In North America and Europe, approximately 285,000 HIV patients treated with ART are affected by excess visceral fat, an important aspect of HIV-associated lipodystrophy. There is currently no approved treatment for this condition.

Products

HIV-associated lipodystrophy

Status:

  • Completed Phase 3 clinical studies
  • New Drug Application for tesamorelin filed with the U.S. Food and Drug Administration

The Syndrome
Caused by various factors, including antiretroviral therapies and the virus itself, HIV-associated lipodystrophy is characterized by body composition changes and associated metabolic abnormalities, including elevated cholesterol/lipid levels, diabetes, high blood pressure and insulin resistance. 

The body composition changes include two independent conditions:

  • Excess fat accumulation, where deep abdominal fat (visceral adipose tissue or VAT)surrounds the internal organs – lipohypertrophy
  • Fat loss where subcutaneous fat loss typically occurs in the face, limbs and buttocks – lipoatrophy

HIV-associated lipodystrophy was first diagnosed in 1998. At this time, it was thought that both fat accumulation and fat loss were caused by the same mechanism and that the fat lost from the face and limbs was redistributed to the abdomen and other areas.  However, recent data suggest that fat accumulation and fat loss are caused by distinct mechanisms.

The Product

Tesamorelin is a stabilized analogue of the growth hormone-releasing factor (GRF) that induces growth hormone (GH) in a specific and physiological manner.

To date, our studies suggest that tesamorelin has several beneficial features: it reduces VAT, without reducing subcutaneous fat and without compromising glycemic control (blood glucose), it increases muscle mass and improves the lipid profile. These characteristics make it an ideal candidate for the treatment of excess VAT, an important aspect of HIV-associated lipodystrophy.

The Market
In 2008, it was estimated that among the 2 million HIV-infected patients in North America and Europe, approximately 285,000 suffer from HIV-associated lipodystrophy.

Based on proprietary market research with payors, patients and physicians, Theratechnologies estimates that by 2012 approximately 380,000 patients treated with antiretrovirals will have HIV-associated lipodystrophy in North America and Europe and that the potential total market size for this condition will be between US$811 million to US $1.3 billion.

There is currently no approved treatment for patients with HIV-associated lipodystrophy.

The Strategy
Since tesamorelin seems to have the potential to treat several conditions, Theratechnologies chose to conduct its first Phase 3 clinical studies in HIV-associated lipodystrophy for the following reasons:

  • Unmet medical need
  • Clinical advantage (tesamorelin can be administered to both pre-diabetic and diabetic patients – respectively 35% and 7% of the targeted patient population)
  • Manageable program
  • Regulatory path fairly straightforward
  • Accessible market with a relatively small number of HIV specialists treat these patients


 

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