Side effects

NNRTI patients switched to Trizivir show lipid improvements

Michael Carter
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Switching to triple NRTI therapy from an NNRTI-based HAART regimen can lead to a significant improvement in lipids without loss of virological control, according to a Europe-wide study published in the August 15th edition of AIDS.

The GlaxoSmithKline TRIZAL study was a randomised, open label study, designed to investigate the safety of switching HAART patients who had achieved an HIV viral load below 50 copies/mL for at least six months to triple NRTI therapy, consisting of Trizivir (AZT, 3TC and abacavir).

Of the 209 patients enrolled in the trial, 40 were taking NNRTI based therapy before randomisation. At week 48 of the study, 65% of the 20 patients who remained on an NNRTI had a viral load below 50 copies/mL compared to 75% of the 20 individuals switched to Trizivir (p=0.49).

Glossary

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).

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.

protease inhibitor (PI)

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

p-value

The result of a statistical test which tells us whether the results of a study are likely to be due to chance and would not be confirmed if the study was repeated. All p-values are between 0 and 1; the most reliable studies have p-values very close to 0. A p-value of 0.001 means that there is a 1 in 1000 probability that the results are due to chance and do not reflect a real difference. A p-value of 0.05 means there is a 1 in 20 probability that the results are due to chance. When a p-value is 0.05 or below, the result is considered to be ‘statistically significant’. Confidence intervals give similar information to p-values but are easier to interpret. 

open-label

A clinical trial where both the researcher and participants know who is taking the experimental treatment. 

There were significant differences between the lipid profiles of the NNRTI and switch patients. By the end of the study, fasting cholesterol had fallen by an average of 1.35mmol/L in the Trizivir patients compared to 0.41mmol/L in the NNRTI arm of the study ((p<0.001). Triglycerides, however did not change significantly in either group.

The investigators conclude, “these data provide the first evidence that switching to Trizivir from NNRTI results in the maintenance of viraemia control and an improvement in total cholesterol. The induction of therapy with an NNRTI followed by a switch to Trizivir may provide a good long-term balance of efficacy and tolerability.”

Further information on this website

Cholesterol - factsheet

Switch to Trizivir after 6 months induction just as effective as multi-class therapy - news story

Avoid Zerit, Trizivir in first-line treatment, new UK guidelines recommend - news story

Major PI-sparing study closes Trizivir arm due to inferiority to efavirenz arms - news story

References

Katlama C et al. Comparison of metabolic abnormalities 48 weeks after switching from highly active antiretroviral therapy containing non-nucleoside reverse transcriptase inhibitor to Trizivir versus continued highly active antiretroviral therapy. AIDS 17: 1855 - 1856, 2003.

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