Fifty people participated and all began the study with a marked and visible reduction in fat tissue in the cheeks (sunken cheeks) as measured by ultrasonography (using ultrasound technology to produce an image). At the time of the report, four people had received three injections, 29 had four injections and 17 had five. All volunteers had a dramatic improvement, with the majority regaining fat tissue in the cheeks. Some participants experienced a slight swelling at the injection site.
The manufacturer claims that New-Fill does not directly fill the spaces left empty by lipoatrophy. Rather, the product is claimed to build or grow a matrix under the skin which is then filled in by the body's own production of collagen.
New-Fill is not currently approved by the FDA and is not commonly available to physicians. For a time, the product was being imported from France for personal use, but in recent months the FDA blocked bulk importation of the product, arguing that the product should be classified as a "device" rather than a drug or natural supplement. The agency feels it is thus not subject to the personal importation rules for drugs. Still some people are successfully bringing back personal supplies of New-Fill from Tijuana, Mexico.
Discussions with the FDA are ongoing, looking for a way to make the product available to people in need while further studies are designed. A major problem is that the supplier is a small company that does not have the resources to conduct clinical trials. Some dermatologists offer products they claim are similar, and a few clinics near the Mexican border treat patients with New-Fill or similar products.
Facial lipoatrophy many not be physically harmful, but it can add a serious psychological burden for people with HIV infection. Although New-Fill has not been proven to be effective, neither has it shown any serious toxicity to date. Project Inform supports the right of people with HIV to have access to this and similar products.
After 24 weeks, there were no differences in anti-HIV activity among the three groups, with 49-59% of the participants experiencing viral load suppression to under 400 copies. However, there were major differences in triglyceride and cholesterol levels among them. People on the nelfinavir combinations saw their cholesterol levels substantially increase compared to those on abacavir who only had a slight increase. However, only people taking d4T/3TC/nelfinavir had substantial increases in triglyceride levels while the other two groups only had minor increases. Cholesterol and triglyceride increases have been associated with lipodystrophy in some people. The study had not yet run long enough to know whether any particular regimen was more likely to result in fat loss or redistribution.
Overall there were no major changes in laboratory markers for diabetes, including fasting glucose and fasting insulin levels. There was, however, a decrease in insulin sensitivity after 48 weeks, but not before. People experienced a progressive increase in markers of fat processing, triglyceride levels and cholesterol levels. The good news is that HDL (good) cholesterol increased as well as LDL (bad) cholesterol resulting in no change in the overall ratio of HDL/LDL. The ratio of HDL to LDL may be even more important than the actual levels.
Additionally, participants saw an increase in weight, trunk fat and limb fat resulting in an overall increase in total body fat. There was also a trend towards an increase in lean tissue. One interesting observation is that insulin resistance developed after weight gain. This can potentially help in better understanding how the lipodystrophy syndromes occur.
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