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Raltegravir vs. Efavirenz: Focus on Lipodystrophy, Lipids and Other Changes

June 30, 2010

Abnormal levels of lipids -- cholesterol and triglycerides -- and blood sugar as well as unwelcome changes to body shape have occurred in some clinical trials, particularly trials of older anti-HIV drugs. To find out if raltegravir (Isentress) is associated with similar problems, researchers conducted a metabolic study comparing raltegravir-based regimens to ones based on efavirenz (Sustiva and in Atripla). After two years, they found that raltegravir was associated with minimal changes in levels of fats and sugar in the blood. Furthermore, no changes in body shape were detected with either study regimen.


Study Details

A large randomized, placebo-controlled trial called Startmrk enrolled nearly 600 participants and randomly assigned them to receive regimens based on either raltegravir or efavirenz. All participants in this study received a combination of two other anti-HIV drugs as follows:

  • tenofovir (Viread)
  • FTC (emtricitabine, Emtriva)

A fixed-dose combination of these two drugs is sold as Truvada.

Researchers conducted a metabolic sub-study of Startmrk with participants who received low-dose X-ray scans called DEXA. These are useful when objectively trying to assess changes in the body's composition of bone, muscle, fat and so on. Particular attention was paid to lipid levels in the blood of participants. In the metabolic sub-study, 55 people received raltegravir and 57 received efavirenz. All participants were from North America.

The profile of these participants at the start of the study was as follows:

  • 20% females, 80% males
  • age: 40 years
  • CD4+ count: 152 cells
  • viral load: 100,000 copies
  • 16% had a history of AIDS


Results

After two years, on average there were relatively small increases in lipid levels in the blood of raltegravir users. Triglyceride levels even fell during the study.

In contrast, lipid levels rose to a larger degree among efavirenz users. Indeed, the difference in lipid levels between raltegravir and efavirenz users after two years was statistically significant for the following lipids:

  • total cholesterol
  • good cholesterol (HDL-C)
  • bad cholesterol (LDL-C)
  • triglycerides

Blood sugar levels rose slightly among raltegravir users but increased blood sugar levels were more common among efavirenz users. This difference was also statistically significant.

For the most part, increased lipid levels exceeded critical threshold levels only in the cases of LDL-C and triglycerides among some efavirenz users.

Changes in body fat were small and not significantly different between the two treatments.

Overall, the results from this metabolic sub-study suggest that after two years of treatment, raltegravir, when used with Truvada, had a minimal impact on lipid and sugar levels in the blood as well as on body shape.


Reference

  1. DeJesus E, Cohen C, Lennox J, et al. Metabolic profiles and body composition changes in treatment-naive HIV-infected patients treated with raltegravir 400 mg twice-daily vs. efavirenz 600 mg each bedtime combination therapy: 96-week follow-up. In: Program and abstracts of the 17th Conference on Retroviruses and Opportunistic Infections, 16-19 February 2010, San Francisco, U.S. Abstract 720.



This article was provided by Canadian AIDS Treatment Information Exchange. It is a part of the publication TreatmentUpdate. Visit CATIE's Web site to find out more about their activities, publications and services.
 

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