Outline of changes to UK 2003 guidelines for treating HIV in adults

Simon Collins, HIV i-Base

The bi-annual review of the UK treatment guidelines, produced by the British HIV Association, is already largely written, and Dr Duncan Churchill provided an outline of the committee’s thinking for the main changes.

The purpose of guidelines is listed as to promote a uniformly high standard of care, to set out the strengths, weaknesses and relevance of research findings, to assist in discussions between purchasers and providers, to act as a basis for clinical audit and as a source of reference for physicians and HIV-positive people.

Key issues

Treatment in primary HIV infection will be recommended if needed to relieve severe symptoms but is not generally recommended otherwise, unless as part of a clinical trial. Treatment during chronic infection remains largely determined by CD4 count, with recommendation to start treatment while still 200-350 cells/mm3 or at higher levels if symptomatic. Exact timing depends on various factors, including determinants of short-term risk.
Considerations for recommending treatment regimens include ease of adherence and minimising toxicity, and should take account of individual factors, e.g. hepatitis B/C, risk of cardiovascular disease, diabetes, psychiatric disease, lifestyle.
Recommended options for starting treatment remain based on the dual nucleoside backbone, plus either an NNRTI or a boosted-PI. The committee believes there is no definitive evidence on which to base a preference but accept that based on the most recent audit that clinicians currently favor NNRTI-based first-line treatment.
Unboosted PI regimens will not be recommended for first choice due to poorer pharmacokinetics, and less convenient dosing.
Triple nucleoside combinations previously favoured by the BHIVA committee such as Trizivir (AZT/3TC/abacavir) are not now recommended due to lower potency shown in recent trials. They will no longer be recommended even for patients with a low baseline VL (<50,000). d4T regimens are not recommended due to increased association with lipodystrophy.
Use of resistance testing is recommended prior to starting treatment. In practice this means that people should receive or have a sample stored for later testing when diagnosed.
Resistance testing is also recommended with any confirmed virological rebound or failure, when the likely cause of failure should be determined before deciding on subsequent treatment. This should prompt assessment of other factors such as resistance, adherence, and pharmacokinetics.
If reasonable options are available, switch regimen as soon as virological rebound is confirmed (two consecutive viral loads >400), otherwise continue current therapy unless at high imminent risk. If at high imminent risk, switching treatment should be considered even if the next regimen is unlikely to be optimally suppressive.
Interrupting or stopping treatment may benefit patients with high pre-treatment CD4 count (not specified in the overview) and undetectable viral load, but careful monitoring is needed. It is not recommended in treatment failure for those with other good options, although salvage patients with no good options, can consider entry into clinical trial of structured treatment interruptions such as Optima.
Two new sections are to be included in the guidelines: one to cover monitoring tests and another to address patients who now find themselves using treatment combinations not now recommended in the guidelines (such as Trizivir or d4T).
Therapeutic drug monitoring (TDM) is seen as being of value in specific circumstances, such as reducing toxicity, and adjusting doses in significant hepatic or renal impairment, and will be referenced as tabled recommendations.
Sections on the management of side effects such as lactic acidosis, metabolic changes and lipodystrophy (to include a stronger recommendation for New-Fill), will be updated and finally, a short section will be included on drugs in development that are likely to be licensed over the next year.

The full guidelines are likely to run to 50 pages plus references, with detailed chapters on many important aspects of HIV care. A shorter summary will also be produced that outlines the main changes. It is hoped that this reduced summary will provide a clearer guide to the general approach to treatment.

The final guidelines together with the summary will then be available to download as a pdf file on the BHIVA website. They will be published in the October issue of HIV Medicine.

Ref: Churchill D – BHIVA treatment guidelines. Symposium session, 9th BHIVA Conference, 24-26 April 2003, Manchester.

Comment

Comments are invited and encouraged from clinicians, community groups, the pharmaceutical industry and other interested parties. As in previous years, these comments will be included on the website to provide a public discussion.

The draft document will be posted to the internet in the first week of June at:
http://www.bhiva.org