Efaviranz + d4T/3TC: 84-week data; open-label, single arm study

This is an open-label, single-arm, multicenter study of efavirenz plus d4T and 3TC in treatment-naÔve individuals. This study compares virologic responses for persons above and below 100,000 copies/ml at baseline, and also compares responses for people with high or low CD4s at baseline. About 90% of the participants were men, and 46% were black. The mean HIV viral load at baseline was 5.50 log (316,000 copies/ml) in the group with >100,000 copies/ml and their mean CD4 was 209; while, it was 4.42 log (26,000 copies/ml) for individuals with <100,000 copies/ml, and their mean CD4 was 273. This was a 48 week study which was extended another 48 weeks.

For those individuals with >200 CD4s at baseline, their mean CD4 and viral load were 479 and 41,700 copies/ml. For those with <200 CD4s at baseline their mean CD4 and viral load were 68 and 251,000 copies/ml. Otherwise, there didn't appear to be any important differences between these groups including racial and gender composition.

ANALYSIS:

Observed Data: Patients with viral load or CD4 measures available at timepoint were analyzed. If information was missing for any reason, person's data is not included

ITT NC=F: Patients with viral load >level of quantification at previous or subsequent timepoint were considered a failure at that timepoint. If viral load measure was missing who achieved viral load below level of quantification at previous & subsequent timepoints are not considered from numerator or denominator.

The differences in response between patients with baseline viral loads „100,000 copies/ml and those with baseline viral loads <100,000 copies/ml were not statistically significant. A mean increase from baseline in CD4 count was 288 (p<0.001).

Overall, mean CD4s increased by 318 from baseline. When baseline CD4 >200 increase was 337, and 269 for those with <200 CD4s at baseline.