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| Efficacy of trizivir as sole hiv treatment after 5 year of triple combination Apr 28, 2003 Based on current clinical research and your professional practice, does taking triziver alone provide long-term benefits of keeping viral loads undetectable? |
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Response from Dr. Boyle
The best study performed to date to examine the efficacy of Trizivir (abacavir + zidovudine + lamivudine co-formulated tablet) is ACTG 5095. The data safety monitoring board (DSMB) stopped the Trizivir arm of that study due to its significant underperformance of the 2 Sustiva/Stocrin (efavirenz) containing arms of that study, one that is Sustiva/Stocrin + Combivir (zidovudine + lamivudine co-formulated tablet) and the other Sustiva/Stocrin + Trizivir. There were several factors cited by the DSMB in making this decision including the significantly lower number of patients on Trizivir alone who achieved <200 copies/mL (the ACTG cutoff) at 48 weeks and the higher rate of failure per 3 months associated with the Trizivir arm. Using an intent to treat analysis (with switches NOT counting as failures), patients in the pooled Sustiva/Stocrin arms had 89% reach <200 copies/mL at 48 weeks versus only 74% of the patients treated with Trizivir and the failure rate (per 3 months) was 3.5% among the patients in the pooled Sustiva/Stocrin arms versus 7% in the Trizivir arm. The conclusion of the DSMB is that Trizivir is inferior to the Sustiva/Stocrin containing regimens. These data from this large, well done study would certainly indicate that relative to Sustiva/Stocrin regimens, Trizivir is not as effective at providing "long-term benefits of keeping viral loads undetectable." | |||||||||
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