Atazanavir, the investigational protease
inhibitor, is being made available by its manufacturer, Bristol Myers Squibb,
in an early access programme (click here for more information about atazanavir).
Early access to atazanavir is likely to be most appropriate for people on HIV therapy currently experiencing serious problems with lipid increases, and for people who need to put together a new HAART regimen after the failure of several previous drug combinations, due either to intolerance or viral rebound. Of particular note is the lack of restriction on combining atazanavir with other investigational agents; this means that atazanavir can be used at the same time as T-20, also available through an early access programme announced earlier this month.
Patients will qualify if they have:
CD4 count below 300 cells/mm3 and viral
load above 5,000 copies/ml (due either to rebound or lack of response to
new regimen).
Inability to construct a new, effective
regimen due to:
lang=EN-GB style='font-family:Symbol'>·
Adverse reactions to other drugs eg nephrolithiasisassociated with indinavir (at least two episodes in the past six months, or
three in total); grade 3 / 4 hypersensitivity reaction; any other grade 3 or 4
toxicity
lang=EN-GB style='font-family:Symbol'>·
Serious triglyceride (>8.5mmol/l) orcholesterol elevations
lang=EN-GB style='font-family:Symbol'>·
Interactions with drugs other thanantiretrovirals that are essential to a patient’s care eg TB drugs
Atazanavir must be combined with at least
two other effective agents; it should not be added to failing therapy as a
single agent. Atazanavir should not be combined with ritonavir or lopinavir.
OR if they have:
Severe hyperlipidemia that has not
responded to lipid-lowering drugs, or where the patient is unable to
tolerate lipid-lowering medication. Hyperlipidemia is defined as
triglycerides above 8.5mmol/l and/or cholesterol levels that meet National
Cholesterol Education Program levels for intervention. Individuals with
significant cardiovascular disease (such as unstable ischaemic heart
disease) or cardiac conduction abnormalities will not be allowed to receive atazanavir because the drug may affect cardiac conduction (PR and QTc interval) especially when co-administered with other agents that share this risk.
For safety reasons, individuals receiving
other experimental drugs through expanded access programmes will be allowed to
participate subject to discussion of their individual case.
Individuals with elevated liver enzyme
levels or bilirubin levels < 1.5 times above the upper limit of normal will
not be eligible.
Individuals who think they may benefit from atazanavir should contact their doctor to discuss whether they will qualify and whether their centre will be able to take part in the early access programme. In the UK
lang=EN-GB>, the following centres are able to prescribe atazanavir through the
expanded access programme:
Brighton & Sussex University.Hospital NHS Trust,
Brighton
Western General Hospital, Edinburgh
Mayday Hospital, Croydon
Royal Liverpool University Hospital, Liverpool
Kobler Clinic, Chelsea & Westminster Hospital, London
Royal Free Hospital, London
Unversity Hospital of Wales, Cardiff
Newcastle General Hospital, Newcastle
St Mary's Hospital, London
Leeds General Infirmary, Leeds
Royal London Hospital - Ambrose King Centre, Whitechapel
St. George's Hospital, London
Newham General Hospital, London
North Manchester General Hospital, Manchester
Royal South Hants Hospital, Southampton
Whittall Clinic, Birmingham
Monklands Hospital, Airdrie
Homerton University Hospital, London
Monkgate Health Centre, York
Birmingham Heartlands Hospital, Birmingham
Three centres in the
lang=EN-GB>Republic
of Irelandlang=EN-GB> are currently awaiting local approval for participation. Other
lang=EN-GB>UK
centres may be added.