Bristol-Myers Squibb Company announced that Reyataz (atazanavir sulfate) has received approval from the US FDA to include new scientific data and dosing in its package insert, or labelling, from BMS Study AI424-045.

With the approval of the supplemental New Drug Application (sNDA), the Reyataz labelling now includes data indicating that combination HIV treatments containing Reyataz/ritonavir and Kaletra (lopinavir/ritonavir; Abbott Laboratories, Inc.) were similar for the primary efficacy outcome measurement of time-averaged difference in change from baseline in HIV RNA level in HIV-infected patients previously taking anti-HIV medicines, a company release said.

However, Study 045 was not large enough to reach a definitive conclusion that Reyataz/ritonavir and Kaletra are equivalent on the secondary efficacy outcome measure of proportions of HIV-1 RNA less than 400 or 50 copies/ml. There are no data regarding the use of Reyataz/ritonavir in patients who have never taken anti-HIV medicines.

Addressing the primary efficacy outcome measurement of the study, Kathleen Squires, Keck School of Medicine of the University of Southern California said, "The expanded Reyataz labelling enables physicians to provide their patients with a once-daily protease inhibitor that, in combination therapy, has been shown in a clinical trial to demonstrate efficacy in viral load reduction similar to Kaletra."

Another secondary endpoint of Study 045 was to compare changes from baseline in lipid values after 48 weeks of treatment. The observed magnitude of dyslipidemia was less with Reyataz (atazanavir sulfate)/ritonavir than with Kaletra. However, the clinical impact of such findings has not been demonstrated. At this time point, the percentage of patients who had total cholesterol greater than or equal to 240 mg/dl was 25 per cent in the Reyataz/ritonavir arm and 26 per cent in the Kaletra arm. The percentage of patients with triglyceride levels greater than or equal to 751 mg/dl was 8 per cent and 12 per cent, respectively.

"Today's sNDA approval represents another strong step forward for Reyataz and for Bristol-Myers Squibb in the treatment of HIV/AIDS," said Anthony Hooper, president, US Pharmaceuticals, Bristol-Myers Squibb Company. "Over 31,000 patients have received a HAART (highly-active antiretroviral therapy) regimen containing Reyataz since it was approved in June 2003. With this approval, doctors have additional information for treating their HIV/AIDS therapy-experienced patients," he added.

BMS Study AI424-045 is an ongoing, randomized, multi-centre trial comparing Reyataz/ritonavir (300 mg/100 mg) once daily to Reyataz with saquinavir soft gelatin capsules (400 mg/1200 mg) once daily, and to Kaletra (400 mg lopinavir/100 mg ritonavir) twice daily, each in combination with tenofovir and one nucleoside reverse transcriptase inhibitor (NRTI), in 347 (of 358 randomized) patients who previously experienced virologic failure on at least two regimens containing PIs, NRTIs and non-nucleoside reverse transcriptase inhibitors (NNRTIs). In Study 045, co-administration of Reyataz and saquinavir did not provide adequate efficacy.

Reyataz is a prescription medicine that has been studied in 48-week trials in both patients who have taken or have never taken anti-HIV medicines. Reyataz does not cure HIV or help prevent passing HIV to others, the release says.