The Body Covers: The 2nd International AIDS Society Conference on HIV Pathogenesis and Treatment
FTC Potent Within a HAART Regimen in Treatment-Naive HIV-Infected Patients With High Viral Loads
July 14, 2003
Examples of this go all the way back to the dose-finding licensing study of nelfinavir (NFV, Viracept), called AG 511. In that study, the two doses of nelfinavir, 500 mg three times a day and 750 mg three times a day, were fairly similar in the early analyses. It was the differences in those who started with high viral loads and the long-term results that made it clear that the 500-mg dose was inadequate. This difference, limited to the high viral load subgroup, cropped up in a pivotal early study of Trizivir (abacavir [ABC, Ziagen] + 3TC [lamivudine, Epivir] + AZT [zidovudine, Retrovir]), foreshadowing the results of ACTG 5095.
For this paper, the authors combined data from two different studies that compared FTC with a comparison agent, combined with a backbone of another nucleoside and a nonnucleoside. Virologic failure was defined as never achieving a viral load less than 50 copies/mL or two consecutive viral loads over 50 copies/mL after achieving success. Here are the trials and the designs:
In FTC 302, the choice of either efavirenz or nevirapine was determined by viral load: all patients with a viral load greater than 100,000 copies/mL received efavirenz, the remainder received nevirapine.
The authors report that the probability of virologic failure among persons with a viral load of more than 100,000 copies/mL at 48 weeks to be:
In the less than 100,000 copies/mL groups the probability is:
The poster concludes that "FTC is a potent once-daily NRTI that provided significant efficacy within a HAART regimen in treatment-naive HIV-infected patients with viral load more than 100,000 copies/mL as well as less than 100,000 copies/mL." I agree with the conclusion. FTC is potent and well tolerated, based on this and other studies presented at this meeting and elsewhere. There have been no hints that the regimen is compromised in patients with high viral loads.
Did this paper add to that conclusion? I have some problems with the poster and the analysis. It is difficult to combine data from differing studies because of obvious differences in the regimens, as well as subtle differences in the time, locale and conduct. This can be dealt with to some degree with sophisticated statistical analysis, but if that was done, it was not discussed in this paper.
Sometimes, the parts themselves stand alone without any help from a combined analysis. FTC, like 3TC, can be used as part of a variety of potent regimens regardless of viral load.
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