TreatmentUpdate
182

2011 January 

Tesamorelin helps reduce belly fat

In this study, HIV-positive participants on stable ART were randomly assigned in a 2 to 1 ratio to receive either tesamorelin (2 mg injected daily) or placebo. In total, 211 participants completed 26 weeks on tesamorelin and 115 others on placebo.

At the time they entered the study, the approximate profile of participants was as follows:

  • 13% females, 87% males
  • most were over their ideal body weight with a body mass index (BMI) of 29
  • 68% of participants had a viral load less than 50 copies/ml
  • CD4+ count – 600 cells

Results

After 26 weeks, participants who received tesamorelin had 15% less visceral fat compared to an increase of 5% visceral fat in participants who received placebo. This difference was statistically significant; that is, not likely due to chance alone.

Researchers also assessed some blood proteins that are suggestive of inflammation. Levels of these proteins fell among participants who received tesamorelin. This suggests that reducing visceral fat likely also reduces inflammation.

Long-term concerns

An important point that needs to be made about this drug is that while it is generally effective, the benefits from its use disappeared within a few months after participants stopped taking it. This might mean that tesamorelin has to be taken for very long periods of time. It is not clear if potential patients are prepared to regularly inject themselves every day with this drug for years.

Theratechnologies, the developer of this drug, has collected health information from volunteers in placebo-controlled and observational studies. Most data collected has been from people who used the drug for between six and 12 months. If tesamorelin is going to be used for longer periods, as seems likely, then long-term monitoring will be essential so that doctors and patients can be certain about its safety.

Another concern is about the cost, which at press time is not yet available. The cost of tesamorelin will be a major factor affecting whether provincial, territorial and other government formularies are prepared to pay for it.

REFERENCE:

Falutz J. Tesamorelin, a growth hormone releasing-factor analogue improves inflammatory markers in HIV-infected patients with excess abdominal fat: relationships between changes in inflammatory markers and visceral adipose tissue (VAT). In: Program and abstracts of the 12th International Workshop on Adverse Drug Reactions and Comorbidities in HIV, 4-6 November 2010, London, UK. Abstract 006.