First audit of BHIVA treatment guidelines reveals suboptimal access to viral load and resistance tests

11 June 2002. Related: Guidelines, BHIVA news.

Simon Collins, HIV i-Base

Given the complexity of treating HIV and the relatively rapid change in approaches to treatment, ensuring access to the latest advances is an obvious patient concern.

It is unfortunate that unlike France, the UK does not run a database that can track how closely recommendations from expert guidelines are followed in clinical care.

It is therefore important that the British HIV Association (BHIVA) decided to run it’s own pilot audit in 2001 to evaluate the impact of the UK treatment guidelines, to collect national aggregate data on patterns of prescription and to provide confidential reports to individual units on how their results compared to national figures.

The preliminary results presented at the 8th Annual BHIVA Conference in York on April 19-21 showed that suboptimal access to care remains a cost-related issue at some centres. It also provided an indication of the usefulness and importance of maintaining up-to-date treatment guidelines in the UK.

Sampling and demographics

This national clinical audit was from an analysis of 2,044 patient summary sheets from 146 centres. Each centre was asked to provide data from the last 10 consecutively seen patients in September 2001 (last 25 patients for larger centres) concerning when treatment was started, which treatments were used, the aims and outcomes of treatment and use of resistance testing. Each patient questionnaire involved a reasonably detailed treatment history and it is encouraging that centres undertook this additional work in a voluntary capacity.

Although the audit included clinics with both large and small numbers of HIV patients from across the UK the sampling method produced a relative under-sampling of patients from very large centres and was not therefore expected to produce a demographically representative sample of the HIV population.

Impact of guidelines

Nine of 147 centres in the survey (6%) had not seen or read the guidelines although 109/147 (74%) said that they had influenced the care provided. In particular, the guidelines were reported to be useful in the active management of patients’ care as well as improving access to funding for treatment and development of local guidelines.

Current health status

Although three-quarters of HIV-positive patients currently had a good CD4 count above 200 cells/mm3 (27% 201-350, 23% 351-500 and 25% >500 cells/mm3), 18% had an AIDS defining count of 51-200 cells/mm3 and four percent had advanced AIDS with a CD4 count under 50 cells/mm3.

Forty-four per cent of patients had undetectable viral load <50 copies/ml and a further 14% were <500 copies/ml. Fifteen per cent were between 500-10,000, 7% between 10,000-30,000 and 15% were over 30,000.

Knowing that 75% of patients in the survey were on treatment, then approximately 15% of people in the total survey are currently on ‘failing’ treatment with a persistently detectable viral load >500 copies/mL. Although the results cannot be exactly extrapolated to the UK national cohort, if we assume 15,000 people are currently on treatment in the UK, this survey provides an indication that 1,200-1,800 people may be currently on a failing combination.

Treatment prescription patterns

Current treatment prescription is broadly in line with guideline recommendations. Three or more drugs were being used in 1,479 of the 1,516 regimens of people on treatment. Thirty-six people were using only two drugs and one person was using monotherapy. Additional notes were collected with most of these cases, and this was reported as patient choice or a temporary measure due to complication of concomitant treatment.

Of the 513 patients not on treatment, 77 (15%) had a CD4 count under 200 and a further nine patients had a history of severe symptoms. Only 26 (including 11 newly diagnosed) were reported to be about to start or restart treatment, reflecting a patient group who still choose to delay treatment even when they are at a high risk of HIV progression.

The recommendation to start treatment at a lower CD4 count seemed to be reflected in the audit results, with fewer people starting treatment at CD4 count over 350 cells/mm3 in 2001 than in 2000. However around a quarter of people in each year started treatment with a CD4 count less than 50 copies/mm3 and although the majority of these cases are explained by late diagnosis (39% diagnosed <50 and 42% diagnosed 51-200), small numbers of patients diagnosed at much higher levels chose to delay treatment until their CD4 counts had fallen to the higher risk group.

Treatment choice and efficacy

Current treatment also broadly follows guideline recommendations with 97.5% of people using three or more drugs. Breakdown by regimen includes 25% of people using two RTIs and single/boosted PI, 55% using two RTIs and an NNRTI, 8% on triple nucleoside and 12% using other 3+ drug combinations. Latest viral load results for people using three or more drugs showed 59% undetectable <50 copies/ml, 18% <500 copies/ml, 10% between 500-10,000 copies/ml and 10% >10,000 copies/ml, although a separate breakdown between people just starting a combination compared to people continuing on a failing combination.

Restricted access to drugs and assays

Few clinics reported individual drug prescription difficulties: three with Trizivir, two with Kaletra/boosted PIs and one with access to tenofovir. Two areas that were not addressed directly were whether costs play a role in deciding whether or not treatment is offered in primary infection and whether the numbers of drugs that can be provided in mega-HAART combinations for treatment experienced patients is limited by cost, and it would be interesting to include this in a future audit.

However, limited access to resistance testing and viral load testing highlighted serious problems. For example, use of an ultrasensitive viral load test (sensitive to 50 copies/mL) has been recognised as standard of care in most hospitals for more than two years and yet 11 clinics (7.5%) have either no or only limited access to this assay. This is an essential test to confirm a maximally suppressive regimen which itself is probably the primary aim of treatment. It is also essential in order to be able to detect an early-failing regimen and therefore minimise the risk of developing further resistance.

Only 94 of the 146 clinics in the audit (63%) have access to viral load tests that are sensitive to specific subtypes, with 23 clinics (16%) having no access; and 27 centres (18%) were uncertain about whether the tests they used were sensitive to non-B strains. This similarly limits the ability to provide optimal treatment management for people with non-B sub-types at these treatment centres.

It is disturbing to learn that resistance testing is similarly not universally available. Eighty-two per cent of clinics report ability to use resistance tests as clinically required, but 14 (9%) are limited in their use and five clinics (3.4%) report not being able to use these tests at all. People at these centres who require access to these tests would be well-advised to register at another centre, although if denial of services is based on costs, then this is an option that would no doubt be encouraged by those health authorities.

Summary

In summary, this preliminary analysis audit provides an important overview of current treatment provision and it is hoped that the 2002 audit can include a larger proportion of patients. Results from individual centres will remain confidential and this was decided in advance of the audit in order to encourage clinics to take part. Individual reports are however available to clinics on request so they can see how the evaluation of their unit compared to the national average.

BHIVA guidelines are available to download in PDF format from:
http://www.bhiva.org

Reference:

Johnson M, Curtis H – BHIVA national clinical audit of ART. 8th BHIVA Conference, 19-21 April 2002, York.
http://www.regordane.demon.co.uk/bhiva