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Metrics details. Facial lipoatrophy is a frequently reported condition associated with use of antiretroviral ARV drugs. A longitudinal study was conducted between and in France. The average age of patients The final visit, scheduled two months after the last injection session, was attended by The overall incidence of AEs per course was Immediate AEs, bleeding 3.
Non-immediate AEs, mainly nodules 5. Non-immediate AEs occurred within a time ranging from 21 days inflammation to days granuloma and all but three of the 13 cases of granuloma resolved. This study demonstrated, in real-life conditions and on a large sample, that PLLA injections were feasible, efficient, and safe when performed by trained physicians. Peer Review reports. Lipodystrophy syndrome is a cluster of long term side effects associated with antiretroviral ARV therapy used for human immunodeficiency virus HIV infection [ 1 ].
Morphological changes are commonly accompanied by metabolic disorders hyperlipidaemia, insulin resistance and hyperglycaemia. Approximately half of all patients treated for HIV in France are affected with lipoatrophy [ 2 ] and choice of treatment for these individuals is largely complicated by this condition [ 3 ]. The prevalence of facial lipoatrophy is high. For these reasons, correction of facial lipoatrophy is an integral part of the management of HIV positive patients who present with this problem [ 7 ].
To date there is no curative medical treatment for facial lipoatrophy; therapeutic options are limited to cosmetic surgery using autologous adipose tissue, or injections of fillers that may be permanent or absorbable to plump sunken cheeks [ 8 ]. Despite this apparently widespread usage, to the best of our knowledge, no study has evaluated the safety of this treatment in real-life conditions in a large number of people with HIV affected by facial lipoatrophy.
Therefore, the aim of this study was to establish the safety, efficacy, and conditions for use of PLLA in that population. The ancillary study of this cohort evaluating Health Related Quality of Life HRQoL in of the 4, patients included in the current study, was published elsewhere [ 10 ]: and the data showed that This was an observational, longitudinal, multicentre, open label study conducted in France from 25 February to 28 February While the primary objective was to describe the safety of Poly-L-lactic acid for treatment of facial lipoatrophy in the context of HIV, the efficacy of the treatment, the description of its use in real life and the adequacy of prescription compared with the recommendations of the French Commission for the Evaluation of Products and Services EPSA [ 11 ] were secondary objectives.