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ROI CONFERENCE: d4T As Effective As AZT In Triple-Drug Cocktail For HIV CHICAGO, IL -- February 4, 1998 -- Using d4T (stavudine) as the cornerstone of triple combination therapy for HIV is at least as effective as using AZT (zidovudine) in three-drug regimens, according to results from the first-ever head-to-head clinical trials comparing such combinations. Preliminary data presented at the Fifth Conference on Retroviruses and Opportunistic Infections also suggest that d4T-based triple combinations may have an advantage over AZT-based combinations in boosting CD4+ cell counts for up to 24 weeks. The Selection of Thymidine Analogue Regimen Therapy (START) I and II trials show that the combinations of d4T/3TC/indinavir, d4T/ddI/indinavir and AZT/3TC/indinavir are equivalent in terms of antiretroviral efficacy. In these studies, each combination was well tolerated, with slightly more minor adverse events reported in patients taking AZT-based combinations. "The START data provide further evidence that d4T and AZT should both be considered first-line, standard-of-care options in triple combination HIV therapy," said Kathleen Squires, MD, associate professor of medicine in the division of infectious diseases at the University of Alabama at Birmingham. "The viral load and CD4+ cell responses in these studies have important implications for physicians and patients in that they provide study results to aid in applying new HIV treatment guidelines to clinical practice." These guidelines, recently issued by the Department of Health and Human Services (DHHS), recommend combining two nucleoside analogues with a protease inhibitor as the standard of care in HIV. In selecting the two nucleoside analogues to be used in three-drug regimens, the guidelines recommend combining a thymidine analogue with non-thymidine analogue. d4T and AZT are the only two thymidine analogues currently available. "Up to now, triple combination regimens have only been compared to two-drug combinations or to monotherapy," Dr. Squires said. "The START trials represent the first head-to-head comparison of the types of triple combination regimens that are recommended in the DHHS guidelines. That means we now have data demonstrating that d4T is at least as good as AZT when used as part of first-line combination regimens." Dr. Squires presented a 24-week analysis of the START I data, covering patients enrolled at 15 sites. These patients were randomised to receive either d4T/3TC/indinavir or AZT/3TC/indinavir for 48 weeks. Patients in the d4T-containing arm experienced a median decrease in viral load (a measure of the amount of HIV in the blood) of 1.95 log, compared to a 1.60 log decrease in the AZT arm. Viral loads were undetectable (less than 500 copies/mL) in 87 percent of patients in the d4T group, versus 80 percent in the AZT group. There was a trend toward greater increases in median CD4+ cell counts in the d4T arm than in the AZT arm (172.5 cells/mL versus 140.5 cells/mL, respectively). "The apparent increases in CD4+ cells are encouraging because preserving immune function is important for long-term management of HIV disease," Dr. Squires explained. She added that both triple combinations were well tolerated, though there were more minor gastrointestinal side effects in the AZT-containing arm. Similar findings emerged from the START II trial, preliminary results of which were presented by Joseph Eron, MD, assistant professor in the department of medicine at the University of North Carolina. In the study, One 100 patients at 14 sites were randomised to receive either d4T/ddI/indinavir or AZT/3TC/indinavir. At 24 weeks, the median viral load reduction was 1.64 log in the d4T/ddI group, versus 1.68 in the AZT/3TC group. Viral load was undetectable in 68 percent of patients taking the d4T-based combination and in 77 percent of those in the AZT arm. Median CD4+ count increases were 210.8 cells/mL and 138.5 cells/mL, respectively. "The START I and II findings support the use of d4T as a backbone of potent antiviral combinations," Dr. Eron said. "Although there is a need for more head-to-head research comparing d4T to AZT in combination therapy, the START trials offer important insights as we re-think the standard of care for people living with HIV/AIDS." More information on: AZT E-mail this page to a friend or colleague! To print, use this version