The pharmacodynamic interaction of antiretroviral (ARV) drug classes in part are responsible for the metabolic toxicities seen in HIV positive patients (pts). This pilot study was designed to evaluate efficacy, safety, and metabolic toxicities associated with two lopinavir/ritonavir (LPV/r) [Kaletra]-based regimens in ARV-naïve pts: dual PI versus a nucleoside-containing regimen.

30 ARV-naive pts were randomized to open-label hard gelatin capsule SQV (Invirase) 800 mg BID (n=16) or ZDV (Retrovir) 300 mg/ 3TC 150 mg BID (n=14), each in combination with LPV/r (Kaletra) 400/100 mg BID for 48 weeks.

Results

Overall median baseline HIV RNA was 177,000 /mL, and CD4 count 175 cells/mm^3. 8 pts discontinued prematurely: 3 in the SQV group (adverse event [AE], n=1) and 5 in the ZDV/3TC group (AE, n=3).

By observed data analysis, 10/13 (77%) pts in the SQV group and 7/9 (78%) in the ZDV/3TC group had HIV RNA <50 c/mL at week 48 (p=0.71).

Corresponding intent-to-treat rates were 63% (SQV) and 50% (ZDV/3TC, p=ns).

All pts at week 48 had HIV RNA <80 c/mL.

Mean increases from baseline to week 48 in CD4 count were 141 (SQV) and 187 (ZDV/3TC) cells/mm³ (p=ns).

Moderate or severe study drug-related AEs occurring in >2 pts included diarrhea, vomiting, and nausea and were similar between groups.

One pt in each regimen experienced Grade 3 total cholesterol (>300 mg/dL) or triglycerides (>750 mg/dL).

Fasting glucose did not change through 48 weeks in both groups.

In conclusion, the authors write, “In this pilot study, anti-HIV activity of the dual boosted PI regimen (LPV/r +SQV) was comparable to a standard regimen of LPV/r+ZDV/3TC.”

“Additional controlled study of appropriate NRTI sparing regimens for long term metabolic toxicities is warranted.”

01/13/06

Reference 
D W Cameron and others. Comparative Safety and Anti-HIV Activity of a Dual Protease Inhibitor (PI) Regimen (lopinavir/ritonavir (LPV/r) + saquinavir (SQV)) versus a Nucleoside-Containing Regimen. Abstract H-523. Abstracts of the 45th Interscience Conference on Antimicrobial Agents and Chemotherapy. December 16-19, 2005. Washington, DC.

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