Treatment with Aquamid (polyacrylamide hydrogel) to correct facial fat loss caused by anti-HIV drugs is safe and effective in the long term, American researchers report in the journal AIDS Research and Human Retroviruses. Very few side-effects were reported in over four years of follow-up and levels of patient satisfaction were extremely high.
Lipoatrophy (fat loss) from the face can be a distressing and stigmatising side-effect of some older anti-HIV drugs. It has been associated with a reluctance to start antiretroviral therapy, poor adherence and interrupting treatment. Furthermore, individuals developing this complication have reported psychological distress.
The use of the drugs most associated with fat loss (d4T and AZT) is now avoided. However, significant numbers of patients developed irreversible fat loss as a consequence of such treatment. For these individuals, corrective cosmetic treatment involving injections with synthetic substances has been shown to be a safe and generally effective short-term treatment.
Investigators from Chicago wished to determine the longer-term safety and efficacy of one such treatment, injections with Aquamid.
The single centre study involved 145 patients with facial fat loss who were treated with Aquamid injections between 2002 and 2004. These individuals received initial Aquamid treatment, the strength of which was adjusted according to the severity of their lipoatrophy. This therapy was repeated every three weeks until the treatment was considered successful.
Information was gathered on the duration of the patients’ HIV infection and antiretroviral therapy, the severity of their facial fat loss (mild, moderate, severe, or very severe), the incidence of side-effects, and the satisfaction of individuals with treatment (not satisfied, satisfied, very satisfied).
Most (83%) of the patients were men and the mean age was 47 years. The patients had been infected with HIV for a considerable time (mean 16 years) and the average duration of antiretroviral therapy was a little over nine years. Just under a third of patients were classified as having severe facial fat loss, with a similar proportion categorised as having moderate facial lipoatrophy.
During a mean of 50 months of follow-up after treatment, only one patient developed a severe adverse event. This was a local bacterial infection that was successfully treated with oral antibiotic therapy. There were no reports of Aquamid migrating from the injection site or of problems with facial movement.
However, 19% of patients reported developing small hidden nodules after treatment, and hardening of the skin occurred in 6%.
There was no association between the severity of the lipoatrophy and the development of infections or nodules. Nor did the number of treatments with Aquamid predict the development of these side-effects.
But the researchers did find an association between hardening of the skin and severity of lipoatrophy (p = 0.025) and the number of sets of injections (p = 0.006).
Levels of patients satisfaction were very high, with 89% stating that they were either 'satisfied' or 'very satisfied' with the outcome of their treatment four years after it was administered. Higher rates of satisfaction were reported by individuals whose fat loss was classified as mild or moderate before treatment. The investigators suggest this indicates that it is important to provide treatment for facial fat loss at the earliest opportunity.
Repeat injections were needed in 9% of patients and 17% of individuals reported mild fat loss after the completion of their therapy. Just over three-quarters of patients said that they would have liked to have had further treatment to improve the aesthetic results. This was despite the fact that there was no longer physical evidence of lipoatrophy.
“High patient satisfaction and the low grade of severe complications at a mean of 50 months after receiving facial [injections] with Aquamid reflect the long-term safety of permanent polyacrylamide hydrogel to revert antiretroviral-related facial lipoatrophy”, conclude the investigators. However they add, “continued and prolonged follow-up of these patients is recommended to treat complications and detect unexpected long-term adverse reactions.”