Atazanavir early access: now available through 20 UK HIV clinics

Keith Alcorn
Estimated reading time 5 minutes
This article is more than 22 years old.

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).

Glossary

lipid

Fat or fat-like substances found in the blood and body tissues. Lipids serve as building blocks for cells and as a source of energy for the body. Cholesterol and triglycerides are types of lipids.

cholesterol

A waxy substance, mostly made by the body and used to produce steroid hormones. High levels can be associated with atherosclerosis. There are two main types of cholesterol: low-density lipoprotein (LDL) or ‘bad’ cholesterol (which may put people at risk for heart disease and other serious conditions), and high-density lipoprotein (HDL) or ‘good’ cholesterol (which helps get rid of LDL).

investigational

In medicine, a drug that is approved by the regulatory authorities (Food and Drug Administration, European Medicines Agency) for testing in clinical trials, but not yet approved for commercial marketing and sale. Also called experimental drug, investigational agent, and investigational new drug (IND).

hyperlipidaemia

High levels of lipids (fat) in the blood, such as cholesterol and triglycerides, which raises the risk of cardiovascular disease.

triglycerides

A blood fat (lipid). High levels are associated with atherosclerosis and are a risk factor for heart disease.

 

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 nephrolithiasis

associated 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) or

cholesterol elevations

lang=EN-GB style='font-family:Symbol'>·       

Interactions with drugs other than

antiretrovirals 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

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 Ireland

lang=EN-GB> are currently awaiting local approval for participation. Other

lang=EN-GB>UK

 centres may be added.

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