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Tesamorelin is an injectable medication marketed under the name EGRIFTA™ in the United States that is administered to reduce excess abdominal fat in HIV-positive people with lipodystrophy. Also known as TH907, it is a synthetic growth hormone–releasing factor (GHRF). A GHRF spurs the production of growth hormone in the body that helps control body shape, energy use, and metabolism. This injection was approved by the United States Food and Drug Administration (FDA) in November 2010 and became available in the U.S. in 2011. Tesamorelin is not indicated for use in children or as a weight loss drug.
The FDA approved tesamorelin as a lipodystrophy treatment for HIV-positive patients on 10 November 2010. HIV-associated lipodystrophy causes metabolic changes in the body that result in altered placement of body fat. As a result, patients with lipodystrophy typically accumulate excess fat around their abdominal organs like the stomach and liver while losing fat in the face, buttocks, and arms and legs.
There is evidence that suggests that lipodystrophy may be triggered by the HIV infection alone or by anti-retroviral medications patients take. The accumulation of excess fat alone is not harmful but can contribute to other health problems, such as pain, muscle strain, and difficulty breathing. Additionally, patients may fear that their changed physical appearance will alert others to their HIV status.
This medication is a synthetic GHRF. It stimulates the production of growth hormones by binding to receptors on anterior pituitary cells. These growth hormones affect metabolism and body shape. Tesamorelin targets fat accumulation in the abdominal area specifically. As this drug releases growth hormones, patients with active cancer should not take it.
The recommended dosage of tesamorelin is one daily 2-milligram subcutaneous injection. The medication is usually injected into the abdomen. The injection site should be rotated, avoiding scars, the navel, and bruises.
Prior to FDA approval, clinical studies were conducted on patients with HIV who had some fat accumulation and whose antiviral therapy was stable. Three studies of 816 patients showed that a daily treatment reduced abdominal fat after 26 weeks. Most patients experienced a reduction of approximately 18 percent. Abdominal fat began to accumulate again once the patients stopped treatment.
Tesamorelin has not shown evidence of drug interaction with any of the HIV antiretroviral drugs. Common side effects include mild joint aches and stiffness, mild swelling, and stiffness in the hands and feet. These problems usually abate with some gentle exercises that loosen the joints. Redness and tenderness at the injection site have also been observed but usually clear quickly. This medication has caused diabetic symptoms in some patients, and it is possible to develop antibodies that render tesamorelin less effective over time.
Patients should be forthcoming with their doctors about any medications, vitamins, and supplements they are taking prior to starting treatment. Diabetic patients will likely be monitored closely while taking this medication. Pregnant women or women who become pregnant while using tesamorelin should be informed of the drug’s potentially hazardous effects on unborn children.