USA-based Gilead Sciences presented strong 144-week data from an ongoing clinical trial comparing a once-daily regimen of its product Truvada (emtricitabine and tenofovir disoproxil fumarate) plus US drug major Bristol-Myers Squibb's Sustiva (efavirenz) versus a twice-daily regimen of UK pharmaceutical major GlaxoSmithKline's Combivir (lamivudine/zidovudine) with Sustiva once-daily, in treatment-naive adults with HIV.
Results from the Phase III, open-label, 503-patient, non-inferiority study, which were presented at the 4th International AIDS Society Conference, held in Sydney, Australia, showed that 71% of Truvada/Sustiva patients versus 58% of those on Combivir/Sustiva achieved and maintained viral load of less than 400 copies/mL using the Time to Loss of Virologic Response algorithm (TLOVR) (p=0.004). 64% of patients in the Truvada/Sustiva arm compared to 56% of those in the Combivir/Sustiva cohort achieved and maintained viral load of less than 50 copies/mL using TLOVR (p=0.08). The mean increase from baseline in CD4 cell counts at week 144 was 312 cells/mm3 and 271cells/mm3 in the Truvada/Sustiva and Combivir/Sustiva arms, respectively (p=0.09), noted Gilead.
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