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The Body Covers: The 7th European Conference on Clinical Aspects and Treatment of HIV-Infection
A Comparison of the Long-Term Antiviral Efficacy of BID and TID Dosing of Nelfinavir in Combination with Stavudine and Lamivudine Beyond 48 Weeks

October 26, 1999

Authored by A. Petersen, F. Antunes, K.N. Arasteh, et al.

Oral Abstract 205

This presentation was further follow up of the important study that has documented the clinical success of using nelfinavir (Viracept) in a twice daily schedule. This study randomized participants to take nelfinavir as either the standard three 250 mg. tablets three times a day, or five tablets twice a day, both in combination with d4T and 3TC. A total of 560 adults were enrolled.

The median initial viral load was five logs (100,000), while the initial CD4 count was 296. Only 5.9% of participants discontinued participation in this study due to adverse events linked to the medications. An additional 15% discontinued participation for reasons other than medication side effects. After an average of one year on the two combinations, the results show very similar results in the two schedules. Both groups report about 82% success in getting the viral load below 400 copies and follow up to week 72 shows that this remains constant in longer term follow up. Using a 50 copy cutoff demonstrates a similar finding, with about 54% of the group reaching this cutoff, using the intent to treat analysis method. Nelfinavir blood levels were done in some of the participants which confirm that the twice-daily schedule is acceptable for this agent. There were no differences reported in the rate of side effects in the two schedules.

This follow-up is reassuring to both health care providers and people taking nelfinavir as a twice daily medication. Since most of the nucleoside inhibitors that are used in combination are also taken twice a day, taking nelfinavir on this same schedule increases the simplicity and desirability of this medication.

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