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Videx EC (Didanosine) demonstrates improved safety, tolerability and comparable efficacy in 48 week study

Results from a 48-week study demonstrate that VIDEX EC (didanosine) capsules had similar efficacy and virologic response compared to VIDEX tablets. Improved safety and tolerability were also seen in patients taking the VIDEX EC treatment regimen. These results were presented today at the Eighth Conference on Retroviruses and Opportunistic Infections in Chicago.

Our study showed that not only is VIDEX EC as efficacious as VIDEX buffered tablets, but also has an improved safety and tolerability profile over the conventional buffered tablet formulation of VIDEX, said Shannon Schrader, M.D, Montrose Clinic, Houston, Texas. More importantly, VIDEX EC will most likely improve adherence and compliance, which is one of the toughest battles in treating the virus.

A randomized study (BMS AI454-158, Abstract #318) of 138 treatment nave patients compares the efficacy and safety of VIDEX EC capsules to VIDEX tablets each taken once-daily in combination with ZERIT (stavudine) and nelfinavir over a 48-week period. Results of each treatment arm show comparable efficacy in suppressing the HIV virus.

In each treatment arm, HIV RNA levels dropped below 400 copies/ml by week 8 of treatment with overall decreases in the VIDEX EC capsule arm being slightly larger than that seen with the tablet formulation (-2.62 log10 HIV RNA copies/ml vs. -2.35 log10 HIV RNA copies/ml).

In addition, significantly fewer patients discontinued in the VIDEX EC capsule arm compared to the VIDEX tablet arm due to adverse events (7% vs. 20%).


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Contact: Amy Hunter
ahunter@porternovelli.com
212-601-8126
Porter Novelli
5-Feb-2001


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