EVALUATION OF A TRIPLE COMBINATION REGIMEN CONTAINING ENTERIC COATED DIDANOSINE ADMINISTERED ONCE-DAILY
Background: Buffered formulations of Videx (ddI) produce gastrointestinal side effects. This trial assessed antiviral activity and safety of encapsulated buffer-free, enteric-coated VIDEX (ddI EC). Methods: AI454-152 was an open-label, randomized, 2-arm multinational study. Treatment-naive subjects (HIV RNA ? 2000 c/mL, CD4 ? 200 cells/mm3) were randomized (1:1) to ddI EC 400 mg QD/d4T/NFV (EC regimen) or Combivir/NFV (Combivir regimen). Primary analysis compared the proportion of subjects with HIV RNA <400 c/mL at Week 48 (drop-outs = failure). Secondary analyses included changes from baseline in HIV RNA and CD4 cell counts. Results: Analyses were performed when all 511 randomized subjects had completed 48 weeks on study. In primary efficacy analysis, similar proportions in both regimens had HIV RNA levels <400 c/mL at Week 48 (EC 56%, Combivir 53%), (difference 3.9% [95% CI –4.7%, 12.4%]). Supporting results were seen for HIV RNA <50 c/mL (37% vs 35%). Similar median decreases in HIV RNA levels were observed in both regimens at Week 48 (EC-2.59, Combivir –2.61 log10 c/mL. Median CD4 cell counts increased in both regimens (EC 120, Combivir 162 cells/mm3). Adverse events included diarrhea (57%, 58%), infection (49%, 39%), nausea (24%, 36%), headache (22%, 17%), peripheral neurologic symptoms (20%, 11%), and asthenia (18%, 22%) in EC and Combivir regimens, respectively. Discontinuation for adverse events was similar in both regimens. Conclusion: VIDEX EC capsules dosed QD provide antiviral activity in a triple regimen similar to a reference triple regimen in treatment-naive, HIV-infected subjects.
BADARO R, GATHE J, GRIMWOOD A, MCLAREN C, KLESCZEWSKI K
HOSPITAL UNIVERSITARIO PROF. EDGARD SANTOS