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new videx dosing announcement
Aug 18, 2000

Have you heard about the letter to physicians recommending 2x vs. 1x daily dosing for Videx?? Here is the excerpt. WHat is your opinion and what is the correct dosage. I take two 400mg tabs once a day. are they advocating 200mg 2x day.?

"BMS has sent letters to physicians concerning a new study which shows that Videx, an anti-AIDS drug, should be given twice daily, not once daily. The study of 756 treatment-naive HIV-infected adults compared Videx given once daily with stavudine and nelfinavir treatment to AZT/lamivudine/nelfinavir therapy. Fifty-nine percent of the AZT group had HIV-RNA levels under 400, but only 50 percent of the Videx group had similar levels. Furthermore, of the patients with HIV RNA under 50 at 48 weeks, 47 percent of the AZT group had undetectable levels, versus only about one-third of the Videx once-daily cohort."

Response from Dr. Pavia

I assume you mean you are taking 2 200 mg tablets once daily, not 2 400 mg tablets.

The BMS announcement is confusing. There are several studies that have shown no difference between videx (ddI) once daily vs twice daily, and the FDA accepted the information. The study that is sited has not been reviewed in detail by most of us, so we have a hard time judging. One strange aspect is that is compares ddI/d4T with combivir, not once daily ddI with twice daily ddI. In another study, START 2, ddI/d4T with crixivan was identical to AZT/3TC with crixivan. What makes this trial different. I suspect it is because of adherence, but we need to see the data.

What is a patient to do? Well, the conservative approach is to do what the FDA says, they are after all, the government. However, if you are doing well on ddI once daily and your virus is suppressed, I don't see any compelling reason to change. I hope that CC, RS, and KS will weigh in on this, so I am not sitting here alone.



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