Approved this week by the US Food and Drug Administration, Egrifta (tesamorelin) reduces abdominal fat as measured by CT scan.
Lipodystrophy is “a condition in which excess fat develops in different areas of the body, most notably around the liver, stomach, and other abdominal organs” the FDA said in a press release yesterday.
“The condition is associated with many antiretroviral drugs used to treat HIV.”
The Treatment Action Campaign explains that lipodystrophy can lead to fat gain around the stomach, breasts or shoulders and fat loss from the face, arms, legs and buttocks.
TAC says that it usually, but not always, develops slowly over months or years – and can “occur rarely in HIV positive people who are not on treatment”.
This visible side effect can impact on people’s self image and qualify of life.
Lipodystrophy is linked to stavudine, or d4T, which was first line therapy in South Africa until 1 April 1 2010 when updated clinical management guidelines were released.
“The updated guidelines will begin to phase out the use of stavudine (d4T) and start replacing it with tenofovir (TDF)… all patients experiencing side effects on d4T or zidovudine (AZT) will be switched to TDF,” the SA National AIDS Council announced at the time.
The FDA explained that Egrifta is a growth hormone releasing factor (GRF) drug that is administered in a once-daily injection.
Dr Curtis Rosebraugh from the FDA’s Center for Drug Evaluation and Research said: “The presence of excess fat with this condition may contribute to other health problems as well as affect a patient’s quality of life, so treatments that demonstrate they are safe and effective at treating these symptoms are important.”
The FDA reported that: “Egrifta was evaluated in two clinical trials involving 816 HIV-infected adult men and women with lipodystrophy and excess abdominal fat.
“Of these, 543 patients received Egrifta during a 26-week, placebo-controlled period. In both studies, patients treated with Egrifta experienced greater reductions in abdominal fat as measured by CT scan, compared with patients receiving another injectable solution (placebo). Some patients reported improvements in their self image.
“The most commonly reported side effects in the studies included joint pain (arthralgia), skin redness and rash at the injection site (erythema and pruritis), stomach pain, swelling, and muscle pain (myalgia). Worsening blood sugar control occurred more often in patients treated with Egrifta than with placebo.
“Whether Egrifta decreases the risk of cardiovascular disease or improves compliance with antiretroviral drugs has not been studied.”