Hoffmann, R. A wiki for the life sciences where authorship matters. Nature Genetics (2008)

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Gulick, R.M. et al.

Gulick, Ribaudo, Shikuma, Lustgarten, Squires, Meyer, Acosta, Schackman, Pilcher, Murphy, Maher, Witt, Reichman, Snyder, Klingman, Kuritzkes,

Triple-nucleoside regimens versus efavirenz-containing regimens for the initial treatment of HIV-1 infection.

BACKGROUND: Regimens containing three nucleoside reverse-transcriptase inhibitors offer an alternative to regimens containing nonnucleoside reverse-transcriptase inhibitors or protease inhibitors for the initial treatment of human immunodeficiency virus type 1 (HIV-1) infection, but data from direct comparisons are limited. METHODS: This randomized, double-blind study involved three antiretroviral regimens for the initial treatment of subjects infected with HIV-1: zidovudine-lamivudine-abacavir, zidovudine-lamivudine plus efavirenz, and zidovudine-lamivudine-abacavir plus efavirenz. RESULTS: We enrolled a total of 1147 subjects with a mean baseline HIV-1 RNA level of 4.85 log10 (71,434) copies per milliliter and a mean CD4 cell count of 238 per cubic millimeter were enrolled. A scheduled review by the data and safety monitoring board with the use of prespecified stopping boundaries led to a recommendation to stop the triple-nucleoside group and to present the results in the triple-nucleoside group in comparison with pooled data from the efavirenz groups. After a median follow-up of 32 weeks, 82 of 382 subjects in the triple-nucleoside group (21 percent) and 85 of 765 of those in the combined efavirenz groups (11 percent) had virologic failure; the time to virologic failure was significantly shorter in the triple-nucleoside group (P<0.001). This difference was observed regardless of the pretreatment HIV-1 RNA stratum (at least 100,000 copies per milliliter or below this level; P< or =0.001 for both comparisons). Changes in the CD4 cell count and the incidence of grade 3 or grade 4 adverse events did not differ significantly between the groups. CONCLUSIONS: In this trial of the initial treatment of HIV-1 infection, the triple-nucleoside combination of abacavir, zidovudine, and lamivudine was virologically inferior to a regimen containing efavirenz and two or three nucleosides.[1]

References

Triple-nucleoside regimens versus efavirenz-containing regimens for the initial treatment of HIV-1 infection. Gulick, R.M., Ribaudo, H.J., Shikuma, C.M., Lustgarten, S., Squires, K.E., Meyer, W.A., Acosta, E.P., Schackman, B.R., Pilcher, C.D., Murphy, R.L., Maher, W.E., Witt, M.D., Reichman, R.C., Snyder, S., Klingman, K.L., Kuritzkes, D.R. N. Engl. J. Med. (2004) [Pubmed]

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