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Double Boosted Saquinavir/Lopinavir Shows Promise for Nucleoside Pretreated Children: Presented at AIDS 2006

By Danny Kucharsky

TORONTO, CANADA -- August 17, 2006 -- Double-boosted saquinavir (SQV)/lopinavir/ritonavir (LPV/r) appears to result in significant CD4 increases and viral load (viral load) declines at 48 weeks in nucleoside pretreated children, according to a study presented here at the 16^th International AIDS Conference (AIDS 2006).

The ongoing study is assessing the 48-week efficacy and safety of double boosted SQV/LPV/r combination in 50 HIV-1 infected children under age 16 years who previously failed nucleoside reverse transcriptase inhibitors (NRTI) and/or non-NRTI (NNRTI)-based regimes and are protease-inhibitor naive. The children will be followed for 96 weeks.

There is limited data supporting the efficacy of saquinavir and lopinavir/ritonavir twice daily in protease-inhibitor-naive HIV-positive patients, particularly for children, explained investigator Torsak Bunupuradah, MD, pediatrician, HIV Netherlands Australia Thailand Research Collaboration, Bangkok, Thailand.

Children involved in the study had a baseline median age of 9.3 years, median viral load of 4.8 HIV RNA log₁₀ copies/mL (interquartile range [IQR] 4.5-5.1) CD4 7% (IQR 3-9.5), CD4 count 160 (IQR 43.5-286.5), median total cholesterol of 144 mg/dL, low-density lipoprotein (LDL) cholesterol of 78 mg/dL, high-density lipoprotein (HDL) of 44 mg/dL, and triglycerides of 104 mg/dL.

The LPV/r dose was 230/57.5 mg/m² BID provided as adult capsules and was supplemented with an oral solution containing LPV/r 80/20 mg/mL. SQV was dosed at 50 mg/kg BID provided as 200-mg SQV capsules.

By week 48, 2 patients had died from bacterial infection and 2 stopped antiretroviral therapy due to intolerance and noncompliance. Three had herpes simplex infection, 2 had pulmonary tuberculosis, and 1 had varicella infection. No child had progression of Center for Disease Control classification.

Significant predictors for virological failure were higher baseline viral load (P = .023), older age (P = .034) and poor adherence by determined by pill count and interview (P = .001).

Median CD4 and CD4-count increase were 8% (IQR 4 to 15.5) and 360 (149 to 510) cells/mm³ and the median viral load reduction was -2.6 log₁₀ copies/mL (IQR -3.2 to -1.3, all P < .001).

Thirty-six (72%) and 28 (56%) children achieved viral load < 400 and < 50 copies/mL (P = .003 and P = .005, respectively).

Antiretroviral therapy-related adverse events of any grade were seen in 13 children (26%), of which 69% were grade 1 to 2 and 31% were grade 3 to 4. Diarrhea and elevated triglyceride levels were the most common adverse events.

Levels of triglycerides and LDL were significantly increased. Median changes (mg/dL) in lipids were triglycerides +19.5 (IQR-22-74, P = .014), LDL +18.0 (IQR 0-36.8, P = .006), and HDL +3 (IQR 0-9, P = NS).

Dr. Bunupuradah noted in his presentation on August 15^th that children who fail NRTI/NNRTI regimens have limited options for second-line therapy and added that much more work in the field is needed.

The research was supported by Roche and Abbott. Roche provided Invirase to children both during and after the study, while Abbott provided Kaletra during the study.


[Presentation title: Efficacy and Safety of Double Boosted Saquinavir (SQV)/Lopinavir in Nucleoside Pre-Treated Children at 48 Weeks. Abstract MOPE0201]

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