BHIVA 2007: Fewer than 1 in 3 began treatment in line with UK guidelines last year

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Timing of ART initiation

Only 30.4% (n=400) began antiretroviral therapy with a CD4 count between 201-350 cells/mm3.

Another 40.6% (n=534) began treatment with a CD4 count between 51-200 cells/mm3.

A further 19% (n=250) commenced ART with a CD4 count below 50 cells/mm3.

One-in-ten (9.6%, n=126) began antiretroviral therapy with a CD4 count above 350 cells/mm3.

Glossary

clinical trial

A research study involving participants, usually to find out how well a new drug or treatment works in people and how safe it is.

exclusion criteria

Defines who cannot take part in a research study. Eligibility criteria may include disease type and stage, other medical conditions, previous treatment history, age, and gender. For example, many trials exclude women who are pregnant, to avoid any possible danger to a baby, or people who are taking a drug that might interact with the treatment being studied.

protease inhibitor (PI)

Family of antiretrovirals which target the protease enzyme. Includes amprenavir, indinavir, lopinavir, ritonavir, saquinavir, nelfinavir, and atazanavir.

renal

Relating to the kidneys.

seroconversion

The transition period from infection with HIV to the detectable presence of HIV antibodies in the blood. When seroconversion occurs (usually within a few weeks of infection), the result of an HIV antibody test changes from HIV negative to HIV positive. Seroconversion may be accompanied with flu-like symptoms.

 

Preliminary data from a national audit of UK patients starting antiretroviral therapy (ART) suggest that whilst late presentation continues to be a problem, late initiation of ART is also of great concern. Only 30% began treatment as currently recommended – with a CD4 count between 201-350 cells/mm3 – and more than 40% of patients diagnosed with HIV for at least six months delayed starting treatment until their CD4 counts were below 200 cells/mm3. The data were presented last week in Edinburgh on the final day of the 13th Annual Conference of the British HIV Association (BHIVA) with the British Infection Society.

Since 2001, BHIVA’s treatment guidelines have recommended that most people starting treatment for the first time should wait until their CD4 count has fallen below 350 cells/mm3 and before they reach 200 cells/mm3.

Dr Nicola Lomax of Homerton University Hospital presented preliminary results of an audit of UK patients starting ART between April 1st and September 30th 2006. Data were received for 1,319 patients from 133 UK HIV treatment centres, although two patients were excluded as ineligible for this analysis, leaving 1,317.

Just over half (n=704; 53.5%) were male and 43.7% (n=576) were female; gender was not stated for the remaining 2.7% (n=37).

Just under half (n=650; 49.4%) were of black African ethnicity. A further 38.3% (n=505) were white and 3.5% (n=46) were of black Caribbean ethnicity. Another 6.4% (n=84) were of ‘other’ ethnicity; and ethnicity was not stated for 2.4% (n=32).

No other demographic information were presented in this preliminary analysis.

Starting ART early

Reasons given for the 126 individuals who began ART at CD4 counts above 350 cells/mm3 included:

  • pregnancy (n=81)
  • symptoms (n=27)
  • recent seroconversion (n=7)
  • chronic renal failure (n=3)
  • clinical trial (n=1)
  • viral load above 100,000 copies/ml and PI resistance (n=1)
  • other (n=5)
  • reasons unclear (n=1)

The full results of this audit will be presented in October at BHIVA's Autumn conference in London. The key outcome will be viral load undetectability at six months following ART initiation.

Starting ART late

Of the 784 individuals who began ART with a CD4 count below 200 cells/mm3, 546 (69.6%) had been diagnosed late (i.e. within six months of commencing treatment).

However, the audit also found that late diagnosis was not a factor for the remaining 30.4%.

A total of 197 patients diagnosed with HIV for more than six months began antiretroviral therapy with a CD4 count between 51-200 cells/mm3. This represented 36.4% of all patients diagnosed with HIV for more than six months and starting ART for the first time.

A further 35 patients diagnosed with HIV for more than six months commenced ART with a CD4 count below 50 cells/mm3. This represented 6.5% of all patients diagnosed with HIV for more than six months and starting ART for the first time.

Comment and analysis

Hilary Curtis, who co-ordinates BHIVA’s audits, told aidsmap that the data were “shocking, although we don't know how many of these patients were attending regularly for care.” She added that “there are no obvious associations with” gender and ethnicity or with centre size or UK region.

She notes that they are in line with data presented by the Health Protection Agency (HPA) at last April’s BHIVA conference in Brighton, which found that more than half of the diagnosed HIV-positive individuals with low CD4 cell counts in 2004 and not on treatment, who were also seen in 2003, had low CD4 cell counts in 2003 and should have already have been on therapy.

The HPA study also found that there was some regional variation in the number of people who ought to have been on treatment but were not, although Ms Curtis notes that “the only regional information we have is inside/outside London which is probably too crude to show up” any meaningful association.

A variety of factors may be at play:

  • Some clinicians may not be following BHIVA guideline recommendations.
  • Some patients may be choosing not to begin ART despite recommendations to do so, due to fear of anti-HIV drug toxicity, or denial of HIV status.
  • Some patients may not be accessing regular HIV treatment and care due to the perception that they were not eligible and may face large bills from the NHS.

In addition, over the past few years some doctors from both sides of the Atlantic have begun to discuss the possibility of the earlier initiation of ART following the publication of positive studies in people who have already done so.

For example, a recent US study found that individuals who started anti-HIV therapy with a CD4 cell count above 350 cells/mm3 were significantly more likely than those who delayed until their CD4 cell count was in the currently recommended 350 – 201 cells/mm3 range to experience an increase in their CD4 cell count to normal levels after six years of antiretroviral therapy. “These data suggest that commencement of [HIV therapy] at a lower CD4 cell count will result in a CD4 cell count that does not return to normal levels; this may be a reason to consider starting [treatment for HIV] before the CD4 cell count decreases to 3”, write the investigators.

A recent editorial in the British Medical Journal concurred: “We therefore suggest that guidelines should now recommend starting treatment at around 350 cells/mm3, so long as the patient is ready”, they write.

If only 30% of individuals in the UK are initiating ART as per current recommendations, it will be important to understand the reasons why this is so before treatment guidelines consider changing their recommendations to earlier initiation.

References

Lomax N et al. BHIVA Audit Session: Set-up of patients starting treatment from naive. 13th Annual Conference of the British HIV Association with the British Infection Society, Edinburgh, 25-28 April 2007.