Treating HIV Lipodystrophy with Egrifta

FDA Approved Drug Shown to Reduce Accumulated Gut Fat by 15-18%

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Photo courtesy Theratechnologies

Classification

Egrifta (tesamorelin) is an injectable, synthetic form of growth-hormone-releasing hormone (GHRH) approved by the U.S. Food and Drug Administration (FDA) in November 2010 for the treatment of HIV-associated lipodystrophy.

About HIV-Associated Lipodystrophy

HIV-associated lipodystrophy is a condition characterized by the sometimes profound redistribution of body fat. The condition commonly presents with a distinct thinning of the face, buttocks, or extremities, while often causing fat to accumulate around the abdomen, breasts, or back of the neck (the latter of which is referred to as being "buffalo hump"-like in appearance).

HIV-associated lipodystrophy has often been linked of some types of antiretroviral medications, including protease inhibitors (PIs) and certain nucleoside reverse transcriptors (NRTIs) like Zerit (stavudine) and Videx (didanosine). The condition may also be a consequence of HIV infection itself, particularly affecting patients who have not yet begun antiretroviral therapy.

While lipodystrophy is seen far less in people with HIV since newer generation antiretrovirals were introduced, it remains a problem since the condition is rarely reversible once it occurs and even if the suspect medications are stopped.

Treatment Indication and Effects

Egrifta is indicated in HIV-infected patients specifically to reduce excess visceral fat (i.e., fat that accumulates in the abdominal cavity and around internal organs). It does not appear to have any impact on lipoatrophy (fat loss) of the face, buttock or limbs, or accumulating fat on either the breasts or back of the neck.

Egrifta works by stimulating the pituitary gland to release human growth hormone (HGH), the effect of which is known to promote lipolysis (i.e., the breakdown of lipids and triglycerides).

Studies have shown that Egrifta therapy can reduce abdominal fat by between 15% and 17% as measured by a CT scan.

Additional trials in 2014 have shown the Egrifta can also reduce accumulated fat around the liver by some 18%.

Dosage and Administration

The recommended adult dosage of Egrift is 2mg injected subcutaneously (beneath the skin) once daily. It is recommended that Egrifta be injected in the abdomen beneath the navel. Rotating injection sites often helps reduce the scarring and/or hardening of skin. 

Egrifta is reconstituted from one drug vial using sterile water, the latter of which is provided in a separate vial (pictured). Once reconstituted, the drug must be used immediately. Non-reconstituted Egrifta must be stored in the refrigerator between 36oF and 46oF (2oC and 8oC).

Egrifta is not indicated for weight loss management.  

Duration and Monitoring of Therapy

Since the long-term effects or potential benefits of therapy are not fully known, every effort should be made to monitor treatment effects by way of either CT scan or comparative waist circumference measurements. Should the patient not demonstrate clear reduction by these methods, then consideration should be given to stopping therapy.

The duration of therapy should always be made in direct consultation with an HIV/AIDS specialist experienced in GHRH therapy, or with consultation between an HIV/AIDS specialist and qualified endocrinologist.   

Glucose levels should also be monitored regularly during the course of therapy since Egrifta may cause glucose intolerance in some, putting the patient at increased risk for developing diabetes.

Common Side Effects (occurring in at least 2% patients)

  • Joint pain (arthralgia)
  • Pain in extremities
  • Muscle pain (myalgia)
  • Injection site redness, swelling or pain
  • Tingling sensation of the skin (paresthesia)
  • Partial numbness of the skin (hypoesthesia)
  • Rash
  • Flushing
  • Itching (pruritis)
  • Nausea
  • Vomiting

Drug Interactions

Egrifta has interactions with the following drugs, lowering the absorption/delivery of both itself and the accompany drug:

Contraindications and Considerations

Egrifta should never be given to anyone with an active malignancy, either newly diagnosed or recurring as HGH may influence neoplastic tissue (tumor) growth. Careful consideration should be made to patients with non-malignant tumors or those with a history of treated or stable malignancies, weighing the potential benefits against the potential risks.

Egrifta is contraindicated in patients who have had pituitary surgery, a pituitary tumor, hypopituitarism, head irradiation, or surgical removal of the pituitary gland (hypophysectomy).

Egrifta is also contraindicated in pregnant women with HIV as visceral tissue is meant to increase during pregnancies and any reduction by way of GHRH therapy may potentially harm the fetus. If pregnancy occurs, discontinue Egrifta therapy.

Egrifta is not indicated if the patient has a known hypersensitivity to tesamorelin or the diuretic Osmitrol (mannitol).

Careful consideration should also be made for those with diabetes as Egrifta can potentially increase insulin growth factor 1 (IGF-1) levels. Regular monitoring should be performed to identify the development or worsening of diabetic retinopathy (persistent or acute retina damage).

Sources:

U.S. Food and Drug Administration (FDA). "FDA approves Egrifta to treat Lipodystrophy in HIV patients." Silver Spring, Maryland; press release issued November 10, 2010.

Stanley, T.; Feldpausch, M.; Oh, J.; et al. "Effects of tesamorelin on hepatic fat in HIV patients: a randomized, placebo-controlled trial." Journal of the American Medical Association (JAMA).  July 23-30, 2014; 312(4):380-389.

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