Healthcare Industry News:  Bristol-Myers Squibb 

Biopharmaceuticals HIV/AIDS Regulatory

 News Release - June 24, 2008

European Commission Approves REYATAZ(R) (Atazanavir Sulfate 100mg, 150mg, 200mg, 300mg), in Combination With Other Antiretroviral Medicinal Products, for use in Treatment Na´ve HIV-1 Infected Adults

REYATAZ(R), Taken With Ritonavir, Provides an Additional Therapy Option in Treatment-Na´ve HIV-1 Infected Adults in the European Union

PARIS, June 24 (HSMN NewsFeed) -- The European Commission has granted marketing authorization for REYATAZ« (atazanavir sulfate 300mg once daily), administered with ritonavir 100 mg once daily and taken in combination with other antiretroviral medicinal products, in antiretroviral treatment-na´ve human immunodeficiency virus-1 (HIV-1) infected adults. The decision means that the use of REYATAZ« in antiretroviral treatment na´ve patients is approved for marketing in the 27 countries of the European Union.

"Efficacy, tolerability and safety are key factors when physicians are selecting a therapy regimen for previously untreated patients," said Jean-Michel Molina, M.D., H˘pital Saint Louis, Paris, France. "REYATAZ« is a very potent and convenient, once-daily protease inhibitor that offers the benefit of good tolerability. It is the first time that a boosted PI with a once-daily regimen is approved in Europe. This offers an additional therapy option for both na´ve and treatment-experienced patients."

The CASTLE study(1) provided the basis for Registration filings for REYATAZ«/ritonavir in treatment-na´ve patients. This large-scale, open-label, randomized study was designed to show the non-inferiority of REYATAZ«/ritonavir to lopinavir/ritonavir in previously untreated HIV-1 infected adult patients.

Same efficacy with a better gastro-intestinal and lipid profile

The results showed that efficacy was similar in both study arms; 78 percent of patients (n=343/440) taking once-daily REYATAZ«/ritonavir met the primary endpoint of achieving undetectable viral load (defined as less than 50 copies/mL) at 48 weeks, compared with 76 percent of patients (n=338/443) taking twice-daily lopinavir/ritonavir.

Safety events in the study were consistent with prior experience, and patients taking REYATAZ«/ritonavir experienced lower rates of Grade 2-4 adverse events such as diarrhoea (2%) and nausea (4%) than those taking lopinavir/ritonavir - 11% and 8%, respectively. Additionally, the REYATAZ«/ritonavir arm was associated with significantly lower increases from baseline compared to the lopinavir/ritonavir arm in total cholesterol, triglycerides and non-HDL cholesterol at 48 weeks (p<0.0001).

As with previous observation, 34% of the patients in the REYATAZ« /ritonavir arm and less than 1% of patients in the twice-daily lopinavir/ritonavir arm experienced elevations in total bilirubin (hyperbilirubinaemia) greater than 2.5 times the upper limit of normal. This elevation was not associated with liver dysfunction as the rates of Grade 3-4 liver enzyme elevations were similar between treatment groups (2% in once-daily REYATAZ«/ritonavir arm vs 1% in the twice-daily lopinavir/ritonavir arm).

About the CASTLE study

The international, multi-center, open-label, 96-week CASTLE study randomized 883 treatment-naive patients infected with HIV-1. Four hundred and forty patients were randomized to receive REYATAZ« 300 mg and ritonavir 100 mg once daily and 443 patients were randomized to receive lopinavir/ritonavir 400/100 mg twice daily, each in combination with a once-daily, fixed-dose combination of emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg.

All patients had a baseline viral load of greater than or equal to 5,000 copies/mL; there was no CD4+ cell count restriction for study entry. The primary endpoint for the study was the proportion of patients with viral load of less than 50 copies/mL at 48 weeks.

Study results

- Efficacy was similar in both study arms - 78 percent of patients (n=343/440) taking once-daily REYATAZ«/ritonavir met the primary endpoint of achieving undetectable viral load (defined as less than 50 copies/mL) at 48 weeks, compared with 76 percent of patients (n=338/443) taking twice-daily lopinavir/ritonavir.

- Patients taking REYATAZ«/ritonavir experienced lower rates of Grade 2-4 adverse events such as diarrhea (2%) and nausea (4%) than those taking lopinavir/ritonavir - 11% and 8%, respectively, consistent with prior experience.

- The REYATAZ«/ritonavir arm was associated with significantly lower increases from baseline compared to lopinavir/ritonavir arm in total cholesterol, triglycerides and non-HDL cholesterol at 48 weeks (p<0.0001).

- As with previous observation, 34% of the patients in the REYATAZ«/ritonavir arm and less than 1% of patients in the twice-daily lopinavir/ritonavir arm experienced elevations in total bilirubin (hyperbilirubinaemia) greater than 2.5 times the upper limit of normal.

- The elevation in bilirubin was not associated with liver dysfunction as the rates of Grade 3-4 liver enzyme elevations were similar between treatment groups (2% in once-daily REYATAZ/r arm vs 1% in the twice-daily lopinavir/ritonavir arm).

About REYATAZ (atazanavir sulfate)

REYATAZ is a prescription medication used in combination with other medicines to treat people infected with the human immunodeficiency virus (HIV). It does not cure HIV or prevent passing HIV to others. REYATAZ« (atazanavir sulfate) is a registered trademark of Bristol-Myers Squibb Company.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life.

(1) Molina, JM, Andrade-Villanueva, J, Echevarria, J. Et al. `Efficacy and Safety of Once-Daily Atazanavir/Ritonavir (ATV/r) Compared to Twice-Daily Lopinavir/Ritonavir (LPV/r), Each in Combination with Tenofovir (TDF) and Emtricitabine (FTC), in Antiretroviral (ARV) Naive HIV-1 Infected Subjects. The CASTLE Study (AI424-138) 48 Week Results. Oral presentation. 15th Conference on Retroviruses and Opportunistic Infections, Boston, USA, 2008.


Source: Bristol-Myers Squibb

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