• Switch to Trizivir Versus Continued HAART Provides Equivalent HIV-1 RNA Suppression at 48 Weeks (TRIZAL - AZL30002)
  Abstract 671
  Authored by C. Katlama (Hôpital Pitié-Salpêtrière, Paris, France), S. Fenske (HIV-Schwerpunktpraxis, Hamburg, Germany), B. Gazzard (Chelsea and Westminster Hosp., London, United Kingdom), A. Lazzarin (San Raffaele Scientific Institute, Milan, Italy), L. Beauvais (GlaxoSmithKline, Marly le Roi, France)
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After much Powerpoint and computer drama including two freezes during the presentation, the results of this study finally came through. It is a large multi-national study, which randomized patients already on ART to Trizivir (TZV, a triple drug combination of AZT, 3TC and abacavir) or to remain on their present therapy.

Patients who had HIV RNA of 400 copies for the previous six months and <50 copies at screening were eligible for this study. The primary endpoint was treatment failure which was defined as virologic failure (two consecutive HIV RNA values >400 copies or premature discontinuation of randomized treatment before 48 weeks). Two hundred and nine patients were randomized equally. Sixty-five percent of the patients were taking two NRTIs and a protease inhibitor at baseline. Treatment failures were both exactly 22 percent in each arm, implying that there is no virologic difference. Two out of five of the failures in the Trizivir arm finished the study with <50 copies without changing medication!

Discontinuation was more common in the continued arm of the study, but possible abacavir hypersensitivity was reported in 11 percent of the Trizivir arm; that is much higher than most reports of hypersensitivity (which are usually in the 3-6% range).

The real differences in the two arms were found in the cholesterol and triglycerides (TG). There were statistically significant differences which began soon after the switch in the Trizivir arm for lower cholesterol and TG's. There was also, as you might expect in a study where one arm (Trizivir) has one pill twice per day, significantly better adherence to therapy in the Trizivir arm.

How does this study benefit patients? Well, think about someone who has to take large numbers of protease inhibitor pills twice or three times per day. If you could simplify that down to one pill twice a day, not only will it impact adherence, but also quality of life. This regimen also spares two of the three classes of ART, saving them for later. It also spares protease inhibitor and insulin resistance and perhaps the lipodystrophy that can accompany them. Finally it helps reduce cholesterol and triglycerides in patients that have a long life ahead of them. Very few downsides to this idea!