Tesamorelin (Egrifta), an analogue of growth hormone-releasing factor, has been approved by the U.S. Food and Drug Administration for treatment of abdominal lipohypertrophy in HIV-infected adults. It is available on most formularies.
Two randomized placebo-controlled Phase III studies provided the primary data supporting tesamorelin approval. All study subjects had abdominal lipohypertrophy and were on stable ART with virologic suppression. At 26 weeks, visceral adipose tissue (VAT) had decreased by a means of about 15% in groups treated with tesamorelin and did not change in placebo groups. At 48 weeks, for subjects continuing on an extension phase of the studies, VAT remained stable or decreased modestly in tesamorelin recipients. In patients who switched from tesamorelin to placebo, however, VAT reaccumulated to patients' pretreatment baselines. Tesamorelin also was associated with modest reductions in waist circumference, patient-reported body image measures, and lipid parameters. It had no effect on subcutaneous adipose tissue (SAT) or weight.
Tesamorelin must be administered by subcutaneous injection; recommended dosage is 2 mg daily. Possible adverse effects include injection site reactions, edema, myalgias and arthralgias, hyperglycemia, and diabetes. Tesamorelin is contraindicated in some patients, including pregnant women (it is an FDA Pregnancy Category X drug) and those with a malignancy. Tesamorelin appears to have no significant effect on ritonavir AUC or Cmax, but there are few studies on interactions with ARVs or other drugs.