New-Fill: facial improvements sustained for two years

New-Fill^TM improves not only the appearance of individuals with severe facial atrophy, but is associated with an improvement in such individuals’ quality of life, according to a French study published in the November 21^st edition of AIDS. What's more, these improvements in both facial appearance and quality of life are sustained for two years. Commenting on these findings, an editorial accompanying the study, recommends the use of New-Fill^TM as “particularly attractive.”

Poly-L-lactic acid, more commonly known as New Fill has been used in cosmetic surgery since the mid 1990s. An earlier reported study found it to be effective at reducing the appearance of facial wasting in HAART-treated patients (see link below).

Investigators recruited 50 patients with severe facial atrophy to a single-arm, open-label study to assess the safety and effectiveness of New-Fill^TM. To be included in the study, individuals were required to have fat thickness of 2mm or less in the upper cheek (nasogenian) area as measured using ultrasound, and have taken HAART for at least three years with a viral load below 5,000 copies/mL in the three months immediately prior to entering the study.

Patients were given New-Fill^TM injections on four separate occasions over a six week period. If an individual had facial total cutaneous thickness of less than 8mm after the fourth set of injections, a fifth set was provided. After completing treatment, the success of poly-L-lactic acid treatment was assessed using clinical examinations, photographs, and ultrasounds at weeks six, 24, 48, 72, and 96. Quality of life was assessed using a questionnaire at weeks twelve, 24, 48, 72 and 96.

The study’s primary endpoint was the proportion of patients with facial total cutaneous thickness of 10mm or more at week 24. Secondary endpoints were changes in facial cutaneous thickness from baseline and quality of life at weeks six, twelve, 24, 48, 72, and 96, the proportion of patients responding, and the tolerability of treatment.

All the patients in the study had severe facial atrophy, with a median facial fat thickness of zero, and median facial cutaneous thickness of 2.9mm. The study members had received extensive anti-HIV treatment, with the median duration of antiretroviral therapy being over eight and a half years.

At week six, after the fourth set of injections was administered, 19% of patients had total cutaneous thickness of 10mm or more, this increased to 41% by week 24 (the study’s primary endpoint), 61% by week 48, before falling to 52% at week 72 and 43% at week 96. The increase in total cutaneous thickness was highly significant (p

Ultrasound evauluations were performed on all patients at each endpoint except for two patients at week six, one patient at week 24, one at week 48, and two individuals at week 72. At week 96, three patients were not evaluated and five individuals did not reach this endpoint.

At week 24 the median increase in total cutaneous thickness from baseline was 6.4mm, reaching a peak of 7.2mm at weeks 48 and 72, before falling to 6.8mm at week 96, however this decline was not statisitically significant.

Overall, 26 patients were provided with four sets of injections, 20 with five, and four individuals needed only three sets.

Investigators also noted that patients’ quality of life improved progressively between baseline and week 48.

No serious side-effects were reported and CD4 and viral load remained stable. During the course of the study, 13 switched from d4T, which has been associated with lipoatrophy in some studies, to treatment with another nucleoside analogue. The investigators did not, however, believe that stopping d4T treatment was the cause of the rapid improvement in facial fat loss since joining the study.

The investigators conclude that their results are “clinically relevant”, as “aesthetic improvement was clearly observed, accompanied by a significant increase in patient quality of life”.

These conclusions and the fact that treatment with poly-L-lactic acid is simple leads the author of an editorial in the same edition of AIDS to describe New-Fill^TM as a “particularly attractive” treatment for facial wasting. However, the editorial stresses that treatment should only be provided by skilled practitioners. The author also says that efforts must continue to design knowledge-based preventative strategies, as well as to understand the causes of lipodystrophy. In addition, new antiviral drugs are needed which do not cause fat loss as well as specific drugs to reverse lipoatrophy.

The December/January edition of AIDS Treatment Update will focus on New Fill^TM as a treatment for lipoatrophy in the face.

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New Fill injections improve facial appearance, reduce anxiety, within 3 months - news story