Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
PR Newswire; Monday, June 29, 1998
French investigators presented the results of the ALBI Study (ANRS 070, abstract 12227), a study sponsored by The French National Agency on AIDS Research. In the study, 151 antiretroviral-naive patients were randomized 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 4% 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," commented 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," added Professor Molina.
In the ALBI Study, 151 antiretroviral-naive patients with baseline viral loads of less than 100,000 copies/mL were randomized to receive either AZT/3TC for six months (group 1), d4T/ddI for three months, and then AZT/3TC for three months (group 2), or d4T/ddI for six months (group 3). Ninety percent of patients in group 3 achieved undetectable viral loads at six months, compared to 59% in group 2 and 43% in group 1. Similarly, CD4+ cell count increases were greater in group 3 (+125/mm3) than in group 2 (+115/mm3) or group 1 (+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," Professor Molina concluded. "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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