Lipodystrophy common, but does not affect adherence in Thai patients

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Lipodystrophy is common among Thai patients taking first-line therapy but has not affected adherence to treatment, a Thai research group reported on Monday at the XVII International AIDS Conference in Mexico City. However, the condition is not being managed by reducing the d4T dose as recommended by the World Health Organization in 2007.

Lipodystrophy – predominantly fat loss from the face, buttocks and limbs – is particularly associated with treatment with d4T, and to a lesser extent, AZT. It can occur whether patients are taking drugs from the NNRTI or protease inhibitor class.

The condition has been observed in 20-30% of patients taking d4T-containing ART, with the frequency and severity of fat loss worsening as time goes on (CHECK frequency).

Glossary

lipodystrophy

A disruption to the way the body produces, uses and distributes fat. Different forms of lipodystrophy include lipoatrophy (loss of subcutaneous fat from an area) and lipohypertrophy (accumulation of fat in an area), which may occur in the same person.

first-line therapy

The regimen used when starting treatment for the first time.

viral breakthrough

An increase in viral load while on antiretroviral treatment.

fixed-dose combination (FDC)

Two or more drugs contained in a single dosage form, such as a capsule or tablet. By reducing the number of pills a person must take each day, fixed-dose combination drugs may help improve adherence.

naive

In HIV, an individual who is ‘treatment naive’ has never taken anti-HIV treatment before.

In developing countries first-line treatment usually includes d4T because the drug is cheap. In Thailand the standard first-line regimen is GPOVir, a locally manufactured fixed-dose combination of d4T, 3TC and nevirapine.

To assess the frequency of lipodystrophy and its effects on quality of life and subsequent adherence to treatment researchers enrolled 753 treatment-naïve HIV- infected patients from 45 community hospitals in northern Thailand between April 2004 and October 2004.

Data collected included HAART regimens and scores on SF12- a 12 item quality of life questionnaire.

Researchers relied on patients self-reporting any problems with lipodystrophy but then interviewed them on its impact on their life and whether they felt it was associated with their therapy.

After three years of follow up 101 patients (13.4%) had died and there were 559 patients from the original cohort (74.2%) available for interview. Mean age was 35.8 years and 53.7% were female.

At the start of the study period 98.9% were taking GPOVir. The rest (1.1%) were started on d4t, lamivudine and efavirenz (Sustiva).

After three years 73.7% were still on d4t, lamivudine and nevirapine and 6.4% were on d4t, lamivudine and efavirenz.

Eighteen per cent of patients had replaced d4T with zidovudine due to lipodystrophy. Overall prevalence of lipodystrophy was 27.7% with the most common site being the cheeks (72% of cases). Female patients and older patients were at significantly increased risk of developing lipodystrophy.

Quality of life was significantly lower in patients with lipodystrophy – both in terms of physical and mental well being.

When asked about their perceptions of lipodystrophy in relationship to HAART, 14.8% felt a very strong desire to change treatment but only 0.6% wanted to stop.

Lipodystrophy was not affecting adherence to treatment – there was no significant difference in adherence or rates of viral rebound among those with and without lipodystrophy. However it should be noted that viral load was measured only if the patient’s CD4 count had fallen compared to the previous six-monthly visit, a measure that is likely to underestimate low-level viral breakthrough due to poor adherence.

Although the study authors recommend an urgent reassessment of recommended regimens in the light of the impact of lipodystrophy on adherence and social stigmatisation, they had not taken steps to reduce the dose of d4T to 30mg twice daily, as recommended by WHO in 2006, midway through the period under analysis. A lowered dose has been associated with a lower rate of lipodystrophy, paradoxically in a study conducted in Bangkok in 2003.

References

Chariyalertsak S et al. Prevalence of lipodystrophy after 3 years of WHO first line ART and its impact on quality of life and negative perception to ART in Thailand. XVII International AIDS Conference, Mexico City, abstract MOPDB101, 2008.