Wednesday, July 14, 2004

IN BRIEF: GLAXOSMITHKLINE PLC

GlaxoSmithKline Plc and Boehringer Ingelheim signed a letter of intent to accelerate development of a co-packaged version of Boehringer's Viramune (nevirapine) and GSK's Combivir (lamivudine and zidovudine). In a press release, GSK said the move is designed to increase treatment options for HIV in the developing world. The availability of the combination package, which would consist of two separate blister packs in one carton, is subject to regulatory authorities and execution of a definitive agreement.

Tuesday, July 6, 2004

IN BRIEF: GLAXOSMITHKLINE PLC

GlaxoSmithKline Plc said it will remain a participant in a large HIV trial sponsored by the National Institutes of Health, The Wall Street Journal reported. The firm had previously told researchers it was withdrawing, causing a delay in the study's start. The trial will compare three treatment regimens among more than 1,000 patients in Africa, Brazil, India and other areas. GSK's pharmaceutical brand Combivir (lamivudine and zidovudine), in conjunction with other antiretroviral agents, is indicated for treating HIV infection.

Friday, April 30, 2004

COMBIVIR OR TRIZIVIR PLUS SUSTIVA ASSOCIATED WITH LOWER VIROLOGIC FAILURE RATE THAN TRIZIVIR ALONE

GlaxoSmithKline Plc's triple-nucleoside combination drug Trizivir (zidovudine, lamivudine and abacavir) appears to be virologically inferior to a regimen of GSK's Combivir (zidovudine and lamivudine) plus Bristol-Myers Squibb Co.'s Sustiva (efavirenz) or a regimen of Trizivir plus Sustiva, according to a new study.   A total of 1,147 patients with an average baseline HIV-1 RNA level of 4.85 log10 copies/mL and an average CD4 cell count of 238/mm3 were randomized to receive Trizivir, Combivir plus Sustiva or Trizivir plus Sustiva. The planned duration of the trial was 96 weeks, and virologic failure was defined as two successive HIV-1 RNA values of 200 or more copies/mL at least 16 weeks after randomization.   After a scheduled review, pairwise comparisons of the three study groups' data showed differences between the Trizivir regimen and each of the Sustiva-containing regimens that met prespecified stopping guidelines. Thus, the data and safety monitoring board recommended the Trizivir arm be discontinued and the other two groups continue double-blind follow-up. They also recommended an analysis of the data from the Trizivir group be compared with pooled data from the Sustiva groups.   During a median 32-week follow-up, virologic failure occurred in 82 patients (21 percent) who received Trizivir as compared with 85 patients (11 percent) in the combined Sustiva groups. Furthermore, the time to virologic failure was significantly shorter in the Trizivir arm than the combined Sustiva arms.   "Our findings suggest that a [Sustiva]-containing regimen is more potent than the triple-nucleoside regimen and support current guidelines that recommend [Sustiva]-based regimens among the preferred options for the initial treatment of HIV-1 infection," the study authors concluded.   These data were published in the April 29 issue of The New England Journal of Medicine.