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Didanosine Intensification in NRTI-Experienced Patients
  AIDS Clinical Care, November 2003
By Judith Currier, MD, MSc
Associate Director, Center for AIDS Research and Education, UCLA Medical Center
Although it is known that didanosine (ddI) retains activity in the setting of 3TC resistance, the performance of this agent in the setting of other reverse transcriptase nucleoside analogue mutations (NAMs) in patients on combination therapy has not been studied extensively. Molina reported results from the JAGUAR trial: a randomized, placebo-controlled, double-blind industry-supported study conducted in 168 clinically stable patients with incomplete virologic suppression as (viral load, 1000-100,000 copies/mL).
Participants were randomized 2:1 to receive weight-adjusted doses of enteric-coated ddI (250 or 400 mg daily) or matching placebo in addition to their current antiretroviral regimen. The cohort had well-preserved CD4 counts (median, 378 cells/mm3) and modest viral-load levels (median, 3.8 log copies/mL). The study was powered to detect a =0.5 log decline in viral load in the ddI arm compared with the placebo arm. Study subjects were allowed to have prior but not current ddI use at baseline. After 4 weeks of follow-up, the median viral-load decline in the ddI group was 0.59 log copies/mL, which was superior to the decline in the placebo group. The virologic response was reduced for those with 4 or more NAMs and for those with the L74V mutation (ddI associated mutation).
Longer-term follow-up is needed to determine whether the initial virologic responses reported in this study can be maintained. Overall, these data may be helpful in selecting patients for whom ddI therapy could be considered as part of a salvage regimen.
Dr. Currier is Associate Editor of ACC.
Molina J et al. Didanosine (ddI) In Treatment-Experienced HIV-Infected Patients: Results from a Randomized Double-Blind Study (AI454-176 Jaguar). 43rd ICAAC 43rd ICAAC, San Diego, September 2003. Abstract H-447.
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