were treated with twice-daily SQV-mesylate capsules and LPV/r. According to lead author Torsak Bunupuradah, MD, Pediatrician, The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Bangkok, Thailand, the children from the Khon Kaen site had a higher mean viral load at baseline than did the children from the Bangkok site (4.9log10 vs 4.7log10, respectively, P =.037). Median CD4 percentage and CD4-count increase were 14% and 558 cells/mm3 at 96 weeks (both P <.001), and the median viral load reduction was -2.8log10 (P <.001). There were no cases of disease progression during the study period. Viral load failure was seen in 1 of the 20 children from the Bangkok site and in 5 of the 30 children from Khon Kaen; 3 of these 6 failures occurred in children with poor adherence to therapy. Three children died from a bacterial infection, while 2 stopped antiretroviral therapy -- 1 due to intolerance and the other due to noncompliance. Therapy-related adverse events were seen in 10 children (20%); of these, 61% were grade 1 to 2 adverse events and 39% were grade 3 to 4. The most common adverse events were diarrhea, vomiting, and elevated triglycerides. Baseline lipoatrophy was reported in the arm (12%) and face (8%); 2% reported abdominal lipohypertrophy at baseline. At 96 weeks, approximately half of the subjects had no change in body shape, while 33%, 43%, and 39% reported fatter arms, face, and abdomen, respectively. A significant increase of 14 points was observed in the median high-density lipoprotein level (P =.004).
[Presentation title: Efficacy and Safety of Double-Boosted SQV/LPV/r Combination at 96 Weeks in Thai Children Who Have Failed NRTI/NNRTI-Based Regimens. Abstract 586]
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