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Coverage of 2006 International
Conference on AIDS

August 14–18, 2006, Toronto, Canada

Kaletra vs Sustiva vs a Combination of the Two

by Martin Delaney, August 17, 2006

In this study reported as a “late-breaker” in Toronto, researchers compared the two regimens most highly recommended in the US Federal Guidelines a Kaletra (lopinavir/ritonavir) regimen and a Sustiva (efavirenz) regimen, both in combination with two nucleoside analogue drugs [NRTIs, or “nukes”]). In addition, the study included a group taking only a combination of the two drugs, Kaletra + Sustiva, but without any NRTIs.

The study followed 753 volunteers for a median of 112 weeks. At the conclusion, there was no statistically significant difference among the three groups with respect to viral load. However, there was a clear trend favoring the Sustiva + two nukes group and the Sustiva + Kaletra group as compared to the Kaletra + two nukes group. The Kaletra + two nukes arm showed a shorter time to rebounds in HIV levels, which was something of a surprise to many observers. However, since the finding was not statistically significant, it is difficult to say just how important the observation is and whether it should affect treatment decisions.

Perhaps the most important finding of the study was that the group who took combined Sustiva and Kaletra performed at least as well as the best conventional arm (Sustiva + two nukes). There is a growing interest among patients, doctors and researchers in finding regimens that do not require people to take two NRTIs. Since 1996, nearly all regimens have included two nukes. However, findings over the last several years have raised considerable concerns over the toxicity of these drugs and many researchers believe people might fare better without them. The combination of Sustiva plus Kaletra points the way toward regimens that are highly potent and durable without using NRTIs. We believe this kind of research will eventually lead to widespread use of two-drug regimens and perhaps even single-drug regimens that work as well as today’s three-drug combinations but with less toxicity.

This study, along with others that are researching “induction / maintenance” approaches to therapy (starting with a higher dose and three drugs then reducing the number of drugs), and the imminent availability of drugs like integrase inhibitors, third generation protease inhibitors, and entry inhibitors are collectively on the verge of changing the entire paradigm of HIV treatment. We believe this change will make taking therapy easier for people with HIV and will produce more effective and longer lasting therapy.

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