Healthcare Industry News: ritonavir
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 Naïve HIV-1 Infected Adults
REYATAZ(R), Taken With ritonavir, Provides an Additional Therapy Optionin Treatment-Naïve 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-naïve human immunodeficiency virus-1 (HIV-1) infected adults. The decision means that the use of REYATAZ® in antiretroviral treatment naïve 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., Hôpital 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 naïve and treatment-experienced patients."
The CASTLE study(1) provided the basis for Registration filings for REYATAZ®/ritonavir in treatment-naïve 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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