They do acknowledge they used three different methods, but it is hard to figure out what the numbers were, or how many were undetectable. I did not analyze it correctly, All did, and I thought I knew what "intent to treat" means but I guess I don't either. They also differentiate between 'intent to treat and "on treat." I don't have time to check it out now. Later. Unless someone else knows.
I did not realize that the arm they refer to as "Sustiva 600 mg+AZT+3TC" actually had patients who were on Sustiva 600 mg+d4t+3TC+Crixivan; if they had detectable viral loads at 16 weeks, crixivan was added and d4t was subsituted for AZT, but the results refer to the superiority of the Sustiva+2 nukes arm.
Kind of deceptive, to report it that way.
Their explanation of terms:
1. Observed data analysis: imo, what you end with at the end, and I think the same as "intent to treat" data
2. * Last-observation-carried-forward data analysis is a method of analyzing data in which missing viral load data is assumed to be equivalent to the last recorded data for that patient. Analysis performed at only 16 and 24 weeks.
3. Non-completer = failure data analysis is a method of reporting data in which missing data is reported as equivalent to failure (i.e., above quantifiable viral load). Only if a patient's viral load measurement is missing or unavailable at one time point in the study, the patient's results are not included in the analysis at that point -- if the patient's viral load was BQL both before and after that point.
Study 005:
<<This study showed Sustiva, given once daily incombination with two nucleoside analogues, Retrovir(R) (zidovudine, AZT) and Epivir(R) (lamivudine, 3TC), suppresses HIV-RNA to BQL after 36 weeks and may therefore offer physicians and patients a new initial HIV treatment regimen. In the 137-patient study, all 11 patients randomized to Sustiva (600mg)/AZT/3TC who had reached the 36-week time point achieved HIV-RNA BQL. Using a more conservative 36-week LOCF analysis, 82 percent of the patients in this arm achieved BQL. The CD4 cell counts of patients in this arm of the study increased an average of more than 100 cells/mm3 at 36 weeks.>>
>>Yesterday, similar data were presented at the Conference from DuPont Pharmaceuticals Study 006 in which, when using the most rigorous analysis for reporting data (a method known as
non-completer = failure), 19.2% more patients receiving Sustiva/AZT/3TC achieved HIV-RNA BQL compared to patients receiving Crixivan/AZT/3TC, which was statistically significant.*>>
Study 006
>>Patients taking the four-drug combination containing Sustiva had statistically superior reduction in HIV-RNA levels less than 50 copies/mL(using an ultrasensitive assay) by multiple methods of data analysis. For example, 74 percent of patients taking the combination containing Sustiva achieved HIV-RNA BQL in the ultrasensitive assay (less than 50 copies/mL)compared to only 45 percent of patients taking a standard three-drug regimen, according to an observed data analysis. Patients taking both regimens achieved CD4 cell count increases of between 85 and 115 cells/mm3 at 24 weeks, using LOCF analysis, and between 95 and 130cells/mm3 using observed data analysis.>>
<<Yesterday, similar data were presented at the Conference from DuPont Pharmaceuticals Study 006 in which, when using the most rigorous analysis for reporting data (a method known as
non-completer = failure), 19.2% more patients receiving Sustiva/AZT/3TC achieved HIV-RNA BQL compared to patients receiving Crixivan/AZT/3TC, which was statistically significant.*>>
|
