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| |  WORLD AIDS CONFERENCE: European Study Suggests d4T/ddI Superiority Over AZT/3TC GENEVA, SWITZERLAND -- June 29, 1998 -- A European study has confirmed the dual nucleoside analogue combination of d4T (stavudine, Zerit(R)) and ddI (didanosine, Videx(R)) is associated with greater improvements in viral load and CD4+ counts than the combination of AZT/3TC. French investigators presented the results of the ALBI Study, a study sponsored by The French National Agency on AIDS Research today at the World AIDS Conference. In the study, 151 antiretroviral-naive patients were randomised to receive either d4T/ddI or AZT/3TC for 24 weeks or d4T/ddI for 12 weeks followed by AZT/3TC for 12 weeks. In the study, 90% of patients treated with d4T/ddI for six months achieved undetectable viral loads (below 500 copies/mL), compared with 43% of patients receiving a six-month course of AZT/3TC therapy. Furthermore, using a test with a sensitivity of less than 50 copies/mL, 47% of patients on d4T/ddI had an undetectable viral load, compared with only four percent receiving AZT/3TC. A six-month course of d4T/ddI was associated with a mean reduction in viral load of -2.23 log10 copies/mL, versus a reduction of only -1.28 log10 copies/mL with AZT/3TC. Six-month treatment with d4T/ddI was associated with a mean CD4+ cell count increase that was twice that seen with AZT/3TC (+125/mm3 vs. +62/mm3). Additionally, investigators found that substitution of AZT/3TC for d4T/ddI did not reinforce the initial antiretroviral effects of d4T/ddI. In fact, patients who received d4T/ddI for three months and then were switched to AZT/3TC for three months, experienced worse outcomes than those who remained on d4T/ddI for six months. "The ALBI study demonstrates that d4T/ddI is a very potent dual nucleoside combination and is superior to AZT/3TC," said Jean-Michel Molina, M.D., Ph.D., professor of infectious disease at Hopital St. Louis, Paris, France. "This might be an important consideration when choosing the foundation for multi-drug combination therapy to treat HIV disease, as current treatment guidelines recommend using two nucleoside analogues as the cornerstone of combination therapy." In the ALBI Study, 151 antiretroviral-naive patients with baseline viral loads of less than 100,000 copies/mL were randomised to receive either AZT/3TC for six months (group one), d4T/ddI for three months, and then AZT/3TC for three months (group two), or d4T/ddI for six months (group three). Ninety percent of patients in group three achieved undetectable viral loads at six months, compared to 59% in group two and 43% in group one. Similarly, CD4+ cell count increases were greater in group three (+125/mm3) than in group two (+115/mm3) or group one (+62/mm3). In terms of tolerability, there was no statistical difference between the three groups, although initially AZT/3TC were not as well tolerated due to gastrointestinal side-effects. "Not only did we find that d4T/ddI did better than AZT/3TC in terms of viral load and immune markers, but we also found that alternating these regimens did not add any benefit," Molina said. "Based on these results, d4T/ddI appears to be more potent than AZT/3TC and could be considered as part of a potent initial combination regimen."
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