Interim analysis comparing TDF to EFV in combination with...( Chicago Sept. 16 2003 An unplanned i...),Health

Chicago, Sept. 16, 2003 An unplanned interim analysis of a study comparing tenofovir disoproxil fumarate (TDF) to efavirenz (EFV) - both given in combination with a fixed-dose investigational co-formulation of Epivir (lamivudine) (3TC) and Ziagen (abacavir sulfate) (ABC) - for the treatment of HIV showed that subjects in the TDF- containing arm experienced an unacceptably high rate of early virologic non-response compared with the EFV-containing arm. The finding led to the protocol being amended to terminate the TDF arm in the study, ESS30009, according to data reported here today at the 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). The precise nature of the interaction leading to non-response in this study is not yet known.

In both study arms, ABC and 3TC were administered in a fixed-dose investigational co-formulation and all drugs were administered once a day (QD). Virologic non-response was defined as <2.0 log10 drop in viral load (VL) by week 8, or a rebound from nadir of 1.0 log10 or greater. The protocol was amended and patients in the TDF arm could discontinue the study or continue the study on an alternative regimen.

The randomized, open-label multicenter study includes 345 antiretroviral treatment-nave patients with HIV infection. A total of 194 patients with 8 weeks or more of VL data were included in the interim analysis. The mean baseline VL was 4.63 log10 copies/mL and the mean CD4+ cell count was 290 cells/mm3 among the patients analyzed. Virologic non-response occurred in 50 of 102 patients (49 percent) taking the TDF combination, compared to 5 of 92 subjects (5 percent) taking the EFV combination. After 8 weeks, VL <400 copies/mL was achieved in 49 percent of TDF subjects compared to 90 percent of EFV subjects. The mean increase in CD4+ cell count was 61 cells/mm3 in the TDF group, compared with 117 cells/mm3 in the EFV group.

"Preliminary resistance data also demonstrated the presence of
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Contact: Elaine Salewske
esalewske@pcipr.com
312-558-1770
Public Communications Inc.
16-Sep-2003

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