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trizivir solo and undetectable.why change?

Mar 31, 2003

dear dr. i have been hiv pos for 5 years. have had undetectable viral load and 500 t-cells since beginning treatment with combivir and crixivan four years ago. 1 year and half ago I switched to trizivir to get away from protease inhibitors.i have done great on the trizivir alone ,still undetectable ,550 t-cells. with the new study must i add something like viread or sustiva now or can i wait for an increase in viral load, or is this too late and the beginning of NRTI resistance. since my viral load is undetectable could i go back to combivir and add viread or taking 3 NRTIs less effective than taking 2 NRTIs and 1 NNRTI.I'M really confused. do i need to change at all if my trizivir is working at the moment? do i go with combivir and viread and save sustiva for later OR switch to combivir and sustiva and save abacavir and viread should i develop resistance to combivir

Response from Dr. Boyle

The data from the newly released ACTG 5095 trial indicate that Trizivir therapy is significantly inferior to treatment with an Sustiva/Stocrin (efavirenz) containing regimen. The failure rate was signficantly higher in the Trizivir arm, and importantly, the risk of failure over time in the trizivir arm was DOUBLE the risk of failure in the Sustiva/Stocrin containing arms. The data safety monitoring board of the National Institues of Health felt the differences were so large that the Trizivir arm was stopped and unblinded, a very unusual step in clinical trials. The ACTG steering committee of the 5095 trial, a very unbiased and well informed group, has decided that based upon the underperformance of the Trizivir arm all patients enrolled in the Trizivir arm should be offered intensification with either Sustiva/Stocrin, the agent there is the most experience with, or Viread (tenofovir). So, to answer your questions. First, ACTG 5095 shows that taking 3 NRTIs (e.g., Trizivir) is inferior to 2NRTIs + efavirenz (Sustiva/Stocrin). Second, there is no data to support a Combivir (AZT + 3TC coformulated tablet) plus Viread combination, while there are a number of studies (including ACTG 5095) that support a Combivir plus Sutiva/Stocrin regimen. Third, whether or not to change your regimen at this point is a tough question. On one side, you could argue that some patients will succeed with a certain therapy, despite the higher odds that the regimen will fail, but on the other side you could argue that the most concerning aspect of the 5095 trial is the high rate of failure in the Trizivir arm when compared with the Sustiva/Stocrin arms of the trial, which continues over time. So, this last question should be posed to your doctor and a decision made based upon the newly determined problems with a Trizivir only regimen. I don't have many patients on Trizivir alone, but the few that I do will get all of the facts and then make a decision about what to do. My recommendation will be that they intensify, since virologic failure is never desirable and the resistance that results may vary widely depending on how rapidly the failure is picked up and acted upon.

percentage of lymphs
Med schedule off a little .....

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