February 6, 2001
Videx was the second NRTI agent brought to market in the early 1990s and has been associated with chalky large pills, bloating, gas, and potent antiviral activity. It was a sheep in wolf's clothing. Efforts to make it better were slow and incremental ranging from switching from chalk to mandarin orange flavor and eventually smaller tablets that still contained a buffer that was responsible for the upset stomachs. Meanwhile, Bristol-Meyers Squibb -- the company that first manufactured this medicine -- were trying to figure out how to make it more tolerable and palatable. They seemed to have fixed the problem. They studied the technology of time release capsules with little coated beadlets that release the medicine in the intestine thereby eliminating the need for the buffer and making a new drug out of an old, unpopular, but useful medicine.
Videx is a useful medicine because it is taken once daily. It is currently recommended to be taken one hour after eating and then to avoid food for two hours after administration, thus rendering it easy for night administration. It can be taken with other medicines, but not with food. The improved tolerability and once-daily administration make this a useful NRTI again and the first to be approved for once-daily use. Clinical applications (320, 321, 491) demonstrate the utility of once-daily regimens using ddI as a cornerstone with previously mentioned research providing other NRTI choices to be paired with NNRTIs as well.
These studies were designed to evaluate the enteric-coated ddI versus the old version of ddI tablets in two different study regimens.
Videx EC results in a lower Cmax, increased Tmax, and equivalent AUCs when compared to chewable ddI. The drug had a favorable profile in terms of ease of use and therefore was relevant to test in this three-drug combination to demonstrate equivalent efficacy to the combivir arm.
The results showed:
The improvements in palatability, with equal efficacy and once-daily administration reestablish Videx as an important antiviral agent. As more agents are available for once-daily usage, Videx EC may be used as a cornerstone of future simplified regimens.
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