Twice-Daily Viracept Dosing OK'd
Twice-daily dosing of the protease inhibitor Viracept (nelfinavir) for the treatment of HIV infection has been approved by the Food and Drug Administration (FDA).
The FDA's action, announced on November 29, 1999, was primarily based on interim results of a Phase III trial of more than 500 participants. Researchers in this study compared the T-cell and viral load counts of people on the previously approved regimen (three 750 mg pills taken three times per day, or TID) versus the newly approved regimen (five 1,250 mg pills per dose taken twice daily, or BID). Both arms of the study demonstrated similar decreases in viral load, increases in T-cell, and similar safety profiles.
Positive Results SeenFor individuals already taking Viracept three times daily, this news poses the question of whether or not it is safe to switch to the twice-daily regimen.
In a small retrospective trial in 1998 (Abstract 51, International Conference on the Discovery and Clinical Development of Antiretroviral Therapies) the efficacy of switching from TID to BID doses of Viracept was studied. Not only was a sustained suppression of viral load seen in this study, but an increase in T-cell in most individuals of the 45-participant study was reported. Moreover, those participants who did not have undetectable viral loads on the TID regimen achieved such levels on the BID regimen.
It was speculated that these results were due to the fact that the BID regimen contains a larger daily dose of Viracept and that adherence was easier to achieve and improved on the twice-daily dosing.
Consult Your ProviderNo significant difference in side effects between the two doses was seen.
In smaller subsequent studies, however, a 1 1/2- to 2-fold increase in diarrhea of mild to moderate levels was reported. Anyone considering switching regimens should be aware of this and discuss anti-motility drugs, diet changes, and other appropriate interventions with his or her health provider.
While adhering to a twice-daily regimen may be easier, the consequences of missing a dose could be more severe, considering the amount of time the drug would not be in your body.
Glenn Gaylord is a treatment advocate in the AIDS Project Los Angeles' Client Health Education and Advocacy Unit. He can be reached by calling (323) 993-1509 or by e-mail at ggaylord@APLA.org.
This article has been reprinted at The Body with the permission of AIDS Project Los Angeles (APLA).
This article was provided by AIDS Project Los Angeles. It is a part of the publication Positive Living.