Atazanavir (Reyataz) provides long-term effects in previously untreated HIV-1 patients: BMS

Atazanavir, a protease inhibitor drug by Bristol-Myers Squibb Company has been shown effective in adult patients infected with HIV-1, who are previously untreated.
Atazanavir is sold under the brand name Reyataz.

Atazanavir (Reyataz) treatment can effectively suppress HIV viral load over 96 weeks in treatment-naïve patients while used in combination with other anti-HIV drugs, according to long-term data from the CASTLE Study, BMS said.

The CASTLE study assessed a once-daily Reyataz/ritonavir (Reyataz/r)-based regimen versus a twice-daily lopinavir/ritonavir (LPV/r)-based regimen in previously untreated adult patients infected with HIV-1.

Data from the study showed enduring virologic response through 96 weeks of treatment with Reyataz/r as part of combination therapy.

US Food and Drug Administration  has approved a labeling update for Reyataz to include long-term data from the CASTLE Study.

In the CASTLE Study, a majority of patients on the Reyataz/r regimen achieved undetectable viral load defined as HIV-1 RNA <50 copies/mL (Reyataz/r 75% vs. LPV/r 68%) – confirming efficacy through 96 weeks.

Low rates of drug resistance were observed at 96 weeks in patients who failed the Reyataz/r regimen, with one patient developing genotypic/phenotypic resistance to Reyataz and five patients developing genotypic/phenotypic resistance to emtricitabine.

In a pre-specified analysis, efficacy in patients with high baseline viral load was demonstrated: 74% of 223 patients in the once-daily Reyataz/r arm achieved undetectable viral load at 96 weeks vs. 67% of 222 patients in the twice-daily LPV/r arm.

In addition, the 96-week data confirmed the effect of Reyataz on lipids. There were lower mean increases from baseline in total cholesterol, LDL cholesterol and triglycerides with Reyataz/r compared to LPV/r; the Reyataz/r arm was associated with the following mean increases from baseline: total cholesterol (13%), LDL cholesterol (14%), HDL cholesterol (21%), and triglycerides (13%). The LPV/r regimen was associated with the following mean increases in lipids: total cholesterol (25%), LDL cholesterol (17%), HDL cholesterol (29%), and triglycerides (50%).

More than one million people are living with HIV and the annual incidence of new infections was 56,300 in the U.S, according to the most recent report from the Centers for Disease Control and Prevention.

Atazanavir (Reyataz) is a protease inhibitor – a central drug class in HIV therapy – that has been studied in both treatment-naive and treatment-experienced HIV-1-infected patients and is administered once daily as part of combination HIV therapy.

Atazanavir (Reyataz) has been approved in 2003 by US FDA. Currently, Atazanavir (Reyataz) has become one of the most prescribed protease inhibitor, in US

Atazanavir (Reyataz) is indicated in combination with other antiretroviral agents for treatment of HIV-1 infection. This is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from controlled studies of 96 weeks (treatment-naive) and 48 weeks (treatment-experienced) duration in adult and pediatric patients at least 6 years of age.

Atazanavir (Reyataz) 300 mg with ritonavir 100 mg is given once daily, all as a single dose, with food for treatment-naive and treatment-experienced adult patients. In treatment-naive adult patients unable to tolerate ritonavir atazanavir (Reyataz) 400 mg (without ritonavir) is given once daily with food.

Bristol-Myers Squibb is a global biopharmaceutical company.