November 19, 1999
Fifty-three percent of patients in the d4T/ddI/IDV arm and 45% of patients in the ZDV/3TC/IDV arm had plasma HIV-1 RNA levels <500 copies/mL at weeks 40 and 48 (P=0.068) in an intention-to-treat analysis. Using <50 copies/mL as the endpoint, 41% of patients in the d4T/ddI/IDV arm but only 35% of patients in the ZDV/3TC/IDV arm achieved complete suppression by weeks 40-48 (P>0.2). The increase above baseline in CD4 count at week 48 was significantly greater for the d4T/ddI/IDV group as compared to the ZDV/3TC/IDV group (P=0.001). There was no significant difference in the rate of serious adverse events between the two groups.
These results demonstrate that d4T/ddI can be combined with IDV as effectively as ZDV/3TC in treatment-naive patients. The START I study, which was presented recently at ICAAC , demonstrated the similar potency of regimens combining d4T/3TC or ZDV/3TC together with a protese inhibitor. Recent studies showed similar when d4T/3TC or d4T/ddI were combined with efavirenz. Taken together these studies show that d4T/3TC, d4T/ddI, and ZDV/3TC can each be used effectively together with a third potent agent such as a PI or NNRTI. The choice of which nucleoside RT inhibitors to use as part of an initial regimen should therefore be based on patient preference, tolerability, and the potential for drug-drug interactions.
1. Squires KE. An open-label, randomized, comparative study of stavudine (d4T) + lamivudine (3TC) + indinavir (IDV) versus zidovudine (ZDV) + 3TC + IDV in treatment of HIV-infected patients: START I [Abstract 506]. 39th ICAAC, San Francisco, 1999)