FDA approves atazanavir in US – a once daily protease inhibitor
1 July 2003. Related: Antiretrovirals.
The Food and Drug Administration (FDA) today announced the approval of atazanavir sulfate (Reyataz ), a protease inhibitor to be used in combination with other anti-retroviral agents for the treatment of patients with HIV infection.
Atazanavir is dosed at two pills taken once daily and needs to be taken with food.
Source: FDA press release
Detailed information on atazanavir is available in documents prepared for the FDA hearing in May, one by the FDA, the other by Bristol-Myers Squibb:
http://www.fda.gov/ohrms/dockets/ac/03/briefing/3950b1.htm
Comment
Atazanavir causes fewer cholesterol and triglyceride problems than the other PIs although limited data available has not so far shown that this translates to reduced levels of lipodystrophy.
Atazanavir is likely to require boosting with low dose (100mg) ritonavir in treatment experienced patients, and this doesn’t appear to reduce the beneficial lipid profile. Early data also indicates that tenofovir reduces both atazanavir and ritonavir levels by up to 25% and these two drugs should not be used together unless atazanaivr durg levels are confirmed using TDM and dosing individualised.
Atazanavir is currently available in the UK in an expanded access programme and doctors should call Dr Ian Hitchcock on 0208 754 3684 who is respnsible for this programme at BMS.