Bristol-Myers Squibb Co. (BMY) said Thursday that the U.S. Food and Drug Administration had approved a labeling update for HIV drug Reyataz to include long-term data from the CASTLE Study. Long-term data from the CASTLE Study showed that treatment with Reyataz/r could effectively suppress HIV viral load over 96 weeks in treatment-naïve patients.
The 96-week CASTLE Study enrolled 883 treatment-naive adults infected with HIV-1, of which 440 patients were randomized to receive Reyataz and ritonavir once daily and 443 patients were randomized to receive fixed-dose lopinavir and ritonavir twice daily. All patients had a baseline viral load of greater than or equal to 5,000 copies/mL, with no CD4+ cell count restriction for study entry. The primary endpoint for the study was the proportion of patients with viral load less than 50 copies/mL at 48 weeks with an intent-to-treat, or ITT analysis according to confirmed virologic response.
In the long term CASTLE Study through 96 weeks, 75% of patients on the Reyataz/r regimen achieved efficacy, versus 68% among LPV/r. Patients with high baseline viral load (=100,000 copies/mL) also achieved efficacy, as 74% of 223 patients in the once-daily Reyataz/r arm achieved undetectable viral load at 96 weeks compared with 67% of 222 patients in the twice-daily LPV/r arm.
The effect of Reyataz on lipids was also confirmed in the 96-week data, being relatively lower mean increases from baseline in total cholesterol, LDL cholesterol and triglycerides with Reyataz/r compared to LPV/r. Safety events at 96 weeks were consistent with the prior experience.
The 48-week results of the study had already demonstrated that 78% of the 440 patients in the REYATAZ/r arm achieved the primary endpoint of achieving undetectable viral, compared with 76% of the 443 patients in the LPV/r arm.
Human immunodeficiency virus, or HIV is a lentivirus (a member of the retrovirus family) that causes acquired immunodeficiency syndrome, or AIDS, a condition in humans in which the immune system begins to fail, leading to life-threatening opportunistic infections. According to a report from the Centers for Disease Control and Prevention Studies, more than one million people are affected by HIV, with an annual incidence of new infections at 56,300 in the U.S. HIV infection in humans is considered pandemic by the World Health Organization, or WHO.
Reyataz is the first once-daily protease inhibitor to be approved by the FDA in June 2003 for combination therapy in HIV treatment. In 2008, the use of Reyataz boosted with Ritonavir in combination therapy, for previously untreated HIV-1 infected adult patients, was approved by the FDA.
Since its approval in 2003, the drug has generated significant revenues to Bristol-Myers Squibb. Reyataz logged in global sales of $1.01 billion for the nine months ended September 30, 2009 -- an increase of 5% over the comparable period last year. Sales of the drug in the U.S. for the nine-month period totaled $531 million, representing a 7% growth over the comparable period a year before. Total Prescription in the U.S. rose 7% year-over-year.
BMY closed Thursday's regular trading at $22.50, on the NYSE.
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