The FINANCIAL — Bristol-Myers Squibb Company (NYSE: BMY) on October 26 announced 96-week data from the CASTLE study, in which 74 percent of the 440 patients in the REYATAZ (atazanavir sulfate)/r arm achieved an undetectable viral load, defined as HIV-1 RNA less than 50 copies/mL, compared with 68 percent of the 443 patients in the lopinavir/r arm.
According to Bristol-Myers Squibb, the difference between treatment arms may have been related to the 16 percent discontinuation rate in the REYATAZ/r arm and the 21 percent discontinuation rate in the lopinavir/r arm. These data from the CASTLE study were presented today at the joint 48th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)/Infectious Diseases Society of America (IDSA) 46th annual conference in Washington, D.C.
“The 96-week analysis of the CASTLE study is consistent with the findings seen at 48 weeks, specifically the non-inferiority of once-daily REYATAZ/r compared to twice-daily lopinavir/r in treatment-naive patients,” said Jean-Michel Molina, M.D., HÃ´pital Saint Louis, Paris, France and from The University of Paris Diderot. “When initiating patients on antiretroviral combination therapy, it is important to include medicines with sustained activity against the virus, along with tolerability, to assist in the long-term treatment of patients with HIV-1.”
The most common grade 2-4 adverse events occurring in greater than or equal to three percent of patients in the once-daily REYATAZ/r arm or the twice-daily lopinavir/r arm were diarrhea (2 percent and 12 percent, respectively), nausea (4 percent and 8 percent, respectively), jaundice (4 percent and 0 percent, respectively).
The REYATAZ®/r arm was associated with significantly lower increases from baseline compared to the lopinavir/r arm in total cholesterol, non-HDL cholesterol, and triglycerides at 96 weeks (p<0.0001). Two percent of patients in the REYATAZ/r arm and nine percent of patients in the lopinavir/r arm required initiation of lipid-lowering therapy while on study.
Safety events in this study were consistent with prior experience. No new or unexpected safety events were identified. Six deaths were reported in the REYATAZ/r arm (equal to one percent of total patients in REYATAZ/r arm) and five deaths were reported in the lopinavir/r arm (equal to one percent of total patients in lopinavir/r arm) at 96 weeks. Fourteen percent of patients in the REYATAZ/r arm and eleven percent of patients in the lopinavir/r arm experienced a serious adverse event.